Protocol
Geriatric assessment and management
with question prompt list using a webbased application for elderly patients with
cancer (MAPLE) to communicate ageingrelated concerns: J-SUPPORT 2101 study
protocol for a multicentre, parallel group,
randomised controlled trial
Ayumu Matsuoka,1 Maiko Fujimori
,1 Boku Narikazu,2 Atsuo Takashima,3
4
5
Takuji Okusaka, Keita Mori, Tatsuo Akechi,6 Taichi Shimazu
,7 Ayumi Okizaki,1
Tempei Miyaji,8 Yoshiyuki Majima,9 Fumio Nagashima,10 Yosuke Uchitomi1
To cite: Matsuoka A,
Fujimori M, Narikazu B, et al.
Geriatric assessment and
management with question
prompt list using a webbased application for elderly
patients with cancer (MAPLE)
to communicate ageing-related
concerns: J-SUPPORT 2101
study protocol for a multicentre,
parallel group, randomised
controlled trial. BMJ Open
2022;12:e063445. doi:10.1136/
bmjopen-2022-063445
► Prepublication history and
additional supplemental material
for this paper are available
online. To view these files,
please visit the journal online
(http://dx.doi.org/10.1136/
bmjopen-2022-063445).
Received 31 March 2022
Accepted 25 August 2022
© Author(s) (or their
employer(s)) 2022. Re-use
permitted under CC BY-NC. No
commercial re-use. See rights
and permissions. Published by
BMJ.
For numbered affiliations see
end of article.
Correspondence to
Dr Maiko Fujimori;
mfujimor@ncc.go.jp
ABSTRACT
Introduction Elderly cancer patients often have ageingrelated physical and psychosocial problems that should be
fully shared with their oncologists. Geriatric assessment
(GA) can assess these ageing-related problems and
guide management. Communication support might also
facilitate implementation of GA-guided management. We
will conduct a multicentre, randomised controlled trial
to examine the efficacy of a programme that combines
a GA summary, management recommendations and
communication support to facilitate ageing-related
communications between elderly Japanese patients
with cancer and their oncologists, and thus to implement
programme-guided management.
Methods and analysis We plan to recruit a total of
210 patients aged ≥70 years, diagnosed with incurable
cancers of gastrointestinal origin, and referred for firstline or second-line chemotherapy. In the intervention
arm, a summary of management recommendations
based on a GA and question prompt list (QPL) will be
provided to patients and shared with their oncologists at
the first outpatient visit after randomisation by trained
intervention providers. For 5 months after the initial
intervention, implementation of GA-guided management
recommendations will be reviewed monthly with the
patients and their oncologists to implement management
as needed. The GA and QPL will be re-evaluated at
3 months, with a summary provided to patients and their
oncologists. Those participants allocated to the usual care
arm will receive usual oncology care. The primary endpoint
is the number of conversations about ageing-related
concerns at the first outpatient visit after randomisation.
Ethics and dissemination This study was approved by
the institutional review board of the National Cancer Center
Japan on 15 April 2021 (ID: 2020–592). Study findings
will be disseminated through peer-reviewed journals and
conference presentations.
Trial registration number UMIN000045428.
STRENGTHS AND LIMITATIONS OF THIS STUDY
⇒ This is the protocol paper of a multicentrer, ran-
⇒
⇒
⇒
⇒
domised controlled trial to examine the efficacy of
a programme that combines a geriatric assessment
(GA), GA-guided management and communication
support using a question prompt list (QPL) for elderly
Japanese patients with cancer.
With the aim of facilitating future implementation,
this study will use a self-reported GA and QPL administered via a web-based application to generate
a GA summary, tailored recommendations and patients’ selected questions.
Due to the nature of the intervention, both patients
and their oncologists would be aware of the allocated arm, which could potentially influence care
during treatment.
The intervention programme is complex, consisting
of a multifactorial component (GA summary, management recommendations and communication
support using QPL), making it difficult to determine
each component’s contribution to the outcomes.
Because this study is limited to patients with gastrointestinal cancers, its generalisability to other
cancers will not be clarified.
INTRODUCTION
Many cancers are ageing-related diseases.1
Japan is a front runner of the super-aged societies, which is defined as greater than 21% of
a population aged ≥65 years,2 and its number
of elderly patients with cancer is increasing.
In Japan, more than 70% of cancer incidences and 80% of cancer mortality occur in
patients aged ≥65 years.3 4 However, elderly
patients are often excluded from clinical
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Open access
trials and they face difficulty due to lack of evidence for
treatment decisions.5 Elderly patients with cancer are
physically, psychologically and socially heterogeneous;
they differ from their younger counterparts in terms of
physical function, psychological well-being, life circumstances and values and preferences.6 Therefore, the treatment and care of elderly patients with cancer are complex
and should be individualised. Subjective assessment by
oncologists based on performance status and chronological age is inadequate to cope with these heterogeneous
conditions, which can lead to overtreatment or undertreatment. The concept of geriatrics, which evaluates
elderly patients in a multifaceted and comprehensive
manner, is necessary in oncology.
