Physical Activity Platform to Improve Bone Health in Cancer Survivors

NCT03651037 | Completed

• 2 other identifiers: THRIVORSBH-01R43CA224412
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Physical Activity; Bone Health

Keywords

cancer; bone health; physical activity; technology platfrom

Outcome Measures

Primary Outcomes (1)

• Number of participants to complete exercise sessions and surveys

  Changes in baseline from exercise naive to exercise activated as well as improvements in well-being survey, patient activation measures, and bone health awareness

  20 weeks

Study Arms (2)

Thrivors+BH

EXPERIMENTAL

For Thrivors+BH, a module will be developed for users 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, users will be able upload and send videos of themselves exercising for feedback and assessment. This version will contain bone health educational content, mindfulness and nutrition resources.

Behavioral: Thrivors+BH

Thrivors Basic

EXPERIMENTAL

A Thrivors Basic version that lacks customization and video content will be developed. This version will contain bone health educational content, mindfulness and nutrition resources.

Behavioral: Thrivors+BH

Interventions

Thrivors+BH BEHAVIORAL

Digital health platform for breast cancer patients that measures adherence and engagement.

Also known as: Thrivors

Thrivors Basic; Thrivors+BH

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female participants diagnosed at 40 - 70 years with non-metastatic breast cancer.
• Able to provide written informed consent.
• Completed chemotherapy, undergoing adjuvant hormonal therapy.
• Not currently on a prescribed exercise plan and cleared for exercise by physician.
• Access to a smart phone (with a data plan), tablet, or computer (with internet access).
• Able and willing to comply with the protocol, including completion of all surveys.

You may not qualify if:

• Less than 4 weeks post-surgery.
• Diagnosis of osteoporosis.
• Currently participating in two or more 30-min. sessions/week of resistance or impact exercises.
• Specific condition(s) or diagnosis, both physical or psychological, or physical exam finding that precludes participation in a physical exercise program.
• Participant has hemodynamically significant heart disease (e.g., heart failure) or an arrhythmic heart condition requiring medical therapy.
• Employees or family members of the investigator, study site, or sponsor directly involved with study management.
• Participants who, in the opinion of the primary investigator, should not participate in the study.

Sponsors & Collaborators

• Thrivors Inc: lead
• Oregon Health and Science University: collaborator
• Masonic Cancer Center, University of Minnesota: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Thrivors Inc

Saint Paul, Minnesota, 55108, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Cathy Skinner, MA

  Thrivors Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: August 29, 2018
• Study Start: January 21, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: September 1, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)