FemaleNCT03115658
Physical Activity and First Degree Female Relatives of Breast Cancer Patients
A study testing Physical Activity in people with Female and First-degree Relative With Breast Cancer, run by University of California, San Diego.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female, First-degree Relative With Breast Cancer
- What is being tested?
- Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 8 Sep 2009to 28 Jan 2011
- 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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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.
- Conditions
- Female, First-degree Relative With Breast Cancer
- Being tested
- Physical Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
12 week print based intervention
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Experimental | 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. Receives: Behavioral: Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minutes of moderate to vigorous physical activity
7-Day Physical Activity Recall
Measured: baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start8 Sep 2009
- Primary completion31 Aug 2010
- Study completion28 Jan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FemaleStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheri Hartman, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115658
- Sponsor's protocol ID
- 2050-09
- Status last verified
- Apr 2017
- First submitted
- 11 Apr 2017
- Last updated
- 14 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22135183Hartman 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.
PubMed 28526031
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and First Degree Female Relatives of Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT03115658
- Acronym / sponsor ID
- 2050-09
- Conditions
- Female, First-degree Relative With Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 8 Sep 2009 (actual)
- Primary completion
- 31 Aug 2010 (actual)
- Study completion
- 28 Jan 2011 (actual)
- First posted
- 14 Apr 2017 (actual)
- 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 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Experimental | Behavioral: Physical ActivityParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 Activity12 week print based intervention | Behavioural | Exercise Intervention |
Primary outcome
Minutes of moderate to vigorous physical activity
Time frame: baseline to 12 weeks
7-Day Physical Activity Recall
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 14 Apr 2017.
- Results publication: PubMed 22135183Hartman 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.
- Derived from this study: PubMed 28526031Hartman 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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity in people with Female and First-degree Relative With Breast Cancer, run by University of California, San Diego.
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 4 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 14 Apr 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?
Minutes of moderate to vigorous physical activity (time frame: baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03115658, which also lists 2 linked publications.
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 14 Apr 2017.