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Completed

NCT Number: NCT05047042

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

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.

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Key information

Conditions

Advanced Cancer Behavior Motor Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cross Cancer Institute, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Advanced Cancer Support in Virtual Rehabilitation and Exercise

Behavioral

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Alberta Health services

Registry information

Official study title

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

Acronym: ACTIVE-North

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 16, 2021
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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