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
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Behavioral: Family-based family cancer literacy intervention
Behavioral: Control
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Family Cancer Literacy to Promote Mammography Screening Among Navajo Women

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 100
Study Start Date: March 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Family-based cancer literacy intervention Behavioral: Family-based family cancer literacy intervention
family based counseling and materials provided in navajo/english including digital stories
Active Comparator: Control
Standard of care
Behavioral: Control
standard of care

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01605630

Contacts
Contact: Christi A Patten, PhD 507-538-7370 patten.christi@mayo.edu

Locations
United States, New Mexico
Dine College Recruiting
Shiprock, New Mexico, United States, 87420
Contact: Mark C Bauer, PhD    505-326-5918    mcbauer@dinecollege.org   
Principal Investigator: Mark C Bauer, PhD         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Christi A Patte, PhD Mayo Clinic
  More Information

No publications provided

Responsible Party: Christi Patten, Professor of Psychology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01605630     History of Changes
Other Study ID Numbers: 11-004328, R21CA152433
Study First Received: May 7, 2012
Last Updated: June 16, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 31, 2014