A Feasibility Study of a Virtual Rehabilitation and Physical Activity Program for People With Advanced Cancer

Advanced Cancer Clinical Trial

— ACTIVE-North  

Official title:

Advanced Cancer Support In Virtual Rehabilitation and Exercise in North Zone (ACTIVE-North): a Feasibility Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05047042
• Other study ID #: HREBA.CC-21-0301
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 17, 2022
• Est. completion date: October 2024

Study information

• Verified date: February 2024
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21
• Est. completion date: October 2024
• Est. primary completion date: February 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Fort McMurray Community Cancer Centre	Fort McMurray	Alberta
Canada	Grande Prairie Regional Cancer Centre	Grande Prairie	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Alberta Health services

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient-reported symptom severity	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.	8 weeks
Other	Patient-reported fatigue	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.	8 weeks
Other	Patient-reported lower extremity functioning	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).	8 weeks
Other	Patient-reported upper extremity functioning	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).	8 weeks
Other	Objective functional lower extremity strength	Sit to Stand Test	8 weeks
Other	Objective functional flexibility of lower back and hamstring muscles	Sit and Reach Test	8 weeks
Other	Objective shoulder range of motion	Shoulder range of motion	8 weeks
Other	Objective measure of static balance	4-stage balance test	8 weeks
Other	Objective measure of aerobic and lower body endurance	2-minute step test	8 weeks
Primary	Completion rate	The number of participants who complete the study intervention, out of the total number of patients who agree to participate in the study intervention	12 months
Secondary	Retention rate	The number of participants completing the post-testing assessments, out of the total number of patients who agree to participate in the study intervention	12 months
Secondary	Adherence rate	The number of sessions attended by the participant as a proportion of the maximum prescribed	12 months
Secondary	Patient safety	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.	12 months