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NCT03955627 · ClinicalTrials.gov registry record · NA
REJOIN Trial for Older Breast Cancer Survivors
A NA study of Breast Cancer Female, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT03955627: Completed NA study of Breast Cancer Female, sponsored by Wake Forest University Health Sciences.
NCT03955627 is a NA study of Breast Cancer Female that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 12 participants, below the 692-participant average among 46 other Breast Cancer Female trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03955627, a NA study of Breast Cancer Female, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this pilot intervention study is to test the effectiveness of a self-management approach (combining education- and exercise-based strategies) for improving arthralgia (joint pain) associated with Aromatase Inhibitors (AI) in older breast cancer survivors. Survivors will be recruited from local cancer clinics prior to the completion of primary cancer treatment, as arthralgia can occur soon after initiating AI medication. Participants will be randomized to one of two groups: an enhanced standard care group (AI prescription plus information) or a treatment group (educational classes plus group exercise sessions). Older survivors (≥60 years) will be targeted because they are at increased risk of medication complications which may impede adherence. For the baseline assessment, a cancer-specific geriatric assessment will be conducted and a blood sample will be collected to interpret the effects of the self-management study in the context of geriatric experiences. Additionally, there will be an assessment of knowledge, PA habits, and AI-related joint pain and AI adherence. These will be measured again at 4, 6 and at follow up at 12 months.
Primary Outcome
The Brief Pain Inventory - Short Form (BPI-sf) is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment
Conditions Studied
Interventions
- BEHAVIORAL Relieving Joint Pain and Improving AI Adherence in Older Breast Cancer Survivors (REJOIN)
Study Locations (1)
North Carolina
- Wake Forest University Health Sciences - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-06-15 |
| Est. Completion | 2025-07-29 |
| Phase | NA |
What the finished NCT03955627 record still lists
NCT03955627 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 692-participant average among 46 other Breast Cancer Female trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Breast Cancer Female appearing as the primary indexed condition, and to 1 intervention - of which Relieving Joint Pain and Improving AI Adherence in Older Breast Cancer Survivors (REJOIN) is the first listed.
NCT03955627 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT03955627 about?
NCT03955627 is a clinical study titled "REJOIN Trial for Older Breast Cancer Survivors". The purpose of this pilot intervention study is to test the effectiveness of a self-management approach (combining education- and exercise-based strategies) for improving arthralgia (joint pain) associated with Aromatase Inhibitors (AI) in older breast cancer survivors. Survivors will be recruited f...
What is the current status of trial NCT03955627?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2021-06-15. Estimated completion is 2025-07-29.
What conditions does trial NCT03955627 study?
This clinical trial studies the following conditions: Breast Cancer Female.
What interventions are being tested in trial NCT03955627?
The interventions under investigation include: Relieving Joint Pain and Improving AI Adherence in Older Breast Cancer Survivors (REJOIN) (BEHAVIORAL).
Who is sponsoring clinical trial NCT03955627?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03955627 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03955627's enrollment target sits among peer trials
12 46th of 46 the lowest of 46 other Breast Cancer Female trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer Female 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.
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