Comprehensive geriatric assessment (CGA) is a multidimensional, interdisciplinary diagnostic process that
focuses on determining the medical, psychosocial and
functional capabilities of elderly adults in order to
develop a coordinated and integrated plan for treatment
and long-term follow-up.7 In geriatrics, CGA has been
shown to reduce mortality, decrease institutionalisation
and readmission, and improve cognitive and physical
functioning, mainly through interventions by a multidisciplinary team.8 9 The term ‘geriatric assessment’ (GA) is
commonly used in oncology instead of CGA because CGA
research in oncology has studied mainly the diagnostic
process for selecting appropriate treatment through
assessment of ageing-related problems without a thorough
focus on geriatric interventions for these problems.10
Recently published randomised controlled trials (RCTs)
in the USA have demonstrated that feedback in the form
of a GA summary and GA-guided management recommendations to patients and their oncologists facilitates
communication about ageing-related concerns (COACH
study),11 and reduces incidences of serious adverse events
related to chemotherapy (GAP70+ study).12
Patient-centred communication is important to help
patients prioritise their concerns, ensuring that decisions
are in line with their values and preferences. Although
studies have shown benefits of communication interventions to facilitate patient-centred communication,13 14
these interventions were not tailored to address ageingrelated concerns of elderly patients with cancer. In fact,
many elderly patients with cancer have ageing-related
symptoms that are not identified, communicated or
addressed in daily oncology practice.15 Communication
interventions might help elderly patients with cancer and
their oncologists share and manage ageing-related problems by recognising these conditions that are often overlooked in daily oncology practice.
Elderly patients with cancer in Japan are less likely to
communicate their values and preferences regarding
treatment to their physicians; therefore, they need
support to express their intentions and preferences based
on their values.16 A question prompt list (QPL) is a list of
specific questions that helps patients express their intentions by facilitating communication with their healthcare
providers and encouraging them to ask their healthcare
2
providers questions.17 A systematic review has shown that
use of a QPL increases the number of questions that
patients ask their physicians.18 We previously conducted
an RCT on the usefulness of QPL in Japanese patients
with advanced cancer undergoing initial anticancer
therapy and found that patients perceived the materials,
including the QPL, to be useful for understanding their
treatment plans.19
Although our study is based on the COACH study,
we hypothesise that feedback in the form of only a GA
summary and GA-guided management recommendations to patients and their oncologists would be insufficient for elderly patients with cancer in Japan to express
their ageing-related concerns. We further hypothesise
that they would need communication support to express
their concerns about problems identified by GA as well
as their interest in GA-guided management recommendations. Therefore, this study will examine the
efficacy of a programme that combines a GA summary,
GA-guided management recommendations as provided
by a multidisciplinary team and communication support
using QPL, with the aims of facilitating communications between elderly patients with cancer and their
oncologists. The rationale for combining these two
interventions is that, after GA identifies ageing-related
concerns not captured in routine oncology practice,
with communication support using QPL, patients will
be able to express their ageing related-concerns to
their oncologists, which will facilitate patient-centred
communication, thereby leading to higher implementation of GA-guided management and improved patient
outcomes (figure 1).
METHODS AND ANALYSIS
This protocol was written in accordance with Standard
Protocol Items: Recommendations for Interventional
Trials (SPIRIT) and SPIRIT PRO Extension Guidelines.20 21
Study design
This study is a single-blind (outcome assessor blind),
parallel-group RCT conducted at the National Cancer
Center Hospital and Kyorin University Hospital. The
study period is from April 2021 to March 2026; the registration period is from September 2021 to March 2024.
Screening
Trained study staff will review a list of potentially eligible
patients (table 1) and approach patients consecutively
with permission from their oncologists.
All elderly patients with cancer who meet inclusion
criteria (1) through (7) will be registered and screened
for GA. Patients having any GA impairment other than
polypharmacy will be randomly assigned to either the
intervention arm or the usual care arm (figure 2).
Matsuoka A, et al. BMJ Open 2022;12:e063445. doi:10.1136/bmjopen-2022-063445
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Figure 1 Conceptual model of this study. In our conceptual model, GA will identify ageing-related concerns not captured in
routine oncology practice. Then, with communication support using QPL, patients will be able to express their ageing-related
concerns to their oncologists, which will facilitate patient-centred communication, thereby leading to higher implementation of
GA-guided management and improved patient health outcomes. GA, geriatric assessment; QOL, quality of life; QPL, question
prompt list.
Geriatric assessment
All participants will undergo a GA that evaluates eight
domains (falls, functional status, psychological status,
nutrition, social support, cognition, polypharmacy and
comorbidity) using electronic patient-reported measures
at baseline (table 2).
These selected assessment tools are based on the
American Society of Clinical Oncology guidelines, Japan
Clinical Oncology Group geriatric research policy and
previous clinical trials.12 15 22–25 Once these GA measures
are entered via a web-based application that was developed in a previous study26 and customised for the present
study, a GA summary and management recommendations tailored to each patient will be generated as a PDF.
This summary will contain information on GA impairments and GA-guided management recommendations
based on literature reviews, guidelines, previous clinical
trials and expert consensus12 15 22–25 27 (table 3). All assessments, other than cognitive and comorbidity measures
performed by the study staff, will be self-administered on
a touchscreen tablet. The study staff will assist patients
who cannot independently complete the assessment.
Randomisation
Participants will be randomly allocated (1:1) to an intervention arm or a usual care arm (figure 2). Computergenerated random allocation sequences will be provided
and centrally controlled by an independent data centre.
