RecruitingNot ApplicableNCT06532877

Telephone Support in Advanced Gastrointestinal Cancer

Telephone Support Program for Patients With Advanced Gastrointestinal Cancer and Their Family Caregivers

Sponsor

Indiana University

Enrollment

488 participants

Start Date

Aug 21, 2024

Study Type

INTERVENTIONAL

Conditions

Caregiver Burden Gastrointestinal Neoplasm Malignant

Summary

The goal of this clinical trial is to see if telephone support programs help patients and their family caregivers adjust to advanced gastrointestinal cancer. A new telephone counseling program that involves practicing strategies for managing stress and symptoms will be compared to a telephone program involving education on quality-of-life issues and psychosocial support. The main questions it aims to answer are: Does our telephone counseling program lower the negative impact of patients' fatigue on their activities, emotions, and thinking abilities compared to a telephone program involving education and support? Does our telephone counseling program lower family caregivers' feelings of burden compared to a telephone program involving education and support? Participants in both study conditions will: Complete 6 weekly telephone sessions of counseling or education/support Complete a telephone booster session Complete 3 telephone interviews over about 5 months

Eligibility

Min Age: 18 Years

Inclusion Criteria10

Patient is at least 3 weeks post-diagnosis of unresectable stage III or stage IV gastrointestinal cancer (i.e., ampullary, anal, appendix, bile duct, colon, esophageal, gallbladder, liver, pancreatic, rectal, small intestine, or stomach cancer) and is receiving cancer care at one of the study sites.
Patient is at least 18 years of age.
Patient can speak and read English.
Patient has an eligible, consenting family caregiver (see criteria below).
Patient has moderate to severe fatigue interference with functioning.
Family caregiver identified by a gastrointestinal cancer patient who meets the eligibility criteria.
Caregiver has significant caregiving burden.
Caregiver lives with the patient or has visited the patient in-person at least twice a week for the past month.
Caregiver is at least 18 years of age.
Caregiver can speak and read English.

Exclusion Criteria10

Patient shows significant psychiatric or cognitive impairment that would preclude providing informed consent and study participation.
Patient reports being able to do little activity on a functional status measure.
Patient is receiving hospice care at screening.
Patient does not have working phone service.
Patient has hearing impairment that precludes participation.
Patient participated in the pilot trial testing the same intervention.
Caregiver shows significant psychiatric or cognitive impairment that would preclude providing informed consent and study participation.
Caregiver does not have working phone service.
Caregiver has hearing impairment that precludes participation.
Patient declines study participation.

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Interventions

BEHAVIORALAcceptance and Commitment Therapy

Patients and caregivers in the acceptance and commitment therapy arm learn new and more adaptive ways to respond to difficult internal experiences (e.g., fatigue, thoughts, and feelings).

BEHAVIORALEducation/Support

Patients and caregivers in the education/support arm discuss their cancer-related concerns and receive education on services available in their medical center and community.