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Trial record 1 of 3 for:    PIONEER | cancer | Edmonton, Canada
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Heal-Me Personalized Online Nutrition and Exercise Routines (PiONEeR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04666558
Recruitment Status : Active, not recruiting
First Posted : December 14, 2020
Last Update Posted : July 13, 2022
Sponsor:
Collaborator:
Alberta Innovates Health Solutions
Information provided by (Responsible Party):
University of Alberta

Brief 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.


Condition or disease Intervention/treatment Phase
Cancer Lung Diseases Liver Diseases Other: Exercise & Nutrition Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : November 30, 2020
Actual Primary Completion Date : December 17, 2021
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard Care
The standard of care response to COVID. Educational materials will be provided to patients via email. The package will include a combination of personalized exercises, and nutrition information for healthy eating. Participants will also receive a Garmin watch to track their activity over the intervention.
Experimental: App-Based, Personnel-Light Care
An app-based, "personnel-light" approach to virtual care with a focus on support through group-based interactions with the Trainers, Dietitians and other participants. The patient's personalized 12-week home based exercise program will be enabled in the app after a baseline exercise specialist appointment. The 10-week nutrition program will be enabled at week 3 after a virtual dietitian assessment in week 2 (~1 hour). The home programs will auto-progress. Participants will also receive a Garmin watch to track their activity over the intervention.
Other: Exercise & Nutrition
App-based live group exercise classes, personalized follow-up asynchronous workouts, live group nutrition classes, and protein tracking.

Experimental: App-Based, Personnel-Intensive Care
An app-based, "personnel-intensive" approach to virtual care with support through a combination of group-based interactions with Trainers, Dietitians and other participants, as well as one-on-one support with Exercise Trainers and Dietitians. In addition to Group 2 features, patient interaction with Trainers will be via live group classes AND 1-to-1 sessions: up to 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. Participants will also receive a Garmin watch to track their activity over the intervention.
Other: 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.




Primary Outcome Measures :
  1. Lower Extremity Functional Scale (LEFS) [ Time Frame: 12 Weeks ]
    The difference in the pre- vs post-intervention change in LEFS score between groups (score range: 0-80, higher scores indicate higher function)


Secondary Outcome Measures :
  1. Upper Extremity Functional Index (UEFI) [ Time Frame: 12 weeks ]
    The difference in the pre- vs post-intervention change in UEFI score between groups (score range: 0-80, higher scores indicate higher function)

  2. Timed Sit-to-Stand (60 & 30 seconds) [ Time Frame: 12 Weeks ]
    The difference in the pre- vs post-intervention change in # of repetitions completed over the Timed Sit-to-Stand between groups

  3. Timed One-Legged Stance [ Time Frame: 12 Weeks ]
    The difference in the pre- vs post-intervention change in Timed One-Legged Stance between groups

  4. 2-Minute Step Test (2MST) [ Time Frame: 12 Weeks ]
    The difference in the pre- vs post-intervention change in the # of steps completed in the 2MST between groups

  5. Sit-and-Reach [ Time Frame: 12 Weeks ]
    The difference in the pre- vs post-intervention change in the sit-and-reach distance between groups

  6. Step Count & Activity Minutes [ Time Frame: 12 Weeks ]
    The difference in the pre- vs post-intervention change in step count and activity minutes (Garmin watch) between groups

  7. Overall Well-Being (The World Health Organization-5 [WHO-5] Well-Being Index) [ Time Frame: 12 Weeks ]
    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)

  8. Resilience (10-Item Connor Davidson Resilience Scale) [ Time Frame: 12 Weeks ]
    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)

  9. General health-related quality of life (36-Item Short Form Survey [SF-36]) [ Time Frame: 12 Weeks ]
    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)

  10. General health-related quality of life (5-Level EQ-5D [EQ-5D-5L]) [ Time Frame: 12 Weeks ]
    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)


Other Outcome Measures:
  1. Physical activity [ Time Frame: 12 Weeks ]
    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

  2. Sedentary Time (International Sedentary Assessment Tool - ISAT) [ Time Frame: 12 Weeks ]
    The difference in the pre- vs post-intervention change in sedentary time, as self-reported on the ISAT between groups

  3. Protein Intake [ Time Frame: 12 Weeks ]
    The difference in the pre- vs post-intervention change in protein intake (grams) between groups, based on 3-day food record(s)

  4. Calorie Intake [ Time Frame: 12 Weeks ]
    The difference in the pre- vs post-intervention change in calorie intake (kilocalories) between groups, based on 3-day food record(s)

  5. Micronutrient Intake [ Time Frame: 12 Weeks ]
    The difference in the pre- vs post-intervention change in micronutrient intake (milligrams) between groups, based on 3-day food record(s)

  6. Beliefs and outcome expectations about exercise [ Time Frame: 12 Weeks ]
    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)

  7. Program acceptability (Unified Theory of Acceptance and Use of Technology - UTAUT) [ Time Frame: 12 Weeks ]
    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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04666558


Locations
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Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2G4
Sponsors and Collaborators
University of Alberta
Alberta Innovates Health Solutions
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT04666558    
Other Study ID Numbers: Pro00103715
First Posted: December 14, 2020    Key Record Dates
Last Update Posted: July 13, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Alberta:
Exercise
Nutrition
Chronic Disease
Virtual
Additional relevant MeSH terms:
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Liver Diseases
Lung Diseases
Digestive System Diseases
Respiratory Tract Diseases