Clinical trial · Interventional
Telephone Support in Advanced Gastrointestinal Cancer
Telephone Support Program for Patients With Advanced Gastrointestinal Cancer and Their Family Caregivers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Caregiver Burden | — | UNRESOLVED | — |
| Gastrointestinal Neoplasm Malignant | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acceptance and Commitment Therapy | Behavioral | — | UNRESOLVED |
| Education/Support | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Acceptance and Commitment Therapy
- description
- Across six weekly 50-minute sessions and a booster session, advanced gastrointestinal cancer patients and caregivers practice various mindfulness exercises, clarify their values, and set specific goals in alignment with their values. Through in-session and home practice of skills, participants learn new and more adaptive ways to respond to unwanted internal experiences (e.g., fatigue, distress). Participants receive handouts on session topics and a compact disc (CD) that the team developed to guide mindfulness practices.
- interventionNames
- Behavioral: Acceptance and Commitment Therapy
- type
- ACTIVE_COMPARATOR
- label
- Education/Support
- description
- Across six weekly 50-minute sessions and a booster session, advanced gastrointestinal cancer patients and caregivers are directed to resources for practical and health information and contact information for psychosocial services. Sessions include an orientation to the patient's medical center and treatment team, education regarding common quality-of-life concerns experienced by cancer patients and caregivers, and an overview of medical center and community resources for addressing these concerns. The therapist also describes resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants receive handouts summarizing session topics and are asked to review them as homework.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 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 Exclusion Criteria: * Caregiver shows significant psychiatric or cognitive impairment that would preclude providing informed consent and study participation. * Caregiver does not have working phone service. * Caregiver has hearing impairment that precludes participation. * Patient declines study participation.
References
Publications (1)
- DERIVEDMosher CE, Shinn EH, Addington EL, Wu W, Bricker JB, Helft PR, Turk AA, Vater LB, Masood A, Jalal SI, Loehrer PJ Sr, Champion VL, Johns SA. Protocol of a randomized trial of acceptance and commitment therapy for patient fatigue interference and caregiver burden in advanced gastrointestinal cancer. Contemp Clin Trials. 2026 Jan;160:108168. doi: 10.1016/j.cct.2025.108168. Epub 2025 Nov 26. PMID 41314597