Breast NeoplasmsNCT02510430
The Plan and Stand Study: Reducing Sitting Time in Breast Cancer Survivors
A study testing Re-Patterning Sitting Time Group and Reducing Sitting Time Group in people with Breast Neoplasms, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Excessive sitting time (sedentary time) has been associated with risk of insulin resistance and other factors which may be relevant to breast cancer prognosis. This 8-week study tests different strategies for helping breast cancer survivors to modify their levels of sitting time. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Re-Patterning Sitting Time Group and Reducing Sitting Time Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2015to 24 Jan 2018
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diagnosed with Stage 0-III breast cancer. Bilateral or multiple primary breast cancers are permitted.
- Completed primary treatment defined as definitive surgery, (neo)adjuvant chemotherapy and/or (neo)adjuvant radiation. Participants still receiving adjuvant endocrine or HER2 targeted therapies are eligible.
- Report sitting for ≥8 accumulated waking hours on a typical day,
- Willing and able to attend 3 study visits at the UW,
- Willing to attempt reduction of sitting time,
- Use the internet on a regular basis,
- Willing and able to complete study requirements, and
- Currently considered postmenopausal (no menstrual periods in past 12 months), even if pre-menopausal at diagnosis.
Who cannot join
- Evidence of recurrence or metastatic disease,
- Unable to move from sitting to standing without difficulty and to walk 1 block.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Sitting Time Interventions in Breast Cancer Survivors
Excessive sitting time (sedentary time) has been associated with risk of insulin resistance and other factors which may be relevant to breast cancer prognosis. This 8-week study tests different strategies for helping breast cancer survivors to modify their levels of sitting time. Participants will be assigned with equal likelihood to one of three groups (1) overall reduction in sitting time, (2) interruption of sitting time with standing breaks, and (3) usual care.
- Conditions
- Breast Neoplasms
- Being tested
- Re-Patterning Sitting Time Group, Reducing Sitting Time Group, Usual Care
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Re-Patterning Sitting Time GroupBehavioural
This is a behavioral intervention to help women interrupt long bouts of sitting time by incorporating standing breaks into their lifestyle.
Reducing Sitting Time GroupBehavioural
This is a behavioral intervention to help women reduce their overall accumulated sitting time by 2 hours per day.
Usual CareBehavioural
This intervention consists solely of follow-up contact to control for attention effects and reduce attrition.
| Study group | Role | What they receive |
|---|---|---|
| Reducing Sitting Time Group | Experimental | This group will be asked to reduce overall accumulated sitting time by 2 hours per day. Receives: Behavioral: Reducing Sitting Time Group |
| Re-Patterning Sitting Time Group | Experimental | This group will be asked to use standing breaks to interrupt long bouts of sitting time. Receives: Behavioral: Re-Patterning Sitting Time Group |
| Usual Care | Placebo comparator | This is an attention control group and is not asked to make changes to sitting time. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as measured by recruitment and retention rates
Feasibility of recruiting participants to the study
Measured: 12 months
Secondary outcomes (3)
Sedentary behavior as measured by ActivPal
Sedentary time as measured by the ActivPAL inclinometer
Measured: 7 days
Physical activity as measured by ActiGraph
Physical activity as measured by the ActiGraph accelerometer
Measured: 7 days
Sedentary time as measured by ActiGraph
Sedentary time as measured by the ActiGraph accelerometer
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study start30 Nov 2015
- Primary completion24 Jan 2018
- Study completion24 Jan 2018
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.
- More trials run by University of Wisconsin, MadisonThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa A Cadmus-Bertram, Ph.D., Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510430
- Sponsor's protocol ID
- 2015-0449
- Other IDs
- UW14101
- Status last verified
- Jul 2018
- First submitted
- 24 Jul 2015
- Last updated
- 6 Jul 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Sitting Time Interventions in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT02510430
- Acronym / sponsor ID
- 2015-0449
- Conditions
- Breast Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 30 Nov 2015
- Primary completion
- 24 Jan 2018 (actual)
- Study completion
- 24 Jan 2018 (actual)
- First posted
- 29 Jul 2015 (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.
Excessive sitting time (sedentary time) has been associated with risk of insulin resistance and other factors which may be relevant to breast cancer prognosis. This 8-week study tests different strategies for helping breast cancer survivors to modify their levels of sitting time. Participants will be assigned with equal likelihood to one of three groups (1) overall reduction in sitting time, (2) interruption of sitting time with standing breaks, and (3) usual care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reducing Sitting Time Group | Experimental | Behavioral: Reducing Sitting Time GroupThis group will be asked to reduce overall accumulated sitting time by 2 hours per day. |
| Re-Patterning Sitting Time Group | Experimental | Behavioral: Re-Patterning Sitting Time GroupThis group will be asked to use standing breaks to interrupt long bouts of sitting time. |
| Usual Care | Placebo comparator | Behavioral: Usual CareThis is an attention control group and is not asked to make changes to sitting time. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- diagnosed with Stage 0-III breast cancer. Bilateral or multiple primary breast cancers are permitted.
- Completed primary treatment defined as definitive surgery, (neo)adjuvant chemotherapy and/or (neo)adjuvant radiation. Participants still receiving adjuvant endocrine or HER2 targeted therapies are eligible.
- Report sitting for ≥8 accumulated waking hours on a typical day,
- Willing and able to attend 3 study visits at the UW,
- Willing to attempt reduction of sitting time,
Key exclusion criteria (2 listed)
- Evidence of recurrence or metastatic disease,
- Unable to move from sitting to standing without difficulty and to walk 1 block.
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 |
|---|---|---|
| Re-Patterning Sitting Time GroupThis is a behavioral intervention to help women interrupt long bouts of sitting time by incorporating standing breaks into their lifestyle. | Behavioural | Re-Patterning Sitting Time Group |
| Reducing Sitting Time GroupThis is a behavioral intervention to help women reduce their overall accumulated sitting time by 2 hours per day. | Behavioural | Reducing Sitting Time Group |
| Usual CareThis intervention consists solely of follow-up contact to control for attention effects and reduce attrition. | Behavioural | Usual Care |
Primary outcome
Feasibility as measured by recruitment and retention rates
Time frame: 12 months
Feasibility of recruiting participants to the study
3 secondary outcomes
Sedentary behavior as measured by ActivPal
Time frame: 7 days
Physical activity as measured by ActiGraph
Time frame: 7 days
Sedentary time as measured by ActiGraph
Time frame: 7 days
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 6 Jul 2018.
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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.
Lisa A Cadmus-Bertram, Ph.D. principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Re-Patterning Sitting Time Group and Reducing Sitting Time Group in people with Breast Neoplasms, run by University of Wisconsin, Madison 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 8 inclusion and 2 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 6 Jul 2018. 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. Some participants in this study may receive a placebo. 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?
Feasibility as measured by recruitment and retention rates (time frame: 12 months). 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 6 Jul 2018.