Clinical trial NCT03131440: Optimization of Remotely Delivered Physical Activity Intervention for Breast Cancer Survivors
Official title: Designing With Dissemination in Mind: Optimization of a mHealth Physical Activity Intervention for Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Physical Activity
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-04-27
Enrollment: 280
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Diagnosed with Stage I-III breast cancer within the last 5 years
2. Have completed last cancer treatment (adjuvant chemotherapy, radiation therapy or surgery) at least 3 months prior to enrollment
3. English speaking
4. Currently participate in less than 60 minutes of moderate and vigorous physical activity per week
5. Own a smartphone
6. Have access to a computer with Internet
7. Participants may be using adjuvant endocrine therapies.
8. 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:

1. Respiratory, joint or cardiovascular problems precluding physical activity
2. Metastatic disease
3. 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:

1. A prior cardiovascular event (i.e. stroke, myocardial infarction)
2. 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)

Primary outcomes:
measure: Adherence to a 12 Week Technology Supported Physical Activity Intervention
timeFrame: 12 weeks
measure: Participant Retention
timeFrame: 12 weeks
measure: Intervention Reach
timeFrame: Baseline
Secondary outcomes:
measure: Change in Moderate to Vigorous Physical Activity From Before to After a 12-Week Intervention
timeFrame: Change from baseline to 12 weeks
measure: Change in Moderate to Vigorous Physical Activity From Pre-Intervention to 24-week Follow-up
timeFrame: Change from baseline to 24 weeks
measure: Change in Fatigue From Before to After a 12-Week Intervention
timeFrame: Change from baseline to 12 weeks
measure: Change in Fatigue From Pre-Intervention to 24-Week Follow-up
timeFrame: Change from baseline to 24 weeks
measure: Change in Physical Function From Before to After a 12-Week Intervention
timeFrame: Change from baseline to 12 weeks
measure: Treatment Effects for Physical Function From Pre-Intervention to 24-week Follow-up
timeFrame: Change from baseline to 24 weeks
measure: Change in Depression From Before to After a 12-Week Intervention
timeFrame: Change from baseline to 12 weeks
measure: Change in Depression From Pre-Intervention to 24-week Follow-up
timeFrame: Change from baseline to 24 weeks
measure: Adherence to During the Full 24-Week Study Period
timeFrame: 24 weeks
measure: Participant Retention at 24 Week Follow-up
timeFrame: 24 weeks
measure: Change in Interleukin-6 (IL-6) From Before to After a12 Week Intervention (Optional)
timeFrame: Change from baseline to 12 weeks
measure: Change in Interleukin-6 (IL-6) From Pre-Intervention to 24-week Follow-up (Optional)
timeFrame: Change from baseline to 24 weeks
measure: Change in Interleukin-10 (IL-10) From Before to After a 12 Week Intervention (Optional)
timeFrame: Change from baseline to 12 weeks
measure: Change in Interleukin-10 (IL-10) From Pre-Intervention to 24-week Follow-up (Optional)
timeFrame: Change from baseline to 24 weeks
measure: Change in Tumor Necrosis Factor-alpha (TNFα) From Before to After a12 Week Intervention (Optional)
timeFrame: Change from baseline to 12 weeks
measure: Change in Tumor Necrosis Factor-alpha (TNFα) From Pre-Intervention to 24-week Follow-up (Optional)
timeFrame: Change from baseline to 24 weeks
measure: Change in C-reactive Protein (CRP) From Before to After a12 Week Intervention (Optional)
timeFrame: Change from baseline to 12 weeks
measure: Change in C-reactive Protein (CRP) From Pre-Intervention to 24-week Follow-up (Optional)
timeFrame: Change from baseline to 24 weeks
measure: Change in Triglycerides From Before to After a 12 Week Intervention (Optional)
timeFrame: Change from baseline to 12 weeks
measure: Change in Triglycerides From Pre-Intervention to 24-week Follow-up (Optional)
timeFrame: Change from baseline to 24 weeks
measure: Change in Blood Glucose From Before to After a 12 Week Intervention (Optional)
timeFrame: Change from baseline to 12 weeks
measure: Change in Blood Glucose From Pre-Intervention to 24-week Follow-up (Optional)
timeFrame: Change from baseline to 24 weeks
measure: Change in High Density Lipoprotein Cholesterol (HDL) From Before to After a12 Week Intervention (Optional)
timeFrame: Change from baseline to 12 weeks
measure: Change in High Density Lipoprotein Cholesterol (HDL) From Pre-Intervention to 24-week Follow-up(Optional)
timeFrame: Change from baseline to 24 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References: