Breast CancerNCT01173861
Effectiveness of a Cancer Center Based Physical Activity Intervention
A study testing Physical activity counseling in people with Breast Cancer and Quality of Life, run by East Carolina University at 1 site in United States.
Trial summary
Purpose: Examine the effectiveness of cancer center-based physical activity counseling on physical activity rates and quality of life in breast cancer survivors. Hypothesis: Participants in the intervention group will indicate greater step counts and quality of life at the end of the intervention compared to the… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Quality of Life, Physical Activity
- What is being tested?
- Physical activity counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Jul 2012
- Phase
- Interventional
- 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
Who may be able to join
- Diagnosis of breast cancer within the last 5 years
- Over the age of 18 years
- female
Who cannot join
- Non-ambulatory
- Poor cognitive function
- Contraindications for exercise as determined by the PAR-Q
Trial locations and contacts
1 site in 1 country.
United States1 site
Leo Jenkins Cancer Center
Greenville, North Carolina, 27834
About this study
Purpose: Examine the effectiveness of cancer center-based physical activity counseling on physical activity rates and quality of life in breast cancer survivors.
Hypothesis: Participants in the intervention group will indicate greater step counts and quality of life at the end of the intervention compared to the control group
- Conditions
- Breast Cancer, Quality of Life, Physical Activity
- Being tested
- Physical activity counseling
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity counselingBehavioural
20-30 minutes of face-to-face physical activity counseling using motivational interviewing followed by 3 20 minute telephone counseling sessions.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity counseling | Experimental | Group receives face-to-face physical activity counseling. Receives: Behavioral: Physical activity counseling |
| Manual | Active comparator | Group receives physical activity manual. Receives: Behavioral: Physical activity counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of a cancer center based physical activity intervention for increasing physical activity in breast cancer survivors.
The primary outcome is to examine the effectiveness of a cancer center based physical activity intervention on increasing physical activity as measured by step counts on a pedometer.
Measured: 8 weeks
Secondary outcomes (1)
Effectiveness of a cancer center based physical activity counseling intervention on increasing quality of life in breast cancer survivors.
The secondary outcome is to examine the effectiveness of a cancer center based physical activity counseling intervention on improving quality of life in breast cancer survivors.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Karvinen, East Carolina University
- Investigators
- Kristina H Karvinen, PhD, Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173861
- Sponsor's protocol ID
- IRB 09-0887
- Status last verified
- Jul 2012
- First submitted
- 25 May 2010
- Last updated
- 13 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Cancer Center Based Physical Activity Intervention
- ClinicalTrials.gov ID
- NCT01173861
- Acronym / sponsor ID
- IRB 09-0887
- Conditions
- Breast Cancer, Quality of Life, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 2 Aug 2010 (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.
Purpose: Examine the effectiveness of cancer center-based physical activity counseling on physical activity rates and quality of life in breast cancer survivors.
Hypothesis: Participants in the intervention group will indicate greater step counts and quality of life at the end of the intervention compared to the control group
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity counseling | Experimental | Behavioral: Physical activity counselingGroup receives face-to-face physical activity counseling. |
| Manual | Active comparator | Behavioral: Physical activity counselingGroup receives physical activity manual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of breast cancer within the last 5 years
- Over the age of 18 years
- female
Key exclusion criteria (3 listed)
- Non-ambulatory
- Poor cognitive function
- Contraindications for exercise as determined by the PAR-Q
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity counseling20-30 minutes of face-to-face physical activity counseling using motivational interviewing followed by 3 20 minute telephone counseling sessions. | Behavioural | Manual, Physical activity counseling |
Primary outcome
Effectiveness of a cancer center based physical activity intervention for increasing physical activity in breast cancer survivors.
Time frame: 8 weeks
The primary outcome is to examine the effectiveness of a cancer center based physical activity intervention on increasing physical activity as measured by step counts on a pedometer.
1 secondary outcome
Effectiveness of a cancer center based physical activity counseling intervention on increasing quality of life in breast cancer survivors.
Time frame: 8 weeks
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 13 Jul 2012.
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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.
Kristina H Karvinen, PhD principal investigator
East Carolina University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity counseling in people with Breast Cancer and Quality of Life, run by East Carolina University at 1 site in United States.
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 3 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 13 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Effectiveness of a cancer center based physical activity intervention for increasing physical activity in breast cancer survivors. (time frame: 8 weeks). 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 13 Jul 2012.