Back to resultsRehabilitation for People With Advanced Cancer
Primary Purpose
Advanced Breast Cancer, Advanced Colorectal Cancer, Cancer Rehabilitation
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
In-person rehabilitaiton group
Virtual rehabilitation group
Sponsored by
About this trial
This is an interventional supportive care trial for Advanced Breast Cancer focused on measuring Cancer Rehabilitation, Virtual Cancer Rehabilitation
Eligibility Criteria
Inclusion Criteria:
- Age 18 years or older
- Diagnosed with locally advanced incurable or metastatic breast or colorectal cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Fully independent with ambulation and transfers with or without ambulatory assistance
- Palliative Performance score of >70 (moderate predictive power estimating life expectancy >6 months)
- Receiving first or second line anti-cancer treatments in the metastatic / incurable setting (a relative proxy for expected survival >6 months)
- Medical clearance to participate from treating physician
Exclusion Criteria:
- Wheelchair level community ambulation
- Moderate or severe non-cancer pain (>6 out of 10 on visual analog scale)
- Moderate or severe cancer bone pain (>Gr 2 bone pain (i.e., moderate pain limiting instrumental ALDs or worse) as measured on CTCAE (see below))
- Severe or uncontrolled depressive symptoms (>20 on PHQ-9)
- Known neurological conditions influencing cognition and preventing safe or appropriate engagement with self-management and exercise recommendations (e.g., dementia, traumatic brain injury, or brain metastasis influencing cognition or causing moderate-to-severe motor-sensory-coordination). Best determined by the referring physician or nurse practitioner.
- Unable to communicate sufficiently in English to complete intervention, questionnaires, and consent.
- Unwillingness to be randomized, participate in a group intervention, or attend individual physical assessments.
- Inability to operate videoconferencing if preference is virtual programming.
Sites / Locations
- Princess Margaret Cancer CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Standard best cancer practice
In-person Intervention arm
Virtual Intervention arm
Arm Description
All participants (intervention arms 1 and 2, and control) will receive usual oncology care by their health care providers which includes recommendations for general aerobic and resistance exercise. Participants in the control group will be of recommended to work towards the recommended 90 minutes moderate to vigorous aerobic exercise, and two days a week of large muscle group strength training as recommended by the ACSM. A general brochure will be provided to all control participants providing education in line with current standard of care. This safety precautions noted these will be indicated brochure will have an open text field on the back which will allow the kinesiologist to provide and general advice at each time point. If there are particular here. Participants in all study arms may also be referred by treating health care providers to usual supportive care or early palliative care services at any time deemed necessary, and will be recorded as part of monthly data collection.
The in-person intervention arm is an 8-week program and four week short maintenance period. This includes 1 hr of in-person, group-based exercise guided by a qualified exercise professional followed by 1 hr of in-person, group based, self-management education provided by a rehabilitation expert to occur immediately following the exercise session. Each participant is given a FitBit® to track steps, heart rate and sleep. Each site (i.e., Toronto and Vancouver) will run independent, in-person exercise and educational programs based on local referrals. Self management sessions include 8 high priority topics for advanced cancer patients including: 1) goal setting, 2) managing pain, 3) reducing fatigue and improving sleep, 4) boosting brain health, 5) eating and cooking for wellness, 6) managing emotions, 7) being mindful, and 8) planning for the future. Education sessions will be run by local experts at each site.
The virtual intervention arm will be an 8-week program plus four week short maintenance period but will include two separate 1 hour sessions per week. This includes: 1) 60 minutes of virtual, group-based, synchronous exercise over a virtual secure platform; and, 2) A separate 60 min virtual synchronous education session provided on a separate day (to prevent virtual fatigue). 3) Encouragement to participate in a home program the other days of the week, striving for the recommended 90 min of moderate to vigorous aerobic exercise and 2 days of week or resistance exercise. The virtual intervention group will combine participants across both study locations and run sessions when sufficient numbers are recruited. Self-management education content will be unchanged to the in-person sessions but conducted over a virtual platform (i.e., videoconferencing) with participants also attending virtually.
Outcomes
Primary Outcome Measures
Drop-out rates as a measure of feasibility (demand/update of intervention)
Number of patients who complete the study/ drop-out will be used to identify feasibility of the intervention.
