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Physical Activity and First Degree Female Relatives of Breast Cancer Patients

Primary Purpose

Female, First-degree Relative With Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical Activity
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Female

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Exercise Intervention

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Minutes of moderate to vigorous physical activity
    7-Day Physical Activity Recall

    Secondary Outcome Measures

    Full Information

    First Posted
    April 11, 2017
    Last Updated
    April 11, 2017
    Sponsor
    University of California, San Diego
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03115658
    Brief Title
    Physical Activity and First Degree Female Relatives of Breast Cancer Patients
    Official Title
    Physical Activity and First Degree Female Relatives of Breast Cancer Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 8, 2009 (Actual)
    Primary Completion Date
    August 31, 2010 (Actual)
    Study Completion Date
    January 28, 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of California, San Diego

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Female, First-degree Relative With Breast Cancer

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Outcomes Assessor
    Allocation
    N/A
    Enrollment
    27 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Exercise Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Physical Activity
    Intervention Description
    12 week print based intervention
    Primary Outcome Measure Information:
    Title
    Minutes of moderate to vigorous physical activity
    Description
    7-Day Physical Activity Recall
    Time Frame
    baseline to 12 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    22135183
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    28526031
    Citation
    Hartman SJ, Rosen RK. Breast cancer relatives' physical activity intervention needs and preferences: qualitative results. BMC Womens Health. 2017 May 19;17(1):36. doi: 10.1186/s12905-017-0392-0.
    Results Reference
    derived

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    Physical Activity and First Degree Female Relatives of Breast Cancer Patients

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