Colorectal NeoplasmsNCT07748377
Increasing Breast and Colorectal Cancer Screening in the Community
A study testing Chi gung: Stay Well, Live Well in people with Colorectal Neoplasms and Breast Neoplasms, run by Icahn School of Medicine at Mount Sinai at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms, Breast Neoplasms
- What is being tested?
- Chi gung: Stay Well, Live Well
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 7 sitesUnited States
- Study dates
- Dec 2026to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites
Henry Street Settlement
New York, New York, 10002
Cindy Singh, 212-766-9200, CSingh@henrystreet.org
University Settlement
New York, New York, 10002
Sofiya Pidzyraylo, 212-475-0150, spidzyraylo@universitysettlement.org
Charles B. Wang Community Health Center
New York, New York, 10013
Naumi Feldman, 212-379-6988, nfeldman@cbwchc.org
VNS Health Chinatown Community Center
New York, New York, 10013
Helen Sit, 917-270-7979, hinglin.sit@vnshealth.org
The Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Lili Liang, 347-270-7705, lili.liang@mssm.edu
Christina Wang, MD, 216-702-0789, Christina.Wang@mountsinai.org
St. Margaret's House
New York, New York, 10038
Claire Guerette, 212-766-8122, cguerette@smhnyc.org
United Chinese Association of Brooklyn
New York, New York, 11223
Ansen Tang, 929-715-5276, M.tang@ucaob.org
About this study
Official title: A Pilot Trial of a Community-Based Strategy to Improve Colorectal and Breast Cancer Screening
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
- Being tested
- Chi gung: Stay Well, Live Well
- Keywords
- Community Engaged Research, Early Detection of Cancer, Colorectal Cancer Screening, Breast Cancer Screening, Patient Navigation, Community Health Workers
- Medical subject headings
- Colorectal Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chi gung: Stay Well, Live WellBehavioural
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 WellBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Chi gung: Stay Well, Live Well | Experimental | Chi gung: Stay Well, Live Well is a community-based intervention using peer education and tailored navigation Receives: 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. Receives: Behavioral: Chi gung: Stay Well, Live Well |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Christina Wang, Icahn School of Medicine at Mount Sinai
- Investigators
- Christina Wang, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748377
- Sponsor's protocol ID
- STUDY-23-01343
- Other IDs
- K08CA283362
- Status last verified
- Oct 2026
- First submitted
- 31 Jul 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of a Community-Based Strategy to Improve Colorectal and Breast Cancer Screening
- ClinicalTrials.gov ID
- NCT07748377
- Acronym / sponsor ID
- STUDY-23-01343
- Conditions
- Colorectal Neoplasms, Breast Neoplasms
- Keywords
- Community Engaged Research, Early Detection of Cancer, Colorectal Cancer Screening, Breast Cancer Screening, Patient Navigation, Community Health Workers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chi gung: Stay Well, Live Well | Experimental | Behavioral: Chi gung: Stay Well, Live WellChi gung: Stay Well, Live Well is a community-based intervention using peer education and tailored navigation |
| Attention Control (AC) Arm | Active comparator | Behavioral: Chi gung: Stay Well, Live WellThis time-matched and attention control group will receive a general health group education session and follow-up telephone calls. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chi gung: Stay Well, Live WellThe 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. | Behavioural | Chi gung: Stay Well, Live Well |
| Chi gung: Stay Well, Live WellThe 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). | Behavioural | Attention Control (AC) Arm |
Primary outcome
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.
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).
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christina Wang, MD principal investigator
Icahn School of Medicine at Mount Sinai
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chi gung: Stay Well, Live Well in people with Colorectal Neoplasms and Breast Neoplasms, run by Icahn School of Medicine at Mount Sinai at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina Wang, MD (216-702-0789, Christina.Wang@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Acceptability Score (time frame: 6 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.