Patient preference as assessed during clinical support as a measure of feasibility (acceptability)
Check-ins with Kinesiologist during assessments will be used to identify intervention acceptability/preference.
Measuring safety/practicality as assessed during one-on-one with the health coach (analyzed as qualitative data)
Completed over MS Teams/in-person and will be a conversational question and answer format.
Secondary Outcome Measures
Demographics
Demographic details will be collected from participants at the time of initial assessment via an intake questionnaire. There are no scales, only patient reported outcome questions.
Disability
Measured using the 12 item World Health Organization Disability Assessment Schedule 2.0 which is a cross-cultural, standardized method for measuring limitations and restrictions on individuals' activities and participation in society.
Physical functioning
Measured using the 10 item physical function subscale of Short-Form Health Survey (scale from 0 (negative health) to 100 (positive health) ).
Social functioning
Measured using the Social difficulties Inventory. A 0.0 score indicates perfect comparison with consensus group and > or equal to 2 indicates unacceptable performance/remedial action required
Depression
Measured using the Patient Health Questionnaire. The test is scored on a scale from 0 to 27, with higher scores indicating more severe symptoms.
Anxiety
Measured using the Generalized Anxiety Disorder 7. The overall GAD 7 score ranges between 0 and 21, 0 meaning no anxiety and 21 meaning severe anxiety.
Physicial activity
Measured using the modified Godin Leisure Score Index (LSI) of the Godin and Shepherd Leisure Time Exercise Questionnaire (GLTEQ)
Quality of Life for advanced cancer - daily life activities
Measured using EuroQol 5 dimension. This measure has 5 levels, with level 1 indicating no problems and level 5 indicating extreme problems
Quality of Life for advanced cancer - wellbeing
Measured using Functional Assessment of Chronic Illness Therapy-Palliative Care. This is a measure of health-related quality of life for persons with advanced cancer.
Symptom Burden
Measured with the 9-item Edmonton Symptom Assessment System. Each symptom is rated from "0 to 10". A score of "0" means you do not have the symptom. A score of "10" means that your symptom is at its very worst.
Safety and Health Care Utilization
Measured using a self-report questionnaire. tilization can be measured as the number of services provided to a patient, such as the number of X rays. More often, however, a variety of procedures and services are of interest, and some measure of "cost" is assigned to each service so that resource intensity can be summed over all provided services.
Weekly Session feedback
Following each educational module, participants will be asked to complete a short feedback form of 7-10 questions. Questions will explore participant's feelings surrounding session length, content, presentation quality, and recommendations for improvement. Additional questions for participants in the virtual arm will be included and inquire about video, audio, and presenter quality.
Physiological measure of height
Participant height at baseline
Physiological measures of weight
Participant weight at all physical assessments (T1, T3, T4, T5, not T2) will be collected. This data will inform calculations for BMI.
Physiological measures of exercise Intensity (Perceived Exertion)
During each exercise class participants will be instructed on the target rated perceived exertion (RPE) goal for that day. The RPE has been found to provide a good estimate of participant heart rate during physical activity54. Following each exercise class, each participants will be asked to provide exercise staff with a RPE score on a scale of 6 (no exertion at all) to 20 (maximal exertion) of effort. Participants who do not achieve the target RPE will be asked to provide a reason (if known).
Physiological measures of total Exercise Participation for sleep
Each participant will be provided a FitBit® to help track purposeful and leisure time physical activity from time point T1 (program intake) through T4 (3 months post program completion). From those consenting, data pertaining to step count sleep will be downloaded from participant accounts at each time point (T2, T3, and T4).
Physiological measures of total Exercise Participation for step count
Each participant will be provided a FitBit® to help track purposeful and leisure time physical activity from time point T1 (program intake) through T4 (3 months post program completion). From those consenting, data pertaining to step count will be downloaded from participant accounts at each time point (T2, T3, and T4).
Physiological measures of total Exercise Participation for heart rate.
Each participant will be provided a FitBit® to help track purposeful and leisure time physical activity from time point T1 (program intake) through T4 (3 months post program completion). From those consenting, data pertaining to heart rate will be downloaded from participant accounts at each time point (T2, T3, and T4).
