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

NCT05069519 | Completed

• 1 other identifier: 2021LS024
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  6 Months

• 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.

  6 Months

Secondary Outcomes (5)

• Change in Body Mass Index (BMI)

  6 Months

• Change in Physical Activity Confidence Scale Score

  6 Months

• Change in Physical Activity Pros and Cons Scale Score

  6 Months

• Change in Social Support Scale Score

  6 Months

• Change in Patient-Reported Outcome Measurement Information System Score

  6 Months

Other Outcomes (1)

• Change in Sentiments

  6 Months

Study Arms (4)

Facebook Condition

EXPERIMENTAL

Participants 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.

Behavioral: Facebook Health Education

Smartwatch Condition

EXPERIMENTAL

Participants assigned to this intervention will use a Fitbit to track daily physical activity (PA), share PA data remotely, and receive personalized feedback.

Behavioral: Personalized Smartwatch

Combined Condition

EXPERIMENTAL

Participants 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.

Behavioral: Personalized Smartwatch; Behavioral: Facebook Health Education

Attention Control

NO INTERVENTION

Participants 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.

Interventions

Personalized Smartwatch BEHAVIORAL

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.

Combined Condition; Smartwatch Condition

Facebook Health Education BEHAVIORAL

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

Combined Condition; Facebook Condition

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Zan Gao

  University of Minnesota School of Kinesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2021
• First Posted: October 6, 2021
• Study Start: November 1, 2021
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: December 23, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)