A stratified block-randomisation method will be used
to ensure balanced allocation by study site, cancer type
(oesophageal, gastric, colorectal, hepatic, biliary tract or
pancreatic) and line of treatment (first or second). Allocation results will be sent electronically to the study staff
at each institution. Participants and their oncologists will
remain unblinded due to the nature of the interventions.
Intervention
GA summary and management recommendations
In the intervention arm, a GA summary and management
recommendations will be presented to the patients and
Table 1 Inclusion and exclusion criteria for patients and oncologists
Participant
Inclusion criteria
Exclusion criteria
Patient
1. Diagnosis of oesophageal, gastric, colorectal, hepatic, biliary
tract or pancreatic cancer
2. Incurable disease (locally advanced stage III, IV or recurrent)
3. Age ≥70 years
4. ECOG Performance Status score of 0–2
5. Scheduled to receive first-line or second-line chemotherapy
6. Able to read, write and understand Japanese
7. Provide written informed consent for trial participation
8. Have at least one impairment of GA domains other than
polypharmacy at the time of registration
1. Currently in clinical practice at participating institutions
2. Oncologists that care for patients with oesophageal, gastric,
colorectal, hepatic, biliary tract or pancreatic cancer
3. Not planning to leave the practice during the next 6 months
1. Scheduled to undergo surgery within
3 months
2. Participating or planning to participate
in other interventional studies for which
intervention by this study would be
undesirable (eg, other psychological or
communication support studies, clinical
trials, etc)
3. Judged to have difficulty participating in
the study by attending oncologists
1. Non-physicians and physicians who are
not oncologists
Oncologist
ECOG, Eastern Cooperative Oncology Group; GA, geriatric assessment.
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Figure 2 Flow diagram. CARE-10, Consultation and Relational Empathy measure-10; CTCAE, Common Terminology
Criteria for Adverse Events; EORTC-QLQ-C-30; European Organization for Research and Treatment of Cancer Quality of Life
Questionnaire Core 30-item version; ePRO, electronic-patient reported outcomes; GA, geriatric assessment; IADL, Instrumental
Activities of Daily Living; PRO-CTCAE, Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse
Events; QOL, quality of life; QPL, question prompt list; RIAS, Roter interaction analysis system; SHARE, setting, how to deliver
bad news, additional information, reassurance and emotional support; TiOS, Trust in Oncologists Scale.
their oncologists at the first outpatient visit after randomisation (figure 2). An intervention provider will explain the
GA summary to the patient and then discuss the patient’s
perceptions of the GA impairments, need for recommended management, resources available at each institution and other specific issues. An intervention provider
will prepare a feedback sheet based on information
Table 2 GA tools
GA domain
Assessment tools
Cut-off points
Falls
Functional
status
History of falls in the past
6 months
The IADL subscale of
the Multidimensional
Functional Assessment
Questionnaire; OARS30
Any history of
falls
Any IADL
deficit
Psychological
status
Patient Health
Questionnaire-947
≥5 points
Nutrition
Mini Nutritional
Assessment48 49
≤11 points
Social support
Living status and
assistance
Living alone
and/or without
any assistance
Cognition
Mini-Cog50
≤2 points
Polypharmacy
Number of medications
Comorbidity
Charlson Comorbidity
Index51
≥5 regularly
scheduled
prescriptions
≥3 points
GA, geriatric assessment; IADL, Instrumental Activities of Daily
Living; OARS, Older American Resources and Services.
4
obtained from the patients, including ageing-related
concerns and their interest in the recommendations, to
reduce oncologists’ burden. An intervention provider will
present QPL on ageing-related concerns as needed, and
the patients can select ageing-related questions from QPL
to ask their oncologists. Oncologists will have autonomy
to incorporate into their practice whatever recommendations are deemed necessary. The multidisciplinary team
at each institution will implement management recommendations with referrals from an oncologist based on
clinical judgement. An intervention provider may help
implement management recommendations with an
oncologist’s approval.
For 5 months after the initial intervention, an intervention provider will review and discuss implementation
of GA-guided management recommendations monthly
with the patients and their oncologists to implement
management as needed. Three months after the initial
intervention, the GA will undergo reevaluation, and
an intervention provider will provide a GA summary,
management recommendations and a feedback sheet
to the patients and their oncologists so that GA-guided
recommendations can be modified and implemented as
needed.
Oncologists will receive a 20-minute lecture on how
to most effectively use GA information in their clinical
practice for elderly patients with cancer. An in-person
group lecture will be provided and include an overview
of the usefulness of GA and GA-guided management in
oncology.
