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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Physical Activity; Chronic Disease; Physical Inactivity; Cancer Survivors; Cancer Survivorship; Physical Activity in Adults
• Intervention / Treatment: Other: mHealth/sFitRx; Other: Fitness Tracker

Detailed Description

Cancer remains a vital public health concern in the U.S. Research has shown that physical activity (PA) provides many physical and mental health benefits after cancer diagnosis and plays an important role in reducing all-cause and cancer-related mortality, as well as cancer incidence, in cancer survivors (CS). Adopting a physically active lifestyle is therefore crucial to decrease cancer risk and improve cancer prognosis and quality of life. However, most CS do not achieve the recommended 150 min/week of moderate-to-vigorous PA (MVPA). This issue is particularly pronounced for CS in low-income, underserved areas who tend to have considerably less access to PA-conducive environments compared to their more affluent peers. It is therefore imperative to study innovative, ease-to-implement health interventions CS that can promote increased engagement and self-regulation of health behaviors, such as PA, while also improving other health outcomes; thereby offering better supportive care.

One promising easy-to-implement medium to improve engagement in and self-regulation of health behaviors is mobile health (mHealth), which includes advanced smartphone application technology often combined with wearables and social media to improve the healthcare delivery experience. Researchers have recently applied such technologies with CS to promote improved health through increased PA and reduced sedentary behavior (SB), with observations promising. Despite promising observations, these studies were often conducted with small samples over short durations (less than or equal to three months), with the interventions lacking personalized PA prescriptions informed by back end big data analysis techniques to further improve intervention implementation. As such, examining how a longer-term tailored, big data-informed mHealth PA intervention in CS might improve health and well-being would fill a major literature gap.

The investigators thus propose a 12-month randomized-controlled trial to investigate how an mHealth-delivered PA intervention informed by big data analysis (hereafter, 'personalized mHealth intervention') can improve the health and well-being of CS over a 12-month period. 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. Comparison Group participants would receive the fitness tracker only. Successful study completion will inform the development of effective, mHealth-delivered PA programs in CS that might guide health professionals in the initiation of such novel programs in lower-income communities with the goal of promoting PA and health in this population.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • University of Tennessee Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; 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; 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.
Active Comparator: Comparison Group; Comparison Group participants would receive the fitness tracker only.	Other: Fitness Tracker; Comparison Group - Will receive the Fitbit Inspire 3 only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Indicators	Participants' height (m) and weight (kg) will be measured at home by themselves, with body mass index (BMI) calculated by their height and weight (kg/m^2).43	Baseline (i.e., pre-intervention), six months, and 12 months.
Health Indicators	Psychosocial beliefs (e.g., self-efficacy, social support) will be assessed by standardized self-report surveys through established questionnaires.45-50	Baseline (i.e., pre-intervention), six months, and 12 months.
Health Indicators	The investigators will assess quality of life (QoL) using the Patient Reported Outcome Measurement Information System44. Investigators are most interested in assessing physical functioning, anxiety, and depression.	Baseline (i.e., pre-intervention), six months, and 12 months.
Physical Activity	Mean calories burned/day and SB/day will also be examined as a secondary outcome. As mentioned previously, investigators will retrieve Fitbit data via Fitabase.40-42	Baseline (i.e., pre-intervention), six months, and 12 months.
Health Indicators	The researchers will assess participants emotions via the Positive and Negative Affect Scale.	Baseline (i.e., pre-intervention), six months, and 12 months.

Collaborators and Investigators

• Sponsor: The University of Tennessee, Knoxville
• Collaborators: University of Tennessee; University of Tennessee Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): April 15, 2027

Study Registration Dates

• First Submitted: February 5, 2025
• First Submitted That Met QC Criteria: February 17, 2025
• First Posted (Actual): February 21, 2025

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Physical Activity; Cancer; Chronic Disease; Physical Inactivity; Rural Health; Cancer patient; U.S Cancer survivors; Tennessee Cancer Survivors; Rural oncology; Cancer outcomes; Cancer Recovery
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Behavior; Neoplasms; Chronic Disease; Motor Activity; Sedentary Behavior; Health Services Administration; Delivery of Health Care; Equipment and Supplies; Electrical Equipment and Supplies; Patient Care Management; Diagnostic Equipment; Wearable Electronic Devices; Telemedicine; Fitness Trackers
• Other Study ID Numbers: UTK IRB-24-07955-XP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No