Anatomic Stage II Breast Cancer AJCC v8PACTNCT03523195
Exercise Intervention After Cancer Treatment for Improving Health in Stage II-III Breast Cancer Survivors
A study testing Exercise Intervention, Informational Intervention and Laboratory Biomarker Analysis in people with Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage IIA Breast Cancer AJCC v8, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This pilot trial studies how well exercise intervention after cancer treatment works in improving physical activity in stage II-III breast cancer survivors. An exercise intervention may promote regular physical activity. Read more about this study
- Who is it for?
- Ages 19 to 64 years
- Conditions the study is for
- Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8
- What is being tested?
- Exercise Intervention, Informational Intervention and Laboratory Biomarker Analysis
- Type of treatment
- Medical device, 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
- 18 Apr 2018to 15 Jul 2019
- 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 19 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Single malignancy with diagnosis of breast cancer diagnosis of stage II-III, estrogen and progesterone positive, HER-2neu negative, and on stable dose of aromatase inhibitor (AI) for past 3 months, with AI expected to be stable for the study duration
- No evidence of disease
- 1-5 years post active treatment for malignancy
- Body mass index 19 to 35
- Sedentary (< 100 minutes of moderate intensity exercise per week)
- English adequate to complete assessments and follow exercise instructions
- Able to independently use transportation to attend 2-day a week onsite exercise training
- Access to a computer or smartphone
Who cannot join
- Current tobacco use or electronic cigarette smoker
- Pregnant
- Diabetes requiring insulin injection
- Lymphedema that restricts range of motion or with worsening symptoms in the past month, or without compression garment
- Weight change of more than 10 pounds in previous 3 months will exclude from study participation at baseline
- Medical or other issue impacting exercise ability or safety, or ability to comply with study procedures (e.g. significant vision or cognitive impairment, major illness, in hospital or other institution), and specifically:
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- Have been hospitalized within 3 months prior to screening for major atherosclerotic events (e.g. myocardial infarction, target-vessel revascularization, coronary bypass surgery, stroke or blood clot) or other major medical condition (as determined by an investigator) that may put the subject at risk because of his/her participation in the study;
- Have an implanted cardiac pacemaker or other implanted cardiac device;
- Have chronic, uncontrolled hypertension as judged by the investigator;
- Have a creatinine clearance < 45 mL/min as calculated by the Cockcroft-Gault equation;
- Subject's hand or legs have mobility impairment from fractures, arthritis, surgery, muscle disease or other injury that may interfere with any study procedure or ability to exercise
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Physical Activity After Cancer Treatment (PACT): Pilot Study of Exercise in Stage II-III Breast Cancer Survivors
This pilot trial studies how well exercise intervention after cancer treatment works in improving physical activity in stage II-III breast cancer survivors. An exercise intervention may promote regular physical activity.
Read the detailed description
PRIMARY OBJECTIVES:
- Estimate the adherence rate of the experimental exercise program, and deem as feasible if at least 80% of participants complete 80% or more of a 12-week, 180 minute aerobic+resistance training program that combines structured, individualized onsite exercise at the Fred Hutch Prevention Center with at-home exercise.
II. Identify up to 5 circulating micro ribonucleic acid (c-miRNA) biomarkers that show the largest differential change from baseline when comparing levels in the exercise program to those in the Fitbit-activity control condition.
SECONDARY OBJECTIVES:
- Explore associations between changes in miRNAs and serum biomarkers (IL-6, lipids, adiponectin and leptin, C-reactive protein [CRP]) and physiological outcomes (resting heart rate, blood pressure, 1 repetition max, 6 minute walk, timed up and go test) of the exercise program.
II. Explore changes in the patient-reported outcomes (PRO) in response to the exercise intervention relative to the control group, and finalize measures to use in the design of the phase III clinical trial based on descriptive changes from baseline to follow-ups in the intervention versus (vs.) control groups.
OUTLINE: Participants are randomized into 1 of 2 arms.
