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Trial record 53 of 961 for:    bone tumors AND NOT metastatic | Recruiting, Not yet recruiting, Available Studies

Physical Activity Platform to Improve Bone Health in Cancer Survivors (THRIVORS+BH)

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ClinicalTrials.gov Identifier: NCT03651037
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : January 23, 2019
Sponsor:
Collaborators:
Oregon Health and Science University
Masonic Cancer Center, University of Minnesota
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Cathy Skinner, Thrivors Inc

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Physical Activity Bone Health Behavioral: Thrivors+BH Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Physical Activity Platform to Improve Bone Health in Cancer Survivors
Actual Study Start Date : January 21, 2019
Estimated Primary Completion Date : August 19, 2019
Estimated Study Completion Date : August 19, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Thrivors+BH
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
Digital health platform for breast cancer patients that measures adherence and engagement.
Other Name: Thrivors

Experimental: Thrivors Basic
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
Digital health platform for breast cancer patients that measures adherence and engagement.
Other Name: Thrivors




Primary Outcome Measures :
  1. Number of participants to complete exercise sessions and surveys [ Time Frame: 20 weeks ]
    Changes in baseline from exercise naive to exercise activated as well as improvements in well-being survey, patient activation measures, and bone health awareness



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03651037


Contacts
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Contact: Cathy Skinner, MA 888-920-2407 BoneHealthStudy@thrivors.com

Locations
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United States, Minnesota
Thrivors Inc Recruiting
Saint Paul, Minnesota, United States, 55108
Contact: Cathy Skinner    888-920-2407    BoneHealthStudy@Thrivors.com   
Sponsors and Collaborators
Thrivors Inc
Oregon Health and Science University
Masonic Cancer Center, University of Minnesota
National Cancer Institute (NCI)

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Responsible Party: Cathy Skinner, Principal Investigator, Thrivors Inc
ClinicalTrials.gov Identifier: NCT03651037     History of Changes
Other Study ID Numbers: THRIVORSBH-01
R43CA224412 ( U.S. NIH Grant/Contract )
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cathy Skinner, Thrivors Inc:
cancer
bone health
physical activity
technology platfrom