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Telephone Support for Advanced Gastrointestinal Cancer Patients and Caregivers

NCT04010227 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2022-12-22

Study results available
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Summary

This trial tests telephone-based Acceptance and Commitment Therapy (ACT), a type of psychotherapy, to reduce fatigue interference with activities, mood, and cognition in advanced gastrointestinal (GI) cancer patients and family caregiver burden. ACT includes mindfulness exercises (e.g., meditations, performing activities with greater awareness), identifying personal values (e.g., family, spirituality), and engaging in activities consistent with these values. A total of 40 patient-caregiver dyads were randomly assigned in equal numbers to either the ACT intervention or an education/support condition. Dyads in both conditions participated in six weekly 50-minute telephone sessions. Outcomes were assessed at baseline, 2 weeks post-intervention, and 3 months post-intervention. The investigators hypothesize that ACT will lead to improved primary and secondary outcomes as compared to education/support. Study findings will inform a large-scale trial of intervention efficacy.

Conditions

  • Gastrointestinal Neoplasms

Interventions

BEHAVIORAL

Acceptance and Commitment Therapy

Across six weekly 50-minute sessions, advanced GI 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 we developed to guide mindfulness practices.

BEHAVIORAL

Education/Support

Across six weekly 50-minute sessions, advanced GI 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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Indiana University

    lead OTHER

Principal Investigators

  • Catherine E Mosher, Ph.D. · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-16
Primary Completion
2021-06-08
Completion
2021-06-08

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04010227 on ClinicalTrials.gov