Clinical trial NCT05047042: A Feasibility Study of a Virtual Rehabilitation and Physical Activity Program for People With Advanced Cancer
Official title: Advanced Cancer Support In Virtual Rehabilitation and Exercise in North Zone (ACTIVE-North): a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Cancer
Keywords: exercise
rehabilitation
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Alberta Health services
First posted: 2021-09-16
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Completion rate
timeFrame: 12 months
Secondary outcomes:
measure: Retention rate
timeFrame: 12 months
measure: Adherence rate
timeFrame: 12 months
measure: Patient safety
timeFrame: 12 months
Other outcomes:
measure: Patient-reported symptom severity
timeFrame: 8 weeks
measure: Patient-reported fatigue
timeFrame: 8 weeks
measure: Patient-reported lower extremity functioning
timeFrame: 8 weeks
measure: Patient-reported upper extremity functioning
timeFrame: 8 weeks
measure: Objective functional lower extremity strength
timeFrame: 8 weeks
measure: Objective functional flexibility of lower back and hamstring muscles
timeFrame: 8 weeks
measure: Objective shoulder range of motion
timeFrame: 8 weeks
measure: Objective measure of static balance
timeFrame: 8 weeks
measure: Objective measure of aerobic and lower body endurance
timeFrame: 8 weeks
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Fort McMurray
country: Canada
facility: Fort McMurray Community Cancer Centre
state: Alberta
city: Grande Prairie
country: Canada
facility: Grande Prairie Regional Cancer Centre
state: Alberta
Study officials:
affiliation: University of Alberta, Faculty of Rehabilitation Medicine
name: Margaret McNeely, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta, Department of Oncology
name: Sonya Lowe, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: