Physical Activity and First Degree Female Relatives of Breast Cancer Patients

Not Applicable

Completed

• Conditions: First-degree Relative With Breast Cancer; Female
• Interventions: Behavioral: Physical Activity

• Registration Number: NCT03115658
• Lead Sponsor: University of California, San Diego

Brief Summary

The purpose of this study is to learn more about encouraging physical activity among first degree female relatives of women with breast cancer. Physical activity can decrease a woman's risk of developing breast cancer, on average, by 20%; however, physical activity interventions have not been developed specifically for first degree female relatives of cancer patients, so currently, it is unknown whether standard physical activity interventions are sufficient for these women or if first degree female relatives would benefit from an enhanced physical activity intervention that addresses information about breast cancer risk reduction. To obtain information about first degree female relatives preferences for a physical activity intervention, this study seeks to have first degree female relatives of breast cancer patients enroll in a standard physical activity intervention developed for healthy men and women. After completion of the three month intervention, the women will be asked to participate in two, one-hour long focus group with 5-7 other participants. The first focus group is to discuss aspects of the physical activity intervention that they liked and did not like, as well as things they think may have enhanced the intervention and made it more relevant to other first-degree relative of breast cancer patients. In the second focus group, participants will be shown enhancements that were developed based on information gathered from the first focus group. Participants will be asked for their feedback on the newly developed enhancements.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-08
• Primary Completion: 2010-08-31
• Study Completion: 2011-01-28
• Status Verified: 2017-04
• Study First Submitted: 2017-04-11
• Study First Submitted QC: 2017-04-11
• Last Update Submitted: 2017-04-11
• Study First Posted: 2017-04-14
• Last Update Posted: 2017-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27

Inclusion Criteria

• Aged 18 to 65
• Have a mother, sister, or daughter who was diagnosed with breast cancer
• Have not been diagnosed with any type of cancer except basal cell carcinoma
• Able to speak and read English
• Sedentary, defined as engaging in less than 90 minutes of moderate-intensity physical activity each week

Exclusion Criteria

• Current of planned pregnancy for next 3 months
• Presence of a known medical condition that would make physical activity unsafe
• History of a severe psychiatric illness
• Plans to move from the area in the next 3 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exercise Intervention	Physical Activity	Participants met with a PhD level psychologist experienced with health behavior change, to set a personalized exercise goal and plan. Participants were told the studies' goal to engage in 150 minutes of moderate intensity or greater physical activity each week, based on the ACSM recommendations, but participants were allowed to set any personal goal. Participants were also instructed on how to self-monitor their physical activity. After the initial meeting all other intervention components were sent through the mail. The intervention consists of three types of print material that were mailed: stage-matched manuals, tailored feedback report, and tip sheets.

Primary Outcome Measures

Name	Time	Method
Minutes of moderate to vigorous physical activity	baseline to 12 weeks	7-Day Physical Activity Recall