Feasibility of a mobile application-based geriatric assessment and communication support intervention for older adults with cancer: protocol for a pilot randomised controlled trial (MAPLE2 pilot)

Abstract

Introduction

Older adults with cancer have ageing-related vulnerabilities that influence their treatment tolerance and decision-making. In our previous randomised controlled trial (MAPLE), integrating geriatric assessment (GA) with communication support using a question prompt list (QPL), delivered by trained intervention providers, facilitated patient–oncologist communication, increased implementation of GA-guided management (GAM) and improved patient outcomes. However, its widespread adoption has been limited by the need for trained personnel and dedicated time. To enhance scalability and sustainability, we developed a mobile application-based intervention to deliver GAM and communication support. This MAPLE2 study aims to evaluate the feasibility of the intervention using this mobile application-based GA and QPL among older adults with cancer.

Methods and analysis

This multicentre, open-label, pilot randomised controlled trial will be conducted at two academic hospitals in Japan. Patients aged≥70 years with solid cancer or lymphoma initiating or changing systemic therapy will undergo baseline GA. Patients with any GA impairment will be randomised to receive either (1) a mobile application-based intervention providing feedback of GA summary with tailored GAM recommendations and QPL or (2) usual care. The primary endpoint is the proportion of participants who complete all of the following interventions using the mobile application: (1) self-administered GA, (2) receipt of the tailored GAM recommendations and QPL and (3) confirmation that their oncologists review the tailored GAM recommendations and QPL at subsequent visits. Forty participants are planned to be enrolled.

Ethics and dissemination

The study has been approved by the Institutional Review Board of the National Cancer Center, Japan (approval number: 2025-089). Written informed consent will be obtained from all participants. Results will be presented at academic conferences and published in peer-reviewed journals.

Trial status

Recruitment has been initiated from 8 September 2025 and is planned to be completed by 31 August 2026, with a follow-up period by 31 August 2027.

Trial registration number

UMIN000058887

STRENGTHS AND LIMITATIONS OF THIS STUDY.

• This multicentre pilot randomised controlled trial employs a prespecified feasibility design with clearly defined completion criteria for a mobile application-based intervention integrating geriatric assessment (GA), GA-guided management (GAM) recommendations and communication support.

• GA is conducted using validated, guideline-concordant instruments and linked to standardised, algorithm-based GAM recommendations with communication support using a question prompt list via a mobile application.

• Delivering the intervention in a digital format may enhance scalability and sustainability by reducing the implementation burden in clinical practice.

• As a pilot study, the sample size is small and the follow-up period is limited.

• The study is not powered to detect clinical effectiveness, but will provide feasibility data for the design of future definitive trials.

Introduction

Cancer disproportionately affects older adults, with individuals aged≥70 years comprising the majority of patients with cancers in Japan.¹ Despite this demographic trend, older adults remain underrepresented in clinical trials, and treatment decisions are often extrapolated from studies involving younger, selected populations.^{2 3} This discrepancy increases the risk of both overtreatment and undertreatment, particularly in patients with ageing-related vulnerabilities such as multimorbidity, functional decline, cognitive impairment, psychological distress and limited social support.⁴

Geriatric assessment (GA) is a multidimensional, interdisciplinary evaluation that identifies ageing-related vulnerabilities and informs individualised management strategies for older adults with cancer.⁵ Large randomised controlled trials (RCTs), including GAP70+ and GAIN, have demonstrated that GA-guided management (GAM) reduces treatment-related toxicities without compromising efficacy.^{6 7} In Japan, our previous RCT (MAPLE study) demonstrated that integrating GA with structured communication support using a question prompt list (QPL) significantly facilitated discussion about ageing-related concerns between older adults with cancer and their attending oncologists, leading to higher implementation of GAM recommendations and improved their health outcomes.8,10

Despite the growing body of evidence, implementation of GA in routine oncology practice remains limited, particularly in resource-constrained settings. Barriers to implementation include the need for trained personnel and the additional time to perform GA, interpret its findings, tailor management and discuss the results with patients.^{11 12} To address these challenges, we developed a mobile application that enables older adults to complete GA independently, automatically generates guideline-concordant GAM recommendations tailored to identified vulnerabilities and produces a personalised QPL linked to the GA results. This digital approach is designed to facilitate patient-centred communication and optimise care delivery while minimising the burden on healthcare providers.

