Clinical trial NCT06840028: Effects of Personalized Exercise Prescriptions Through Mobile Health on Physical Activity and Health Outcomes in the Cancer Survivors
Official title: Effects of Personalized Exercise Prescriptions Through Mobile Health on Physical Activity and Health Outcomes in the Cancer Survivors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer Survivors
Chronic Disease
Physical Activity
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
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
Collaborators: name: University of Tennessee
name: University of Tennessee Medical Center
First posted: 2025-02-21
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Physical Activity
timeFrame: Baseline (i.e., pre-intervention), six months, and 12 months.
Secondary outcomes:
measure: Health Indicators
timeFrame: Baseline (i.e., pre-intervention), six months, and 12 months.
measure: Health Indicators
timeFrame: Baseline (i.e., pre-intervention), six months, and 12 months.
measure: Health Indicators
timeFrame: Baseline (i.e., pre-intervention), six months, and 12 months.
measure: Physical Activity
timeFrame: Baseline (i.e., pre-intervention), six months, and 12 months.
measure: Health Indicators
timeFrame: Baseline (i.e., pre-intervention), six months, and 12 months.
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
Study officials:
References: