advanced or recurrent gastric, colorectal, and esophagus cancer
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| Perceived decision-making process in post-intervention consultations (Decisional Conflict Scale) | — |
Secondary
| Measure | Time 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
National Cancer Center Group of Supportive Care and Survivorship Research, Institute for Cancer Control