Rehabilitation for People With Advanced Cancer

University Health Network, Toronto111 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

111

Conditions

Advanced Breast Cancer Advanced Colorectal Cancer Cancer Rehabilitation

Interventions

In-person rehabilitaiton groupBEHAVIORAL

participants who have chosen to complete the study intervention by coming in for their 8 week education and exercise sessions.

Virtual rehabilitation groupBEHAVIORAL

Participants who have chosen to complete the study virtually instead of in-person sessions.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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) ).

Time frame: 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: 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.

Time frame: 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.

Time frame: 6 months

Physicial activity

Measured using the modified Godin Leisure Score Index (LSI) of the Godin and Shepherd Leisure Time Exercise Questionnaire (GLTEQ)

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 8 weeks

Physiological measure of height

Participant height at baseline

Time frame: 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.

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 6 months

Physiological measures of cardiorespiratory fitness

Measured with the six minute walk test (6MWT)

Time frame: 6 months

Physiological measures of muscular strength

Measured with hand grip strength for upper body

Time frame: 6 months

Physiological measures of endurance

Measured with 30-second sit to stand test for lower body strength

Time frame: 6 months

Physiological measures of balance

Measured with the Balance test

Time frame: 6 months

Physiological measures of Performance

Measured with the 4-meter Gait speed test

Time frame: 6 months