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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: Completed NA study of Breast Cancer, sponsored by University of Miami.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Acceptability is measured using a participant self-report scale that was created specifically for this project. This 16-item questionnaire assesses perceived satisfaction with the program, perceived comprehension of the material, comfort with group sessions, perceived competence of the interventionist, satisfaction with project staff, and ratings of project materials on a 4-point Likert scale (completely agree-completely disagree).

Conditions Studied

Interventions

  • BEHAVIORAL Group Sessions

Study Locations (2)

Florida

  • Jackson Health System - Miami
  • University of Miami - Miami

Trial Details

FieldValue
Enrollment Target 114 participants
Start Date 2008-12
Est. Completion 2015-05
Phase NA
University of Miami

721 total trials

What the finished NCT02272335 record still lists

NCT02272335 is an interventional study that assigns participants to a tested intervention. The registered 114 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 (96% lower).

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 a single indexed study location in 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.

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 NCT02272335's enrollment target sits among peer trials

114 529th of 1224 higher than 695 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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Source: ClinicalTrials.gov NCT02272335, the US trial registry maintained by the National Library of Medicine. NCT02272335 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.