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CancerNCT05069519

Implementing Personalized Exercise Prescriptions Through Mobile Health in the Elderly Cancer Survivors

A study testing Personalized Smartwatch and Facebook Health Education in people with Cancer, run by University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Cancer remains a vital public health concern in the U.S. Research evidence has shown that physical activity provides many physical and mental health benefits after cancer diagnosis and plays an important role in reducing all-cause, cancer-related death and cancer events in the elderly cancer survivors (CS). Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Cancer
What is being tested?
Personalized Smartwatch and Facebook Health Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
1 siteUnited States
Study dates
1 Nov 2021to 30 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have had one or more of the cancers of interest (i.e., breast, colon, bladder, prostate, endometrium, esophagus, lung, kidney \& renal pelvis, stomach)
  • Complete active cancer treatment at least three months prior to enrollment, with the exception of anti- hormonal therapy
  • Possess an Android or Apple smartphone
  • Having a Facebook account, or are willing to make one
  • Engage in some type of physical activity (PA) as assessed by PA readiness survey.

Who cannot join

  • Diagnosed with stage IV cancer
  • Completed primary cancer treatment (e.g., surgery, radiotherapy) less than six months ago with new cancer diagnosis or recurrence

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Minnesota

    Minneapolis, Minnesota, 55455

Other trials in United States

About this study

Cancer remains a vital public health concern in the U.S. Research evidence has shown that physical activity provides many physical and mental health benefits after cancer diagnosis and plays an important role in reducing all-cause, cancer-related death and cancer events in the elderly cancer survivors (CS). Adopting a physically active lifestyle may decrease cancer risks, improve cancer prognosis and quality of life.

However, most CS did not achieve recommended 150 min/week of moderate-to- vigorous physical activity (PA [MVPA]). This issue is particularly pronounced for CS in low-income areas who tend to have considerably less access to PA-conducive environments compared to urban peers. To this accord, it is imperative to promote PA in elderly CS to offer appropriate supportive care. Thus, implementing innovative PA interventions with the goal of improving their self-regulatory health behaviors in CS is paramount.

Read the detailed description

Cancer remains a vital public health concern in the U.S. Research evidence has shown that physical activity provides many physical and mental health benefits after cancer diagnosis and plays an important role in reducing all-cause, cancer-related death and cancer events in the elderly cancer survivors (CS). Adopting a physically active lifestyle may decrease cancer risks, improve cancer prognosis and quality of life.

However, most CS did not achieve recommended 150 min/week of moderate-to- vigorous physical activity (PA [MVPA]). This issue is particularly pronounced for CS in low-income areas who tend to have considerably less access to PA-conducive environments compared to urban peers. To this accord, it is imperative to promote PA in elderly CS to offer appropriate supportive care. Thus, implementing innovative PA interventions with the goal of improving their self-regulatory health behaviors in CS is paramount.

One promising area of technology for increasing health behaviors is mobile health (m-health), which includes new technologies such as smartphone app, wearables, and social media in improving quality of healthcare. 6-8 Recently, researchers have applied such technologies to promote health through increased individual PA and reduced sedentary behavior in CS and some findings are promising. Despite positive findings, limitations of the preceding literature such as small samples, lacked personalized prescriptions, and lacked big data analysis are worth noting. Further, geographic environment not only affects individual's PA but is also an important pathway through which socio-economic inequalities create health disparities. Intervention impacts may be magnified in environments (e.g., urban vs. rural) stimulating more PA, with urban leading to higher PA than rural. According to Social Ecological Model, combined interventions yielded better outcomes than single level interventions. Yet, few studies examined interactive effects of the technologies on PA and other outcomes in CS, a major gap for advancing tailored intervention. In response, the primary aim of this project is to examine effects of combination of a personalized smartwatch and a Facebook health education intervention on CS' PA (daily steps) as compared to personalized Facebook only, personalized smartwatch only, and attention control conditions, over a 6-month period. This project will also determine the effects of the m-health interventions on CS' personal (e.g., daily calories, fitness, body composition, quality of life, and beliefs) and interpersonal (social support) health outcomes.

Empirical evidence also suggests a positive link between community participation and emotions (e.g., empathy and satisfaction), which may facilitate social support and subsequent sustained behavior in CS. Understanding the effect of social support and positive emotions on PA promotion is current lacking and necessary for us to explore a potential new type of intervention for healthcare outcome. With the advancement of technology, social media and apps focusing on promoting a healthy lifestyle have been increasingly used in cancer prevention and management. Further, a sentiment analysis of online patient-authored text, or retrieving information about a patient's perception, has the potential to offer new insights on the health impact of online social support and behavior, but such analysis generally requires manual annotations which can be time-consuming and costly for health professionals. To gain these new insights, health informatics approaches (e.g., text mining techniques and natural language processing [NLP] of large datasets, including sentiment analysis ) can be leveraged to examine the relationship between changes in emotions and health outcomes among online community members. This study also attempts to explore the relationships between patients' sentiments, smart watch data and other health outcomes across time.

This project attempts to examine innovative m-health interventions on CS's PA and health outcomes while offering personalized exercise prescriptions via big data analysis. If successful, it can significantly impact the development of effective and remote PA programs to promote health and protect diseases in CS. Moreover, its findings can guide health professionals and local communities to initiate such novel intervention programs with the goal of promoting PA and health in elderly CS, particularly during or post the pandemic.

