RECRUITING

Telephone Support in Advanced Gastrointestinal Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-08-21
Study Completion:2029-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06532877

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient is at least 3 weeks post-diagnosis of unresectable stage III or stage IV gastrointestinal cancer (i.e., anal, colon, esophageal, gallbladder, liver, pancreatic, rectal, small intestine, or stomach cancer) and is receiving cancer care at one of the study sites.
  2. * Patient is at least 18 years of age.
  3. * Patient can speak and read English.
  4. * Patient has an eligible, consenting family caregiver (see criteria below).
  5. * Patient has moderate to severe fatigue interference with functioning.
  1. * Patient shows significant psychiatric or cognitive impairment that would preclude providing informed consent and study participation.
  2. * Patient reports being able to do little activity on a functional status measure.
  3. * Patient is receiving hospice care at screening.
  4. * Patient does not have working phone service.
  5. * Patient has hearing impairment that precludes participation.
  6. * Patient participated in the pilot trial testing the same intervention.

Contacts and Locations

Study Contact

Hannah Mullin
CONTACT
317-278-4005
cancerq@iu.edu

Principal Investigator

Catherine E Mosher, Ph.D.
PRINCIPAL_INVESTIGATOR
Indiana University Indianapolis

Study Locations (Sites)

Northwestern Medicine
Chicago, Illinois, 60611
United States
Eskenazi Health
Indianapolis, Indiana, 46202
United States
Indiana University Health
Indianapolis, Indiana, 46202
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Indiana University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-21
Study Completion Date2029-02

Study Record Updates

Study Start Date2024-08-21
Study Completion Date2029-02

Terms related to this study

Keywords Provided by Researchers

  • Gastrointestinal Neoplasms
  • Family Caregivers
  • Acceptance and Commitment Therapy
  • Fatigue
  • Psychotherapy
  • Caregiver Burden

Additional Relevant MeSH Terms

  • Gastrointestinal Neoplasm Malignant
  • Caregiver Burden