Family Cancer Literacy to Promote Mammography Screening Among Navajo Women

NCT01605630 | Completed Phase 1

• 2 other identifiers: 11-004328R21CA152433
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Acceptability of the intervention

  Participants will be asked if they found the intervention to be helpful or not and if they would recommend it to other women

  Participants will be assesed at 3 month follow-up

Secondary Outcomes (2)

• Changes in Cancer Literacy Measure

  participants will be assessed at baseline and at 3 month follow-up

• completion of mammography screening

  participants will be assessed from the time of enrollment to 3 month follow-up

Study Arms (2)

Family-based cancer literacy intervention

EXPERIMENTAL

Behavioral: Family-based family cancer literacy intervention

Control

ACTIVE COMPARATOR

Standard of care

Behavioral: Control

Interventions

Family-based family cancer literacy intervention BEHAVIORAL

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

Family-based cancer literacy intervention

Control BEHAVIORAL

standard of care

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• aged 40 years or older and

You may not qualify if:

• In Phase 2, we will recruit a total of 40 patient-family member pairs. To be eligible for the study, the NNBCCPP patient must:
• be aged 40 years or older,
• provide written informed consent,
• be referred to the NNBCCPP as a "no-show" for mammography screening after three scheduling attempts,
• have no prior history of mammography screening,
• have no prior history of breast cancer, and
• 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:
• be female,
• aged 18 years or older,
• be fluent and literate in Navajo,
• be interested and able to participate, and
• provide written informed consent.
• Phase 2: History of breast cancer or mammography screening

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Dine College

Shiprock, New Mexico, 87420, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Christi A Patte, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: May 7, 2012
• First Posted: May 25, 2012
• Study Start: March 1, 2012
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2017
• Last Updated: December 19, 2017

Record last verified: 2017-12

Locations

US (1)