Breast NeoplasmsNCT01272401
Quality of Life in Breast Cancer Patients and Survivors
An observational study of Breast Neoplasms, run by University of Illinois at Urbana-Champaign.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Community dwelling breast cancer patients and survivors
Who may be able to join
- 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
Who cannot join
- Under the age of 18
- Male
- Have never been diagnosed with breast cancer
About this study
Official title: Determinants and Correlates of Physical Activity in Breast Cancer Survivors
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.
Read the 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.
- Conditions
- Breast Neoplasms
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients and survivors | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (4)
Self-efficacy for engaging in physical activity and overcoming barriers to physical activity.
Measured: Baseline
Physical activity as measured by questionnaire and 7 day accelerometry.
Measured: Baseline
Self-efficacy for engaging in physical activity and overcoming barriers to physical activity.
Measured: 6 months
Physical activity as measured by questionnaire and 7 day accelerometry.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study startJun 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Edward McAuley, University of Illinois at Urbana-Champaign
- Investigators
- Edward McAuley, PhD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01272401
- Sponsor's protocol ID
- UIUC_IRB_10085
- Other IDs
- 1F31AG034025-01A1
- Status last verified
- Feb 2017
- First submitted
- 2 Jul 2010
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants and Correlates of Physical Activity in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT01272401
- Acronym / sponsor ID
- UIUC_IRB_10085
- Conditions
- Breast Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Jun 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 7 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients and survivors | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community dwelling breast cancer patients and survivors
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Under the age of 18
- Male
- Have never been diagnosed with breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward McAuley, PhD principal investigator
University of Illinois at Urbana-Champaign
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by University of Illinois at Urbana-Champaign.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.