Family Cancer Literacy to Promote Mammography Screening Among Navajo Women
18 Years
N/A
Female
Breast Cancer
Trial Information
Family Cancer Literacy to Promote Mammography Screening Among Navajo Women
This proposal describes a community-based participatory research study to develop and pilot
test a new behavioral intervention to promote mammography screening among Navajo women.
From a public health perspective, the intervention has the potential to reach many Navajo
women, as 80% of women scheduled for mammography appointments do not follow through. These
women (over 1,500 each year) are referred to the Nation Breast and Cervical Cancer
Prevention Program (NNBCCPP). A key barrier toward implementing cancer prevention and
control efforts in the Navajo community is a lack of cancer literacy or cultural and
conceptual knowledge regarding cancer. Other barriers to screening are fear of cancer,
stigma of cancer (even talking about cancer) often experienced by the patient, family and
community, and lack of knowledge about the etiology of cancer and importance of early
detection. Therefore, communication about cancer is impeded within Navajo families and the
community.
This proposal builds on our successful partnership and collaboration with Diné College (the
Navajo tribal college). The proposed study is designed to assess the feasibility and
potential efficacy of a cancer-literacy focused, family-based intervention on completion of
mammography screening for Navajo women. The intervention will include culturally and
linguistically appropriate educational materials about cancer (e.g., the Navajo Cancer
Glossary). The project will be implemented in two phases. During Phase 1, the
investigators will develop the family cancer literacy intervention with feedback from our
community advisory committee. In addition, the Cancer Literacy Measure will be adapted for
Navajo women through focus groups and individual interviews. Phase 2 will consist of a
formative evaluation of the intervention. The NNBCCPP patient and a female family member
will be randomly assigned in pairs to the control condition (existing NNBCCPP health
education services, N=40 pairs) or to receive these health education services plus the
family cancer literacy intervention (N=40 pairs). The investigators will assess the
intervention's feasibility and acceptability as indicated by the recruitment and retention
rates and qualitative ratings of treatment acceptability. In addition, the investigators
will examine the effect of the intervention compared with the control group on the
proportion of women who complete mammography screening at 3-month follow-up documented by
NNBCCPP records. The investigators will also examine changes in Cancer Literacy Measure
scores from baseline to 3-month follow-up among both patients and family members. The
investigators expect that as a result of this project, the investigators will have developed
a replicable, feasible, and acceptable intervention, the efficacy of which can be tested in
future large-scale randomized clinical trials. In addition, the adapted Cancer Literacy
Measure could be used in future cancer prevention and control projects within the Navajo
Nation. The overall objective is to reduce breast cancer morbidity and mortality among
Navajo women.
Inclusion Criteria:
In Phase 1, we will recruit 17 Navajo women for individual interviews (n=5) and focus
groups (n=12) to adapt our measures. Eligibility criteria are:
1. aged 40 years or older and
2. provides written informed consent. We chose to develop our measures based on feedback
from the general community of women who are screening eligible instead of matching
the inclusion/exclusion criteria to that used in the formative evaluation of the
intervention (Phase 2). This will enhance our ability to use the Cancer Literacy
Measure and other assessments in subsequent breast cancer prevention and control
studies.
In Phase 2, we will recruit a total of 40 patient-family member pairs. To be eligible for
the study, the NNBCCPP patient must:
1. be aged 40 years or older,
2. provide written informed consent,
3. be referred to the NNBCCPP as a "no-show" for mammography screening after three
scheduling attempts,
4. have no prior history of mammography screening,
5. have no prior history of breast cancer, and
6. can identify a female family member or other individual who resides in or near the
home who could participate in the project.
In addition, the family member must:
1. be female,
2. aged 18 years or older,
3. be fluent and literate in Navajo,
4. be interested and able to participate, and
5. provide written informed consent.
Exclusion Criteria:
Phase 2: History of breast cancer or mammography screening
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Acceptability of the intervention
Outcome Description:
Participants will be asked if they found the intervention to be helpful or not and if they would recommend it to other women
Outcome Time Frame:
Participants will be assesed at 3 month follow-up
Safety Issue:
No
Authority:
United States: Institutional Review Board
Study ID:
11-004328
NCT ID:
NCT01605630
Start Date:
March 2012
Completion Date:
April 2014
Related Keywords:
- Breast Cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Dine College | Shiprock, New Mexico 87420 |