ARM 0: Participants wear Fitbit and receive written information on healthy exercise and diet recommendations.
ARM 1: Participants complete exercise program including aerobic and resistance exercises over 60 minutes 3 times per week for 12 weeks. Exercise is supervised all 3 times during weeks 1-2. During weeks 3-12, exercise is supervised 2 times a week, with home-based coaching for an additional 60 minutes a week.
- Conditions
- Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8
- Being tested
- Exercise Intervention, Informational Intervention, Laboratory Biomarker Analysis, Monitoring Device, Questionnaire Administration
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
Complete exercise program
Informational InterventionOther
Receive written information on healthy exercise and diet recommendations
Laboratory Biomarker AnalysisOther
Blood tests
Monitoring DeviceDevice
Also called Monitor
Wear Fitbit
Questionnaire AdministrationOther
Ancillary studies
Physical Performance TestingOther
Also called Physical Function Testing
Performance of physical tests
| Study group | Role | What they receive |
|---|---|---|
| Arm 0 (written information) | Active comparator | Participants wear Fitbit and receive written information on healthy exercise and diet recommendations. Receives: Other: Informational Intervention; Other: Laboratory Biomarker Analysis; Device: Monitoring Device; Other: Questionnaire Administration; Other: Physical Performance Testing |
| Arm I (exercise program) | Experimental | Participants complete exercise program including aerobic and resistance exercises over 60 minutes 3 times per week for 12 weeks. Exercise is supervised all 3 times during weeks 1-2. During weeks 3-12, exercise is supervised 2 times a week, with home-based coaching for an additional 60 minutes a week. Receives: Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration; Other: Physical Performance Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Will assess the percent of expected onsite sessions attended by participants as determined by Prevention Center attendance log.
Measured: Up to 26 weeks
Differential micro ribonucleic acid expression
Will compare between arms. Descriptive statistics will be provided. Will calculate the log-fold change between baseline measure and post-baseline measure, and the difference in the log-fold change will be calculated between the two arms.
Measured: At baseline, 13, and 26 weeks
Secondary outcomes (1)
Percent of expected home exercise sessions completed as determined by the home exercise logs for those choosing to not come in for a third weekly session
Measured: Up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start18 Apr 2018
- Primary completion15 Jul 2019
- Study completion15 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage II Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Karen Syrjala, Principal investigator, Fred Hutch/University of Washington Cancer ConsortiumJulie Gralow, Principal investigator, Fred Hutch/University of Washington Cancer ConsortiumMarie-Laure Crouch, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523195
- Sponsor's protocol ID
- 9988
- Other IDs
- NCI-2018-00544, 9988, P30CA015704
- Acronym
- PACT
- Status last verified
- Jul 2019
- First submitted
- 1 May 2018
- Last updated
- 22 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity After Cancer Treatment (PACT): Pilot Study of Exercise in Stage II-III Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT03523195
- Acronym / sponsor ID
- PACT / 9988
- Conditions
- Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 14 May 2018 (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 pilot trial studies how well exercise intervention after cancer treatment works in improving physical activity in stage II-III breast cancer survivors. An exercise intervention may promote regular physical activity.
Detailed description
PRIMARY OBJECTIVES:
- Estimate the adherence rate of the experimental exercise program, and deem as feasible if at least 80% of participants complete 80% or more of a 12-week, 180 minute aerobic+resistance training program that combines structured, individualized onsite exercise at the Fred Hutch Prevention Center with at-home exercise.
II. Identify up to 5 circulating micro ribonucleic acid (c-miRNA) biomarkers that show the largest differential change from baseline when comparing levels in the exercise program to those in the Fitbit-activity control condition.
SECONDARY OBJECTIVES:
- Explore associations between changes in miRNAs and serum biomarkers (IL-6, lipids, adiponectin and leptin, C-reactive protein [CRP]) and physiological outcomes (resting heart rate, blood pressure, 1 repetition max, 6 minute walk, timed up and go test) of the exercise program.
