CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 84 enrolled
Drug / intervention
Acceptance and Commitment Therapy +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04010227
NCT04010227N/ACompleted

Telephone Support for Advanced Gastrointestinal Cancer Patients and Their Family Caregivers

Indiana University·interventional·Posted Jul 8, 2019·Updated Dec 22, 2022

In Brief

A clinical study evaluating Acceptance and Commitment Therapy and Education/Support for Gastrointestinal Neoplasms. Completed, enrolled 84 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJul 8, 2019
Enrollment StartSep 16, 2019
Primary CompletionJun 8, 2021
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 7.0 years ago

Interventions

Acceptance and Commitment Therapybehavioral

Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers practice various mindfulness exercises, clarify their values, and set specific goals in alignment with their values. Through in-session and home practice of skills, participants learn new and more adaptive ways to respond to unwanted internal experiences (e.g., fatigue, distress). Participants receive handouts on session topics and a compact disc (CD) that we developed to guide mindfulness practices.

Education/Supportbehavioral

Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers are directed to resources for practical and health information and contact information for psychosocial services. Sessions include an orientation to the patient's medical center and treatment team, education regarding common quality-of-life concerns experienced by cancer patients and caregivers, and an overview of medical center and community resources for addressing these concerns. The therapist also describes resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants receive handouts summarizing session topics and are asked to review them as homework.