Recruiting

Observational Study

Sponsor:

Indiana University

Code:

NCT06532877

Conditions

Gastrointestinal Neoplasm Malignant

Caregiver Burden

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Acceptance and Commitment Therapy

Education/Support

Study Details

Brief 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

Conditions

Gastrointestinal Neoplasm Malignant

Caregiver Burden

Study ID

NCT06532877

Start date

Aug 21, 2024

Status verified date

Jul, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Feb, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

488 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Acceptance and Commitment Therapy

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.

active comparator: Education/Support

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.

Interventions

Acceptance 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).

Education/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.

Primary outcome measure

  • Fatigue Interference Subscale of Fatigue Symptom Inventory [ Time Frame: 2 weeks and 3 months post-intervention ]
  • Short-form of Zarit Burden Interview [ Time Frame: 2 weeks and 3 months post-intervention ]

Central Contacts and Locations

Central contacts

Hannah Mullin

317-278-4005cancerq@iu.edu

Locations

Northwestern Medicine

Recruiting

Chicago, Illinois, United States, 60611

Eskenazi Health

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Hannah Mullin

317-278-4005cancerq@iu.edu

Indiana University Health

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Hannah Mullin

317-278-4005cancerq@iu.edu

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Indiana University

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • Gastrointestinal Neoplasms
  • Family Caregivers
  • Acceptance and Commitment Therapy
  • Fatigue
  • Psychotherapy
  • Caregiver Burden

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-07-06.