Communication support using QPL
In this study, a QPL that was developed based on our
previous studies19 28 29 to support shared decision-making
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Table 3 GA-guided management recommendations
GA impairments
Recommendations
Any history of falls
Any IADL deficit
1.Referral to physical therapy and/or occupational therapy
1–1. Strength and balance training; introduce home exercise programme
1–2. Assist according to IADL disability
1–3. Provide support according to falling risk
2.Referral to medical social workers and/or nurses
2–1. Provide support according to IADL disability
2–2. Evaluate home safety, adjust environmental factors (fall prevention) and use
nursing care services
3.Review falling risk due to polypharmacy and adjust medications as needed (referral
to pharmacist)
1.Referral to a psychologist and/or psychiatrist
1–1. Cognitive-behavioural therapy and pharmacotherapy
2.Referral to medical social workers and/or nurses
2–1. Referral to hospital-based psychological support services
2–2. Referral to local social activities (eg, community comprehensive support centre)
Patient Health Questionnaire-9 ≥5
Mini Nutritional Assessment ≦11
1.Referral to a dietician
1–1. Assess nutritional status and provide nutritional guidance
1–2. Provide information materials and brochures
1–3. Provide information on nutritional supplements and prescribe nutritional
supplements
2. Referral to social workers as needed (assistance with shopping and meal
preparation)
Living alone and/or without any
assistance
1.Referral to medical social workers and/or nurses
1–1. Apply for long-term care insurance and referral to community comprehensive
support centre
1–2. Referral to transportation services, home care/nursing care and support group
1–3. Identify and establish key persons in case of anyone’s absence
Mini-Cog ≦2
1. Referral to a cognitive specialist or memory clinic (psychiatrist or neurologist)
1–1. Evaluate decision-making ability and capacity to consent as needed
1–2. Counsel on risk of delirium and reduce medications at risk of delirium
2. Encourage family/caregivers to participate in consultation and treatment decisions
3. Reduce the number of medications or adjust dosage and administration (referral to
a pharmacist)
1.Referral to a pharmacist
1–1. Reduce the number of medications or adjust dosage and/or administration
1–2. Discontinue PIMs
2.Consult with nurses and/or a pharmacist to confirm adherence
2–1. Determine patient’s understanding of medication, missed doses and patient’s
ability to manage medications and decipher text on a medication bag
3. Involve family and caregiver in treatment decisions and management of
comorbidities
4. Review prescriptions and management of comorbidities by family physicians,
geriatricians and other specialists
≧5 medications
Charlson Comorbidity Index ≧3
GA, geriatric assessment; IADL, Instrumental Activities of Daily Living; PIMs, potentially inappropriate medications.
for treatment of elderly patients with cancer will be used
to facilitate communications with attending oncologists.
The QPL consists of 75 questions categorised into 8
topics and a free-writing section for other ageing-related
questions based on the opinions of elderly patients with
cancer, oncologists and geriatricians (table 4).
Patient communication coaching using the QPL consists
of three parts: (1) reading a list and selecting questions
that the patient prefers to discuss with their oncologists
and prioritising selected questions via a web-based application; (2) discussing the reasons for and background
Matsuoka A, et al. BMJ Open 2022;12:e063445. doi:10.1136/bmjopen-2022-063445
behind selecting the questions and identifying difficult
questions to ask and (3) practicing asking their oncologists these questions. Patients are given a 14-page A4
size QPL brochure for reference after the intervention.
An intervention provider will prepare a feedback sheet,
including a list of selected questions rephrased in the
patients’ own words, if necessary, for patients to present
to their oncologists before the first outpatient visit after
randomisation (figure 2).
Three months after the initial intervention, an intervention provider will provide communication support
5
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Open access
Table 4 Domains of QPL and sample questions
Domains
Sample questions
1. Diagnosis and disease
► May I ask again what the diagnosis is ?
stage
2. Current and future treatment ► Do comorbidities affect treatment or are they made worse by treatment?
► What treatment options do other patients in my situation have?
3. Management of current and ► Why do the symptoms I am experiencing now occur? How long will they last?
possible future symptoms
► What are the symptoms or side effects of treatment that may occur in the future?
4. Daily life activities
► Can I discuss long-term care insurance?
► I am concerned about meal preparation and shopping. Are there any services available in
►
►
►
►
my community?
Do I need to reduce the number of medications I usually take ?
Can I discuss my lack of appetite, difficulty eating and weight loss?
I am concerned about future visits to the hospital. Can I discuss transportation service?
I want to exercise to keep my fitness level up. Can you introduce me to an exercise
programme that I can do at home?
5. Care and expected
prognosis after standard
treatment
► Can I discuss home care and long-term care for the future?
► Can I ask what my future prospects might be?
6. Needs of caregivers
► Can someone listen to my family’s concerns and worries?
7. Psychological distress and
management
► Can I discuss my concerns and worries?
► I am having trouble enjoying or maintaining interest in things I used to enjoy. Can I discuss
8. Values
this with someone?
► Can I tell you what is important to me in choosing treatment and what I really want to
prioritise or continue in my life?
QPL, question prompt list.
using QPL and a feedback sheet for patients to present to
their oncologists along with their GA results.
Intervention providers will be clinical psychologists,
nurses, physicians or hospital staff who have participated
in intensive training using an intervention manual. They
will hold weekly meetings to review all intervention
sessions with supervision by the primary investigator to
maintain quality. Intervention providers do not need to
have prior experience or training for patient-centred
communication. Through our training programme and
periodic feedback, even lay hospital staff with little clinical experience will be able to provide the intervention
with fidelity.
In the usual care arm, participants will receive usual
oncology care. Participants and their oncologists will not
receive GA results at the time of registration unless severe
cognitive or psychological problems are revealed.
Concomitant treatments will not be restricted.
Stopping rules for participants
The protocol intervention will be discontinued under
the following conditions: (1) the attending oncologists
deem it necessary to discontinue the intervention, (2) the
patient requests discontinuation of the intervention, (3)
the patient dies during the intervention period, (4) the
patient’s condition suddenly deteriorates after registration, (5) a protocol violation or ineligibility is discovered
or (6) the patient withdraws consent to participate. The
investigator will report the reasons for the discontinuation
6
of the intervention to the data centre. Follow-up assessments, including questionnaires, will continue unless
consent is withdrawn.
