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Physical Activity and First Degree Female Relatives of Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT03115658
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : April 14, 2017
Sponsor:
Information provided by (Responsible Party):
Sheri Hartman, 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.

Condition or disease Intervention/treatment
Female First-degree Relative With Breast Cancer Behavioral: Physical Activity

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
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 : September 8, 2009
Primary Completion Date : August 31, 2010
Study Completion Date : January 28, 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Minutes of moderate to vigorous physical activity [ Time Frame: baseline to 12 weeks ]
    7-Day Physical Activity Recall



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sheri Hartman, Assistant Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03115658     History of Changes
Other Study ID Numbers: 2050-09
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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