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NCT04651452 · ClinicalTrials.gov registry record · NA
Writing Interventions in Breast Cancer Patients Taking Aromatase Inhibitors
A NA study of Breast Cancer, sponsored by Carnegie Mellon University.
- Active
- Registry status
- NA
- Development phase
- 250
- Enrollment target
- 1
- Study location
NCT04651452: Active NA study of Breast Cancer, sponsored by Carnegie Mellon University.
NCT04651452 is a NA study of Breast Cancer that is active but no longer recruiting, run by Carnegie Mellon University. The registered enrollment target is 250 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04651452, a NA study of Breast Cancer, is active but no longer recruiting, sponsored by Carnegie Mellon University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 250 participants
- Enrollment target
- 1
- Study location
Study Summary
Aromatase inhibitors are a powerful medication for reducing the risk of recurrence and increasing survival in postmenopausal breast cancer patients. However, these medications can lead to intolerable side effects, poor medication adherence, and increased stress levels. This project's broad objective is to assess whether an intervention can improve medication adherence and reduce physical symptoms and stress in breast cancer patients prescribed aromatase inhibitors. Participants will be randomly assigned to a values affirmation or reflective journaling condition. Interventions will be writing-based, one essay per month for six months. Physical symptoms and perceived stress will be assessed at baseline, post-intervention (one month after the intervention), and follow-up (six months from the post-intervention assessment and seven months after the end of the intervention). Furthermore, an electronic pill bottle will continuously assess daily compliance so that medication adherence rates during the intervention, post-intervention, and follow-up can be calculated.
Primary Outcome
The Breast Cancer Prevention Trial Symptom Checklist is a 43 item self-report of physical symptoms specific to breast cancer treatment. Participants rate how bothered they were by each symptom in the last 4 weeks on a five-point Likert scale ranging from 0 (Not at all) to 4 (Extremely). Item 43 is an open response question that asks participants to indicate and rate any additional symptoms they may be experiencing. Component symptom scale scores (e.g. musculoskeletal pain, cognitive problems, we
Conditions Studied
Interventions
- BEHAVIORAL Value Affirmation
- BEHAVIORAL Reflective Journaling
Study Locations (1)
Pennsylvania
- Carnegie Mellon University - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2021-02-01 |
| Est. Completion | 2026-04-30 |
| Phase | NA |
What the registry record for NCT04651452 still lists
NCT04651452 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Value Affirmation is the first listed.
NCT04651452 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04651452 about?
NCT04651452 is a clinical study titled "Writing Interventions in Breast Cancer Patients Taking Aromatase Inhibitors". Aromatase inhibitors are a powerful medication for reducing the risk of recurrence and increasing survival in postmenopausal breast cancer patients. However, these medications can lead to intolerable side effects, poor medication adherence, and increased stress levels. This project's broad objective...
What is the current status of trial NCT04651452?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 250 participants. The study started on 2021-02-01. Estimated completion is 2026-04-30.
What conditions does trial NCT04651452 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT04651452?
The interventions under investigation include: Value Affirmation (BEHAVIORAL), Reflective Journaling (BEHAVIORAL).
Who is sponsoring clinical trial NCT04651452?
This trial is sponsored by Carnegie Mellon University, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04651452 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04651452's enrollment target sits among peer trials
250 323rd of 1224 higher than 895 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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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