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

NCT05047042 | Completed

• 1 other identifier: HREBA.CC-21-0301
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 3

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.

Conditions

Advanced Cancer

Keywords

exercise; rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Retention rate

  12 months

• Adherence rate

  12 months

• Patient safety

  12 months

Other Outcomes (9)

• Patient-reported symptom severity

  8 weeks

• Patient-reported fatigue

  8 weeks

• Patient-reported lower extremity functioning

  8 weeks

Study Arms (1)

Advanced Cancer Support in Virtual Rehabilitation and Exercise

EXPERIMENTAL

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

Interventions

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.

Advanced Cancer Support in Virtual Rehabilitation and Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Health services: collaborator

Study Sites (3)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Fort McMurray Community Cancer Centre

Fort McMurray, Alberta, T9H 1P2, Canada

Location

Grande Prairie Regional Cancer Centre

Grande Prairie, Alberta, T8V 2E8, Canada

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Telerehabilitation; Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Margaret McNeely, PhD

  University of Alberta, Faculty of Rehabilitation Medicine

  PRINCIPAL INVESTIGATOR

• Sonya Lowe, MD PhD

  University of Alberta, Department of Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 16, 2021
• Study Start: January 17, 2022
• Primary Completion: February 5, 2024
• Study Completion: February 5, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

CA (3)