# Acceptance and Commitment Therapy for Patient Fatigue Interference and Caregiver Burden in Advanced Gastrointestinal Cancer

> **NIH NIH R01** · INDIANA UNIVERSITY INDIANAPOLIS · 2024 · $645,910

## Abstract

Project Summary/Abstract
Fatigue interference with activities, mood, and cognition is one of the most prevalent and distressing concerns
of advanced gastrointestinal cancer patients. As fatigue interferes with patient functioning, family caregivers
often report feeling burdened by increasing responsibilities. Evidence-based interventions addressing cancer
patient fatigue interference and caregiver burden are lacking. In pilot studies, acceptance and commitment
therapy (ACT) has shown potential for reducing symptom-related suffering in cancer patients. We recently
conducted a pilot study testing a novel, dyadic ACT intervention for patients and family caregivers coping with
advanced gastrointestinal cancer. The intervention combines acceptance and mindfulness exercises (e.g.,
meditations, performing activities with greater awareness) with identification of personal values and
engagement in activities consistent with these values. This telephone-based intervention showed strong
evidence of feasibility, acceptability, and promise for reducing patient fatigue interference with functioning and
caregiver burden. The proposed phase II trial seeks to more definitively examine the efficacy of our telephone-
based ACT intervention for advanced gastrointestinal cancer patients with moderate to severe fatigue
interference and their family caregivers with significant caregiving burden. In this trial, 244 patient-caregiver
dyads will be randomly assigned in equal numbers to either the ACT intervention or an education/support
control condition. Dyads in both conditions will attend six weekly 50-minute telephone sessions. The primary
aim of this study is to test the effect of telephone-delivered ACT on patient fatigue interference and caregiver
burden. Secondary outcomes include patient sleep interference and patient and caregiver engagement in daily
activities and quality of life. Outcomes will be assessed at baseline, 2 weeks post-intervention, and 3 months
post-intervention. This trial will also examine whether increases in psychological flexibility, defined as full
awareness of the present moment while persisting in action aligned with personal values, account for the
beneficial effect of ACT on primary outcomes. Demonstrating ACT’s efficacy will support its adoption in cancer
care. This trial will also lay the groundwork for further application and testing of ACT with a wide range of
patients and caregivers coping with serious illnesses and functional outcomes.

## Key facts

- **NIH application ID:** 10858962
- **Project number:** 1R01CA289486-01
- **Recipient organization:** INDIANA UNIVERSITY INDIANAPOLIS
- **Principal Investigator:** Catherine E Mosher
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $645,910
- **Award type:** 1
- **Project period:** 2024-05-01 → 2029-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10858962

## Citation

> US National Institutes of Health, RePORTER application 10858962, Acceptance and Commitment Therapy for Patient Fatigue Interference and Caregiver Burden in Advanced Gastrointestinal Cancer (1R01CA289486-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10858962. Licensed CC0.

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