Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05186727 |
| Other study ID # |
00005038 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2021 |
| Est. completion date |
September 30, 2022 |
Study information
| Verified date |
October 2022 |
| Source |
State University of New York at Buffalo |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The overall goal of this study is to reduce breast cancer morbidity and mortality disparities
among African American women by actively engaging family history as a tool to modify
screening regimens and enhance communication between women and their providers. Therefore,
this rationale is reflected the project title: "You cannot change your family history, but
you can change what you do with it: A peer-based education program to reduce breast cancer
risk in African American women"
This study will develop and test an educational curriculum that highlights the importance of
knowing family history and sharing it with health care providers. The curriculum will include
tools to gather family history and discuss it with providers to guide the delivery of care.
The investigators will assess the effectiveness of the curriculum in group and one-on-one
settings and when delivered by a Patient Ambassador (peer train-the trainer model) or a
researcher.
The specific objectives of the study are to:
Obj. 1: Develop a CBPR-based curriculum- using a community based participatory research
(CBPR) approach, that highlights the importance of family history as a risk factor for breast
cancer that includes tools to collect family history information and discuss it with
providers to enable a family history based screening regimen.
Obj. 2: Train Patient Ambassadors- Patient Ambassadors, women from the community who act as
community messengers to deliver the curriculum.
Obj. 3: Pilot Implementation and Extensive Evaluation of the Curriculum- Assess two modes of
delivery, group vs one-on-one, and Peer Ambassadors vs. a researcher.
Obj. 4: Dissemination- of the curricular products, implementation pilot results, and
implementation guides for communities and practices- via publications and other channels in
preparation for grant submits to enhance the program.
Description:
Women from underserved communities are eligible to participate in the educational workshop
and the evaluation of the study. We aim to recruit 200 women; 50 randomized into each arm
(researcher group, researcher one-on-one, Patient Ambassador group, Patient Ambassador
one-on-one) of the evaluation. Participants will be recruited from community-based sources
such as the Buffalo Research Registry, primary care practices, and word of mouth through
Patient Voices Network, Our Curls, and other community-based organizations. It is anticipated
that most of these women will be African American as recruitment will be geared toward
predominately African American communities. A marketing flyer, available in e-mail or print
format, will be developed to disseminate through the various community-based strategies.
Women will be consented and randomized telephonically. Randomization without replacement will
be used for every four women consented to ensure equal groups. The research associate will
conduct the baseline assessment will be collected over the telephone to maintain the
evaluation separate from the implementation of the curriculum. Curriculum content areas
include: Breast health knowledge, Breast cancer knowledge, Family History Genetics, Breast
Cancer Genetic Testing Methods, and how to collect family history information. Women
randomized into the one-on-one phone interventions will be immediately linked to either the
Patient Ambassador or researcher who will be administering the curriculum. An initial contact
will be made for introductions, to describe the process and schedule four additional times
for phone calls. One phone call will be made per week for four weeks. A packet of materials,
that include curriculum handouts and supporting tools, will be sent to the participant for
follow-up calls. The Patient Ambassador or professional will then follow up with each
participant according to the arranged schedule. For participants randomized to the group
sessions, 4 dates will be offered at the time of consent for an average of 12-13 participants
at each group. Participants will be asked to choose one date. The same materials and tools
will be given to the women at the beginning of the session. The curriculum will be delivered
in a more didactic approach with time for group interaction and hands on activities. The
sessions will be conducted via ZOOM. A fidelity checklist will be created that a member of
the research team will complete for both group sessions and will spot check 20% or the
on-on-one needs to complete to ensure completion of the full curriculum and protocols is
adhered to. Once a month contacts will be made by the individual that delivered the
curriculum as a retention strategy. Assessments are conducted immediately after the
intervention and three months after the close of the education. These surveys will consist of
the same measures included in the baseline and will add a measure about satisfaction with the
curriculum, the facilitator, and the mode of delivery.
