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A Feasibility Study of a Virtual Rehabilitation and Physical Activity Program for People With Advanced Cancer (ACTIVE-North)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05047042
Recruitment Status : Recruiting
First Posted : September 16, 2021
Last Update Posted : June 6, 2023
Sponsor:
Collaborator:
Alberta Health services
Information provided by (Responsible Party):
University of Alberta

Study Description
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Brief Summary:
Background: People with advanced cancer experience fatigue and loss of functioning, which often worsens as their cancer progresses. Rehabilitation programs may help to reduce fatigue and improve overall physical function. People with advanced cancer who live in rural and remote areas lack access to cancer-specific rehabilitation and exercise expertise to manage complex symptoms of high intensity. Their access to in-person services at tertiary sites are further reduced due to public health requirements for physical distancing during the severe acute respiratory syndrome coronavirus 2 pandemic. Aim: To test the feasibility of a virtual program delivered by a team of cancer-specific rehabilitation, exercise and pain and symptom experts for remote and rural patients with advanced cancer to address their symptoms, functioning and quality of life. Design: The virtual program will be tailored to the individual person, and consist of online exercise modules, online supervised interactive group class and one-to-one virtual meetings with an exercise or rehabilitation specialist and a palliative care physician. Relevance: This study will determine whether a virtual multidisciplinary rehabilitation and exercise program is feasible for people with advanced cancer. Further, it will provide insight on how fatigue and loss of functioning can best be managed for this population in remote and rural locations.

Condition or disease Intervention/treatment Phase
Advanced Cancer Behavioral: Advanced Cancer Support in Virtual Rehabilitation and Exercise Not Applicable

Detailed Description:
Aim: To determine the feasibility of a virtual rehabilitation and therapeutic exercise intervention which is designed and delivered virtually by an interdisciplinary team for advanced cancer patients in Alberta Health Services North Zone. Objectives: 1) To examine the primary feasibility outcome of completion rate, with a target of 50% of participants who complete the virtual rehabilitation and therapeutic exercise intervention out of all participants who agreed to participate in the study; 2) To explore secondary feasibility outcomes of retention rate, adherence rate and patient safety of participants in the virtual rehabilitation and therapeutic exercise intervention; 3) To provide preliminary data on the effect of a virtual rehabilitation and therapeutic exercise intervention on the symptom burden, physical function, and overall quality of life of advanced cancer patients, and 4) To explore participants' experience, barriers, and facilitators after participating in the virtual rehabilitation and therapeutic exercise intervention. Methods: A pilot study using single group pre- to post-test with mixed methods data collection will allow us to determine the feasibility of a virtual rehabilitation and therapeutic exercise intervention (proof of concept) to be used in the full-scale study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Advanced Cancer Support In Virtual Rehabilitation and Exercise in North Zone (ACTIVE-North): a Feasibility Study
Actual Study Start Date : January 17, 2022
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Advanced Cancer Support in Virtual Rehabilitation and Exercise
The intervention will take place in participants' homes, at times convenient for the participant. Programming will be administered virtually through the University of Alberta's Cancer Rehabilitation Clinic, which is fully equipped for virtual delivery of services. The study intervention will be tailored to the individual with respect to their baseline strength, symptom profile and prior experience with exercise. Pre- and post-testing will be done virtually. The mode, intensity and duration of each exercise session will be based on the participant's baseline fitness and status that day. Variations on each exercise will be provided to ensure an appropriate movement and intensity and to allow for individual prescription. Resistance bands will be used to provide resistance during strengthening and balance retraining exercises. The interactive group class will be led virtually by an exercise or rehabilitation specialist.
 Behavioral: Advanced Cancer Support in Virtual Rehabilitation and Exercise
The study intervention will consist of an individualized 8-week program of online exercise modules, supervised interactive group class and one-to-one consultations with an exercise or rehabilitation specialist and a pain and symptom physician, delivered via secure live Zoom sessions.


