Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02272335 · ClinicalTrials.gov registry record · NA
Facilitating Adjustment in Low Income Black Women With Breast Cancer
A NA study of Breast Cancer, sponsored by University of Miami.
- Completed
- Registry status
- NA
- Development phase
- 114
- Enrollment target
- 2
- Study locations
NCT02272335 is a NA study of Breast Cancer that has completed, run by University of Miami. The registered enrollment target is 114 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT02272335, a NA study of Breast Cancer, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- NA
- Development phase
- 114 participants
- Enrollment target
- 2
- Study locations
Study Summary
The main goal of the proposed study is to test whether a successful stress management intervention can be effectively implemented in natural settings in the community and will be acceptable to a community dwelling, low income population of African American women with breast cancer. Hypothesis 1: There will be no differences between women randomized to either the Cognitive Behavioral Stress Management (CBSM) or the Cancer Wellness and Education condition (CW) on ratings of acceptability of the program. Hypothesis 2: Women randomized to the CBSM condition will show greater decreases over time in cancer-specific distress and greater increases over time in quality of life as compared to women in the CW condition over the course of the study from baseline to six month follow-up. Hypothesis 3: Women randomized to the CBSM condition will show greater improvement in pain levels, sleep disturbance and fatigue as compared to women in the CW condition over the course of the study from baseline to six month follow-up. Hypothesis 4: Women randomized to the CBSM condition will report fewer sick days, earlier return to work, fewer unanticipated health care visits, fewer visits to the Emergency Department and better follow-up with oncologists as compared to women in the CW condition over the course of the study from baseline to six month follow-up. Hypothesis 5: Women randomized to the CBSM condition will show more normalized patterns of diurnal cortisol (e.g., greater increase in negative AM-PM slope) as compared to women in the CW condition over the course of the study from baseline to six month follow-up. Hypothesis 6: Women randomized to the CBSM condition will show more less normalized patterns of heart rate variability (e.g., more variation) as compared to women in the CW condition over the course of the study from baseline to six month follow-up.
Conditions Studied
Interventions
- BEHAVIORAL Group Sessions
Study Locations (2)
Florida
- Jackson Health System - Miami
- University of Miami - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2008-12 |
| Est. Completion | 2015-05 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02272335
The ClinicalTrials.gov registry entry for NCT02272335 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 114 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 (96% lower). The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Group Sessions is the first listed.
NCT02272335 reports 2 study locations spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT02272335 about?
NCT02272335 is a clinical study titled "Facilitating Adjustment in Low Income Black Women With Breast Cancer". The main goal of the proposed study is to test whether a successful stress management intervention can be effectively implemented in natural settings in the community and will be acceptable to a community dwelling, low income population of African American women with breast cancer. Hypothesis 1: Th...
What is the current status of trial NCT02272335?
This trial is currently completed. It is a NA study. The enrollment target is 114 participants. The study started on 2008-12. Estimated completion is 2015-05.
What conditions does trial NCT02272335 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT02272335?
The interventions under investigation include: Group Sessions (BEHAVIORAL).
Who is sponsoring clinical trial NCT02272335?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02272335 being conducted?
This trial has 2 study locations across Florida. 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.
-
Harnessing Analysis RNA Expression and Molecular Subtype to Optimize Novel TherapY MBCA
RECRUITING · NA
-
Post-operative Radiotherapy Omission in Selected Patients With Early Breast Cancer Trial International VErsion (PROSPECTIVE)
RECRUITING · NA
-
Resistance and Aerobic Exercise for Prevention in Women With Dense Breasts (REP-D)
RECRUITING · NA
-
Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)
RECRUITING · NA
-
A Randomized Controlled Trial (RCT) to Determine the Efficacy of a Multidisciplinary CBT Based Pain Management Program for the Treatment of Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS) in Breast Cancer Survivors
RECRUITING · NA
-
Precise Oncology Interventions in Nutrition and Training (OnPoint)
RECRUITING · NA
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.