Physiological measures of cardiorespiratory fitness
Measured with the six minute walk test (6MWT)
Physiological measures of muscular strength
Measured with hand grip strength for upper body
Physiological measures of endurance
Measured with 30-second sit to stand test for lower body strength
Physiological measures of balance
Measured with the Balance test
Physiological measures of Performance
Measured with the 4-meter Gait speed test
Full Information
NCT ID
NCT05424068
First Posted
April 13, 2022
Last Updated
March 27, 2023
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT05424068
Brief Title
Rehabilitation for People With Advanced Cancer
Official Title
Project 3 - Phase II, Preference Based, Randomized Controlled Trial of Group-Based, In Person Versus Virtual, Cancer Rehabilitation for People With Metastatic / Advanced Breast or Colorectal Cancers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2022 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The proposed study is a Phase II, feasibility, randomized controlled preference based study. This will be conducted in Vancouver and Toronto and includes breast and colorectal cancers.
Detailed Description
Cancer rehabilitation interventions that address common impairments and focus on maintaining or reducing the rate of functional decline are greatly needed for the growing population of cancer survivors living with incurable or metastatic cancer. In the curative setting, the main gaps in care include lack of referral and barriers to access care; however, in the metastatic setting, high quality evidence on safety, acceptability, and efficacy is still required. In response, based on the results of a need assessments (n=50) of this population and input from palliative care experts, we recently developed the CaRE-Advanced Cancer (CaRE-AC) program. Similar to CaRE@ELLICSR, CaRE-AC is an 8-week multidimensional, group-based program with exercises classes and selfmanagement skills teaching. A single-arm phase I pilot of this program is currently being conducted to assess the feasibility and acceptability (Co-PIs Jones/Langelier). To date, 14 patients have enrolled and 9 patients have completed the program (64%). All participants reported feeling the program was safe and 90% were satisfied with the structure and content.
Data collection is expected to be complete be the end of 2019 and the findings will inform revisions to the program format and content. To build on this work, Project Three is a Phase II feasibility RCT of the CaRE-AC program. Results will inform the development of a multicentre pragmatic RCT protocol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Breast Cancer, Advanced Colorectal Cancer, Cancer Rehabilitation
Keywords
Cancer Rehabilitation, Virtual Cancer Rehabilitation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
117 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard best cancer practice
Arm Type
No Intervention
Arm Description
All participants (intervention arms 1 and 2, and control) will receive usual oncology care by their health care providers which includes recommendations for general aerobic and resistance exercise. Participants in the control group will be of recommended to work towards the recommended 90 minutes moderate to vigorous aerobic exercise, and two days a week of large muscle group strength training as recommended by the ACSM. A general brochure will be provided to all control participants providing education in line with current standard of care. This safety precautions noted these will be indicated brochure will have an open text field on the back which will allow the kinesiologist to provide and general advice at each time point. If there are particular here. Participants in all study arms may also be referred by treating health care providers to usual supportive care or early palliative care services at any time deemed necessary, and will be recorded as part of monthly data collection.
Arm Title
In-person Intervention arm
Arm Type
Experimental
Arm Description
The in-person intervention arm is an 8-week program and four week short maintenance period. This includes 1 hr of in-person, group-based exercise guided by a qualified exercise professional followed by 1 hr of in-person, group based, self-management education provided by a rehabilitation expert to occur immediately following the exercise session. Each participant is given a FitBit® to track steps, heart rate and sleep. Each site (i.e., Toronto and Vancouver) will run independent, in-person exercise and educational programs based on local referrals. Self management sessions include 8 high priority topics for advanced cancer patients including: 1) goal setting, 2) managing pain, 3) reducing fatigue and improving sleep, 4) boosting brain health, 5) eating and cooking for wellness, 6) managing emotions, 7) being mindful, and 8) planning for the future. Education sessions will be run by local experts at each site.
Arm Title
Virtual Intervention arm
Arm Type
Experimental
Arm Description
The virtual intervention arm will be an 8-week program plus four week short maintenance period but will include two separate 1 hour sessions per week. This includes: 1) 60 minutes of virtual, group-based, synchronous exercise over a virtual secure platform; and, 2) A separate 60 min virtual synchronous education session provided on a separate day (to prevent virtual fatigue). 3) Encouragement to participate in a home program the other days of the week, striving for the recommended 90 min of moderate to vigorous aerobic exercise and 2 days of week or resistance exercise. The virtual intervention group will combine participants across both study locations and run sessions when sufficient numbers are recruited. Self-management education content will be unchanged to the in-person sessions but conducted over a virtual platform (i.e., videoconferencing) with participants also attending virtually.
