N/A
N=80
Telephone Support for Advanced Gastrointestinal Cancer Patients and Caregivers
Gastrointestinal Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT04010227 ↗Enrolled (actual)
80
Serious AEs
6.5%
Results posted
Dec 2022
Primary outcome: Primary: Fatigue Interference Subscale of Fatigue Symptom Inventory — 3.93; 3.47; 4.27; 4.26 units on a scale — p=0.60
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acceptance and Commitment Therapy (Behavioral); Education/Support (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fatigue Interference Subscale of Fatigue Symptom Inventory |
3.93; 3.47; 4.27; 4.26 | 0.60 |
| PRIMARY Short-form of Zarit Burden Interview |
13.92; 16.37; 15.32; 18.17 | 0.96 |
| SECONDARY Patient-Reported Outcome Measurement Information System (PROMIS) Sleep-Related Impairment |
57.37; 52.99; 56.91; 53.86 | 0.75 |
| SECONDARY PROMIS Ability to Participate in Social Roles and Activities |
45.02; 42.42; 45.58; 46.14; 42.56; 40.40 | 0.33 |
| SECONDARY Acceptance and Action Questionnaire-II |
13.82; 14.52; 13.85; 15.97; 17.77; 17.45 | 0.91 |
| SECONDARY McGill Quality of Life Questionnaire-Revised |
17.30; 16.89; 13.48; 14.80; 28.58; 29.98 | 0.74 |
| SECONDARY PROMIS Global Health |
46.11; 45.34; 45.58; 44.68; 45.01; 43.48 | 0.92 |
| SECONDARY Value Progress Subscale of the Valuing Questionnaire. |
21.71; 21.30; 22.71; 21.66; 23.05; 21.14 | 0.94 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04010227). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.