Telephone support for patients with advanced gastrointestinal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Northwestern Medicine
  Chicago, Illinois, United States Recruiting
• Eskenazi Health
  Indianapolis, Indiana, United States 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
• Email: cancerq@iu.edu
• Phone: 317-278-4005

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.