UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058887 |
|---|---|
| Receipt number | R000067348 |
| Scientific Title | Geriatric Assessment and Management with Quetsion Prompt List using Mobile APpLications for Elderly Patients with Cancer (MAPLE-2): Pilot study |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/08/25 13:47:01 |
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Basic information
Public title
Mobile application for geriatric assessment and communication support to facilitate personalized multidisciplinary care in older adults with cancer (MAPLE2 pilot)
Acronym
MAPLE2 pilot
Scientific Title
Geriatric Assessment and Management with Quetsion Prompt List using Mobile APpLications for Elderly Patients with Cancer (MAPLE-2): Pilot study
Scientific Title:Acronym
MAPLE2 pilot
Region
| Japan |
Condition
Condition
Solid tumor or lymphoma
Classification by specialty
| Geriatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Our previous study (the MAPLE study) demonstrated that integrating geriatric assessment (GA) with structured communication support using a question prompt list (QPL) significantly facilitated discussion about aging-related concerns, leading to higher implementation of GA-guided management (GAM) recommendations and improved health outcomes among older adults with cancer. The MAPLE2 pilot study aims to evaluate the feasibility of a newly developed mobile application-based GA and QPL intervention among older adults with cancer aged 70 years or older who are initiating or changing systemic anticancer therapy.
Basic objectives2
Others
Basic objectives -Others
Feasibility
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
The proportion of participants in the intervention arm who complete the full intervention program at the first outpatient visit following the initial intervention
Key secondary outcomes
1. Health outcomes: incidence and severity of adverse events assessed by CTCAE and PRO-CTCAE within three months of randomization; proportion of participants who continued treatment as planned for three months; incidence of unscheduled hospital visits or unplanned hospital admissions within three months; functional status assessed by the OARS-IADL questionnaire at baseline and three months; quality of life (QOL) assessed by the EORTC QLQ-C30 at baseline and three months
2. Communication outcomes: communication satisfaction assessed by the CARE-10 at the first outpatient visit following the initial intervention and three months
3. Intermediate outcomes: the number of GAM recommendations implemented by their treating oncologists for participants in both arms within three months
4. Acceptability outcomes: consent rate, perceived usefulness and burden of the mobile application-based intervention program (from both physicians and patients) at the first outpatient visit following the initial intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention will, in principle, be conducted by patients themselves using the mobile application, with investigators assisting them as needed.
1. GA: Patients will complete the GA on the mobile application during waiting time before consultation. Based on the GA results, predefined management recommendations for identified vulnerable domains will be automatically generated.
2. QPL: According to the GA results, a tailored QPL will be generated and displayed in the application. Patients will identify their aging-related concerns and express their preferences regarding treatment and care by responding to the questions.
3. Care Plan Sharing: A tailored care plan will be created within the application, based on GA results and selected QPL items. The generated care plan will be shared between patients and physicians at the first outpatient visit following the intervention.
Interventions/Control_2
Usual care
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Diagnosis of solid cancer or malignant lymphoma
2. Age >=70 years
3. Scheduled to initiate or change the line of systemic anticancer therapy (chemotherapy, molecularly targeted therapy, or immunotherapy)
4. ECOG Performance Status of 0-2
5. Ability to read, write, and understand Japanese
6. Provision of written informed consent
7. Presence of at least one impaired GA domain at the time of registration
Key exclusion criteria
1. Participation or planned participation in other interventional studies that may interfere with this study (e.g., other psychological or communication support studies, or therapeutic clinical trials)
2. Judged by their attending oncologists to be unsuitable for participation
3. Presence of severe cognitive impairment without a proxy or legal representative
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Maiko |
| Middle name | |
| Last name | Fujimori |
Organization
National Cancer Center
Division name
Division of Survivorship Research, Institute for Cancer Control
Zip code
1040045
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo
TEL
0335475201
mfujimori@ncc.go.jp
Public contact
Name of contact person
| 1st name | Ayumu |
| Middle name | |
| Last name | Matsuoka |
Organization
National Cancer Center
Division name
Division of Survivorship Research, Institute for Cancer Control
Zip code
1040045
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo
TEL
0335475201
Homepage URL
aymatsuo@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center IRB
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo
Tel
0335475201
irst@ml.res.ncc.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2030 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 25 | Day |
Last modified on
| 2025 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067348
