Unique ID issued by UMIN | UMIN000045428 |
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Receipt number | R000051299 |
Scientific Title | Randomized Controlled Trial to Develop a Program for Geriatric Assessment and Management by Mobile Applications for Elderly Patients with Advanced and Recurrent Cancer |
Date of disclosure of the study information | 2021/09/13 |
Last modified on | 2023/03/12 10:46:25 |
Geriatric Assessment and Management with Question Prompt List using a Web-based Application for Elderly Cancer Patients to Communicate Aging-related Concerns - Randomized Controlled Trial -
MAPLE
Randomized Controlled Trial to Develop a Program for Geriatric Assessment and Management by Mobile Applications for Elderly Patients with Advanced and Recurrent Cancer
MAPLE
Japan |
advanced or recurrent esophageal cancer, gastric cancer, colorectal cancer, liver cancer, biliary cancer, and pancreatic cancer
Gastroenterology | Hepato-biliary-pancreatic medicine |
Malignancy
NO
A randomized, controlled phase III trial to investigate whether a program consisting of management based on comprehensive geriatric assessment (CGA) and communication support by mobile applications will facilitate communication about aging-related concerns between patients and their oncologists for elderly patients with cancer who are scheduled to start new chemotherapy.
Efficacy
Confirmatory
Explanatory
Phase III
Number of conversations about aging-related concerns during consultation at the first outpatient visit after randomization
1. Health outcomes: overall survival at 6 and 12 month, treatment failure free survival (TFFS), assessment of the frequency and severity of adverse events of chemotherapy within 3 months (CTCAE/PRO-CTCAE), prevalence of dose modification within 3 months (treatment modification, dose reduction, and/or discontinuation), unscheduled hospitalization and emergency department visits within 3 months, functional status (IADL) at 3 and 6 month, Quality of life at 3 and 6 month (EORTC-QLQ-C30)
2. Communication outcomes: quality of communication about aging-related concerns, physician communication behavior (SHARE/RIAS), satisfaction with communication (CARE-10) at the first outpatient visit after randomization, 3 and 6 month, and trust in oncologists (TiOS) at the first outpatient visit after randomization
3. Intermediate outcome: The number of geriatric problems successfully addressed for participants in the intervention arm within 3 months
4. Other outcomes: Patients' assessment survey on the burden and usefulness of the intervention, Oncologists' assessment survey on the burden and usefulness of the intervention
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Educational,Counseling,Training
Behavior,custom | Maneuver |
Based on the manual, clinical psychologist, nurses, physicians, or hospital staff as the interventionist will:
1) Explain the Geriatric Assessment (GA) summary to the patient and then discuss the patient's perception about GA impairments and need for recommended management; then prepare a feedback sheet based on information obtained from the patients, such as aging-related concerns and their interest in the recommendations,
2) Provide communication support using Question Prompt List (QPL), assist patients in organizing and communicating aging-related concerns and intentions for treatment and care to their oncologists; then prepare a feedback sheet including a list of selected questions,
3) Provide feedback on the results of 1) and 2) to their oncologist using a feedback sheet.
Interventions will be conducted just prior to the first outpatient visit after randomization. Interventionists are clinical psychologists, nurses, physicians, or hospital staff who have completed training based on the manual in advance.
For the 5 months after the initial intervention, interventionists will review and discuss implementation of GA-guided management monthly with the patients and their oncologists to implement management as needed. At 3 months after the initial GA+QPL, GA will be reassessed, and management will be revised if necessary, and feedback on GA+QPL will be provided to patients and oncologists in the same manner as that in the first intervention.
Usual care
70 | years-old | <= |
Not applicable |
Male and Female
1. Diagnosis of esophageal, gastric, colorectal, hepatic, biliary tract, or pancreatic cancer
2. Incurable disease (locally advanced stage III/IV or recurrent)
3. Age 70 years or older
4. ECOG Performance Status score of 0-2
5. Scheduled to receive first- 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. 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 (e.g., other psychological or communication support studies, clinical trials, etc.)
3. Judged to have difficulty participating in the study by attending oncologists
210
1st name | Maiko |
Middle name | |
Last name | Fujimori |
National Cancer Center
Group for Supportive Care and Survivorship Research, Institute for Cancer Control
104-0045
5-1-1 Tsukiji Chuo-ku Tokyo
0335475201
mfujimori@ncc.go.jp
1st name | Ayumu |
Middle name | |
Last name | Matsuoka |
National Cancer Center
Group for Supportive Care and Survivorship Research, Institute for Cancer Control
104-0045
5-1-1 Tsukiji Chuo-ku Tokyo
03-3547-5201
aymatsuo@ncc.go.jp
National Cancer Center
AMED
Other
Japan
National Cancer Center IRB
03-3547-5201
03-3547-5201
irst@ml.res.ncc.go.jp
NO
2021 | Year | 09 | Month | 13 | Day |
Unpublished
Open public recruiting
2021 | Year | 04 | Month | 15 | Day |
2021 | Year | 04 | Month | 15 | Day |
2021 | Year | 09 | Month | 21 | Day |
2025 | Year | 03 | Month | 31 | Day |
2021 | Year | 09 | Month | 09 | Day |
2023 | Year | 03 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051299
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