Heal-Me Personalized Online Nutrition and Exercise Routines

Cancer Clinical Trial

— PiONEeR  

Official title:

Heal-Me PiONEeR (Personalized Online Nutrition and Exercise Routines) - Reconnecting Vulnerable Outpatients With Multidisciplinary Care - a Randomized Controlled Trial Assessing 3 Levels of Online Programming in the Time of COVID

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04666558
• Other study ID #: Pro00103715
• Status: Completed
• Phase: N/A
• Start date: November 30, 2020
• Est. completion date: August 31, 2022

Study information

• Verified date: July 2022
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare 12-weeks of virtual multidisciplinary programming provided at three levels of support intensity to determine impacts on clinical outcomes, acceptability, and cost amongst outpatients with cancer, liver disease, or lung disease.

Participants will be randomized to one of three groups: (i) standard care, (ii) a personnel-light app-based intervention, (iii) a personnel-intensive app-based intervention. Participants randomized to standard care will receive exercise and nutrition resources as well as a Garmin watch. Participants in the experimental groups will receive standard care, plus a 12-week multidisciplinary app-based personalized program involving 12 weeks of exercise programming and 10-weeks of nutrition programming. Participants in study group 3 will receive additional one-on-one care.

The Research Ethics Board at the University of Alberta has approved this study. The protocol will measure patient-related outcome measures including physical function, quality of life, social isolation, and anxiety, as well as measures of acceptability and cost. 216 participants will take part in this study (n=72 per arm).

Analyses: fitness testing and patient-reported outcomes will be administered before and after the intervention. Fitness and patient-reported outcomes will be compared using linear mixed models with random effects. App acceptability will be compared between groups using Chi-Square.

Description:

INTRODUCTION:

COVID-19 related social distancing have a profound impact on vulnerable people living with chronic conditions, including cancer and organ failure. Pre-pandemic, many of these patients relied on and benefited from multidisciplinary supports and structured programming to maintain well-being and function. Many of these in-person supports are not currently available, which has disconnected these patients from the care they need to stay well.

Virtual modalities are a promising solution that allow multidisciplinary programs (i.e. exercise and nutrition) to continue to deliver support for these patients when social distancing doesn't allow these programs to run in-person. However, it's currently unclear whether virtual programming is acceptable in these populations, and what level of support is best in terms of benefits and costs.

The purpose of this study is to compare 12-weeks of virtual multidisciplinary programming provided at three levels of support intensity to determine impacts on clinical outcomes, acceptability, and cost amongst outpatients with cancer, liver disease, or lung disease.

OBJECTIVES:

1. As compared to control, assess the impact of a 12-week virtual exercise and nutrition program (delivered at 2 levels of support) on: physical function and mental health outcomes.

2. As compared to the modeled costs of in-person programming, assess the cost of a 12-week virtual exercise and nutrition program (delivered at 2 levels of support).

3. Assess the acceptability of the virtual exercise and nutrition programming to patients and members of the study team who deliver the intervention.

METHODS:

This is a mixed-methods, 12-week randomized controlled trial with randomization to one of three study groups with increasing virtual multidisciplinary support for outpatients. Participants will include people living with one of the following three chronic conditions: cancer, lung disease, or lung or liver disease (post-transplantation).

Group 1 - The standard of care response to COVID. Educational materials will be provided to patients via email. As needed, the package will include a combination of personalized exercises, disease-tailored tips for healthy eating and COVID precautions. Ad hoc telephone or virtual contact with patients will be at the providers' discretion.

Group 2 - An app-based, "personnel-light" approach to virtual care with a focus on support through group-based interactions with the Trainers and other participants during live group exercise and nutrition classes (~3/week). The patient's personalized 12-week home based exercise program will be enabled in the app after a baseline exercise specialist appointment and the 10-week nutrition program will be enabled at week 3 after a dietitian assessment in week 2. The home programs will auto-progress.

Group 3 - An app-based, "personnel-intensive" approach. In addition to Group 2 features, patient interaction with Trainers will be via live group classes AND 1-to-1 sessions: seven 1-to-1 consultations with an exercise specialist and three 1-to-1 consultations with a dietitian to review progress and goals and make any necessary modifications to programming.

OUTCOMES & ANALYSES:

All analyses adhere to the intention-to-treat-principle (ITT). Fitness assessments and patient-reported outcomes will be collected at baseline and 12-weeks. Primary and secondary outcomes from these data will be analyzed using linear mixed models with random effects. Adherence and app acceptability (survey) will be compared between groups using the chi-square. Costs of each level of support will be compared with the cost of in-person programming using a publicly funded provincial payer perspective and will be presented in the Net Benefit framework.

