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Not yet recruiting NCT07748377

Increasing Breast and Colorectal Cancer Screening in the Community

No phase Interventional Colorectal Neoplasms Breast Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Chi gung: Stay Well, Live Well, Chi gung: Stay Well, Live Well.
Who it may be relevant to
Registry conditions: Colorectal Neoplasms, Breast Neoplasms. Basic parameters: 45 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Pilot Trial of a Community-Based Strategy to Improve Colorectal and Breast Cancer Screening

Overview

The goal of the proposed study is to conduct a pilot randomized controlled trial (RCT) of Chi gung, a community-based intervention using peer education and tailored navigation to simultaneously improve colorectal (CRC) and breast cancer (BC) screening rates.

Interventions

  • Behavioral Chi gung: Stay Well, Live Well
    The intervention consists of a A) 90-minute group education session led by a community health worker (CHW) that 1) addresses CRC and BC incidence, mortality, development, symptoms, and screening tests, in addition to shared beliefs and common obstacles to CRC and BC screening, 2) involves experiential education (e.g., demonstrations of stool based testing and colonoscopy bowel preparation), 3) question and answer session, and 4) take-home materials summarizing CRC and BC screening information an
  • Behavioral Chi gung: Stay Well, Live Well
    The attention control arm will receive a A) time-matched (90-minute) general health didactic on risk factors for cancer and take-home materials on concepts discussed, and B) telephone calls to address concepts covered in the presentation (number of calls will be based on the average frequency of peer navigation calls in the intervention arm).

Primary outcome measures

  • Intervention Acceptability Score [Time frame: 6 Months]
  • Number of Navigation Calls [Time frame: 6 Months]
  • Intervention Adaptation Score [Time frame: Baseline, Immediately Post-Education Session, 6 Months]
  • The Proportion of Participants Who Have Completed Recommended Screening Tests. [Time frame: 6 Months]

Eligibility criteria

Inclusion criteria

  • Age 45-75 years old
  • Self-identify as Chinese and born outside of the U.S.
  • Speaks Mandarin, Cantonese, or English
  • Not up to date on BC screening (i.e., have not had a mammogram within the past two years)
  • Not up to date on CRC screening (i.e., have not had any of the following tests)
  • Colonoscopy within the past 10 years
  • Fecal immunochemical tests/fecal occult blood tests within the past year or multi-target stool DNA test within the past three years
  • Flexible sigmoidoscopy within the past 5 years
  • CT colonography within the past 5 years

Exclusion criteria

  • Life expectancy ≤ 10 years or other pre-existing conditions whereby CRC or BC screening would not be recommended
  • Personal history of BC or CRC
  • Prior history of a total colectomy or mastectomy
  • Lacks capacity to provide informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

United States · 7 centers
  • Henry Street Settlement — New York
  • University Settlement — New York
  • Charles B. Wang Community Health Center — New York
  • VNS Health Chinatown Community Center — New York
  • The Icahn School of Medicine at Mount Sinai — New York
  • St. Margaret's House — New York
  • United Chinese Association of Brooklyn — New York

Identifiers

NCT: NCT07748377 · STUDY-23-01343 · K08CA283362

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