Clinical trial NCT04010227: Telephone Support for Advanced Gastrointestinal Cancer Patients and Caregivers
Official title: Telephone Support for Advanced Gastrointestinal Cancer Patients and Their Family Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Neoplasms
Keywords: Acceptance and Commitment Therapy
Fatigue
Family Caregivers
Psychotherapy
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-07-08
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Advanced gastrointestinal cancer patient-family caregiver dyads (N = 40) were randomly assigned in equal numbers to Acceptance and Commitment Therapy (ACT) or education/support using a stratified block randomization scheme to balance the groups by patient performance status (patient-reported Eastern Cooperative Oncology Group \[ECOG\] scores 0 or 1 vs. 2).
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: This trial evaluates the feasibility, acceptability, and preliminary efficacy of telephone-based Acceptance and Commitment Therapy (ACT) on fatigue interference in advanced gastrointestinal (GI) cancer patients and family caregiver burden as well as secondary outcomes. The study team recruited advanced GI cancer patients receiving care at the Indiana University Simon Cancer Center or Eskenazi Health hospital. Potentially eligible patients were mailed an introductory letter signed by their oncologist and the PI along with a consent form. The letter had a number to call if they did not wish to be contacted further. A research assistant (RA) called all prospective participants who did not opt out approximately 1 to 2 weeks after the letter was mailed. The RA described the study as outlined in the consent form and answered any questions. Then the RA administered an eligibility screening to those who consented to participate. Eligible and consenting patients identified a potentially eligible family caregiver. If the family caregiver was eligible and consented to participate, then the patient and caregiver each completed a baseline phone assessment. Following baseline assessments, patient-caregiver dyads (N = 40 dyads) were randomly assigned in equal numbers to ACT or education/support using a stratified block randomization scheme to balance the groups by patient performance status (patient-reported Eastern Cooperative Oncology Group \[ECOG\] scores 0 or 1 vs. 2). Dyads in both study conditions completed six weekly 50-minute telephone sessions with the first session occurring one week after baseline. For ACT participants, adherence to home practice during the past week was assessed and recorded during each session. Feasibility will be examined via accrual, attrition, and adherence rates, and acceptability will be evaluated using a mixed methods approach (qualitative and quantitative). Blind interviewers assessed outcomes during follow-up phone assessments at 2 weeks and 3 months post-intervention.

Eligibility criteria: 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.

Primary outcomes:
measure: Fatigue Interference Subscale of Fatigue Symptom Inventory
timeFrame: 2 weeks and 3 months post-intervention
measure: Short-form of Zarit Burden Interview
timeFrame: 2 weeks and 3 months post-intervention
Secondary outcomes:
measure: Patient-Reported Outcome Measurement Information System (PROMIS) Sleep-Related Impairment
timeFrame: 2 weeks and 3 months post-intervention
measure: PROMIS Ability to Participate in Social Roles and Activities
timeFrame: 2 weeks and 3 months post-intervention
measure: Acceptance and Action Questionnaire-II
timeFrame: 2 weeks and 3 months post-intervention
measure: McGill Quality of Life Questionnaire-Revised
timeFrame: 2 weeks and 3 months post-intervention
measure: PROMIS Global Health
timeFrame: 2 weeks and 3 months post-intervention
measure: Value Progress Subscale of the Valuing Questionnaire.
timeFrame: 2 weeks and 3 months post-intervention
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Eskenazi Health
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Simon Comprehensive Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University
name: Catherine E Mosher, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mosher 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.
citation: Mosher 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.