Breast CancerNCT02969291
A Home-Based Study to Enhance Activity in Breast Cancer Survivors
A study testing Reduced Sedentary Time Intervention (RSTI) in people with Breast Cancer, run by Baystate Medical Center at 1 site in United States.
Trial summary
There is a well-documented association between physical activity \& risk for breast cancer development and recurrence. It is known that exercise interventions have been effective at increasing physical activity levels in breast cancer survivors. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Reduced Sedentary Time Intervention (RSTI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Oct 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 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage I-III breast cancer survivors 20-80 who have completed primary treatment (surgery, radiation and/or chemotherapy) greater than 6 months but less than 5 years ago. Patients may be on adjuvant hormonal therapy
- BMI > 25 (overweight or class I/II obese)
- Not meeting current guidelines for regular exercise as defined by less than 150 minutes a week of moderate to vigorous physical activity
- No gain or loss of >10% body weight over the prior 6 months.
Who cannot join
- Known diabetes
- Known coronary artery disease
- Pregnancy
- Any injury that would limit mobility or require use of assisted mobility devices
- Weight gain or loss of >10% body weight over the prior 6 months
- Greater than 150 minutes a week of moderate to vigorous physical activity
- Inability to provide informed consent
- Non-english speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Baystate Medical Center
Springfield, Massachusetts, 01109
About this study
There is a well-documented association between physical activity \& risk for breast cancer development and recurrence. It is known that exercise interventions have been effective at increasing physical activity levels in breast cancer survivors. Knowing that breast cancer survivors are less active than non-cancer patients, a less active lifestyle places them at risk of obesity and poor overall health, which in turn also increases risk of cancer and cancer recurrence. Not all the reasons for the risk reduction are clear, however it is known that hormones and other inflammatory markers play a role.
This study has three goals:
- To investigate the feasibility of a home intervention designed to reduce sedentary behavior.
- Describe the effects of the intervention on levels of sedentary behavior, physical activity, and symptoms.
- Assess cost of the intervention.
Read the detailed description
There is a well-documented association between physical activity and risk for breast cancer development and recurrence. Exercise training interventions have been effective at increasing physical activity levels in breast cancer survivors, however they require 1) a large degree of patient initiative to achieve positive health outcomes associated with sustained behavioral change and 2) facilities and oversight that may be prohibitive in a clinical setting. Although most activity-based research to date has focused on increasing levels of moderate to vigorous physical activity (MVPA) for breast cancer survivors, large epidemiological studies suggest that breast cancer survivors are also more sedentary when compared to non-cancer controls. A recent meta-analysis of controlled intervention trials designed to promote physical activity among sedentary cancer survivors found that none of the trials within the scope of the review succeeded in achieving 75% or better adherence to prescribed exercise guidelines, leading the authors to question whether shifting the target of intervention from MVPA to reductions in sedentary time might be a more realistic goal. Recent research suggests that interventions designed to reduce sedentary time in breast cancer survivors have the potential to yield clinically meaningful health benefits, especially for individuals at higher risk for sedentary behaviors, however the optimal method of intervention is not clear.
Aim 1: Feasibility of the intervention Assess the feasibility of an intervention designed to reduce sedentary behavior in breast cancer survivors. The behavioral intervention will involve the review of a 7-day baseline snapshot of sedentary behavior and physical activity patterns, combined with tailored activity prompts described over the following 6 weeks.
Aim 2: Effects of the intervention Aim 2a: Describe a preliminary range of effect sizes of the intervention on levels of sedentary behavior, physical activity and symptoms of cancer survivorship (e.g. cancer related fatigue).
Aim 2b: Evaluate the relationship between change in sedentary behavior and change in cancer-relevant outcomes, such as fatigue and biomarkers of cancer recurrence (e.g. IGF-1, Leptin), following the reduced sedentary time intervention.
Aim 3: Assessment of intervention components Aim 3a: Quantitatively assess overall cost of the intervention and its individual components, dose delivered and dose received by intervention participants Aim 3b: Quantitatively describe intervention participants' perspectives on the impact of the individual intervention components, including which components appeared most useful for reducing sedentary time.
