Physical Activity and First Degree Female Relatives of Breast Cancer Patients

Sponsor

University of California, San Diego (Other)

Overall Status

Completed

CT.gov ID

NCT03115658

Collaborator

(none)

Enrollment

Arm

16.7

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Female First-degree Relative With Breast Cancer	Behavioral: Physical Activity	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Physical Activity and First Degree Female Relatives of Breast Cancer Patients

Actual Study Start Date :

Sep 8, 2009

Actual Primary Completion Date :

Aug 31, 2010

Actual Study Completion Date :

Jan 28, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise Intervention 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.	Behavioral: Physical Activity 12 week print based intervention

Arm

Intervention/Treatment

Experimental: Exercise Intervention

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.

Behavioral: Physical Activity

12 week print based intervention

Outcome Measures

Primary Outcome Measures

Minutes of moderate to vigorous physical activity [baseline to 12 weeks]
7-Day Physical Activity Recall

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of California, San Diego

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sheri Hartman, Assistant Professor, University of California, San Diego

ClinicalTrials.gov Identifier:

NCT03115658

Other Study ID Numbers:

2050-09

First Posted:

Apr 14, 2017

Last Update Posted:

Apr 14, 2017

Last Verified:

Apr 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Apr 14, 2017