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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: Completed NA study, sponsored by Indiana University.
NCT04010227 is a NA study that has completed, run by Indiana University. The registered enrollment target is 84 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Seven items are rated on 11-point scales (0=no interference to 10=extreme interference) that assess the extent to which fatigue in the past week interfered with general level of activity, ability to bathe and dress, normal work activity (including housework), ability to concentrate, relations with others, enjoyment of life, and mood. The seven items are summed with higher total scores indicating greater fatigue interference. The total score range is 0 to 70. This is the primary outcome for patie
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 |
What the finished NCT04010227 record still lists
NCT04010227 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Acceptance and Commitment Therapy is the first listed.
NCT04010227 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04010227's enrollment target sits among peer trials
84 983rd of 2000 higher than 1,011 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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