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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: Completed NA study, sponsored by University of Oklahoma.
NCT04126642 is a NA study that has completed, run by University of Oklahoma. The registered enrollment target is 57 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The study plans to assess the differences between the 8 week and baseline values of scores from validated scales for evaluating anxiety (GAD7) and depression (PHQ and CESD). Exact 95% confidence intervals will be estimated for the difference between the 8 week and baseline scores in the intervention and control groups. The scale scores for anxiety and depression obtained from the EMA measurements will also be modeled, which are correlated within participants. Thus, we will use linear mixed model
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 |
What the finished NCT04126642 record still lists
NCT04126642 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Intervention group is the first listed.
NCT04126642 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04126642's enrollment target sits among peer trials
57 1261st of 2000 higher than 739 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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