Assessment measures
Table 5 shows the schedule of outcome measurements.
Primary outcome measure
The primary outcome is the number of conversations
about ageing-related concerns during consultation, which
is used to evaluate whether the intervention facilitates
discussions between patients and their oncologists. At the
first outpatient visit within 4 weeks from the baseline GA,
the conversation between patients and their oncologist
will be audio-recorded and transcribed verbatim. Based on
the COACH study,22 a content analysis framework will be
used to assess how to identify ageing-related concerns and
whether stated concerns are acknowledged and considered further by the oncologist (quality of discussion) and
to determine whether acknowledged concerns motivate
implementation of management recommendations. For
each transcript, coding will be performed directly by two
coders who have received extensive training and supervision by the principal investigator, are blind to the study
hypotheses and the allocation and are not involved in any
other aspect of the study.
Secondary outcome measures
We will evaluate several health outcomes as secondary
outcome measures. Our hypothesis is that the
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Matsuoka A, et al. BMJ Open 2022;12:e063445. doi:10.1136/bmjopen-2022-063445
Table 5
Schedule of outcome measurements
Baseline
Primary registration Secondary registration 1st outpatient visit after GA
◯
GA
Patient characteristics*
Number of ageing-related conversations
Ⓞ
Quality of ageing-related conversations
Ⓞ
Ⓞ
36
and SHARE
CARE-1038 39
Ⓞ
40 41
Ⓞ
TiOS
Ⓞ
CTCAE
Ⓞ
Prevalence of dose modifications
Ⓞ
Implementation of GA-guided
management
Ⓞ
GA evaluation
Ⓞ
Ⓞ
◯
QPL evaluation
•
GA+QPL evaluation
△
△
PRO-CTCAE
Ⓞ
Ⓞ
Ⓞ
IADL30
Ⓞ
Ⓞ
Ⓞ
Ⓞ
Ⓞ
Ⓞ
33–35
31 32
QOL
Overall survival rate
12 months
•
△
RIAS
6 months
◯
Oncologist
characteristics†
37
3 months
Ⓞ
Ⓞ
7
Open access
◯ will be evaluated among all participants at the primary registration. Ⓞ will be evaluated among all participants after the secondary registration. • will be evaluated among
participants in the intervention arm. △ will be evaluated among attending oncologists in the intervention arm.
*Patient characteristics include age, gender, highest level of education, employment status, marital status, financial concerns and self-rated health.
†Oncologist characteristics include age, gender, years in practice and years in oncology practice.
CARE-10, Consultation and Relational Empathy measure-10; CTCAE, Common Terminology Criteria for Adverse Events; GA,geriatric assessment; IADL, Instrumental Activities
of Daily Living; PRO-CTCAE, Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events; QOL, quality of life; QPL, question prompt list; RIAS,
Roter interaction analysis system; SHARE, setting, how to deliver bad news, additional information, reassurance and emotional support; TiOS, Trust in Oncologists Scale.
BMJ Open: first published as 10.1136/bmjopen-2022-063445 on 26 September 2022. Downloaded from http://bmjopen.bmj.com/ on August 31, 2023 by guest. Protected by copyright.
intervention will facilitate ageing-related communication
between patients and their oncologists (primary outcome
and proximal outcome), thereby leading to higher implementation of GA-guided management (intermediate
outcome), which in turn will lead to improved patient
health outcomes (figure 1). We will also evaluate communication outcomes as proximal outcome measures.
Health outcomes
1. Overall survival rate at 6 months and 12 months.
Overall survival is defined as the time from randomisation to death from any cause or last contact, whichever
is earlier.
2. Treatment failure-free survival, which is defined as the
time from randomisation to treatment discontinuation
for any cause or last contact, whichever is earlier.
3. Grade 3–5 chemotherapy-related treatment toxicity
within 3 months evaluated according to the National
Cancer Institute (NCI) Common Terminology Criteria
for Adverse Events V.5.0 by physicians and/or nurses.
4. Prevalence of dose modification within 3 months
(treatment modification, dose reduction and/or discontinuation).
5. Unscheduled hospitalisation and emergency department visits within 3 months.
6. Functional status using the OARS-IADL questionnaire30
(electronic-patient reported outcomes (ePRO)) consisting of seven questions rated on a three-point Likert
scale; the Japanese version was translated and validated
by Ogawa et al (unpublished data).
