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Quality of Life in Breast Cancer Patients and Survivors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01272401
First Posted: January 7, 2011
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Edward McAuley, University of Illinois at Urbana-Champaign
  Purpose
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.

Condition
Breast Neoplasms

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Determinants and Correlates of Physical Activity in Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Edward McAuley, University of Illinois at Urbana-Champaign:

Primary Outcome Measures:
  • 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. [ Time Frame: Baseline ]
  • 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. [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Self-efficacy for engaging in physical activity and overcoming barriers to physical activity. [ Time Frame: Baseline ]
  • Physical activity as measured by questionnaire and 7 day accelerometry. [ Time Frame: Baseline ]
  • Self-efficacy for engaging in physical activity and overcoming barriers to physical activity. [ Time Frame: 6 months ]
  • Physical activity as measured by questionnaire and 7 day accelerometry. [ Time Frame: 6 months ]

Enrollment: 500
Study Start Date: June 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Breast cancer patients and survivors

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community dwelling breast cancer patients and survivors
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01272401


Sponsors and Collaborators
University of Illinois at Urbana-Champaign
National Institute on Aging (NIA)
Investigators
Principal Investigator: Edward McAuley, PhD University of Illinois at Urbana-Champaign
  More Information

Responsible Party: Edward McAuley, Professor, University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT01272401     History of Changes
Other Study ID Numbers: UIUC_IRB_10085
1F31AG034025-01A1 ( U.S. NIH Grant/Contract )
First Submitted: July 2, 2010
First Posted: January 7, 2011
Last Update Posted: February 23, 2017
Last Verified: February 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