Intervention Type
Behavioral
Intervention Name(s)
In-person rehabilitaiton group
Intervention Description
participants who have chosen to complete the study intervention by coming in for their 8 week education and exercise sessions.
Intervention Type
Behavioral
Intervention Name(s)
Virtual rehabilitation group
Intervention Description
Participants who have chosen to complete the study virtually instead of in-person sessions.
Primary Outcome Measure Information:
Title
Drop-out rates as a measure of feasibility (demand/update of intervention)
Description
Number of patients who complete the study/ drop-out will be used to identify feasibility of the intervention.
Time Frame
6 months
Title
Patient preference as assessed during clinical support as a measure of feasibility (acceptability)
Description
Check-ins with Kinesiologist during assessments will be used to identify intervention acceptability/preference.
Time Frame
6 months
Title
Measuring safety/practicality as assessed during one-on-one with the health coach (analyzed as qualitative data)
Description
Completed over MS Teams/in-person and will be a conversational question and answer format.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Demographics
Description
Demographic details will be collected from participants at the time of initial assessment via an intake questionnaire. There are no scales, only patient reported outcome questions.
Time Frame
6 months
Title
Disability
Description
Measured using the 12 item World Health Organization Disability Assessment Schedule 2.0 which is a cross-cultural, standardized method for measuring limitations and restrictions on individuals' activities and participation in society.
Time Frame
6 months
Title
Physical functioning
Description
Measured using the 10 item physical function subscale of Short-Form Health Survey (scale from 0 (negative health) to 100 (positive health) ).
Time Frame
6 months
Title
Social functioning
Description
Measured using the Social difficulties Inventory. A 0.0 score indicates perfect comparison with consensus group and > or equal to 2 indicates unacceptable performance/remedial action required
Time Frame
6 months
Title
Depression
Description
Measured using the Patient Health Questionnaire. The test is scored on a scale from 0 to 27, with higher scores indicating more severe symptoms.
Time Frame
6 months
Title
Anxiety
Description
Measured using the Generalized Anxiety Disorder 7. The overall GAD 7 score ranges between 0 and 21, 0 meaning no anxiety and 21 meaning severe anxiety.
Time Frame
6 months
Title
Physicial activity
Description
Measured using the modified Godin Leisure Score Index (LSI) of the Godin and Shepherd Leisure Time Exercise Questionnaire (GLTEQ)
Time Frame
6 months
Title
Quality of Life for advanced cancer - daily life activities
Description
Measured using EuroQol 5 dimension. This measure has 5 levels, with level 1 indicating no problems and level 5 indicating extreme problems
Time Frame
6 months
Title
Quality of Life for advanced cancer - wellbeing
Description
Measured using Functional Assessment of Chronic Illness Therapy-Palliative Care. This is a measure of health-related quality of life for persons with advanced cancer.
Time Frame
6 months
Title
Symptom Burden
Description
Measured with the 9-item Edmonton Symptom Assessment System. Each symptom is rated from "0 to 10". A score of "0" means you do not have the symptom. A score of "10" means that your symptom is at its very worst.
Time Frame
6 months
Title
Safety and Health Care Utilization
Description
Measured using a self-report questionnaire. tilization can be measured as the number of services provided to a patient, such as the number of X rays. More often, however, a variety of procedures and services are of interest, and some measure of "cost" is assigned to each service so that resource intensity can be summed over all provided services.
Time Frame
6 months
Title
Weekly Session feedback
Description
Following each educational module, participants will be asked to complete a short feedback form of 7-10 questions. Questions will explore participant's feelings surrounding session length, content, presentation quality, and recommendations for improvement. Additional questions for participants in the virtual arm will be included and inquire about video, audio, and presenter quality.
Time Frame
8 weeks
Title
Physiological measure of height
Description
Participant height at baseline
Time Frame
6 months
Title
Physiological measures of weight
Description
Participant weight at all physical assessments (T1, T3, T4, T5, not T2) will be collected. This data will inform calculations for BMI.