- Conditions
- Breast Cancer
- Being tested
- Reduced Sedentary Time Intervention (RSTI)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced Sedentary Time Intervention (RSTI)Behavioural
Following 7 days of baseline activity monitoring a study investigator will download the information from the monitor, evaluate the periods of sedentary behavior and create a tailored RSTI for each participant. For example, the investigator may notice a long stretch of sitting in the evening following a meal and identify several exercises that can be done indoors during that time, or if the participant is amiable to walking breaks and a period after work is identified the investigator might suggest the appropriate walking activity at that time. This program has been successful in sedentary overweight office workers and investigators will use similar techniques.
| Study group | Role | What they receive |
|---|---|---|
| Reduced Sedentary Time Intervention | Other | Reduced Sedentary Time Intervention (RSTI) Receives: Behavioral: Reduced Sedentary Time Intervention (RSTI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedentary Time
Change in minutes/day of sedentary time as recorded by ActivPal in all 25 participants pre and post intervention.
Measured: 8 weeks
Secondary outcomes (15)
Activity Level
Change in Activity level as recorded by Actigraph monitor in all 25 participants
Measured: 8 weeks
Glucose
Change in fasting glucose ( mmol/L)in all 25 participants
Measured: 8 weeks
Insulin
Change in insulin (pmol/L) in all 25 participants
Measured: 8 weeks
Total cholesterol
Change in total cholesterol (mmol) in all 25 participants
Measured: 8 weeks
High density lipoprotien cholesterol
Change in high density lipoprotein cholesterol (mmol) in all 25 participants
Measured: 8 weeks
Triglyceride
Change in triglycerides (mmol) in all 25 participants
Measured: 8 weeks
Body Mass Index
Change in Body Mass Index (kg/m2) in all 25 participants
Measured: 8 weeks
Waist Circumference
Change in waist circumference in cm in all 25 participants
Measured: 8 weeks
Systolic Blood pressure
Change in systolic blood pressure measured in mmHg in all 25 participants
Measured: 8 weeks
Diastolic Blood pressure
Change in diastolic blood pressure measured in mmHg in all 25 participants
Measured: 8 weeks
Cancer-related fatigue measured by change in PROMIS short form 8a in all 25 participants
Measured: 8 weeks
Cancer-related fatigue as measured by change in Visual Analog scale in all 25 participants
Measured: 8 weeks
Sedentary behavior self -efficacy
Change in Sedentary Behavior Self-Efficacy Scale (modified from BARSE) in all 25 participants
Measured: 8 weeks
Change in EORTC-QLQ-C30 scores in all 25 participants
Measured: 8 weeks
Assessment of Intervention
Change in Assessment of Intervention questions on a scale of 1-5 in all 25 participants
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 posted21 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2018
- Study completionOct 2018
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baystate Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Massachusetts, Amherst
- Responsible party
- Sponsor
- Investigators
- Grace Makari-Judson, MD, Principal investigator, Baystate Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969291
- Sponsor's protocol ID
- 776553-5
- Status last verified
- Jul 2019
- First submitted
- 2 Nov 2016
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Home-Based Study to Enhance Activity in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT02969291
- Acronym / sponsor ID
- 776553-5
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Baystate Medical CenterUniversity, hospital or other
- Collaborators
- University of Massachusetts, Amherst
- Study start
- Oct 2016
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 21 Nov 2016 (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.
There is a well-documented association between physical activity \& risk for breast cancer development and recurrence. It is known that exercise interventions have been effective at increasing physical activity levels in breast cancer survivors. Knowing that breast cancer survivors are less active than non-cancer patients, a less active lifestyle places them at risk of obesity and poor overall health, which in turn also increases risk of cancer and cancer recurrence. Not all the reasons for the risk reduction are clear, however it is known that hormones and other inflammatory markers play a role.
This study has three goals:
- To investigate the feasibility of a home intervention designed to reduce sedentary behavior.
- Describe the effects of the intervention on levels of sedentary behavior, physical activity, and symptoms.
- Assess cost of the intervention.
Detailed description
There is a well-documented association between physical activity and risk for breast cancer development and recurrence. Exercise training interventions have been effective at increasing physical activity levels in breast cancer survivors, however they require 1) a large degree of patient initiative to achieve positive health outcomes associated with sustained behavioral change and 2) facilities and oversight that may be prohibitive in a clinical setting. Although most activity-based research to date has focused on increasing levels of moderate to vigorous physical activity (MVPA) for breast cancer survivors, large epidemiological studies suggest that breast cancer survivors are also more sedentary when compared to non-cancer controls. A recent meta-analysis of controlled intervention trials designed to promote physical activity among sedentary cancer survivors found that none of the trials within the scope of the review succeeded in achieving 75% or better adherence to prescribed exercise guidelines, leading the authors to question whether shifting the target of intervention from MVPA to reductions in sedentary time might be a more realistic goal. Recent research suggests that interventions designed to reduce sedentary time in breast cancer survivors have the potential to yield clinically meaningful health benefits, especially for individuals at higher risk for sedentary behaviors, however the optimal method of intervention is not clear.