7. Quality of life measured by the European Organization
for Research and Treatment of Cancer Quality of Life
Questionnaire Core 30-item version31 (ePRO) consisting of 30 items, including functional scales (physical,
role, cognitive, emotional and social), global health
and Quality of Life (QOL) scale, symptoms scale and/
or items (fatigue, nausea and vomiting, pain, dyspnoea,
sleep disturbance, appetite loss, constipation and diarrhoea) and financial impact; the Japanese version was
validated by Kobayashi et al.32
8. Core items (12 symptoms) of the NCI’s PatientReported Outcomes Version of the Common
Terminology Criteria for Adverse Events system; the
Japanese version33–35 (ePRO) was linguistically and psychometrically validated by Kawaguchi et al and Miyaji
et al.34 35
Communication outcomes
1. Patient-centred communication behaviours will be
analysed based on impression ratings by two blinded
coders. The analysis will use audio-recorded oncology
visits for all participants and assess the total score of
the 27 SHARE categories: setting, how to deliver the
bad news, additional information, reassurance and
emotional support.36 In addition, patient-preferred
communication behaviours will be analysed using the
40 categories of the Roter interaction analysis system
(RIAS).37
8
2. Communication satisfaction using the Consultation
and Relational Empathy measure38 39 (ePRO) consisting of 10 items rated on a 5-point Likert scale; the Japanese version was translated and validated by Aomatsu
et al.38
3. Trust in Oncologists Scale40 41 (ePRO) consisting of five
items rated on a five-point Likert scale; the Japanese
version was translated and validated by the authors
(unpublished data).
Intermediate outcomes
1. The number of geriatric problems successfully addressed for participants in the intervention arm.
Other outcomes
1. Patients’ assessment surveys on the burden and usefulness of the intervention, including ‘Was it difficult to
answer the (GA) questions?’, ‘Did you feel burdened
by the (GA) questions?’, ‘Did you feel burdened by the
intervention (GA+QPL)?’, ‘Did you find the intervention (GA+QPL) helpful in organising your thoughts?’
and ‘Did the intervention (GA+QPL) help you talk
with your doctor?’.
2. Oncologists’ assessment surveys on the burden and
usefulness of the intervention, including ‘Was the intervention (GA+QPL) useful to you?’ and ‘Did you feel
burdened by the intervention (GA+QPL)?’.
Secondary outcome measures 1–5, and intermediate
outcome measure 1 will be collected through medical
charts, consulting the oncologists if needed. Secondary
outcome measures 6–8, communication outcome measures 2 and 3 and other outcome measure 1 will be collected
through ePRO using a touchscreen tablet. Secondary
other outcomes measure 2 will be collected using a paper
form for the convenience of attending oncologists.
Harms
No specific serious adverse events are anticipated for
participants in this study. Patients will be subjected to
time burdens of 30–40 min for the study intervention and
10–20 min for the GA as well as baseline and follow-up
questionnaires. There is no direct financial cost associated with study participation, but we recognise that
patients are donating their time to participate. Patients
will not be compensated for their participation.
Compensation
If patients develop any unforeseen health issues due
to study participation, they will be adequately treated
according to standard medical care as covered by National
Health Insurance.
Sample size estimation
Sample size and power considerations are based on
the primary outcome of the number of conversations about ageing-related concerns. In our preliminary study (unpublished data) of 40 Japanese elderly
patients with cancer, the number of ageing-related
concerns discussed during their consultations was 1.4
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Open access
in the usual care arm and 2.3 in the intervention arm
(SD 1.3). Along with the results of a previous study on
communication in Japanese patients with cancer,19 we
defined the clinically minimally important difference in
the number of ageing-related conversations as 1.0. The
design has 80% power with a significance level of 0.05
(two-sided) to detect a difference of 1.0 in the number
of conversations about ageing-related concerns with an
SD of 2.5. Assuming a 5% withdrawal rate, 210 is the
targeted accrual.
Statistical analysis
In accordance with intention-to-treat principles, the
primary outcome will be analysed to examine the intervention effect parameters for all randomly assigned
subjects. To compare categorical variables, Fisher’s exact
tests will be used. Continuous measures will be compared
using the Wilcoxon rank-sum test. Overall survival and
treatment failure-free survival will be estimated using the
Kaplan-Meier method and compared using log-rank test.
No interim analysis is planned.
Missing data
Every effort will be made to facilitate participants’
completion of questionnaires, but missing data will inevitably occur due to dropout. We will evaluate the patterns
of missing data and associations of missingness with
other available variables. Based on the missing at random
assumption, the parameter estimates from the mixedmodel analyses should be unbiased. However, if the data
are suspected of being missing not at random, a sensitivity
analysis using selection and/or pattern-mixture models
will be performed to determine the impact on the results.
If the estimates are similar to the ones obtained from the
simpler analysis of only complete cases, we will report the
complete-case analysis results.
Patient and public involvement statement
This study protocol was co-designed by a patient with
cancer and family member of a patient with pancreatic
cancer, and was reviewed by patient and public involvement (PPI) representatives. PPI representatives will help
our team disseminate the results of this study. The QPL
was reviewed and revised based on comments from elderly
patients with cancer who were treated at the National
Cancer Center in Tokyo.
Data management, central monitoring, data monitoring and
auditing
Except for audio-recorded data, all data will be collected
through electronic data capture (EDC) and ePRO
systems. Paper questionnaires will be used for patients
with physical or cognitive limitations. Data management
and central monitoring will be performed by the J-SUPPORT Data Science Team using EDC Viedoc (Viedoc
Technologies AB, Uppsala, Sweden). No auditing is
planned for this study.
Matsuoka A, et al. BMJ Open 2022;12:e063445. doi:10.1136/bmjopen-2022-063445
Publication policy
The protocol and study results will be submitted to peerreviewed journals. The first author of the main paper
should be a member of the steering committee. The list
of coauthors will be determined prior to submission of
each paper.