Conditions
Cancer
Being tested
Personalized Smartwatch, Facebook Health Education
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Personalized SmartwatchBehavioural

    Participants will continue with standard care, but will receive a Fitbit and be encouraged to participate in at least 150 min. moderate-to-vigorous physical activity (5 sessions aerobic exercise, 30 min. per session; and 2 sessions of strength training) per week if their body condition allows throughout the intervention period. The previously established daily and weekly exercise prescription will be offered to participants based on their previous week Fitbit data.

    PA improvements will be tailored over time based on each participant's previous week PA and they will be encouraged to increase PA by 5-10 min/week if possible depending on specific situations. Participants will save each workout and synchronize the Fitbit PA data to its app where they only share daily data and receive weekly personalized exercise prescriptions established in pilot studies.

  • Facebook Health EducationBehavioural

    Participants assigned to this condition will receive a Fitbit smartwatch, continue with standard care, but will receive health education tips developed in the investigators' previous studies from a private Facebook group in which only group members and researchers can access. Additionally, the investigators will track login counts, analyze their post activity and online sentiments via texting mining and natural language processing, and then offer weekly personalized feedback based on the data to facilitate social support

Study groups in NCT05069519
Study groupRoleWhat they receive
Facebook ConditionExperimentalParticipants assigned to this intervention will take part in personalized Facebook health education, receive a smartwatch, receive weekly health education, share sentiments on Facebook, and receive personalized feedback.
Receives: Behavioral: Facebook Health Education
Smartwatch ConditionExperimentalParticipants assigned to this intervention will use a Fitbit to track daily physical activity (PA), share PA data remotely, and receive personalized feedback.
Receives: Behavioral: Personalized Smartwatch
Combined ConditionExperimentalParticipants assigned to this condition will receive both Fitbit and Facebook health education programs, (The Smartwatch and Facebook Conditions). The investigators will also provide weekly personalized feedback, based on PA data and sentiment analysis, that have been developed in prior pilot studies.
Receives: Behavioral: Personalized Smartwatch; Behavioral: Facebook Health Education
Attention ControlNo interventionParticipants assigned to the control condition will not receive any intervention. They will receive a Fitbit smartwatch, and continue with their standard care currently done in their life during the intervention period.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Daily Steps

    Participants' 1-week daily steps will be assessed using Fitbit Charger 4. They will be instructed to wear the Fitbit on the non-dominant wrist at all times throughout the study and daily steps will be recorded. Daily steps will be measured at baseline, 3 months, and 6 months, and the difference between baseline and 6 months will be reported.

    Measured: 6 Months

  2. Change in Daily Calories Burned

    Participants' 1-week daily calories burned will be assessed using Fitbit Charger 4. They will be instructed to wear the Fitbit on the non-dominant wrist at all times throughout the study and daily steps will be recorded. Daily calories burned will be measured at baseline, 3 months, and 6 months, and the difference between baseline and 6 months will be reported.

    Measured: 6 Months

Secondary outcomes (5)
  1. Change in Body Mass Index (BMI)

    Participants will self-report their height and weight which will be used to calculate BMI, which is calculated as body weight (in kg) divided by height (in cm) squared. BMI will be measured at baseline, 3 months, and 6 months, and the difference between baseline and 6 months will be reported.

    Measured: 6 Months

  2. Change in Physical Activity Confidence Scale Score

    The Physical Activity Confidence Scale will be used to assess beliefs regarding self-efficacy. Belief will be measured on a five-point Likert scale (1-5) where higher values represent greater beliefs of self-efficacy. Physical Activity Confidence will be measured at baseline, 3 months, and 6 months, and the difference between baseline and 6 months will be reported.

    Measured: 6 Months

  3. Change in Physical Activity Pros and Cons Scale Score

    The Physical Activity Pros and Cons Scale will be used to assess beliefs regarding outcome expectancy. Belief will be measured on a five-point Likert scale (1-5) where higher values represent greater beliefs of outcome expectancy. Physical Activity Pros and Cons will be measured at baseline, 3 months, and 6 months, and the difference between baseline and 6 months will be reported.

    Measured: 6 Months

  4. Change in Social Support Scale Score

    The Social Support Scale will be used to assess beliefs regarding social support. Belief will be measured on a five-point Likert scale (1-5) where higher values represent greater beliefs of social support. Social support will be measured at baseline, 3 months, and 6 months, and the difference between baseline and 6 months will be reported.

    Measured: 6 Months

  5. Change in Patient-Reported Outcome Measurement Information System Score

    The Patient-Reported Outcome Measurement Information System, a five-point Likert scale (1-5), will be used to measure quality of life via physical functioning, anxiety, and depression, where higher scores represent greater quality of life. Quality of life will be measured at baseline, 3 months, and 6 months, and the difference between baseline and 6 months will be reported.

    Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2021
  2. Study start1 Nov 2021
  3. Primary completion30 Oct 2022
  4. Study completion30 Oct 2022

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05069519
Sponsor's protocol ID
2021LS024
Status last verified
Dec 2022
First submitted
25 Sep 2021
Last updated
23 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Personalized Smartwatch and Facebook Health Education in people with Cancer, run by University of Minnesota 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 23 Dec 2022. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in Daily Steps (time frame: 6 Months). The study lists 2 primary outcomes in all. 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 23 Dec 2022.

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