Actively Recruiting
Telephone Support in Advanced Gastrointestinal Cancer
Led by Indiana University · Updated on 2026-01-23
488
Participants Needed
4
Research Sites
232 weeks
Total Duration
On this page
Sponsors
I
Indiana University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Telephone Support in Advanced Gastrointestinal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is at least 3 weeks post-diagnosis of unresectable stage III or stage IV gastrointestinal cancer (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.
- Patient has moderate to severe fatigue interference with functioning.
- Family caregiver identified by a gastrointestinal cancer patient who meets the eligibility criteria.
- Family caregiver has significant caregiving burden.
- Family caregiver lives with the patient or has visited the patient in-person at least twice a week for the past month.
- Family caregiver is at least 18 years of age.
- Family caregiver can speak and read English.
You will not qualify if you...
- Patient shows significant psychiatric or cognitive impairment that would prevent informed consent and 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 prevents participation.
- Patient participated in the pilot trial testing the same intervention.
- Family caregiver shows significant psychiatric or cognitive impairment that would prevent informed consent and participation.
- Family caregiver does not have working phone service.
- Family caregiver has hearing impairment that prevents participation.
- Patient declines study participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Northwestern Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
2
Eskenazi Health
Indianapolis, Indiana, United States, 46202
Not Yet Recruiting
3
Indiana University Health
Indianapolis, Indiana, United States, 46202
Actively Recruiting
4
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
H
Hannah Mullin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here