The MAPLE2 pilot study is a multicentre, open-label, pilot RCT designed to evaluate the feasibility of this mobile application-based GA, GAM and QPL intervention among older adults with cancer initiating or changing systemic anticancer therapy.

Methods and analysis

The study protocol was developed in accordance with Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2025 statement and the SPIRIT-PRO extension for protocols involving patient-reported outcomes.^{13 14} A completed SPIRIT checklist is provided in the online supplemental material.

Study design

This study is a multicentre, open-label, parallel-group, pilot RCT to be conducted at two academic hospitals in Japan. The study period is scheduled from September 2025 to August 2027, with participant enrolment planned between September 2025 and August 2026. Participants will be followed up for 3 months after intervention. The primary objective is to evaluate the feasibility and acceptability of a digital health intervention that integrates a mobile application-based GA with tailored GAM recommendations and QPL for personalised communication support.

Screening

Candidate patients will be recruited at the outpatient medical oncology clinics of the National Cancer Center Hospital and Kyorin University Hospital, Tokyo, Japan. Trained research staff will screen candidate patients and approach them after obtaining permission from their attending oncologists. Patients who meet the inclusion criteria (1–6) in table 1 will undergo a baseline GA evaluating eight domains: falls, functional status, psychological status, nutrition, social support, cognition, polypharmacy and comorbidity (table 2). GA will be conducted using electronic patient-reported outcome measures at baseline. The selected assessment tools are based on the American Society of Clinical Oncology guidelines, the Japan Clinical Oncology Group geriatric research policy, and previous clinical trials.5,715 Except for the Mini-Cog, all assessments are self-administered by participants using a touchscreen tablet.

Table 1. Inclusion and exclusion criteria.

Inclusion criteria	Exclusion criteria
Diagnosis of solid cancer or malignant lymphoma Age≥70 years Planned to initiate or change the systemic anticancer therapy (chemotherapy, molecularly targeted therapy or immunotherapy) ECOG Performance Status of 0–2 Ability to read, write and understand Japanese Provision of written informed consent Presence of at least one impaired GA domain at the time of registration	Current or planned participation in other interventional studies that may interfere with this study (eg, other psychological or communication support studies, or therapeutic clinical trials) Judged by the attending oncologists to be unsuitable for participation Severe cognitive impairment without a proxy or legal representative

ECOG, Eastern Cooperative Oncology Group; GA, geriatric assessment.

Table 2. GA tools.

GA domain	Assessment tools	Cut-off points
Falls	History of falls in the past 6 months	History of falls
Functional status	OARS IADL21	Presence of any IADL deficit
Psychological status	Patient Health Questionnaire-934	≥5 points
Nutrition	Mini Nutritional Assessment35	≤11 points
Social support	Living status and assistance	Living alone and/or without any assistance
Cognition	Mini-Cog36	≤2 points
Polypharmacy	Number of medications	≥5 regularly scheduled prescriptions
Comorbidity	OARS Comorbidity21	≥3 conditions or any condition causing a great deal of interference

GA, geriatric assessment; IADL, Instrumental Activities of Daily Living; OARS, Older American Resources and Services.

Randomisation and allocation

Among the screened patients, those with at least one impaired GA domain (criterion 7) will be randomly allocated to either the intervention or usual care arm. Random allocation will be computer-generated and centrally managed by an independent data centre. A stratified block randomisation method will be used to ensure balanced allocation by study site, cancer type, treatment goal (curative vs palliative) and line of treatment. Allocation results will be communicated electronically to study staff at each participating institution. Owing to the nature of the intervention, neither participants nor their attending oncologists will be blinded to the group assignment.

Intervention

GA summary and GAM recommendation

After completing electronic GA, the system will automatically generate a personalised GA summary that includes a list of identified impairments across GA domains and tailored GAM recommendations, which are picked up from clinical guidelines, literature reviews, previous clinical trials and expert consensus5,715 (table 3).

Table 3. GA-guided management recommendations.

