Cancer SurvivorsNCT06840028
Effects of Personalized Exercise Prescriptions Through Mobile Health on Physical Activity and Health Outcomes in the Cancer Survivors
A study testing mHealth/sFitRx and Fitness Tracker in people with Cancer Survivors and Chronic Disease, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Survivors, Chronic Disease, Physical Activity
- What is being tested?
- mHealth/sFitRx and Fitness Tracker
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to 15 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
About this study
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.
Read the 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.
- Conditions
- Cancer Survivors, Chronic Disease, Physical Activity, Cancer Survivorship, Physical Inactivity, Physical Activity in Adults
- Being tested
- mHealth/sFitRx, Fitness Tracker
- 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
- Medical subject headings
- Chronic Disease, Motor Activity, Sedentary Behavior, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth/sFitRxOther
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.
Fitness TrackerOther
Comparison Group - Will receive the Fitbit Inspire 3 only.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: mHealth/sFitRx |
| Comparison Group | Active comparator | Comparison Group participants would receive the fitness tracker only. Receives: Other: Fitness Tracker |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (i.e., pre-intervention), six months, and 12 months.
Secondary outcomes (5)
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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline (i.e., pre-intervention), six months, and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start1 Mar 2025
- Primary completion15 Apr 2027 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tennessee, University of Tennessee Medical Center
- Responsible party
- Principal investigator, Zan Gao, The University of Tennessee, Knoxville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840028
- Sponsor's protocol ID
- UTK IRB-24-07955-XP
- Status last verified
- Apr 2026
- First submitted
- 5 Feb 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Personalized Exercise Prescriptions Through Mobile Health on Physical Activity and Health Outcomes in the Cancer Survivors
- ClinicalTrials.gov ID
- NCT06840028
- Acronym / sponsor ID
- UTK IRB-24-07955-XP
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Collaborators
- University of Tennessee, University of Tennessee Medical Center
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: mHealth/sFitRxExperimental 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 | Active comparator | Other: Fitness TrackerComparison Group participants would receive the fitness tracker only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth/sFitRxExperimental 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. | Other | Experimental Group |
| Fitness TrackerComparison Group - Will receive the Fitbit Inspire 3 only. | Other | Comparison Group |
Primary outcome
Physical Activity
Time frame: Baseline (i.e., pre-intervention), six months, and 12 months.
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.
5 secondary outcomes
Health Indicators
Time frame: Baseline (i.e., pre-intervention), six months, and 12 months.
Health Indicators
Time frame: Baseline (i.e., pre-intervention), six months, and 12 months.
Health Indicators
Time frame: Baseline (i.e., pre-intervention), six months, and 12 months.
Physical Activity
Time frame: Baseline (i.e., pre-intervention), six months, and 12 months.
Health Indicators
Time frame: Baseline (i.e., pre-intervention), six months, and 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth/sFitRx and Fitness Tracker in people with Cancer Survivors and Chronic Disease, run by The University of Tennessee, Knoxville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity (time frame: Baseline (i.e., pre-intervention), six months, and 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.