Aim 1: Feasibility of the intervention Assess the feasibility of an intervention designed to reduce sedentary behavior in breast cancer survivors. The behavioral intervention will involve the review of a 7-day baseline snapshot of sedentary behavior and physical activity patterns, combined with tailored activity prompts described over the following 6 weeks.
Aim 2: Effects of the intervention Aim 2a: Describe a preliminary range of effect sizes of the intervention on levels of sedentary behavior, physical activity and symptoms of cancer survivorship (e.g. cancer related fatigue).
Aim 2b: Evaluate the relationship between change in sedentary behavior and change in cancer-relevant outcomes, such as fatigue and biomarkers of cancer recurrence (e.g. IGF-1, Leptin), following the reduced sedentary time intervention.
Aim 3: Assessment of intervention components Aim 3a: Quantitatively assess overall cost of the intervention and its individual components, dose delivered and dose received by intervention participants Aim 3b: Quantitatively describe intervention participants' perspectives on the impact of the individual intervention components, including which components appeared most useful for reducing sedentary time.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reduced Sedentary Time Intervention | Other | Behavioral: Reduced Sedentary Time Intervention (RSTI)Reduced Sedentary Time Intervention (RSTI) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stage I-III breast cancer survivors 20-80 who have completed primary treatment (surgery, radiation and/or chemotherapy) greater than 6 months but less than 5 years ago. Patients may be on adjuvant hormonal therapy
- BMI > 25 (overweight or class I/II obese)
- Not meeting current guidelines for regular exercise as defined by less than 150 minutes a week of moderate to vigorous physical activity
- No gain or loss of >10% body weight over the prior 6 months.
Key exclusion criteria (8 listed)
- Known diabetes
- Known coronary artery disease
- Pregnancy
- Any injury that would limit mobility or require use of assisted mobility devices
- Weight gain or loss of >10% body weight over the prior 6 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 |
|---|---|---|
| Reduced Sedentary Time Intervention (RSTI)Following 7 days of baseline activity monitoring a study investigator will download the information from the monitor, evaluate the periods of sedentary behavior and create a tailored RSTI for each participant. For example, the investigator may notice a long stretch of sitting in the evening following a meal and identify several exercises that can be done indoors during that time, or if the participant is amiable to walking breaks and a period after work is identified the investigator might suggest the appropriate walking activity at that time. This program has been successful in sedentary overweight office workers and investigators will use similar techniques. | Behavioural | Reduced Sedentary Time Intervention |
Primary outcome
Sedentary Time
Time frame: 8 weeks
Change in minutes/day of sedentary time as recorded by ActivPal in all 25 participants pre and post intervention.
15 secondary outcomes
Activity Level
Time frame: 8 weeks
Glucose
Time frame: 8 weeks
Insulin
Time frame: 8 weeks
Total cholesterol
Time frame: 8 weeks
High density lipoprotien cholesterol
Time frame: 8 weeks
Triglyceride
Time frame: 8 weeks
Body Mass Index
Time frame: 8 weeks
Waist Circumference
Time frame: 8 weeks
Systolic Blood pressure
Time frame: 8 weeks
Diastolic Blood pressure
Time frame: 8 weeks
Cancer-related fatigue measured by change in PROMIS short form 8a in all 25 participants
Time frame: 8 weeks
Cancer-related fatigue as measured by change in Visual Analog scale in all 25 participants
Time frame: 8 weeks
Sedentary behavior self -efficacy
Time frame: 8 weeks
Change in EORTC-QLQ-C30 scores in all 25 participants
Time frame: 8 weeks
Assessment of Intervention
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 17 Jul 2019.
- Individual participant dataSharing planned: Undecided
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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.
Grace Makari-Judson, MD principal investigator
Baystate Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduced Sedentary Time Intervention (RSTI) in people with Breast Cancer, run by Baystate Medical Center 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 4 inclusion and 8 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 17 Jul 2019. 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?
Sedentary Time (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 17 Jul 2019.