Telephone Support in Advanced Gastrointestinal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndiana University
About this trial
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 criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Acceptance and Commitment Therapy
- Education/Support
Treatment groups
488 Participants
are divided into 2 treatment groupsSponsors and collaborators
Indiana University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Northwestern University
Collaborator
M.D. Anderson Cancer Center
Collaborator
Eskenazi Health
Collaborator
Source ClinicalTrials.gov