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NCT05703178 · ClinicalTrials.gov registry record · Phase 3
Web-based Pain Coping Skills Training for Breast Cancer Survivors With AI-Associated Arthralgia
A Phase 3 study of Breast Cancer and Pain, Chronic, sponsored by Northwestern University.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 452
- Enrollment target
- 2
- Study locations
NCT05703178 is a Phase 3 study of Breast Cancer and Pain, Chronic that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 452 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (84% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT05703178, a Phase 3 study of Breast Cancer and Pain, Chronic, is actively recruiting participants, sponsored by Northwestern University.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 452 participants
- Enrollment target
- 2
- Study locations
Study Summary
The main goal of this clinical trial is to test benefits of completing online pain coping skills training program in women who have been diagnosed with stage I-III breast cancer, who have completed their primary cancer treatment, who are taking an AI medication, and who have arthralgia. Arthralgia is a type of joint, bone, and muscle pain that is a common side effect of AI medications. The main questions it aims to answer are: 1. Whether online pain coping skills training reduces the severity of pain and the interference it causes in women's daily lives. 2. Whether online pain coping skills training improves emotional distress, quality of life, and adherence to AI medications. 3. Whether benefits of online pain coping skills training are at least partially caused by women's increased confidence that they can manage their pain and a reduction in unhelpful thinking patterns about pain. 4. Whether online pain coping skills training improves effects of AI medications on sleep problems and symptoms of menopause like hot flashes and night sweats. Participants can complete all parts of the study at home. They will: 1. Complete four sets of questionnaires throughout the study, which will take about 9 to 10 months. 2. Attend 3 meetings in the first month of the study, all of which can be held via a video conference. 3. Use an electronic pill bottle to track their use of their AI medication. 4. Be randomized (like flipping a coin) to one of two study arms: They will either receive education about AIs and arthralgia or they will receive this education along with access to an online pain coping skills training program. Research will compare the education group to the education plus online pain coping skills training group to see if online pain coping skills training has the benefits mentioned above.
Conditions Studied
Interventions
- OTHER Education
- BEHAVIORAL Online Pain Coping Skills Training
Study Locations (2)
Illinois
- Northwestern University - Chicago
North Carolina
- Duke University - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 452 participants |
| Start Date | 2023-01-19 |
| Est. Completion | 2026-11-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05703178
The ClinicalTrials.gov registry entry for NCT05703178 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 452 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (84% lower). The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Education is the first listed.
NCT05703178 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Illinois, North Carolina.
Frequently Asked Questions
What is clinical trial NCT05703178 about?
NCT05703178 is a clinical study titled "Web-based Pain Coping Skills Training for Breast Cancer Survivors With AI-Associated Arthralgia". The main goal of this clinical trial is to test benefits of completing online pain coping skills training program in women who have been diagnosed with stage I-III breast cancer, who have completed their primary cancer treatment, who are taking an AI medication, and who have arthralgia. Arthralgia i...
What is the current status of trial NCT05703178?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 452 participants. The study started on 2023-01-19. Estimated completion is 2026-11-30.
What conditions does trial NCT05703178 study?
This clinical trial studies the following conditions: Breast Cancer, Pain, Chronic, Arthralgia.
What interventions are being tested in trial NCT05703178?
The interventions under investigation include: Education (OTHER), Online Pain Coping Skills Training (BEHAVIORAL).
Who is sponsoring clinical trial NCT05703178?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05703178 being conducted?
This trial has 2 study locations across Illinois, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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