CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 280 enrolled
Drug / intervention
Core +5 morebehavioral
Likely dose
Not stated in record
Key inclusion· 6
  • Diagnosed with Stage I-III breast cancer within the last 5 years
  • Completed last cancer treatment (chemotherapy, radiation, or surgery) at least 3 months prior to enrollment
  • Currently participate in less than 60 minutes of moderate and vigorous physical activity per week
  • English speaking
Key exclusion· 5
  • Metastatic disease
  • Respiratory, joint or cardiovascular problems precluding physical activity
  • Planned elective surgery during intervention/follow-up that would interfere with participation (e.g., breast reconstructive surgery)
  • Prior cardiovascular event (stroke, myocardial infarction) - applies only if participating in optional blood collection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03131440
NCT03131440N/ACompleted

Designing With Dissemination in Mind: Optimization of a mHealth Physical Activity Intervention for Breast Cancer Survivors

Northwestern University·interventional·Posted Apr 27, 2017·Updated Mar 10, 2023

In Brief

A clinical study evaluating Core, Support Calls, and 4 other interventions for Breast Cancer Female and Physical Activity. Completed, enrolled 280 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedApr 27, 2017
Enrollment StartApr 24, 2017
Primary CompletionJun 17, 2019
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 9.2 years ago

Interventions

Corebehavioral

The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

Support Callsbehavioral

Participants will receive 6 bi-weekly phone calls from study staff.

App+behavioral

Participants will receive "deluxe" version of smartphone app with additional features.

Online gymbehavioral

Participants will receive access to online exercise videos.

App notificationsbehavioral

Participants will receive motivational app notifications

Buddybehavioral

Participants will choose a buddy to receive a Fitbit and support them during the intervention.