Effects of Personalized Exercise Prescriptions Through Mobile Health on Physical Activity and Health Outcomes in the Cancer Survivors

NCT06840028 | Active Not Recruiting

• 1 other identifier: UTK IRB-24-07955-XP
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Participation in regular physical activity is vital to a healthy lifestyle. Research has shown that regular participation in physical activity among cancer survivors is not only able to improve health outcomes, but is also related to their quality of life. As we live in an age of technology, health wearables and smartphone apps might be one novel manner by which to help cancer survivors increase physical activity as well as improve health outcomes. Yet, the effectiveness of wearable and app as a tool for health promotion among cancer survivors is largely unstudied. The purpose of this study is to evaluate the effectiveness of a personalized m-health intervention via fitness wearable (Fitbit Inspire 3) exercise app (sFitRx) on physical activity, weight, quality of life, individual beliefs, and emotions among cancer survivors.

Conditions

Chronic Disease; Physical Activity; Cancer Survivors; Cancer Survivorship; Physical Inactivity; Physical Activity in Adults

Keywords

U.S Cancer survivors; Tennessee Cancer Survivors; Cancer patient; Cancer; Chronic Disease; Physical Activity; Physical Inactivity; Rural oncology; Rural Health; Cancer outcomes; Cancer Recovery

Outcome Measures

Primary Outcomes (1)

• Physical Activity

  Physical Activity. CS's mean steps/day will be the primary outcome and will be assessed using Fitbit Inspire. Participants will be instructed to wear the Fitbit on the non-dominant wrist at all times throughout the study.

  Baseline (i.e., pre-intervention), six months, and 12 months.

Secondary Outcomes (5)

• Health Indicators

  Baseline (i.e., pre-intervention), six months, and 12 months.

• Health Indicators

  Baseline (i.e., pre-intervention), six months, and 12 months.

• Health Indicators

  Baseline (i.e., pre-intervention), six months, and 12 months.

• Physical Activity

  Baseline (i.e., pre-intervention), six months, and 12 months.

• Health Indicators

  Baseline (i.e., pre-intervention), six months, and 12 months.

Study Arms (2)

Experimental Group

EXPERIMENTAL

Experimental Group participants would receive access to a study-developed mHealth application, sFitRx, that delivers personalized PA programming as well as be provided with a fitness tracker to monitor their habitual PA levels.

Other: mHealth/sFitRx

Comparison Group

ACTIVE COMPARATOR

Comparison Group participants would receive the fitness tracker only.

Other: Fitness Tracker

Interventions

mHealth/sFitRx OTHER

Experimental Group - Will receive a personalized mHealth application and fitness tracker. Specifically, Experimental Group participants will receive the sFitRx smartphone application that provides weekly personalized PA interventions informed by big data analysis. They will also receive a Fitbit Inspire 3 to track real-time PA, with PA data uploaded to Fitabase. Importantly, the PA data from the Fitbit Inspire 3 will inform the big data analyses used to generate the personalized PA intervention provided by the sFitRx application.

Experimental Group

Fitness Tracker OTHER

Comparison Group - Will receive the Fitbit Inspire 3 only.

Comparison Group

Eligibility Criteria

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

You may qualify if:

• Participant must be at least 18 years of age
• Participant was previously diagnosed with stage 0-III cancer
• Participant have had one or more of the cancers of interest (e.g., breast, lung)
• Participant completed active cancer treatment at least three months prior to enrollment, with the exception of continued maintenance immunotherapy or endocrine therapy
• Participant possess basic English communication capability
• Participant do not participate in other health promotion programs
• Participant is an Android or Apple smartphone owner
• Participant is willing to participate in mHealth-delivered programs
• Participant is willing to consent and be randomized
• Participant has no contraindications to PA participation

You may not qualify if:

• Participant is currently undergoing chemotherapy or radiation as primary cancer treatment
• Having any contraindications that might interfere with PA engagement, such as a medical condition and pacemaker implant
• Plan to relocate or travel for \>two weeks during the study period;
• Presence of distant metastasis
• Planning or preparing for surgery as primary treatment or as a reconstruction procedure in the next 3 months
• Have a stage 4 cancer diagnosis
• Participant is already engaging in ≥75 min/week of vigorous-intensity PA, ≥150 min/week of moderate-intensity PA, or an equivalent combination of both over the last 3 months
• An unstable mental condition that would prevent following study protocols
• Reporting a Physical Activity Readiness Questionnaire (PAR-Q) score that indicates PA may be unsafe
• Being a prisoner, pregnant, or planning to become pregnant

Sponsors & Collaborators

• University of Tennessee Medical Center: collaborator
• The University of Tennessee, Knoxville: lead
• University of Tennessee: collaborator

Study Sites (1)

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Chronic Disease; Motor Activity; Sedentary Behavior; Neoplasms

Interventions

Telemedicine; Fitness Trackers

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Department Head

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 21, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): April 15, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (1)