Increasing Breast and Colorectal Cancer Screening in the Community

NCT07748377 | Not Yet Recruiting

• 2 other identifiers: STUDY-23-01343K08CA283362
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Colorectal Neoplasms; Breast Neoplasms

Keywords

Community Engaged Research; Early Detection of Cancer; Colorectal Cancer Screening; Breast Cancer Screening; Patient Navigation; Community Health Workers

Outcome Measures

Primary Outcomes (4)

• Intervention Acceptability Score

  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.

  6 Months

• Number of Navigation Calls

  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).

  6 Months

• Intervention Adaptation Score

  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.

  Baseline, Immediately Post-Education Session, 6 Months

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

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

  6 Months

Study Arms (2)

Chi gung: Stay Well, Live Well

EXPERIMENTAL

Chi gung: Stay Well, Live Well is a community-based intervention using peer education and tailored navigation

Behavioral: Chi gung: Stay Well, Live Well

Attention Control (AC) Arm

ACTIVE COMPARATOR

This time-matched and attention control group will receive a general health group education session and follow-up telephone calls.

Behavioral: Chi gung: Stay Well, Live Well

Interventions

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.

Chi gung: Stay Well, Live Well

Eligibility Criteria

• Age: 45 Years - 75 Years
• Gender Eligibility Details: Since the goal of this program is to simultaneously improve CRC and BC screening rates as proof-of-concept for a multi-cancer screening support strategy, only persons who are advised to undergo routine CRC and BC screening, per national guidelines, will be eligible for inclusion.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Cancer Institute (NCI): collaborator

Study Sites (7)

Henry Street Settlement

New York, New York, 10002, United States

Location

University Settlement

New York, New York, 10002, United States

Location

Charles B. Wang Community Health Center

New York, New York, 10013, United States

Location

VNS Health Chinatown Community Center

New York, New York, 10013, United States

Location

The Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

St. Margaret's House

New York, New York, 10038, United States

Location

United Chinese Association of Brooklyn

New York, New York, 11223, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Christina Wang, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Wang, MD

CONTACT

216-702-0789; Christina.Wang@mountsinai.org

Lili Liang

CONTACT

347-270-7705; lili.liang@mssm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 5, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Researchers who provide a methodologically sound proposal. To achieve aims in the approved proposal. Specify Other Mechanism. De-identified public-use data files will be deposited in a data repository and accessible to researchers who agree to the repository's Terms of Use. Restricted-use data files will be available upon execution of a Data Use Agreement approved by the Icahn School of Medicine at Mount Sinai; requests should be directed to the Principal Investigator.

Locations

US (7)