Telephone Support Program for Patients With Advanced Gastrointestinal Cancer and Their Family Caregivers
Indiana University
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
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 (GI) cancer (Aim 1) as well as secondary outcomes (Aim 2). This trial also examines increases in psychological flexibility as a hypothesized mediator of ACT's effects on patient fatigue interference and caregiver burden (Aim 3). Finally, two core aspects of psychological flexibility (i.e., mindfulness/acceptance and commitment/behavior change processes) are examined as exploratory mediators of ACT's…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Patient Inclusion Criteria: * 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). * Patient has moderate to severe fatigue interference with functioning. Patient Exclusion Criteria: * Patient sh…
Interventions
- BehavioralAcceptance 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).
- BehavioralEducation/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.
Locations (4)
- Northwestern MedicineChicago, Illinois
- Eskenazi HealthIndianapolis, Indiana
- Indiana University HealthIndianapolis, Indiana
- MD Anderson Cancer CenterHouston, Texas