Clinical trial NCT05424068: 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
Overall status: RECRUITING
Phase: NA
Conditions: Advanced Breast Cancer
Advanced Colorectal Cancer
Cancer Rehabilitation
Keywords: Cancer Rehabilitation
Virtual Cancer Rehabilitation
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Drop-out rates as a measure of feasibility (demand/update of intervention)
timeFrame: 6 months
measure: Patient preference as assessed during clinical support as a measure of feasibility (acceptability)
timeFrame: 6 months
measure: Measuring safety/practicality as assessed during one-on-one with the health coach (analyzed as qualitative data)
timeFrame: 6 months
Secondary outcomes:
measure: Demographics
timeFrame: 6 months
measure: Disability
timeFrame: 6 months
measure: Physical functioning
timeFrame: 6 months
measure: Social functioning
timeFrame: 6 months
measure: Depression
timeFrame: 6 months
measure: Anxiety
timeFrame: 6 months
measure: Physicial activity
timeFrame: 6 months
measure: Quality of Life for advanced cancer - daily life activities
timeFrame: 6 months
measure: Quality of Life for advanced cancer - wellbeing
timeFrame: 6 months
measure: Symptom Burden
timeFrame: 6 months
measure: Safety and Health Care Utilization
timeFrame: 6 months
measure: Weekly Session feedback
timeFrame: 8 weeks
measure: Physiological measure of height
timeFrame: 6 months
measure: Physiological measures of weight
timeFrame: 6 months
measure: Physiological measures of exercise Intensity (Perceived Exertion)
timeFrame: 6 months
measure: Physiological measures of total Exercise Participation for sleep
timeFrame: 6 months
measure: Physiological measures of total Exercise Participation for step count
timeFrame: 6 months
measure: Physiological measures of total Exercise Participation for heart rate.
timeFrame: 6 months
measure: Physiological measures of cardiorespiratory fitness
timeFrame: 6 months
measure: Physiological measures of muscular strength
timeFrame: 6 months
measure: Physiological measures of endurance
timeFrame: 6 months
measure: Physiological measures of balance
timeFrame: 6 months
measure: Physiological measures of Performance
timeFrame: 6 months
Other outcomes:
measure: Performance Status
timeFrame: 6 months
measure: Measure of performance status
timeFrame: 6 months
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Jennifer Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References: