Increasing Breast and Colorectal Cancer Screening in the Community
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-75
SponsorIcahn School of Medicine at Mount Sinai
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Chi gung: Stay Well, Live Well
BehavioralThe 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
BehavioralThe 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).
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Chi gung: Stay Well, Live WellExperimental treatment 1 intervention
Group B: Attention Control (AC) ArmActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
6 Months2
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).
Time frame
6 Months3
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.
Time frame
Baseline, Immediately Post-Education Session, 6 Months4
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.
Time frame
6 MonthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Icahn School of Medicine at Mount Sinai
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov
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