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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03115658
Other study ID # 2050-09
Secondary ID
Status Completed
Phase N/A
First received April 11, 2017
Last updated April 11, 2017
Start date September 8, 2009
Est. completion date January 28, 2011

Study information

Verified date April 2017
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date January 28, 2011
Est. primary completion date August 31, 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Behavioral:
Physical Activity
12 week print based intervention

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Diego

References & Publications (1)

Hartman SJ, Dunsiger SI, Marcus BH. A pilot study of a physical activity intervention targeted towards women at increased risk for breast cancer. Psychooncology. 2013 Feb;22(2):381-7. doi: 10.1002/pon.2101. Epub 2011 Dec 2. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Minutes of moderate to vigorous physical activity 7-Day Physical Activity Recall baseline to 12 weeks
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