Family Cancer Literacy to Promote Mammography Screening Among Navajo Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Mayo Clinic
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Christi Patten, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01605630
First received: May 7, 2012
Last updated: June 16, 2014
Last verified: June 2014

May 7, 2012
June 16, 2014
March 2012
April 2015   (final data collection date for primary outcome measure)
Acceptability of the intervention [ Time Frame: Participants will be assesed at 3 month follow-up ] [ Designated as safety issue: No ]
Participants will be asked if they found the intervention to be helpful or not and if they would recommend it to other women
Same as current
Complete list of historical versions of study NCT01605630 on ClinicalTrials.gov Archive Site
  • Changes in Cancer Literacy Measure [ Time Frame: participants will be assessed at baseline and at 3 month follow-up ] [ Designated as safety issue: No ]
    Participants will be asked about breast cancer screening knowledge and attitudes including cultural barriers to screening
  • completion of mammography screening [ Time Frame: participants will be assessed from the time of enrollment to 3 month follow-up ] [ Designated as safety issue: No ]
    Based on program records we will determine if participants completed mammography screening or not
Same as current
Not Provided
Not Provided
 
Family Cancer Literacy to Promote Mammography Screening Among Navajo Women
Family Cancer Literacy to Promote Mammography Screening Among Navajo Women

The no show rate for mammography screening is high among Navajo women. One barrier to preventive screening is a lack of cancer literacy including low knowledge and cultural attitudes (e.g., fatalism) about screening. The investigators will examine the potential feasibility and acceptability of a cancer literacy intervention for families of Navajo women who have no showed for three consecutive times to mammography screening who have never or rarely been screened in the past.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Behavioral: Family-based family cancer literacy intervention
    family based counseling and materials provided in navajo/english including digital stories
  • Behavioral: Control
    standard of care
  • Experimental: Family-based cancer literacy intervention
    Intervention: Behavioral: Family-based family cancer literacy intervention
  • Active Comparator: Control
    Standard of care
    Intervention: Behavioral: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
April 2015
April 2015   (final data collection date for primary outcome measure)

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

Female
18 Years and older
Yes
Contact: Christi A Patten, PhD 507-538-7370 patten.christi@mayo.edu
United States
 
NCT01605630
11-004328, R21CA152433
No
Christi Patten, Mayo Clinic
Mayo Clinic
National Cancer Institute (NCI)
Principal Investigator: Christi A Patte, PhD Mayo Clinic
Mayo Clinic
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP