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NCT04374825 · ClinicalTrials.gov registry record · NA
Optimizing Quality of Life in Women Living With Metastatic Breast Cancer
A NA study, sponsored by Northwestern University.
- Completed
- Registry status
- NA
- Development phase
- 31
- Enrollment target
NCT04374825: Completed NA study, sponsored by Northwestern University.
NCT04374825 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 31 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04374825, a NA study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- NA
- Development phase
- 31 participants
- Enrollment target
Study Summary
The purpose of this study is to develop and tailor an intervention program to improve the quality of life in women living with metastatic breast cancer. In the first phase of this study, we conducted patient focus groups to gather information about the unique challenges of living with MBC and what kinds of support women would like to receive in a tailored Acceptance and Commitment Therapy (ACT) intervention. In the second phase of the study, we will conduct a three-arm randomized controlled trial to the tailored ACT intervention with both a Cognitive Behavioral Stress Management (CBSM) intervention and usual care. The CBSM and ACT intervention groups will meet with a trained facilitator and 8-9 other patients, once per week via videoconference for 90 minute sessions over the course of 8 weeks.
Primary Outcome
Using the previously validated NIH PROMIS profile, change in HRQoL will be assessed from baseline to 1. mid-intervention (week 4), 2. immediately post-intervention (week 8), and a 3. one month follow-up.
Interventions
- BEHAVIORAL Acceptance and Commitment Therapy (ACT)
- BEHAVIORAL Cognitive Behavioral Stress Management (CBSM)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2019-04-24 |
| Est. Completion | 2021-03-08 |
| Phase | NA |
What the finished NCT04374825 record still lists
NCT04374825 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Acceptance and Commitment Therapy (ACT) is the first listed.
NCT04374825 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04374825 about?
NCT04374825 is a clinical study titled "Optimizing Quality of Life in Women Living With Metastatic Breast Cancer". The purpose of this study is to develop and tailor an intervention program to improve the quality of life in women living with metastatic breast cancer. In the first phase of this study, we conducted patient focus groups to gather information about the unique challenges of living with MBC and what k...
What is the current status of trial NCT04374825?
This trial is currently completed. It is a NA study. The enrollment target is 31 participants. The study started on 2019-04-24. Estimated completion is 2021-03-08.
What interventions are being tested in trial NCT04374825?
The interventions under investigation include: Acceptance and Commitment Therapy (ACT) (BEHAVIORAL), Cognitive Behavioral Stress Management (CBSM) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04374825?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04374825's enrollment target sits among peer trials
31 1592nd of 2000 higher than 408 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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