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NCT04126642 · ClinicalTrials.gov registry record · NA
Project Persist: mHealth for Cancer Survivorship
A NA study, sponsored by University of Oklahoma.
- Completed
- Registry status
- NA
- Development phase
- 57
- Enrollment target
NCT04126642 is a NA study that has completed, run by University of Oklahoma. The registered enrollment target is 57 participants.
The verdict
NCT04126642, a NA study, has completed, sponsored by University of Oklahoma.
- COMPLETED
- Registry status
- NA
- Development phase
- 57 participants
- Enrollment target
Study Summary
Many studies have shown that anxiety and depression are associated with reduced treatment adherence and poor treatment outcomes among patients undergoing cancer treatments. Given the negative consequences of psychological symptoms for cancer patients, it is important to effectively identify and address emotional distress among cancer patients. However, many barriers exist that limit access to effective treatments. Mobile health (mHealth) technologies offer the potential for remote monitoring and on demand management of psychological needs among cancer patients. This pilot randomized controlled trial (RCT) will assess the initial feasibility of a phone-delivered intervention for anxiety and depressive symptoms among cancer patients that are receiving active radiation treatments. A total of 60 participants will be randomized to in-person and smartphone-based assessment only (n=30) or assessment plus smartphone-based intervention (n=30). Both groups will be followed for 8 weeks (6 weeks while undergoing radiation therapy for breast or gynecological cancer + 2 weeks following radiation therapy). It is expected that patients who are randomized to the intervention group will report that the smartphone app is easy to use, app content is useful, and will show greater improvements in reported anxiety, depression, and quality of life compared with the assessment only group. Data from this pilot study will be used to inform the development of mHealth interventions that will be tested in future fully powered RCTs.
Interventions
- BEHAVIORAL Intervention group
- BEHAVIORAL Assessment only group
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2020-07-27 |
| Est. Completion | 2023-10-19 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04126642
The ClinicalTrials.gov registry entry for NCT04126642 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Oklahoma, which has 358 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Intervention group is the first listed.
NCT04126642 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04126642 about?
NCT04126642 is a clinical study titled "Project Persist: mHealth for Cancer Survivorship". Many studies have shown that anxiety and depression are associated with reduced treatment adherence and poor treatment outcomes among patients undergoing cancer treatments. Given the negative consequences of psychological symptoms for cancer patients, it is important to effectively identify and addr...
What is the current status of trial NCT04126642?
This trial is currently completed. It is a NA study. The enrollment target is 57 participants. The study started on 2020-07-27. Estimated completion is 2023-10-19.
What interventions are being tested in trial NCT04126642?
The interventions under investigation include: Intervention group (BEHAVIORAL), Assessment only group (BEHAVIORAL).
Who is sponsoring clinical trial NCT04126642?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
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