Clinical trial NCT01272401: Quality of Life in Breast Cancer Patients and Survivors
Official title: Determinants and Correlates of Physical Activity in Breast Cancer Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2011-01-07
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community dwelling breast cancer patients and survivors

Brief summary: The purpose of this study is to determine how physical activity, other lifestyle factors, and psychosocial factors are related to quality of life and other health outcomes across the breast cancer survival spectrum from diagnosis to long term survival in a nationally representative sample of breast cancer patients and survivors across a 6 month period of time.

Detailed description: Participants in this study will be asked to sign an informed consent, wear an activity monitor (similar to a pedometer) for 7 consecutive days and complete a packet of questionnaires. The questionnaires will take about 45 minutes to complete. All materials will be sent to participants via the US Postal Service and will need to be mailed back in the provided self-addressed stamped envelopes within 2 weeks. Participants will be asked to repeat these same assessments again in 6 months. NO lab visits will be required for participation. Women from all across the U.S. who have been diagnosed with breast cancer at any point in their lives are being sought. There is no limit on time since diagnosis or treatment status.

Eligibility criteria: Inclusion Criteria:

* Female
* Have received a breast cancer diagnosis and consider self a breast cancer patient or survivor
* Aged 18 years and older
* English speaking
* No limit on time since diagnosis

Exclusion Criteria:

* Under the age of 18
* Male
* Have never been diagnosed with breast cancer

Primary outcomes:
measure: Quality of life. Health-related quality of life will be assessed utilizing a breast cancer specific quality of life measure and global quality of life will be assessed using the satisfaction with life scale.
timeFrame: Baseline
measure: Quality of life. Health-related quality of life will be assessed utilizing a breast cancer specific quality of life measure and global quality of life will be assessed using the satisfaction with life scale.
timeFrame: 6 months
Secondary outcomes:
measure: Self-efficacy for engaging in physical activity and overcoming barriers to physical activity.
timeFrame: Baseline
measure: Physical activity as measured by questionnaire and 7 day accelerometry.
timeFrame: Baseline
measure: Self-efficacy for engaging in physical activity and overcoming barriers to physical activity.
timeFrame: 6 months
measure: Physical activity as measured by questionnaire and 7 day accelerometry.
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Edward McAuley, PhD
role: PRINCIPAL_INVESTIGATOR
References: