Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Breast Cancer Survivors
  • Endometrial Cancer Survivors
  • Physical Activity
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: one control arm, two randomized arms. every subject starts with a base intervention, non-responders will be randomized to one of the two arms.Masking: Single (Outcomes Assessor)Masking Description: Stratified randomization. Assessors will be blinded to which arm the participant is in.Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

An adaptive approach that tries minimal, low resource treatments (i.e., technology tools) for everyone first, and reserves the use of higher-resource components (e.g., coaching) for survivors who fail to increase MVPA, offers a promising alternative to traditional approaches. This engages women who ...

An adaptive approach that tries minimal, low resource treatments (i.e., technology tools) for everyone first, and reserves the use of higher-resource components (e.g., coaching) for survivors who fail to increase MVPA, offers a promising alternative to traditional approaches. This engages women who lack the time or transportation to participate in more intensive interventions, yet avoids providing high-resource components to those who would respond well to a lower-dose intervention. Our success with integrating Fitbit MVPA data into the electronic health record (EHR) with the capability to provide weekly progress feedback to participants via the EHR's patient portal represents a relatively low resource (vs. coaching or supervised exercise) and potentially efficacious16-19 minimal intervention that could be augmented as needed. Placement of the intervention within the EHR is a major advance because it communicates that MVPA is central to survivors' health and is a priority of the cancer care team. Clinicians can be engaged to ensure the intervention is viewed as integral to survivorship care with minimal burden by referring patients to an EHR-based intervention, endorsing intervention messages delivered via the EHR and reviewing a patient's progress at their clinic visits using simple EHR alerts. While the Fitbit plus EHR integration (Fitbit+EHR) minimal intervention will be sufficient for some survivors to increase their MVPA, others will need more support. Little data exists to determine what strategies would be most effective for augmenting a minimal intervention. Further, it is unknown how long the minimal intervention should be continued before augmentations are used. Some survivors may need more support early on, while others may initially succeed but later fail as the weekly MVPA goal increases. Still others may falter initially and recover. Thus, this project uses an innovative adaptive experimental approach, to determine the optimal augmentation tactics to our minimal (Fitbit+EHR) MVPA intervention in inactive breast and endometrial cancer survivors (n=320). All women will receive the Fitbit+EHR intervention. Those who do not respond (meet ?80% of MVPA goal over previous 4 weeks) will be randomized to one of two more intensive augmentation tactics using technology, alone, or in combination with a more traditional component: (1) online gym with access to exercise videos or (2) coaching calls. Participants in the minimal intervention will be evaluated for non-response every 4 weeks so augmentation is delivered when they lapse. Responders will continue with the minimal intervention. The primary outcome is accelerometer-measured weekly minutes of MVPA at 6 months. The investigator will also examine the effects of the intervention sequences on symptom burden and functional performance, important indicators of morbidity in these populations. This is the first systematic effort to develop an adaptive MVPA intervention in any cancer population. Knowledge gained from this study will inform the development of effective, scalable clinic-based interventions to improve quality of life and reduce disease burden among breast and endometrial cancer survivors.

Tracking Information

NCT #
NCT04262180
Collaborators
  • Northwestern University
  • National Cancer Institute (NCI)
Investigators
Principal Investigator: Lisa Cadmus-Bertram, Ph.D. University of Wisconsin, Madison Principal Investigator: Siobhan Phillips, Ph.D., MPH Northwestern University, Chicago