Advanced CancerACTIVE-NorthNCT05047042
A Feasibility Study of a Virtual Rehabilitation and Physical Activity Program for People With Advanced Cancer
A study testing Advanced Cancer Support in Virtual Rehabilitation and Exercise in people with Advanced Cancer, run by University of Alberta at 3 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Advanced Cancer Support in Virtual Rehabilitation and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 3 sitesCanada
- Study dates
- 17 Jan 2022to 5 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Fort McMurray Community Cancer Centre
Fort McMurray, Alberta, T9H 1P2
Grande Prairie Regional Cancer Centre
Grande Prairie, Alberta, T8V 2E8
About this study
Official title: Advanced Cancer Support In Virtual Rehabilitation and Exercise in North Zone (ACTIVE-North): a Feasibility Study
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.
Read the 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.
- Conditions
- Advanced Cancer
- Being tested
- Advanced Cancer Support in Virtual Rehabilitation and Exercise
- Keywords
- exercise, rehabilitation
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced Cancer Support in Virtual Rehabilitation and ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Advanced Cancer Support in Virtual Rehabilitation and Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (3)
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
Measured: 12 months
Adherence rate
The number of sessions attended by the participant as a proportion of the maximum prescribed
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start17 Jan 2022
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services
- Responsible party
- Sponsor
- Investigators
- Margaret McNeely, PhD, Principal investigator, University of Alberta, Faculty of Rehabilitation MedicineSonya Lowe, MD PhD, Principal investigator, University of Alberta, Department of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047042
- Sponsor's protocol ID
- HREBA.CC-21-0301
- Acronym
- ACTIVE-North
- Status last verified
- Dec 2024
- First submitted
- 8 Sep 2021
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Cancer Support In Virtual Rehabilitation and Exercise in North Zone (ACTIVE-North): a Feasibility Study
- ClinicalTrials.gov ID
- NCT05047042
- Acronym / sponsor ID
- ACTIVE-North / HREBA.CC-21-0301
- Conditions
- Advanced Cancer
- Keywords
- exercise, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Alberta Health services
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced Cancer Support in Virtual Rehabilitation and Exercise | Experimental | Behavioral: Advanced Cancer Support in Virtual Rehabilitation and ExerciseThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advanced Cancer Support in Virtual Rehabilitation and ExerciseThe 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. | Behavioural | Advanced Cancer Support in Virtual Rehabilitation and Exercise |
Primary outcome
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
3 secondary outcomes
Retention rate
Time frame: 12 months
Adherence rate
Time frame: 12 months
Patient safety
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret McNeely, PhD principal investigator
University of Alberta, Faculty of Rehabilitation Medicine
Sonya Lowe, MD PhD principal investigator
University of Alberta, Department of Oncology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advanced Cancer Support in Virtual Rehabilitation and Exercise in people with Advanced Cancer, run by University of Alberta at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.