Physical Activity Platform to Improve Bone Health in Cancer Survivors
Condition: Breast Cancer; Physical Activity; Bone Health
Study type: Interventional

Summary: 
      Cancer treatment-induced bone loss and the subsequent risk of fractures in both men and women
      impacts not just survivors' quality of life, but is also a significant burden on national
      health care. Clinical studies have reported that moderate-intensity resistance exercises
      prevent a decline in bone health in female cancer survivors, and that strength training may
      reduce complications associated with cancer such as fatigue, muscle wasting, and bone loss.
      Unfortunately, only a small percentage of women who have had cancer, engage in and adhere to
      a strength training exercise routine.

      The investigators have developed an internet-based application, Thrivors, that guides cancer
      survivors through exercise routines with light-to-moderate strength training in the home
      setting, and connects them to survivorship resources. In this Phase I proposal, the
      investigators will develop and deploy an enhanced version, Thrivors+BH, that disseminates
      resistance training exercises specifically impacting bone health (BH), integrated with
      video-based interactive feedback and tracking of adherence to exercise routines.

      The goal is to validate Thrivors+BH as a novel tool to bridge the gaps between cancer
      survivorship, physical activity, value-based care and health care organizations (providers
      and payers), to positively impact bone health in breast cancer survivors.
    

Detailed description: 
      Significance: Cancer treatment-induced bone loss and the subsequent risk of fractures in both
      men and women is a significant burden on national health care. The number of cancer survivors
      in the United States will reach 18 million by 2022 and by 2025, the projected burden of
      osteoporosis is $25.3 billion. Cancer patients treated with medications that lower hormone
      levels face an increased risk of fractures. Clinical studies report that moderate- intensity
      resistance exercises prevent a decline in bone health in female cancer survivors, and that
      strength training may reduce complications associated with cancer such as fatigue, muscle
      wasting, and bone loss. Unfortunately, only a small percentage of female cancer survivors
      engage in and adhere to a strength training exercise routine. Several factors account for
      this low level of engagement such as poor awareness of the benefits of exercise, lack of
      motivation, and the lack of affordable and easily accessible exercise programs designed for
      cancer survivors. Internet-based self-managed programs of exercises and guidance can
      potentially address these problems, and can be scaled for broader dissemination.

      Innovation: The Thrivors internet-based platform seeks to shift the current paradigm of poor
      adherence to exercise by providing an affordable and accessible means of improving outcomes
      for cancer survivors. The proposed product, Thrivors+BH, will be a first-of-its-kind offering
      of clinically validated bone health exercises that can be customized to a cancer survivor's
      pain and energy levels, with several novel interactive feedback features. The product will
      also have supportive modules for connecting with a community of other users, mindfulness
      training, nutritional advice and a repository of educational information. The Thrivors
      platform is scalable, device-agnostic, and allows analysis of de-identified usage data. With
      commercialization potential for healthcare providers and health insurance payers, Thrivors
      provides a value-based care delivery model focused on outcomes. There are multiple important
      physiologic and psychosocial secondary conditions that could be positively impacted by the
      Thrivors platform. For this specific application, the investigators will focus on adherence
      to bone health exercises.

      Hypothesis: The investigators hypothesized that breast cancer survivors' adherence to an
      exercise regimen for bone health can be improved by enhancing the interactive and
      customizable features of a cloud-based, device-agnostic delivery method. To test the
      hypothesis and to establish the technical feasibility of the product, the investigators
      propose the following specific aims:

      Specific Aim 1: Develop an enhanced participant experience platform for bone health-specific
      exercises.

      For Thrivors+BH, a module will be developed for participants to input pain and energy levels,
      enabling real-time customization of exercise regimens. Modules of clinically validated bone
      health exercises with instructional videos will be developed. Additionally, participants will
      be able upload and send videos of themselves exercising for feedback and assessment. A
      Thrivors Basic version that lacks customization and video content will be developed. Both
      versions will contain bone health educational content, mindfulness and nutrition resources.
      Milestones: Over a 2-month period, development, usability testing (assessing content,
      features, input controls, navigational ease and click-through capabilities) and refinement
      will be completed, to enable deployment in a randomized clinical trial.

      Specific Aim 2: Measure participant adherence and engagement. The two versions of the
      platform will be deployed in a 20-week, two-arm randomized controlled trial of 50 breast
      cancer survivors. Adherence to exercise sessions (primary outcome) and platform usage will be
      measured by platform software, while user engagement (secondary outcomes) will be assessed by
      surveys. Milestones: Differences between primary and secondary outcomes for the control and
      intervention groups will be evaluated. Usage statistics, motivational responses and user
      feedback will be used to further refine platform features and content.

      The outcomes of this study will help validate the utility of the Thrivors platform in
      improving cancer survivors' adherence and engagement to exercise routines that positively
      impact post-treatment recovery. In the near-term, the findings will inform the design of a
      12-month Phase II study to evaluate changes in biomarkers of bone health. In the longer term,
      the project aligns with the business goal to disseminate the Thrivors platform to a larger
      population of male and female cancer survivors across ethnic/racial minority groups, rural
      populations, and low socioeconomic status groups. The project also aligns with the mission of
      the NCI to develop innovative technology and service delivery models that increase the
      adoption, uptake, and sustainability of evidence-based interventions to improve public
      health.
    

Intervention name(s): Thrivors+BH
Intervention type(s): Behavioral
Intervention description(s): Digital health platform for breast cancer patients that measures adherence and engagement.
Other intervention name(s): Thrivors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: cancer; bone health; physical activity; technology platfrom