• Table 31

GA impairments	Recommendations
History of falls Presence of any IADL deficit	1. Referral to physical therapy and/or occupational therapy 1.1. Provide strength and balance training; introduce a home exercise programme 1.2. Provide assistance according to the IADL disability 1.3. Provide support according to fall risk 2. Referral to medical social workers and/or nurses 2.1. Provide support according to the IADL disability 2.2. Evaluate home safety, adjust environmental factors (fall prevention), and use nursing care services 3. Review fall risk due to polypharmacy and adjust medications as needed (referral to pharmacist)
Patient Health Questionnaire-9≥5	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)
Mini Nutritional Assessment≤11	1. Referral to a dietician 1.1. Assess nutritional status; provide nutritional guidance 1.2. Provide educational materials 1.3. Provide information on or prescribe nutritional supplements 2. Referral to social workers as needed (eg, 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; referral to the community comprehensive support centre 1.2. Referral to transportation services, home care/nursing care and support group 1.3. Identify and establish contact with key persons in case of caregiver 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 delirium risk; reduce medications associated with delirium 2. Encourage family/caregivers to participate in consultation and treatment decisions 3. Reduce the number of medications or adjust dosage and/or administration (referral to a pharmacist)
≥5 medications ≥3 comorbidities or any comorbidity causing a great deal of interference	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. Assess patient’s understanding of medication, missed doses and their ability to manage prescriptions 3. Involve family members and caregivers in treatment decisions and comorbidity management 4. Review prescriptions and comorbidity management with family physicians, geriatricians and other specialists

GA, geriatric assessment; IADL, Instrumental Activities of Daily Living; PIMs, potentially inappropriate medications.

Communication support using GA, GAM recommendations and QPL

Participants in the intervention arm will receive a GA summary, individualised GAM recommendations and a tailored QPL for communication support, automatically provided via a mobile application (figure 1). Patients will be prompted to respond to a series of application-based questions using simple inputs (eg, ‘yes’ or ‘no’). These responses will enable the system to determine the following: (1) patients’ awareness of each GA domain impairment; (2) their preferences regarding GAM recommendations and (3) the QPL items most relevant to their concerns. Based on this information, the application will generate individualised GAM recommendations with a tailored QPL, displayed within the application interface for patients to review before their next oncology consultation. The attending oncologist will then receive a printed version of these individualised GAM recommendations with a tailored QPL. Research staff will be available to assist patients in using the application if needed, including providing step-by-step guidance and real-time technical support for participants with limited digital literacy. Participants may use either a study-provided tablet or their own smartphone, according to their preference and device compatibility. This support is intended to reduce technical barriers while maintaining participant independence in completing the intervention.

Figure 1. Conceptual adaptations from the prior MAPLE trial to the current MAPLE2 pilot study This figure is an original illustration created by the authors to depict key conceptual modifications of the intervention between the prior MAPLE trial and the present study. In our previous MAPLE trial, a programme combining a GA summary with communication support from trained intervention providers significantly improved communication about ageing-related concerns, leading to higher implementation of GA-guided management and improved patients’ health outcomes. In the MAPLE2 pilot study, several adaptations have been introduced: (1) the intervention programme has been automated through a mobile application, with research staff providing only technical support for app use; (2) the primary outcome is the feasibility of the app-based intervention and (3) communication outcomes (number of ageing-related concerns) and survival outcomes have been omitted. GA, geriatric assessment; QPL, question prompt list.

Participants in the usual care arm will undergo baseline GA only for eligibility screening. GA results will not be disclosed to their attending oncologists unless deemed clinically necessary. They will receive standard oncological care without structured communication support.

In both arms, concomitant treatments will not be restricted.

Stopping rules for participants

The protocol intervention will be discontinued if any of the following conditions occur: (1) attending oncologist’s determination that discontinuation is medically necessary; (2) patient’s request to discontinue the intervention; (3) deterioration of the patient’s condition after registration; (4) patient’s death during the intervention period; (5) protocol violation or ineligibility or (6) withdrawal of consent to participate. The investigator will report the reasons for the discontinuation of the intervention to the data centre. Follow-up assessments, including patient-reported questionnaires, will continue unless the patient explicitly withdraws consent for further participation.

Outcome measures

Table 4 shows the schedule of outcome measurements.

Table 4. Schedule of outcome measurements.

