Ignite Creation Date:
2025-12-24 @ 1:52 PM
Ignite Modification Date:
2025-12-30 @ 8:47 PM
Study NCT ID:
NCT03523195
Status:
COMPLETED
Last Update Posted:
2019-07-22
First Post:
2018-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Intervention After Cancer Treatment for Improving Health in Stage II-III Breast Cancer Survivors
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Study Overview
Official Title:
Physical Activity After Cancer Treatment (PACT): Pilot Study of Exercise in Stage II-III Breast Cancer Survivors
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PACT
Brief 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.
Detailed Description:
PRIMARY OBJECTIVES:
I. 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:
I. 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.
I. 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:
I. 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2018-00544 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 9988 | OTHER | Fred Hutch/University of Washington Cancer Consortium | View | |
| P30CA015704 | NIH | None | https://reporter.nih.gov/quic… | View |