Time Frame
6 months
Title
Physiological measures of exercise Intensity (Perceived Exertion)
Description
During each exercise class participants will be instructed on the target rated perceived exertion (RPE) goal for that day. The RPE has been found to provide a good estimate of participant heart rate during physical activity54. Following each exercise class, each participants will be asked to provide exercise staff with a RPE score on a scale of 6 (no exertion at all) to 20 (maximal exertion) of effort. Participants who do not achieve the target RPE will be asked to provide a reason (if known).
Time Frame
6 months
Title
Physiological measures of total Exercise Participation for sleep
Description
Each participant will be provided a FitBit® to help track purposeful and leisure time physical activity from time point T1 (program intake) through T4 (3 months post program completion). From those consenting, data pertaining to step count sleep will be downloaded from participant accounts at each time point (T2, T3, and T4).
Time Frame
6 months
Title
Physiological measures of total Exercise Participation for step count
Description
Each participant will be provided a FitBit® to help track purposeful and leisure time physical activity from time point T1 (program intake) through T4 (3 months post program completion). From those consenting, data pertaining to step count will be downloaded from participant accounts at each time point (T2, T3, and T4).
Time Frame
6 months
Title
Physiological measures of total Exercise Participation for heart rate.
Description
Each participant will be provided a FitBit® to help track purposeful and leisure time physical activity from time point T1 (program intake) through T4 (3 months post program completion). From those consenting, data pertaining to heart rate will be downloaded from participant accounts at each time point (T2, T3, and T4).
Time Frame
6 months
Title
Physiological measures of cardiorespiratory fitness
Description
Measured with the six minute walk test (6MWT)
Time Frame
6 months
Title
Physiological measures of muscular strength
Description
Measured with hand grip strength for upper body
Time Frame
6 months
Title
Physiological measures of endurance
Description
Measured with 30-second sit to stand test for lower body strength
Time Frame
6 months
Title
Physiological measures of balance
Description
Measured with the Balance test
Time Frame
6 months
Title
Physiological measures of Performance
Description
Measured with the 4-meter Gait speed test
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Performance Status
Description
Performance Status - Measured with the Palliative Performance Scale version 2.0. The scale ranges from 0% to 100% with zero indicating death and 100% indicating normal/no evidence of disease.
Time Frame
6 months
Title
Measure of performance status
Description
The Eastern Cooperative Oncology Group measure of performance status describes a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.). The scale runs from 0 to 5, with 0 denoting perfect health and 5 death.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 years or older
Diagnosed with locally advanced incurable or metastatic breast or colorectal cancer
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Fully independent with ambulation and transfers with or without ambulatory assistance
Palliative Performance score of >70 (moderate predictive power estimating life expectancy >6 months)
Receiving first or second line anti-cancer treatments in the metastatic / incurable setting (a relative proxy for expected survival >6 months)
Medical clearance to participate from treating physician
Exclusion Criteria:
Wheelchair level community ambulation
Moderate or severe non-cancer pain (>6 out of 10 on visual analog scale)
Moderate or severe cancer bone pain (>Gr 2 bone pain (i.e., moderate pain limiting instrumental ALDs or worse) as measured on CTCAE (see below))
Severe or uncontrolled depressive symptoms (>20 on PHQ-9)
Known neurological conditions influencing cognition and preventing safe or appropriate engagement with self-management and exercise recommendations (e.g., dementia, traumatic brain injury, or brain metastasis influencing cognition or causing moderate-to-severe motor-sensory-coordination). Best determined by the referring physician or nurse practitioner.
Unable to communicate sufficiently in English to complete intervention, questionnaires, and consent.
Unwillingness to be randomized, participate in a group intervention, or attend individual physical assessments.
Inability to operate videoconferencing if preference is virtual programming.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charmaine Silva, MSc
Phone
4165818453
Email
charmaine.silva@uhn.ca
First Name & Middle Initial & Last Name or Official Title & Degree
David Langelier, MD
Email
david.langelier@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Jones, PhD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charmaine Silva, MSc
Email
charmaine.silva@uhn.ca
12. IPD Sharing Statement
Learn more about this trial
Rehabilitation for People With Advanced Cancer
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