	Screening	Baseline	Registration	First outpatient visit after GA	3 months
GA		*
Patient characteristics†	*
Completion of the full intervention protocol				‡
CTCAE					*
Prevalence of treatment modifications					*
Healthcare utilisation					*
IADL			*		*
QOL			*		*
PRO-CTCAE			*		*
CARE-10			*	*	*
Implementation of GAM					*
Burden and usefulness of intervention for patients				‡
Burden and usefulness of intervention for oncologists				§

^*Evaluated among all participants.

^†Patient characteristics include age, sex, highest level of education, employment status, marital status, financial concerns and self-rated health.

^‡Evaluated among all participants in the intervention arm.

^§Will be evaluated among attending oncologists in the intervention arm.

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.

Primary outcome

The primary outcome is feasibility, defined as the proportion of participants in the intervention arm who complete all of the following intervention procedures: (1) self-administered GA using the mobile application, (2) receiving personalised GAM recommendations and QPL through application-based questionnaires and (3) confirmation that the attending oncologists reviewed the GAM recommendations and QPL at the subsequent outpatient visit, as assessed via a post-consultation questionnaire for the oncologist. Reasons for non-completion will be obtained from participants.

Secondary outcomes

Health outcomes

• Incidence of grade≥3 adverse events within 3 months of randomisation, evaluated by the attending oncologists and/or nurses according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V.5.0.

• Prevalence of treatment modifications within 3 months of randomisation, defined as any change of treatment occurring after the first treatment cycle, such as dose reductions or stopping any of the chemotherapy agents (eg, from combination to monotherapy), and/or treatment discontinuation for any reason.

• Incidence of unscheduled hospital visits or unplanned hospital admissions within 3 months of randomisation.

• Functional status, assessed using the Older Americans Resources and Services–Instrumental Activities of Daily Living (OARS-IADL) questionnaire²¹ (electronic-patient reported outcomes (ePRO)) at baseline and 3 months of randomisation. This instrument consists of seven items, each rated on a 3-point Likert scale. The Japanese version has been translated and validated by Ogawa et al (unpublished data).

• Quality of life (QOL), assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30²² (EORTC QLQ-C30) (ePRO) at baseline and 3 months of randomisation. This 30-item instrument includes five functional domains (physical, role, cognitive, emotional and social), a global health status/QOL scale, nine symptom scales/items (fatigue, nausea and vomiting, pain, dyspnoea, sleep disturbance, appetite loss, constipation and diarrhoea), and one item assessing financial difficulties. The Japanese version has been validated by Kobayashi et al.²³

• Patient-reported adverse events, assessed using the 12 core symptom items from the NCI’s Patient-Reported Outcomes version of the CTCAE²⁴ (PRO-CTCAE) (ePRO) at baseline and 3 months of randomisation. The Japanese version has been linguistically and psychometrically validated.^{25 26}

Communication outcomes

• Communication satisfaction, assessed using the Consultation and Relational Empathy (CARE) measure²⁷ (CARE-10) (ePRO) at the first outpatient visit and 3 months of randomisation. The CARE-10 consists of 10 items rated on a 5-point Likert scale. The Japanese version has been translated and validated by Aomatsu et al.²⁸

Intermediate outcomes

• Number of GAM recommendations implemented by attending oncologists for participants in both arms within 3 months of randomisation. Although GAM recommendations are blinded to patients and their oncologists in the usual care arm, their implementation will be assessed in both arms through a medical chart review.

Acceptability outcomes

• Patient-reported perception about the burden and usefulness of the intervention, rated on a 5-point Likert scale, assessed at the first outpatient visit after randomisation using items such as ‘Did you feel burdened by the overall 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?’

• Oncologists’ perception about the burden and usefulness of the intervention, rated on a 5-point Likert Scale, assessed at the first outpatient visit after randomisation using items such as ‘Did you find the intervention (GA+QPL) useful in your clinical practice?’ and ‘Did you feel burdened by the overall intervention (GA+QPL)?’

Secondary outcome measures 1–3 and 8 will be obtained through medical chart reviews, supplemented by information from the attending oncologists if required. Secondary outcome measures 4–7 and 9 will be obtained via ePRO using the mobile application. Secondary outcome measure 10 will be obtained via a paper form for the convenience of the attending oncologists.

