MedTrace Logo

Telephone Support in Advanced Gastrointestinal Cancer

NCT06532877 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 488

Last updated 2026-01-23

No results posted yet for this study

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

Conditions

  • Gastrointestinal Neoplasm Malignant
  • Caregiver Burden

Interventions

BEHAVIORAL

Acceptance 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).

BEHAVIORAL

Education/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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Northwestern University

    collaborator OTHER

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • Eskenazi Health

    collaborator OTHER

  • Indiana University

    lead OTHER

Principal Investigators

  • Catherine E Mosher, Ph.D. · Indiana University Indianapolis

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-21
Primary Completion
2029-02-28
Completion
2029-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06532877 on ClinicalTrials.gov