N/A
Completed N=269
Optimization of Remotely Delivered Physical Activity Intervention for Breast Cancer Survivors
Breast Cancer Female · Physical Activity
Source: ClinicalTrials.gov NCT03131440 ↗
Enrolled (actual)
269
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcomePrimary: Adherence to a 12 Week Technology Supported Physical Activity Intervention — 93.0 Percentage of Days Fitbit Worn
Summary
The overall objective of the proposed research is to pilot test the feasibility and acceptability of a set of more scalable technology-supported physical activity promotion intervention strategies in breast cancer survivors using tMultiphase Optimization Strategy Trial (MOST) methodology. MOST involves highly efficient randomized experimentation to assess the effects of individual intervention strategies, and thereby identify which strategies and what strategy levels make the important contributions to the overall program's effect on physical activity. This information then guides assembly of an optimized physical activity program, that achieves target outcomes with least resource consumption and participant burden. The resulting intervention will have great potential for scalability because it uses technology (smartphones) participants already own and requires no on-site visits.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adherence to a 12 Week Technology Supported Physical Activity Intervention |
93.0 | — |
| PRIMARY Participant Retention |
93.3 | — |
| PRIMARY Intervention Reach |
50.8 | — |
| SECONDARY Change in Moderate to Vigorous Physical Activity From Before to After a 12-Week Intervention |
57.9; 55.5; 59.8; 49.3; 44.3; 53.6 | — |
| SECONDARY Change in Moderate to Vigorous Physical Activity From Pre-Intervention to 24-week Follow-up |
28.5; 25.9; 25.3; 15.1; 15.8; 24.6 | — |
| SECONDARY Change in Fatigue From Before to After a 12-Week Intervention |
-3.1; -3.3; -2.8; -2.2; -2.0; -2.7 | — |
| SECONDARY Change in Fatigue From Pre-Intervention to 24-Week Follow-up |
-3.5; -4.0; -3.6; -3.3; -3.0; -3.6 | — |
| SECONDARY Change in Physical Function From Before to After a 12-Week Intervention |
2.4; 2.3; 2.2; 1.4; 2.5; 2.0 | — |
| SECONDARY Treatment Effects for Physical Function From Pre-Intervention to 24-week Follow-up |
2.2; 2.4; 2.4; 2.0; 2.7; 2.2 | — |
| SECONDARY Change in Depression From Before to After a 12-Week Intervention |
-2.2; -2.2; -2.6; -1.8; -2.1; -2.2 | — |
| SECONDARY Change in Depression From Pre-Intervention to 24-week Follow-up |
-1.7; -1.8; -1.6; -1.8; -1.8; -1.8 | — |
| SECONDARY Adherence to During the Full 24-Week Study Period |
80.0 | — |
| SECONDARY Participant Retention at 24 Week Follow-up |
90 | — |
| SECONDARY Change in Interleukin-6 (IL-6) From Before to After a12 Week Intervention (Optional) |
-0.07; -0.06; -0.05; -0.08; 0.01; -0.02 | — |
| SECONDARY Change in Interleukin-6 (IL-6) From Pre-Intervention to 24-week Follow-up (Optional) |
0.14; 0.13; 0.09; 0.06; 0.17; 0.14 | — |
| SECONDARY Change in Interleukin-10 (IL-10) From Before to After a 12 Week Intervention (Optional) |
0.03; -0.01; -0.01; -0.02; 0.03; 0 | — |
| SECONDARY Change in Interleukin-10 (IL-10) From Pre-Intervention to 24-week Follow-up (Optional) |
0.11; 0.04; 0.06; 0.06; 0.08; 0.05 | — |
| SECONDARY Change in Tumor Necrosis Factor-alpha (TNFα) From Before to After a12 Week Intervention (Optional) |
0.22; -0.27; -0.11; -0.27; -0.17; -0.13 | — |
| SECONDARY Change in Tumor Necrosis Factor-alpha (TNFα) From Pre-Intervention to 24-week Follow-up (Optional) |
0.22; 0.14; 0.07; -0.03; 0.24; 0.09 | — |
| SECONDARY Change in C-reactive Protein (CRP) From Before to After a12 Week Intervention (Optional) |
-0.04; -0.14; 0.14; 0.22; -0.02; 0.07 | — |
| SECONDARY Change in C-reactive Protein (CRP) From Pre-Intervention to 24-week Follow-up (Optional) |
0.05; -0.09; -0.06; 0.01; -0.07; -0.09 | — |
| SECONDARY Change in Triglycerides From Before to After a 12 Week Intervention (Optional) |
-17.35; 6.63; -14.96; 28.08; 9.01; 4.40 | — |
| SECONDARY Change in Triglycerides From Pre-Intervention to 24-week Follow-up (Optional) |
-10.81; 5.15; 3.60; 17.12; 20.99; 16.10 | — |
| SECONDARY Change in Blood Glucose From Before to After a 12 Week Intervention (Optional) |
1.16; 3.90; 2.68; 3.83; 3.29; 2.62 | — |
| SECONDARY Change in Blood Glucose From Pre-Intervention to 24-week Follow-up (Optional) |
-3.13; -3.03; -1.33; -1.20; 0.38; -1.55 | — |
| SECONDARY Change in High Density Lipoprotein Cholesterol (HDL) From Before to After a12 Week Intervention (Optional) |
0.37; 3.43; 5.19; 1.18; 3.91; 0.31 | — |
| SECONDARY Change in High Density Lipoprotein Cholesterol (HDL) From Pre-Intervention to 24-week Follow-up(Optional) |
2.72; 0.59; 2.01; 0.51; 4.50; 0.57 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with Stage I-III breast cancer within the last 5 years
- Have completed last cancer treatment (adjuvant chemotherapy, radiation therapy or surgery) at least 3 months prior to enrollment
- English speaking
- Currently participate in less than 60 minutes of moderate and vigorous physical activity per week
- Own a smartphone
- Have access to a computer with Internet
- Participants may be using adjuvant endocrine therapies.
- Willing to be waitlisted for future wave if current wave reaches capacity
Exclusion Criteria
-Women will be excluded if they report any of the following:
- Respiratory, joint or cardiovascular problems precluding physical activity
- Metastatic disease
- Planned elective surgery during duration of the intervention/follow-up that would interfere with participation (e.g., breast reconstructive surgery).
ONLY IF PARTICIPATING IN OPTIONAL BLOOD COLLECTION:
- A prior cardiovascular event (i.e. stroke, myocardial infarction)
- Have been diagnosed with an acute or chronic immune system medical conditions, or conditions that impact immune and endocrine function (e.g., CFS, Lupus, rheumatoid arthritis, Hepatitis C, or immunosuppressive treatment requiring conditions)
Data sourced from ClinicalTrials.gov (NCT03131440). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.