Skip to content

Shared decision making for elderly advanced cancer patients

Support program to promote shared decision making for elderly with advanced gastric and colorectal cancer - ShareD-Elderly

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000041867
Enrollment
40
Registered
2020-09-23
Start date
2020-10-19
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced or recurrent gastric, colorectal, and esophagus cancer

Interventions

Based on the manual, the interventionist conducts: 1)Geriatric Assessment (GA): a guideline-based assessment of elderly&#39
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 cho

Sponsors

Institute for Cancer Control, National Cancer Center, Tokyo, Japan
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Perceived decision-making process in post-intervention consultations (Decisional Conflict Scale)

Secondary

MeasureTime frame
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)

Countries

Japan

Contacts

Public ContactKyoko Obama

National Cancer Center Group of Supportive Care and Survivorship Research, Institute for Cancer Control

kobama@ncc.go.jp03-3547-5201

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026