Outcome Measures
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Primary Outcome Measures :
  1. Completion rate [ Time Frame: 12 months ]
    The number of participants who complete the study intervention, out of the total number of patients who agree to participate in the study intervention


Secondary Outcome Measures :
  1. Retention rate [ Time Frame: 12 months ]
    The number of participants completing the post-testing assessments, out of the total number of patients who agree to participate in the study intervention

  2. Adherence rate [ Time Frame: 12 months ]
    The number of sessions attended by the participant as a proportion of the maximum prescribed

  3. Patient safety [ Time Frame: 12 months ]
    The number and type of adverse events which may arise during the study intervention, including but limited to death, a life-threatening event, inpatient hospitalization, or a persistent or significant incapacity or substantial disruption of the ability to conduct basic activities of daily living.


Other Outcome Measures:
  1. Patient-reported symptom severity [ Time Frame: 8 weeks ]
    Edmonton Symptom Assessment System - Revised: Symptom severity or intensity is rated on an 11-point scale (0 = no symptom, 10 = worst possible symptom), with higher scores indicating worse symptom intensity.

  2. Patient-reported fatigue [ Time Frame: 8 weeks ]
    Brief Fatigue Inventory: Patient-rated numerical scale comprised of 9 items; the first three items ask patients to rate the severity of their fatigue at its "worst," "usual," and "now" during normal waking hours, with 0 being "no fatigue" and 10 being "fatigue as bad as you can imagine." The last six items assess the amount that fatigue has interfered with different aspects of the patient's life during the past 24 hours.

  3. Patient-reported lower extremity functioning [ Time Frame: 8 weeks ]
    Lower Extremity Functional Scale: Patient questionnaire administered by the study coordinator and comprised of 20 items; each item is an activity rated on a 5-point scale (0 = extreme difficulty or unable to perform activity, 4 = no difficulty).

  4. Patient-reported upper extremity functioning [ Time Frame: 8 weeks ]
    Upper Extremity Functional Scale: Patient questionnaire comprised of 8 items; each item is an activity rated on a 10-point scale (1 = no problem, 10 = major problem / can't do at all).

  5. Objective functional lower extremity strength [ Time Frame: 8 weeks ]
    Sit to Stand Test

  6. Objective functional flexibility of lower back and hamstring muscles [ Time Frame: 8 weeks ]
    Sit and Reach Test

  7. Objective shoulder range of motion [ Time Frame: 8 weeks ]
    Shoulder range of motion

  8. Objective measure of static balance [ Time Frame: 8 weeks ]
    4-stage balance test

  9. Objective measure of aerobic and lower body endurance [ Time Frame: 8 weeks ]
    2-minute step test


Eligibility Criteria
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Information from the National Library of Medicine

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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:

  1. The ability to understand, provide informed consent in, and speak English;
  2. Patient reported fatigue or loss of physical functioning of moderate to severe severity (Edmonton Symptom Assessment System - Revised score ≥ 4/10);
  3. Primary residence in Alberta Health Services North Zone;
  4. Internet access in the patient's home residence.

Exclusion Criteria:

  1. Any absolute contraindications to exercise (including acute myocardial infarction within 2 days, symptomatic/severe aortic stenosis, decompensated heart failure, symptomatic/hemodynamically significant cardiac arrhythmias, unstable angina not previously stabilized by medical therapy, acute aortic dissection, acute myocarditis/pericarditis, acute pulmonary embolus/infarction);
  2. Palliative Performance Scale level of 30% or less;
  3. Any person who, in the opinion of the treating physician, is within the last days to hours of life.
Contacts and Locations
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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): NCT05047042


Contacts
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Contact: Christopher Sellar, PhD 780-492-6007 frmace@ualberta.ca

Locations
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Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Sonya Lowe, MD         
Fort McMurray Community Cancer Centre Recruiting
Fort McMurray, Alberta, Canada, T9H 1P2
Contact: Dallas Kuhr, MD         
Grande Prairie Regional Cancer Centre Recruiting
Grande Prairie, Alberta, Canada, T8V 2E8
Contact: Petra Grendarova, MD         
Sponsors and Collaborators
University of Alberta
Alberta Health services
Investigators
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Principal Investigator: Margaret McNeely, PhD University of Alberta, Faculty of Rehabilitation Medicine
Principal Investigator: Sonya Lowe, MD PhD University of Alberta, Department of Oncology
More Information
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT05047042    
Other Study ID Numbers: HREBA.CC-21-0301
First Posted: September 16, 2021    Key Record Dates
Last Update Posted: June 6, 2023
Last Verified: June 2023

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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
rehabilitation
Additional relevant MeSH terms:
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Neoplasms