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NCT Number: NCT07748377

Increasing Breast and Colorectal Cancer Screening in the Community

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.

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Key information

Age range

45 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Charles B. Wang Community Health Center, New York, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chi gung: Stay Well, Live Well

Behavioral

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 and local resources; and B) peer navigation assistance by telephone to address ongoing obstacles to CRC and BC screening completion, conducted over a 6 month period.

Primary outcomes

  1. Intervention Acceptability Score

    Time frame: 6 Months

    This will measure whether the participants will accept the intervention. Acceptability will be measured through surveys (likert-rated items) and open-ended questions (semi-structured interviews). The minimum score is 6 and the maximum score is 42; higher scores indicate the intervention is acceptable.

  2. Number of Navigation Calls

    Time frame: 6 Months

    This will measure how well the participants can be navigated through the healthcare system and connected to resources using this intervention. Integration will be measured through review of navigation call logs and will include number of navigation calls completed per participant, number of self-reported healthcare visits by the participant, and open-ended questions (semi-structured interviews).

  3. Intervention Adaptation Score

    Time frame: Baseline, Immediately Post-Education Session, 6 Months

    This will measure how well the intervention was adapted to address colorectal cancer (CRC) and breast cancer (BC) screening beliefs, benefits, barriers, and self-efficacy. Adaptation will be measured through surveys (likert-rated) and open-ended questions (semi-structured interviews). These measures are investigator-developed subscales informed by the literature. On the beliefs subscale, the minimum score is 17 and the maximum score is 85; higher scores indicate more favorable screening beliefs. On the benefits subscale, the minimum score is 3 and the maximum score is 15; on the barriers subscale, the minimum score is 5 and the maximum score is 25. Higher scores indicate greater perceived benefits and greater perceived barriers, respectively. On the self-efficacy subscale, the minimum score is 8 and the maximum score is 40; higher scores indicate greater self-efficacy to complete screening.

  4. The Proportion of Participants Who Have Completed Recommended Screening Tests.

    Time frame: 6 Months

    The proportion of participants who have completed recommended CRC and BC screening tests to assess intervention efficacy.

Study contacts

Contact information is provided by the study sponsor or research team.

Christina Wang, MD

CONTACT

[email protected]

216-702-0789

Lili Liang

CONTACT

[email protected]

347-270-7705

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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