Breast Neoplasms, Colorectal Neoplasms
Conditions
Keywords
Community Engaged Research, Early Detection of Cancer, Colorectal Cancer Screening, Breast Cancer Screening, Patient Navigation, Community Health Workers
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.
Interventions
BEHAVIORALChi 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 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.
Sponsors
Icahn School of Medicine at Mount Sinai
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Acceptability Score | 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 | 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 | 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. | 6 Months | The proportion of participants who have completed recommended CRC and BC screening tests to assess intervention efficacy. |
Countries
United States
Contacts
CONTACTChristina Wang, MD
CONTACTLili Liang
PRINCIPAL_INVESTIGATORChristina Wang, MD
Icahn School of Medicine at Mount Sinai
Outcome results
None listed