Ethics and dissemination
This study protocol was reviewed and approved by the
protocol review committee of Japan Supportive, Palliative and Psychosocial Oncology Group as a J-SUPPORT
2101 study and the institutional review boards at each
participating institution. This study will be conducted in
accordance with the ethical guidelines for clinical studies
published by the Japanese Ministry of Education, Science
and Technology and the Ministry of Health, Labour and
Welfare, the modified Act on the Protection of Personal
Information and the ethical principles for research on
human subjects stipulated in the Declaration of Helsinki
and its amendments. If important protocol modifications
are necessary, the investigators will discuss and report
them to the review committee for approval. With regard
to dissemination, the results obtained will be submitted to
peer-reviewed journals. The main and relevant findings
will be presented at conferences.
DISCUSSION
Our intervention programme is unique in combining a
GA summary and management recommendations with
communication support using a QPL. Several RCTs in the
USA have demonstrated the efficacy of GA and GA-guided
management for elderly patients with cancer.12 22 23
There seems to be two core components of GA-guided
management among these trials: (1) stratifying elderly
patients with cancer based on GA results in order to select
appropriate treatment and (2) intervening in impaired
GA domains with a multidisciplinary team.27 This study
focuses on GA-guided management by a multidisciplinary
team. In prior studies, limited implementation of GA
management recommendations did not improve patient
outcomes, even when GA results and management recommendations were presented to attending oncologists.42 43
To improve patient outcomes, it is necessary to successfully implement GA-guided management.
This study is expected to provide new evidence building
on the COACH study, which demonstrated that feedback
in the form of a GA summary and GA-guided management
recommendations to patients and their oncologists facilitates communication about ageing-related concerns.22
Our study differs from the COACH study in the following
ways: (1) an intervention provider will review and discuss
GA results and GA-guided management recommendations with patients and then provide a feedback sheet
based on information derived from the patients in order
to reduce the oncologists’ burden, (2) an intervention
provider will provide communication support using QPL
and help patients communicate ageing-related concerns
9
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Open access
to their oncologists and (3) an intervention provider will
meet with the patients and oncologists monthly to review
and facilitate implementation of GA-guided management as needed. We hypothesise that our intervention
combining a GA summary and management recommendations with communication support using QPL will
facilitate patient-centred communication about ageingrelated concerns, even among Japanese elderly patients
with cancer who are less likely to express their values
and preferences to their oncologists, thereby leading to
successful implementation of GA-guided management.
Previous studies in the USA have shown that older, nonWhite, lower-income or less-educated patients tend to
ask their physicians fewer questions, resulting in less
effective communication.44–46 Therefore, we believe that
our intervention, if proven effective, would benefit not
only Japanese elderly patients with cancer but also other
vulnerable populations who may be less likely to express
their concerns to their oncologists, thereby contributing
to reducing healthcare disparities.
No data exist on whether an increased number of
ageing-related conversations will improve QOL, maintain physical function, decrease treatment-related toxicities and prolong patient survival. However, we chose the
number of ageing-related conversations as the primary
outcome for this study because GA-guided management
will not be implemented in daily oncology practice, and
thus not lead to the improvement of patient outcomes,
unless these problems are well recognised and shared
between patients and their oncologists.
In this study, trained intervention providers will
perform the GA+QPL intervention in an interview format
over 30–40 min. For future implementation of the intervention programme, in addition to the study’s web-based
system on a touch-panel screen, electronic media such as
AI-navigated self-administered GA and communication
support might be more applicable to reducing burdens
of time and human resources.
Study strengths and limitations
The main strength of our study is that communication
support using QPL is combined with GA. This approach
is expected to facilitate patient-centred communication
regarding ageing-related concerns, even among vulnerable populations who are generally less likely to express
their values and preferences to their oncologists. This
study has three methodological limitations. First, due to
the nature of the intervention, both patients and their
oncologists would be aware of the allocated arm, which
could potentially influence care during treatment. We
have not chosen a cluster-randomised study design, so
there might be a risk of contamination in that oncologists could learn from the intervention model and apply
that knowledge to other patients, given that they will be
exposed to both arms. However, we consider this risk to
be low because it is unlikely for oncologists to identify
ageing-related problems unless GA is performed; ageingrelated concerns are not captured by routine oncology
10
assessments.15 22 Actually, GA is not performed in routine
oncology practice at the participating institutions.
Second, because the intervention programme is complex
and consists of multifactorial components, each component’s contribution to the outcomes would be hard to
ascertain. Third, because this study is limited to patients
with gastrointestinal cancers, its generalisability to other
cancers will not be clarified.
Author affiliations
1
Division of Supportive Care, Survivorship and Translational Research, Institute for
Cancer Control, National Cancer Center Japan, Tokyo, Japan
2
Department of Oncology and General Medicine, IMSUT Hospital, Institute of
Medical Science, University of Tokyo, Tokyo, Japan
3
Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital,
Tokyo, Japan
4
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center
Hospital, Tokyo, Japan
5
Clinical Trial Coodination Office, Shizuoka Cancer Center, Shizuoka, Japan
6
Department of Psychiatry and Cognitive-Behavioral Medicine, Graduate School of
Medical Sciences and Medical School, Nagoya City University, Nagoya, Japan
7
Division of Behavioral Sciences, Institute for Cancer Control, National Cancer
Center Japan, Tokyo, Japan
8
Department of Clinical Trial Data Management, Tokyo University Graduate School of
Medicine, Tokyo, Japan
9
NPO Pancreatic Cancer Action Network Japan, Tokyo, UK
10
Department of Medical Oncology, Kyorin University Faculty of Medicine, Tokyo,
Japan
Acknowledgements We thank Ms A Akama and Mr N Akama for data
management support. We thank Dr Y Tsubata, Dr T Nishijima and Dr H Yamamoto
for their advice about our study. We also thank Ms H Aiyoshi, Ms M Ueda, Ms
C Unozawa, Ms R Otoshi, Ms R Sugihara, Ms I Tanaka, Ms K Hata and Ms M
Kanamaru for their assistance with this study.
