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NCT04010227 · ClinicalTrials.gov registry record · NA
Telephone Support for Advanced Gastrointestinal Cancer Patients and Caregivers
A NA study, sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 84
- Enrollment target
NCT04010227 is a NA study that has completed, run by Indiana University. The registered enrollment target is 84 participants.
The verdict
NCT04010227, a NA study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 84 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Acceptance and Commitment Therapy
- BEHAVIORAL Education/Support
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2019-09-16 |
| Est. Completion | 2021-06-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04010227
The ClinicalTrials.gov registry entry for NCT04010227 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Acceptance and Commitment Therapy is the first listed.
NCT04010227 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04010227 about?
NCT04010227 is a clinical study titled "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,...
What is the current status of trial NCT04010227?
This trial is currently completed. It is a NA study. The enrollment target is 84 participants. The study started on 2019-09-16. Estimated completion is 2021-06-08.
What interventions are being tested in trial NCT04010227?
The interventions under investigation include: Acceptance and Commitment Therapy (BEHAVIORAL), Education/Support (BEHAVIORAL).
Who is sponsoring clinical trial NCT04010227?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
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