Status:
RECRUITING
Telephone Support in Advanced Gastrointestinal Cancer
Lead Sponsor:
Indiana University
Collaborating Sponsors:
National Cancer Institute (NCI)
Northwestern University
Conditions:
Gastrointestinal Neoplasm Malignant
Caregiver Burden
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 in...
Detailed Description
This trial tests the effects of telephone-delivered acceptance and commitment therapy (ACT) on patient fatigue interference with functioning and family caregiver burden in advanced gastrointestinal (G...
Eligibility Criteria
Inclusion
- Patient
- 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.
- 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.
- Patient
Exclusion
- 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 Inclusion Criteria:
- 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.
- Caregiver
Key Trial Info
Start Date :
August 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2029
Estimated Enrollment :
488 Patients enrolled
Trial Details
Trial ID
NCT06532877
Start Date
August 21 2024
End Date
February 1 2029
Last Update
December 18 2024
Active Locations (4)
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1
Northwestern Medicine
Chicago, Illinois, United States, 60611
2
Eskenazi Health
Indianapolis, Indiana, United States, 46202
3
Indiana University Health
Indianapolis, Indiana, United States, 46202
4
MD Anderson Cancer Center
Houston, Texas, United States, 77030