advanced or recurrent esophageal cancer, gastric cancer, colorectal cancer, liver cancer, biliary cancer, and pancreatic cancer
Conditions
Interventions
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 pa
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 Questi
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 ju
Sponsors
National Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of conversations about aging-related concerns during consultation at the first outpatient visit after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactAyumu Matsuoka
National Cancer Center Group for Supportive Care and Survivorship Research, Institute for Cancer Control
Outcome results
None listed