Family Cancer Literacy to Promote Mammography Screening Among Navajo Women

NCT ID: NCT01605630

Last Updated: 2017-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2017-12-31

Brief Summary

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Family-based cancer literacy intervention

Group Type: EXPERIMENTAL

Family-based family cancer literacy intervention

Intervention Type: BEHAVIORAL

family based counseling and materials provided in navajo/english including digital stories

Control

Standard of care

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: BEHAVIORAL

standard of care

Interventions

Family-based family cancer literacy intervention

family based counseling and materials provided in navajo/english including digital stories

Intervention Type: BEHAVIORAL

Control

standard of care

Intervention Type: BEHAVIORAL

Eligibility 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

Exclusion Criteria

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.

Phase 2: History of breast cancer or mammography screening

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Christi Patten

Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christi A Patte, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Dine College

Shiprock, New Mexico, United States

Countries

United States

Other Identifiers

R21CA152433

Identifier Type: NIH

Identifier Source: secondary_id

View Link

11-004328

Identifier Type: -

Identifier Source: org_study_id