UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041867 |
|---|---|
| Receipt number | R000047717 |
| Scientific Title | Support program to promote shared decision making for elderly with advanced gastric and colorectal cancer |
| Date of disclosure of the study information | 2020/09/23 |
| Last modified on | 2023/03/01 10:33:53 |
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Basic information
Public title
Shared decision making for elderly advanced cancer patients
Acronym
ShareD-Elderly
Scientific Title
Support program to promote shared decision making for elderly with advanced gastric and colorectal cancer
Scientific Title:Acronym
ShareD-Elderly
Region
| Japan |
Condition
Condition
advanced or recurrent gastric, colorectal, and esophagus cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A randomized, controlled phase II trial to investigate whether a communication support program including GA facilitates shared decision making in elderly patients with advanced cancer who are starting new treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Perceived decision-making process in post-intervention consultations (Decisional Conflict Scale)
Key secondary outcomes
1. Patient outcomes: IADL/ADL, depression(GDS), and anxiety(GAD-7)
2. Communication outcomes: satisfaction with communication(CARE-10), physician communication behavior (SHARE&RIAS), and perceptions of collaborative decision making(SDM-Q-9)
3. Treatment outcomes: assessment of the frequency and severity of adverse events of chemotherapy (PRO-CTCAE/CTCAE)
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
| Maneuver | Other |
Interventions/Control_1
Based on the manual, the interventionist conducts:
1)Geriatric Assessment (GA): a guideline-based assessment of elderly's physical, cognitive and social functioning to assess their vulnerability to treatment.
2)Communication coaching: role-playing to help elderly sort out their goals and values regarding treatment choices using the question promotion list (QPL) and express them to their doctor
3)Providing feedback on the results of the GA and QPL to the patient/family as well as the doctor.
Interventions will be carried out prior to the consultation with the doctor.
Within this process, psychological support will be provided when necessary. Interventionists are clinical psychologists, psycho-oncologists, and nurses who have completed training in accordance with the manual in advance.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Diagnosed with gastric or colorectal cancer (colon or rectal cancer) and starting initial or new* cancer therapy
2. Gastric cancer Stage IV or recurrence, or colorectal cancer Stage III/IV or recurrence**.
3. Age at the date of study enrollment is 65 years or older
4. ECOG Performance Status: 0-2
5. Be able to read, write, and understand Japanese.
*Cancer medication (intravenous and oral), radiotherapy, and palliative treatment.
**There are no restrictions on prior treatment even if this diagnosis is a recurrence.
Key exclusion criteria
1. With active, overlapping cancer***
2. Scheduled to undergo surgical treatment within 3 months from the date of study enrollment
However, disease-free period of 5 years or less does not include a history of any of the following cancers, such as stage 0 clinical stage cancer with a complete response or complete resection with treatment:
Gastric cancer (adenocarcinoma, common type): Stage 0 to stage I
Colon cancer (adenocarcinoma): Stage 0 to stage I
Rectal cancer (adenocarcinoma): Stage 0 to stage I, stage 2 to stage 3
Esophageal cancer (squamous cell carcinoma, adenosquamous cell carcinoma, basal cell carcinoma): Stage 0
Breast cancer (noninvasive ductal carcinoma and noninvasive lobular carcinoma): Stage 0
Breast cancer (invasive ductal carcinoma, invasive lobular carcinoma, and Paget's disease): Stage 0 - stage IIA
Cancer of the uterine body (endometrial adenocarcinoma and mucinous adenocarcinoma): Stage I
Prostate cancer (adenocarcinoma): Stage I-II
Cervical cancer (squamous cell carcinoma): Stage 0
Thyroid cancer (papillary carcinoma, follicular carcinoma): Stage I, II and III
Kidney cancer (paleoscleral carcinoma, anaplastic cell carcinoma): Stage I
Other lesions equivalent to intramucosal cancer
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 Behavioral Sciences Research, Center for Public Health Sciences
Zip code
104-0045
Address
5-1-1 Tsukiji Chuo-ku Tokyo
TEL
03-3547-5201
mfujimor@ncc.go.jp
Public contact
Name of contact person
| 1st name | Kyoko |
| Middle name | |
| Last name | Obama |
Organization
National Cancer Center
Division name
Group of 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
kobama@ncc.go.jp
Sponsor or person
Institute
Institute for Cancer Control, National Cancer Center, Tokyo, Japan
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
5-1-1 Tsukiji Chuo-ku Tokyo
Tel
03-3547-5201
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
国立がん研究センター中央病院（東京）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 23 | Day |
Related information
URL releasing protocol
https://www.geriatriconcology.net/issue/S1879-4068(22)X0008-8?pageStart=1
Publication of results
Partially published
Result
URL related to results and publications
https://www.geriatriconcology.net/issue/S1879-4068(22)X0008-8?pageStart=1
Number of participants that the trial has enrolled
40
Results
Patients' perception did not significantly differ between groups after the consultation. The number of aging-related concerns discussed between patients and oncologists was significantly increased in the intervention group than in the usual care group. The time to complete Geriatric assessment was eleven minutes on average, and seventy percent of the patients performed a self-administered Geriatric assessment without any assistance.
Results date posted
| 2023 | Year | 03 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Among 40 randomly assigned patients, one patient in the intervention group did not complete the intervention due to poor health; 33 of 40 patients had completed 3-month follow-up. There were no group differences in the baseline medical and sociological background. Thirty-one of 40 patients had abnormal G8 score.
Participant flow
Participants were recruited from the Departments of Gastrointestinal Medical Oncology at the National Cancer Center Hospital Tokyo, Japan. The inclusion criteria were as follows: patients 65 years or older with incurable esophageal, gastric, or colorectal cancer; scheduled to start new chemotherapy, patients were required have an Eastern Cooperative Oncology Group performance status score of 0-2; provision of written consent prior to participation, and ability to read, write, and understand Japanese. Exclusion criteria were patients who were judged by the attending physician to have difficulty participating in the study; scheduled to undergo surgery within 3 months. Trained research assistants reviewed the electric medical records and listed the potentially eligible patients. Research assistants approached eligible patients consecutively with permission from their oncologists. In order to enroll and allocate patients immediately prior to the treatment decision-making, those patients who were still receiving their previous treatment were informed about the study and their consent was obtained so that they could be enrolled in the study when they need to discuss about treatment change with their physicians.
Adverse events
N/A
Outcome measures
The key outcomes were the shared decision-making process and the feasibility. The shared decision-making process was evaluated in both subjective and objective ways, patients' perceptions using a decisional conflict scale, and the number of communications using audio-recorded data. Feasibility was evaluated by the time and the assistance to perform Geriatric assessment, and the usefulness and the burden of the program.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 23 | Day |
Last modified on
| 2023 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047717
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