Shared decision making for elderly advanced cancer patients

Phase 2

• Conditions: advanced or recurrent gastric, colorectal, and esophagus cancer

• Registration Number: JPRN-UMIN000041867
• Lead Sponsor: Institute for Cancer Control, National Cancer Center, Tokyo, Japan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-23
• Study Completion: 2021-05-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perceived decision-making process in post-intervention consultations (Decisional Conflict Scale)

Secondary Outcome Measures

Name	Time	Method
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)