Telephone Support for Advanced Gastrointestinal Cancer Patients and Caregivers

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.

Sex

All

Minimum age

18 Years

Patient Inclusion Criteria:

* Patient is at least 3 weeks post-diagnosis of unresectable stage III or stage IV gastrointestinal cancer (i.e., anal, colon, esophageal, gallbladder, liver, pancreatic, rectal, small intestine, or stomach cancer) and is receiving care at the Indiana University Simon Cancer Center or Eskenazi Health.
* Patient is at least 21 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.

Caregiver Inclusion Criteria:

* Family caregiver identified by a stage IV gastrointestinal cancer patient who meets the eligibility criteria.
* Caregiver has significant caregiving burden or distress
* 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.

• BACKGROUNDMosher CE, Secinti E, Kroenke K, Helft PR, Turk AA, Loehrer PJ Sr, Sehdev A, Al-Hader AA, Champion VL, Johns SA. Acceptance and commitment therapy for fatigue interference in advanced gastrointestinal cancer and caregiver burden: protocol of a pilot randomized controlled trial. Pilot Feasibility Stud. 2021 Apr 20;7(1):99. doi: 10.1186/s40814-021-00837-9. PMID 33879253
• RESULTMosher CE, Secinti E, Wu W, Kashy DA, Kroenke K, Bricker JB, Helft PR, Turk AA, Loehrer PJ, Sehdev A, Al-Hader AA, Champion VL, Johns SA. Acceptance and commitment therapy for patient fatigue interference and caregiver burden in advanced gastrointestinal cancer: Results of a pilot randomized trial. Palliat Med. 2022 Jul;36(7):1104-1117. doi: 10.1177/02692163221099610. Epub 2022 May 30. PMID 35637615