Interviews will be conducted with participants, caregivers, and program instructors to determine program acceptability and barriers and facilitators. Inductive content analysis will be used to analyze qualitative data.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: August 31, 2022
• Est. primary completion date: December 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 18 years of age

• In one of the following 3 disease groups:

1. Cancer survivor who has completed treatment or is receiving maintenance therapy

2. Patient who is currently post-transplantation from liver or lung transplantation

3. Patient with chronic lung disease who may or may not be listed for organ transplantation

• Previous enrolment in exercise rehabilitation program (i.e. rehabilitation "graduate")

• Access to an Internet connected device with video and audio capabilities

Exclusion Criteria:

• Compassionate care

• Unsafe to participate in a virtual exercise program

• Unable to provide informed consent

Related Conditions & MeSH terms

• Cancer
• Liver Diseases
• Lung Diseases

Intervention

Other:
• Exercise & Nutrition
App-based live group exercise classes, personalized follow-up asynchronous workouts, live group nutrition classes, and protein tracking.
• Exercise & Nutrition
App-based live group exercise classes, personalized follow-up asynchronous workouts, live group nutrition classes, and protein tracking. Additional one-one-one exercise and nutrition support is provided too.

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Alberta Innovates Health Solutions

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical activity	The difference in the pre- vs post-intervention change in proportion of "yes" answers to the single-item physical activity questionnaire from pre- to post-intervention between groups	12 Weeks
Other	Sedentary Time (International Sedentary Assessment Tool - ISAT)	The difference in the pre- vs post-intervention change in sedentary time, as self-reported on the ISAT between groups	12 Weeks
Other	Protein Intake	The difference in the pre- vs post-intervention change in protein intake (grams) between groups, based on 3-day food record(s)	12 Weeks
Other	Calorie Intake	The difference in the pre- vs post-intervention change in calorie intake (kilocalories) between groups, based on 3-day food record(s)	12 Weeks
Other	Micronutrient Intake	The difference in the pre- vs post-intervention change in micronutrient intake (milligrams) between groups, based on 3-day food record(s)	12 Weeks
Other	Beliefs and outcome expectations about exercise	The difference in the pre- vs post-intervention change in the 6-item COM-B scale between groups (score range: 0-120, higher scores indicate higher capability, opportunity, motivation)	12 Weeks
Other	Program acceptability (Unified Theory of Acceptance and Use of Technology - UTAUT)	The difference in the pre- vs post-intervention change in the UTAUT scale between groups (score range: 0-92, higher scores indicate higher app acceptance and use)	12 Weeks
Primary	Lower Extremity Functional Scale (LEFS)	The difference in the pre- vs post-intervention change in LEFS score between groups (score range: 0-80, higher scores indicate higher function)	12 Weeks
Secondary	Upper Extremity Functional Index (UEFI)	The difference in the pre- vs post-intervention change in UEFI score between groups (score range: 0-80, higher scores indicate higher function)	12 weeks
Secondary	Timed Sit-to-Stand (60 & 30 seconds)	The difference in the pre- vs post-intervention change in # of repetitions completed over the Timed Sit-to-Stand between groups	12 Weeks
Secondary	Timed One-Legged Stance	The difference in the pre- vs post-intervention change in Timed One-Legged Stance between groups	12 Weeks
Secondary	2-Minute Step Test (2MST)	The difference in the pre- vs post-intervention change in the # of steps completed in the 2MST between groups	12 Weeks
Secondary	Sit-and-Reach	The difference in the pre- vs post-intervention change in the sit-and-reach distance between groups	12 Weeks
Secondary	Step Count & Activity Minutes	The difference in the pre- vs post-intervention change in step count and activity minutes (Garmin watch) between groups	12 Weeks
Secondary	Overall Well-Being (The World Health Organization-5 [WHO-5] Well-Being Index)	The difference in the pre- vs post-intervention change in The World Health Organization-5 (WHO-5) Well-Being Index between groups (score range: 0-25, higher scores indicate higher well-being)	12 Weeks
Secondary	Resilience (10-Item Connor Davidson Resilience Scale)	The difference in the pre- vs post-intervention change in resilience, as measures by the 10-Item Connor Davidson Resilience Scale, between groups (score range: 0-40, higher scores indicate higher resilience)	12 Weeks
Secondary	General health-related quality of life (36-Item Short Form Survey [SF-36])	The difference in the pre- vs post-intervention change in health-related quality of life, as measured by the SF-36, between groups (score range: 0-100, higher scores indicate a more favorable health state)	12 Weeks
Secondary	General health-related quality of life (5-Level EQ-5D [EQ-5D-5L])	The difference in the pre- vs post-intervention change in health-related quality of life, as measured by the EQ-5D-5L, between groups (visual analogue score range: 0-100, higher scores indicate a more favorable health state)	12 Weeks