Harms

No serious adverse events are anticipated in this study. However, participants may experience a time burden associated with the intervention procedures as well as the baseline and follow-up assessments. The protocol intervention is expected to require 30–40 min, and the baseline GA, along with baseline and follow-up questionnaires, will require an additional 10–20 min.

There are no direct financial costs to patients for participating in the study, although we acknowledge the time commitment required. No monetary compensation will be provided.

Compensation

If participants experience any unforeseen health issues related to study participation, they will receive appropriate treatment under the Japanese National Health Insurance system.

Sample size estimation

According to the CONSORT 2010 extension for pilot and feasibility trials,²⁹ a sample size of approximately 10% of the future definitive trial is considered appropriate for pilot testing. We are planning a subsequent large-scale, multicentre RCT with a hybrid type 1 implementation-effectiveness design,^{30 31} in which the primary endpoint will be the incidence of grade≥3 adverse events within 3 months. In the preceding MAPLE trial, the incidence of grade≥3 adverse events at 3 months was 50.9% in the intervention arm and 66.4% in the usual care arm.¹⁰ Assuming event rates of 50% (intervention) and 65% (control), with a two-sided alpha error of 0.05 and power of 80%, the required sample size for hypothesis testing in the definitive trial would be 366 participants. Based on this, the planned sample size for this pilot trial was set at 40 participants (20 per arm), accounting for potential dropouts.

In addition, the decision criteria for feasibility are prespecified, referring to the previous reports on mobile application-based interventions for patients with cancer.^{32 33} The intervention in this study is considered feasible if the completion rate is≥75%, feasible but requiring modification if the completion rate is 45–74%, and not feasible if the completion rate is <45%. 20 patients in the intervention arm preserve power of 80% with a two-sided alpha error of 0.05, assuming an expected completion rate of 75% with a threshold of 45%.

Statistical analysis

The completion rate will be reported as a proportion with corresponding 95% CIs. Secondary outcomes will be summarised descriptively. Between-group comparisons will be conducted using t-tests or Mann–Whitney U tests for continuous variables and χ² or Fisher’s exact tests for categorical variables. No formal hypothesis testing is planned. All statistical analyses will be performed using two-sided tests with a significance level of 0.05.

Missing data

Every effort will be made to facilitate participants’ completion of questionnaires, but missing data will inevitably occur due to dropout or incomplete responses. Missing data will be summarised descriptively, and the extent and patterns of missingness will be reported for each outcome. Given the pilot and feasibility nature of this study, no imputation methods will be applied, and the potential implications of missing data will be considered when interpreting feasibility outcomes.

Patient and public involvement

This study protocol was co-designed in collaboration with a cancer survivor and a family member of a patient with pancreatic cancer, and reviewed by patient and public involvement (PPI) representatives. PPI representatives will also assist the research team in disseminating the study results. Furthermore, the protocol was reviewed and revised based on the feedback from PPI representatives during the Scientific Advisory Board meeting of the Survivorship Care and Quality of Life Research Association (SaQRA).

Data management, central monitoring and auditing

All study data will be collected using electronic data capture and ePRO systems and stored on institutional servers in compliance with national data protection regulations. All data will be de-identified prior to analysis. Data management and central monitoring will be conducted by designated personnel from the Department of Survivorship Research, National Cancer Institute for Cancer Control, who are independent of the study team. No auditing is planned for this study.

Ethics and dissemination

This study will be conducted in accordance with the Ethical Guidelines for Medical and Biological Research Involving Human Subjects issued by the Japanese Ministry of Education, Culture, Sports, Science and Technology and the Ministry of Health, Labour and Welfare, the amended Act on the Protection of Personal Information, and the ethical principles outlined in the Declaration of Helsinki and its subsequent amendments. Written informed consent will be obtained from all participants prior to enrolment, including consent for publication of anonymised data (online supplemental material). Any substantial protocol modifications will be discussed by the investigators and submitted to the relevant ethics review committee for approval before implementation.

Publication policy

The study protocol and subsequent study results will be submitted for publication in peer-reviewed journals. The first author of the primary manuscript will be a member of the steering committee. The list of coauthors will be determined in advance of each manuscript submission, in accordance with authorship criteria defined by the International Committee of Medical Journal Editors.