II. Explore changes in the patient-reported outcomes (PRO) in response to the exercise intervention relative to the control group, and finalize measures to use in the design of the phase III clinical trial based on descriptive changes from baseline to follow-ups in the intervention versus (vs.) control groups.
OUTLINE: Participants are randomized into 1 of 2 arms.
ARM 0: Participants wear Fitbit and receive written information on healthy exercise and diet recommendations.
ARM 1: Participants complete exercise program including aerobic and resistance exercises over 60 minutes 3 times per week for 12 weeks. Exercise is supervised all 3 times during weeks 1-2. During weeks 3-12, exercise is supervised 2 times a week, with home-based coaching for an additional 60 minutes a week.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 0 (written information) | Active comparator | Other: Informational Intervention, Other: Laboratory Biomarker Analysis, Device: Monitoring Device, Other: Questionnaire Administration, Other: Physical Performance TestingParticipants wear Fitbit and receive written information on healthy exercise and diet recommendations. |
| Arm I (exercise program) | Experimental | Behavioral: Exercise Intervention, Other: Laboratory Biomarker Analysis, Other: Questionnaire Administration, Other: Physical Performance TestingParticipants complete exercise program including aerobic and resistance exercises over 60 minutes 3 times per week for 12 weeks. Exercise is supervised all 3 times during weeks 1-2. During weeks 3-12, exercise is supervised 2 times a week, with home-based coaching for an additional 60 minutes a week. |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Single malignancy with diagnosis of breast cancer diagnosis of stage II-III, estrogen and progesterone positive, HER-2neu negative, and on stable dose of aromatase inhibitor (AI) for past 3 months, with AI expected to be stable for the study duration
- No evidence of disease
- 1-5 years post active treatment for malignancy
- Body mass index 19 to 35
- Sedentary (< 100 minutes of moderate intensity exercise per week)
Key exclusion criteria (11 listed)
- Current tobacco use or electronic cigarette smoker
- Pregnant
- Diabetes requiring insulin injection
- Lymphedema that restricts range of motion or with worsening symptoms in the past month, or without compression garment
- Weight change of more than 10 pounds in previous 3 months will exclude from study participation at baseline
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 |
|---|---|---|
| Exercise InterventionComplete exercise program | Behavioural | Arm I (exercise program) |
| Informational InterventionReceive written information on healthy exercise and diet recommendations | Other | Arm 0 (written information) |
| Laboratory Biomarker AnalysisBlood tests | Other | Arm 0 (written information), Arm I (exercise program) |
| Monitoring DeviceAlso: MonitorWear Fitbit | Device | Arm 0 (written information) |
| Questionnaire AdministrationAncillary studies | Other | Arm 0 (written information), Arm I (exercise program) |
| Physical Performance TestingAlso: Physical Function TestingPerformance of physical tests | Other | Arm 0 (written information), Arm I (exercise program) |
Primary outcome
Adherence
Time frame: Up to 26 weeks
Will assess the percent of expected onsite sessions attended by participants as determined by Prevention Center attendance log.
Differential micro ribonucleic acid expression
Time frame: At baseline, 13, and 26 weeks
Will compare between arms. Descriptive statistics will be provided. Will calculate the log-fold change between baseline measure and post-baseline measure, and the difference in the log-fold change will be calculated between the two arms.
1 secondary outcome
Percent of expected home exercise sessions completed as determined by the home exercise logs for those choosing to not come in for a third weekly session
Time frame: Up to 26 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 22 Jul 2019.
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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.
Karen Syrjala principal investigator
Fred Hutch/University of Washington Cancer Consortium
Julie Gralow principal investigator
Fred Hutch/University of Washington Cancer Consortium
Marie-Laure Crouch principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention, Informational Intervention and Laboratory Biomarker Analysis in people with Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage IIA Breast Cancer AJCC v8, run by Fred Hutchinson Cancer 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 8 inclusion and 11 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 22 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?
Adherence (time frame: Up to 26 weeks). The study lists 2 primary outcomes in all. 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 22 Jul 2019.