Contributors MF is the principal investigator. AM is the project manager. MF,
AM, BN, AT, TO, YM, FN and YU developed the intervention programme, including
the question prompt list, the geriatric assessment summary and management
recommendations. MF, AM, BN, AT, KM, AT, TS, AO, TM, YM, FN and YU participated
in the study design. KM played a chief role in developing the statistical parts. AO
and TM played roles in the data management. MF and AM drafted the manuscript.
All authors prepared the protocol, agree with the final protocol and revisions and
participated in, read and approved the final manuscript.
Funding This study is supported by a grant-in-aid for Japan Agency for Medical
Research and Development (21ck0106682h0001). This funding source has no role
in the design of this study and will not have any role during its execution, analyses,
interpretation of the data or decision to submit results.
Competing interests All authors declare that they have no competing interests
regarding this work. BN reports grant from Ono Pharmaceutical and Takeda
Pharmaceutical, and personal fees from Ono Pharmaceutical, Bristol-Myers Squibb,
Taiho Pharmaceutical, and Daiichi Sankyo. TO reports grant from AstraZeneca,
Bristol-Myers Squibb, MSD, Eisai, Syneos Health, EP-CRSU and Incyte, and personal
fees from AstraZeneca, MSD, Incyte, Eisai, Taiho Pharmaceutical, Yakult Honsha,
Ono Pharmaceutical, Pfizer, Daiichi Sankyo, Nihon Servier, Nippon Shinyaku,
Chugai Pharmaceutical, Meiji Seika Pharma, ElmediX and Johnson & Johnson.
AT reports grants from MSD, Ono Pharmaceutical, Daiichi Sankyo, Sumitomo
Dainippon Pharma, Taiho Pharmaceutical, Pfizer, Hutchison MediPharma, Isofol
Medical and Incyte, and personal fees from Chugai Pharmaceutical, Eli Lilly, Taiho
Pharmaceutical, MSD and Ono Pharmaceutical. TA reports grant from Daiichi
Sankyo, Eisai, Fujifilm RI Pharma, MSD, Otsuka Pharmaceutical and Shionogi,
personal fees from Igaku-Shoin, AstraZeneca, Chugai Pharmaceutical, Daiichi
Sankyo, Sumitomo Dainippon Pharma, Eisai, Janssen Pharmaceutical, Kyowa
Kirin, Eli Lilly, MSD, Meiji Seika Pharma, Mochida Pharmaceutical, NIPRO, Nippon
Zoki Pharmaceutical, Otsuka Pharmaceutical, Pfizer, Takeda Pharmaceutical and
Viatris, and pending patents (2019-017498 & 2020-135195). FN reports grants
from Ono Pharmaceutical, MSD, Merck BioPharma, Janssen Pharmaceutical,
Takeda Pharmaceutical, Chugai Pharmaceutical, AstraZeneca, Eisai, Mochida
Pharmaceutical, Sanofi, Sumitomo Dainippon Pharma, Bayer, Astellas and Incyte,
Matsuoka A, et al. BMJ Open 2022;12:e063445. doi:10.1136/bmjopen-2022-063445
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Open access
and personal fees from Ono Pharmaceutical, Eli Lilly, MSD, Chugai Pharmaceutical,
Taiho Pharmaceutical, Kyowa Kirin and Yakult Honsha.
Patient and public involvement Patients and/or the public were involved in the
design, or conduct, or reporting, or dissemination plans of this research. Refer to
the Methods section for further details.
Patient consent for publication Consent obtained directly from patient(s)
Ethics approval The protocol was reviewed and approved by the Institutional
Review Board of the National Cancer Center on April 15, 2021 (ID: 2020-592) as
well as by the J-SUPPORT Scientific Advisory Board. The patient consent form is
attached to this submission as Appendix A, B.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement No data are available. Not applicable, because this is
a protocol paper.
Supplemental material This content has been supplied by the author(s). It has
not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been
peer-reviewed. Any opinions or recommendations discussed are solely those
of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and
responsibility arising from any reliance placed on the content. Where the content
includes any translated material, BMJ does not warrant the accuracy and reliability
of the translations (including but not limited to local regulations, clinical guidelines,
terminology, drug names and drug dosages), and is not responsible for any error
and/or omissions arising from translation and adaptation or otherwise.
Open access This is an open access article distributed in accordance with the
Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which
permits others to distribute, remix, adapt, build upon this work non-commercially,
and license their derivative works on different terms, provided the original work is
properly cited, appropriate credit is given, any changes made indicated, and the use
is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
ORCID iDs
Maiko Fujimori http://orcid.org/0000-0003-1639-3390
Taichi Shimazu http://orcid.org/0000-0001-6000-9830
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