Telephone support for patients with advanced gastrointestinal cancer

Telephone Support Program for Patients With Advanced Gastrointestinal Cancer and Their Family Caregivers

This study is testing whether a telephone counseling program can help patients with advanced gastrointestinal cancer and their caregivers manage stress and fatigue better than standard support.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 488 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Indiana University (other)
• Locations: 4 sites (Chicago, Illinois and 3 other locations)
• Trial ID: NCT06532877 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a telephone counseling program using acceptance and commitment therapy (ACT) for patients with advanced gastrointestinal cancer and their family caregivers. Participants will engage in six weekly telephone sessions focused on managing stress and symptoms, compared to a program that provides education and psychosocial support. The study aims to determine if the ACT program reduces fatigue interference in patients and alleviates caregiver burden. Additionally, it will explore psychological flexibility as a potential mediator of these effects.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are at least three weeks post-diagnosis of unresectable stage III or IV gastrointestinal cancer and experiencing moderate to severe fatigue.

Not a fit: Patients with significant psychiatric or cognitive impairments, those receiving hospice care, or those unable to participate due to communication barriers may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly improve the quality of life for patients and reduce the burden on their caregivers.

How similar studies have performed: Other studies have shown promise in using telephone-based interventions for cancer support, indicating that this approach may be effective.

Eligibility criteria

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.

Where this trial is running

Chicago, Illinois and 3 other locations

• Northwestern Medicine — Chicago, Illinois, United States (RECRUITING)
• Eskenazi Health — Indianapolis, Indiana, United States (NOT_YET_RECRUITING)
• Indiana University Health — Indianapolis, Indiana, United States (RECRUITING)
• MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Catherine E Mosher, Ph.D. — Indiana University Indianapolis
• Study coordinator: Hannah Mullin

Conditions: Gastrointestinal Neoplasm Malignant, Caregiver Burden, Gastrointestinal Neoplasms, Family Caregivers, Acceptance and Commitment Therapy, Fatigue, Psychotherapy