Program Official
Principal Investigator
Catherine E
Mosher
Awardee Organization
Indiana University Indianapolis
United States
Fiscal Year
2024
Activity Code
R01
Early Stage Investigator Grants (ESI)
Not Eligible
Project End Date
NIH RePORTER
For more information, see NIH RePORTER Project 1R01CA289486-01
Acceptance and Commitment Therapy for Patient Fatigue Interference and Caregiver Burden in Advanced Gastrointestinal Cancer
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 telephonebased 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.
Clinical Trials
Study Name | Clinical Trial ID |
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Telephone Support in Advanced Gastrointestinal Cancer | NCT06532877 |