UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045428
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

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Basic information

Public title

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 -

Acronym

MAPLE

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

Scientific Title:Acronym

MAPLE

Region

Japan


Condition

Condition

advanced or recurrent esophageal cancer, gastric cancer, colorectal cancer, liver cancer, biliary cancer, and pancreatic cancer

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

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.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase III


Assessment

Primary outcomes

Number of conversations about aging-related concerns during consultation at the first outpatient visit after randomization

Key secondary outcomes

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


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom Maneuver

Interventions/Control_1

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.

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 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

Key exclusion criteria

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

Target sample size

210


Research contact person

Name of lead principal investigator

1st name Maiko
Middle name
Last name Fujimori

Organization

National Cancer Center

Division name

Group for Supportive Care and Survivorship Research, Institute for Cancer Control

Zip code

104-0045

Address

5-1-1 Tsukiji Chuo-ku Tokyo

TEL

0335475201

Email

mfujimori@ncc.go.jp


Public contact

Name of contact person

1st name Ayumu
Middle name
Last name Matsuoka

Organization

National Cancer Center

Division name

Group for Supportive Care and Survivorship Research, Institute for Cancer Control

Zip code

104-0045

Address

5-1-1 Tsukiji Chuo-ku Tokyo

TEL

03-3547-5201

Homepage URL


Email

aymatsuo@ncc.go.jp


Sponsor or person

Institute

National Cancer Center

Institute

Department

Personal name



Funding Source

Organization

AMED

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Cancer Center IRB

Address

03-3547-5201

Tel

03-3547-5201

Email

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

2021 Year 09 Month 13 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

Open public recruiting

Date of protocol fixation

2021 Year 04 Month 15 Day

Date of IRB

2021 Year 04 Month 15 Day

Anticipated trial start date

2021 Year 09 Month 21 Day

Last follow-up date

2025 Year 03 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

2021 Year 09 Month 09 Day

Last modified on

2023 Year 03 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051299


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name