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
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancer||Behavioral: Advanced Cancer Support in Virtual Rehabilitation and Exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|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|
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.
- 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
- 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
- Adherence rate [ Time Frame: 12 months ]The number of sessions attended by the participant as a proportion of the maximum prescribed
- 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.
- 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.
- 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.
- 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).
- 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).
- Objective functional lower extremity strength [ Time Frame: 8 weeks ]Sit to Stand Test
- Objective functional flexibility of lower back and hamstring muscles [ Time Frame: 8 weeks ]Sit and Reach Test
- Objective shoulder range of motion [ Time Frame: 8 weeks ]Shoulder range of motion
- Objective measure of static balance [ Time Frame: 8 weeks ]4-stage balance test
- Objective measure of aerobic and lower body endurance [ Time Frame: 8 weeks ]2-minute step test
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.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- The ability to understand, provide informed consent in, and speak English;
- Patient reported fatigue or loss of physical functioning of moderate to severe severity (Edmonton Symptom Assessment System - Revised score ≥ 4/10);
- Primary residence in Alberta Health Services North Zone;
- Internet access in the patient's home residence.
- 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);
- Palliative Performance Scale level of 30% or less;
- Any person who, in the opinion of the treating physician, is within the last days to hours of life.
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
|Contact: Christopher Sellar, PhDemail@example.com|
|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|
|Principal Investigator:||Margaret McNeely, PhD||University of Alberta, Faculty of Rehabilitation Medicine|
|Principal Investigator:||Sonya Lowe, MD PhD||University of Alberta, Department of Oncology|
|Responsible Party:||University of Alberta|
|Other Study ID Numbers:||
|First Posted:||September 16, 2021 Key Record Dates|
|Last Update Posted:||June 6, 2023|
|Last Verified:||June 2023|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|