Discussion

Building on previous evidence demonstrating the benefits of GAM with communication support, this pilot RCT aims to assess the feasibility of a digital intervention that integrates GA with structured communication support using GAM and QPL; it will be delivered through a mobile application for older adults with cancer, in which implementation barriers, such as time and workforce required to perform GA and interpret its findings, tailor management strategies and communicate results to patients,^{8 11 12} are expected to be overcome by leveraging digital technology to provide tailored GAM recommendations with a personalised QPL. Furthermore, adopting a randomised design will enable preliminary estimation of effect sizes for key outcomes, particularly grade≥3 adverse events, which will be a candidate primary endpoint in the subsequent trial. Thus, this study will provide important information for the development of a future multicentre hybrid effectiveness–implementation trial (Hybrid Type 1 design).^{30 31}

The application-based intervention programme was developed using data from the prior MAPLE trial, in which conversations between patients and intervention providers were recorded and categorised by GA domain. Using text mining techniques, key elements, such as commonly selected QPL items and frequently used patient expressions, were extracted. These elements were used to create domain-specific best-practice scenarios, algorithmically incorporated into the application to personalise communication support and enhance clinical relevance. This automation enables delivery of tailored, scenario-based guidance without requiring face-to-face facilitation by trained intervention providers (figure 1). It is expected that this approach will enable older adults to independently complete GA and receive individualised guidance in a user-friendly digital format, while reducing the burden on healthcare providers.

The primary endpoint of this study is the completion rate of the protocol intervention. The decision criterion of a≥75% completion rate as the acceptable feasibility was based on prior studies of mobile application–based interventions in oncology, where completion rates of 70–80% have been commonly used to indicate acceptable feasibility.^{32 33} Given that the present intervention requires patients to independently complete the GA and QPL using a digital platform, a modest level of burden is anticipated. Furthermore, research staff support and the provision of study devices are expected to mitigate barriers such as limited digital literacy. Thus, it is considered that a completion rate of 75% is a realistic and clinically meaningful benchmark. Even if the primary endpoint is not met, the prespecified three-tier decision criteria (≥75% feasible; 45–74% feasible with modifications; <45% not feasible) allow refinement of the intervention referring to the reasons for discontinuation collected in this study. Therefore, the selected cut-off provides a balanced standard, reflecting both evidence from prior digital health studies and the pragmatic considerations for the subsequent definitive Hybrid Type 1 trial.

In addition to feasibility, this randomised study also aims to evaluate the clinical outcomes such as treatment-related adverse events, healthcare utilisation, communication satisfaction, IADL and QOL as the secondary endpoints. The deliberate inclusion of a broad range of outcomes is consistent with the exploratory nature of pilot trials and provides preliminary data on multiple domains that are highly relevant to geriatric oncology. Collecting these data will allow us to assess variability, effect size and data completeness, which are critical for selecting the most appropriate primary and secondary endpoints for the subsequent definitive Hybrid Type 1 trial. Furthermore, the inclusion of multiple outcomes enables a more comprehensive understanding of the potential impact of the intervention on both clinical and patient-centred aspects of care, beyond feasibility alone.

This study has some limitations. First, selection bias may occur because patients with cognitive impairment or limited digital literacy may be less likely to participate. However, the provision of staff support and rental tablets may help mitigate this issue. Second, since blinding is not possible due to the nature of the intervention, patient and provider behaviour may be influenced by knowledge of group assignment. Finally, as a pilot study with a small sample size and a limited follow-up period, it is not powered to detect statistically significant differences in the effectiveness outcomes.

Despite these limitations, this pilot study represents an important step towards developing scalable, sustainable and patient-centred strategies to personalise care for older adults with cancer. By embedding GA and communication support into an accessible mobile application, the MAPLE2 pilot study will lay the foundation for a future definitive trial, and ultimately facilitate the broader implementation of geriatric oncology principles in routine oncology practice.

The funder has no role in the design of the study, data collection, analysis, interpretation or the decision to submit the manuscript for publication.

Data availability statement

Data sharing not applicable as no datasets generated and/or analysed for this study.