Advanced Breast CancerNCT05424068
Rehabilitation for People With Advanced Cancer
A study testing In-person rehabilitaiton group and Virtual rehabilitation group in people with Advanced Breast Cancer and Advanced Colorectal Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Breast Cancer, Advanced Colorectal Cancer, Cancer Rehabilitation
- What is being tested?
- In-person rehabilitaiton group and Virtual rehabilitation group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteCanada
- Study dates
- 2 Dec 2022to 16 Jan 2026
- 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
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- In-person rehabilitaiton group, Virtual rehabilitation group
- Keywords
- Cancer Rehabilitation, Virtual Cancer Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-person rehabilitaiton groupBehavioural
participants who have chosen to complete the study intervention by coming in for their 8 week education and exercise sessions.
Virtual rehabilitation groupBehavioural
Participants who have chosen to complete the study virtually instead of in-person sessions.
| Study group | Role | What they receive |
|---|---|---|
| Standard best cancer practice | No intervention | 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. |
| In-person Intervention arm | Experimental | 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. Receives: Behavioral: In-person rehabilitaiton group |
| Virtual Intervention arm | Experimental | 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. Receives: Behavioral: Virtual rehabilitation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Secondary outcomes (23)
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.
Measured: 6 months
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.
Measured: 6 months
Physical functioning
Measured using the 10 item physical function subscale of Short-Form Health Survey (scale from 0 (negative health) to 100 (positive health) ).
Measured: 6 months
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
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Physicial activity
Measured using the modified Godin Leisure Score Index (LSI) of the Godin and Shepherd Leisure Time Exercise Questionnaire (GLTEQ)
Measured: 6 months
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
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 8 weeks
Physiological measure of height
Participant height at baseline
Measured: 6 months
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.
Measured: 6 months
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).
Measured: 6 months
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).
Measured: 6 months
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).
Measured: 6 months
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).
Measured: 6 months
Physiological measures of cardiorespiratory fitness
Measured with the six minute walk test (6MWT)
Measured: 6 months
Physiological measures of muscular strength
Measured with hand grip strength for upper body
Measured: 6 months
Physiological measures of endurance
Measured with 30-second sit to stand test for lower body strength
Measured: 6 months
Physiological measures of balance
Measured with the Balance test
Measured: 6 months
Physiological measures of Performance
Measured with the 4-meter Gait speed test
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start2 Dec 2022
- Primary completion30 Jul 2025
- Study completion16 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Jones, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424068
- Sponsor's protocol ID
- 21-5539
- Status last verified
- Feb 2026
- First submitted
- 13 Apr 2022
- Last updated
- 25 Feb 2026
- 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 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05424068
- Acronym / sponsor ID
- 21-5539
- Keywords
- Cancer Rehabilitation, Virtual Cancer Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 16 Jan 2026 (actual)
- First posted
- 21 Jun 2022 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard best cancer practice | No intervention | –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. |
| In-person Intervention arm | Experimental | Behavioral: In-person rehabilitaiton groupThe 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. |
| Virtual Intervention arm | Experimental | Behavioral: Virtual rehabilitation groupThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| In-person rehabilitaiton groupparticipants who have chosen to complete the study intervention by coming in for their 8 week education and exercise sessions. | Behavioural | In-person Intervention arm |
| Virtual rehabilitation groupParticipants who have chosen to complete the study virtually instead of in-person sessions. | Behavioural | Virtual Intervention arm |
Primary outcome
Drop-out rates as a measure of feasibility (demand/update of intervention)
Time frame: 6 months
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)
Time frame: 6 months
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)
Time frame: 6 months
Completed over MS Teams/in-person and will be a conversational question and answer format.
23 secondary outcomes
Demographics
Time frame: 6 months
Disability
Time frame: 6 months
Physical functioning
Time frame: 6 months
Social functioning
Time frame: 6 months
Depression
Time frame: 6 months
Anxiety
Time frame: 6 months
Physicial activity
Time frame: 6 months
Quality of Life for advanced cancer - daily life activities
Time frame: 6 months
Quality of Life for advanced cancer - wellbeing
Time frame: 6 months
Symptom Burden
Time frame: 6 months
Safety and Health Care Utilization
Time frame: 6 months
Weekly Session feedback
Time frame: 8 weeks
Physiological measure of height
Time frame: 6 months
Physiological measures of weight
Time frame: 6 months
Physiological measures of exercise Intensity (Perceived Exertion)
Time frame: 6 months
Physiological measures of total Exercise Participation for sleep
Time frame: 6 months
Physiological measures of total Exercise Participation for step count
Time frame: 6 months
Physiological measures of total Exercise Participation for heart rate.
Time frame: 6 months
Physiological measures of cardiorespiratory fitness
Time frame: 6 months
Physiological measures of muscular strength
Time frame: 6 months
Physiological measures of endurance
Time frame: 6 months
Physiological measures of balance
Time frame: 6 months
Physiological measures of Performance
Time frame: 6 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 25 Feb 2026.
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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.
Jennifer Jones, PhD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-person rehabilitaiton group and Virtual rehabilitation group in people with Advanced Breast Cancer and Advanced Colorectal Cancer, run by University Health Network, Toronto at 1 site 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 7 inclusion and 8 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 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Drop-out rates as a measure of feasibility (demand/update of intervention) (time frame: 6 months). The study lists 3 primary outcomes in all. 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 25 Feb 2026.