Sedentary BehaviorNCT05260723
RISE - Reduce Sitting Time Among Breast Cancer Survivors
A study testing Behavioral: Sit Less in people with Sedentary Behavior and Sedentary Time, run by University of California, San Diego at 1 site in United States.
Trial summary
This 3-month study will test whether a program to reduce sitting time, for breast cancer survivors experiencing some physical limitations, can improve their physical function and other important aspects of quality of life. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Sedentary Behavior, Sedentary Time, Breast Cancer
- What is being tested?
- Behavioral: Sit Less
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2022to 7 May 2023
- 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer survivors (stages I-IV) at least 1 year post active treatment (e.g., chemotherapy, radiotherapy)
- Breast cancer was treated with chemotherapy, radiation, immunotherapy, and/or endocrine therapy
- self-report difficulties with physical function
- self-report low levels of moderate to vigorous physical activity
- self-report high levels of sitting time
Who cannot join
- medical condition that interferes with ability to safely stand or stay balanced
- other cancer diagnoses that occurred after their breast cancer diagnosis
- Stage IV breast cancer with brain metastases or less than 12 months life-expectancy
- unable to commit to a 3-month study
Trial locations and contacts
1 site in 1 country.
United States1 site
Moores UCSD Cancer Center
La Jolla, California, 92093
About this study
Official title: RISE - A Pilot Study to Reduce Sitting Time Among Breast Cancer Survivors
This 3-month study will test whether a program to reduce sitting time, for breast cancer survivors experiencing some physical limitations, can improve their physical function and other important aspects of quality of life.
Read the detailed description
Many cancer survivors experience long-term physical problems following their cancer treatments and can often seem much older than same age peers who were never treated for cancer. This is known as accelerated aging. One way to improve accelerated aging is to increase moderate to vigorous intensity exercise; however, for many cancer survivors, especially those with physical limitations, increasing exercise levels is not possible. Another potential way to improve accelerated aging may be to decrease the amount of time spent sitting. Long periods of sitting are related to many physical and health problems. Cancer survivors spend more than 9 hours a day sitting and often increase the amount they sit after their cancer treatments. This study could help identify realistic intervention targets for many cancer survivors and be used to guide recommendations for improving physical function and quality of life after cancer.
- Conditions
- Sedentary Behavior, Sedentary Time, Breast Cancer
- Being tested
- Behavioral: Sit Less
- Keywords
- Physical Function, Cognitive Function, Quality of Life
- Medical subject headings
- Sedentary Behavior, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral: Sit LessBehavioural
The Sit Less arm uses habit formation, social cognitive theory, and motivational interviewing techniques to support behavior change and includes: 1) 7 health coaching sessions to set personalized goals and review progress; 2) wearing an activPAL (thigh worn accelerometer that measures sitting time); 3) intervention tools to support behavior change (e.g., standing desk, wrist worn monitor).
| Study group | Role | What they receive |
|---|---|---|
| Sit Less | Experimental | The primary goal of the Sit Less arm is to reduce the total amount of time spent sitting each day and break up prolonged bouts of sitting. Receives: Behavioral: Behavioral: Sit Less |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention rate of enrolled participants
Percent of participants returning for the 3 month measures
Measured: 3 months
Secondary outcomes (4)
4 meter walk test
Measure of physical functioning
Measured: 3 months
30-second Sit-to-Stand Test
Measure of physical functioning
Measured: 3 months
Timed Up and Go (TUG)
Measure of physical functioning
Measured: 3 months
Patient Reported Measurement Information System - Physical Function
Measure of Self-Report Physical Function, standardized T-score, higher scores indicated better functioning
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start29 Mar 2022
- Primary completion7 Apr 2023
- Study completion7 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 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
- NCT05260723
- Sponsor's protocol ID
- PILOT 171548
- Status last verified
- May 2023
- First submitted
- 9 Feb 2022
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RISE - A Pilot Study to Reduce Sitting Time Among Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT05260723
- Acronym / sponsor ID
- PILOT 171548
- Conditions
- Sedentary Behavior, Sedentary Time, Breast Cancer
- Keywords
- Physical Function, Cognitive Function, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 7 Apr 2023 (actual)
- Study completion
- 7 May 2023 (actual)
- First posted
- 2 Mar 2022 (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.
This 3-month study will test whether a program to reduce sitting time, for breast cancer survivors experiencing some physical limitations, can improve their physical function and other important aspects of quality of life.
Detailed description
Many cancer survivors experience long-term physical problems following their cancer treatments and can often seem much older than same age peers who were never treated for cancer. This is known as accelerated aging. One way to improve accelerated aging is to increase moderate to vigorous intensity exercise; however, for many cancer survivors, especially those with physical limitations, increasing exercise levels is not possible. Another potential way to improve accelerated aging may be to decrease the amount of time spent sitting. Long periods of sitting are related to many physical and health problems. Cancer survivors spend more than 9 hours a day sitting and often increase the amount they sit after their cancer treatments. This study could help identify realistic intervention targets for many cancer survivors and be used to guide recommendations for improving physical function and quality of life after cancer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sit Less | Experimental | Behavioral: Behavioral: Sit LessThe primary goal of the Sit Less arm is to reduce the total amount of time spent sitting each day and break up prolonged bouts of sitting. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Breast cancer survivors (stages I-IV) at least 1 year post active treatment (e.g., chemotherapy, radiotherapy)
- Breast cancer was treated with chemotherapy, radiation, immunotherapy, and/or endocrine therapy
- self-report difficulties with physical function
- self-report low levels of moderate to vigorous physical activity
- self-report high levels of sitting time
Key exclusion criteria (4 listed)
- medical condition that interferes with ability to safely stand or stay balanced
- other cancer diagnoses that occurred after their breast cancer diagnosis
- Stage IV breast cancer with brain metastases or less than 12 months life-expectancy
- unable to commit to a 3-month study
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 |
|---|---|---|
| Behavioral: Sit LessThe Sit Less arm uses habit formation, social cognitive theory, and motivational interviewing techniques to support behavior change and includes: 1) 7 health coaching sessions to set personalized goals and review progress; 2) wearing an activPAL (thigh worn accelerometer that measures sitting time); 3) intervention tools to support behavior change (e.g., standing desk, wrist worn monitor). | Behavioural | Sit Less |
Primary outcome
Retention rate of enrolled participants
Time frame: 3 months
Percent of participants returning for the 3 month measures
4 secondary outcomes
4 meter walk test
Time frame: 3 months
30-second Sit-to-Stand Test
Time frame: 3 months
Timed Up and Go (TUG)
Time frame: 3 months
Patient Reported Measurement Information System - Physical Function
Time frame: 3 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 12 May 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral: Sit Less in people with Sedentary Behavior and Sedentary Time, run by University of California, San Diego 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 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 12 May 2023. 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?
Retention rate of enrolled participants (time frame: 3 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 12 May 2023.