Princess Margaret Cancer Centre
Toronto, Ontario, M5G2M9, Canada
NCT Number: NCT05424068
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Toronto, Ontario, M5G2M9, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
participants who have chosen to complete the study intervention by coming in for their 8 week education and exercise sessions.
Participants who have chosen to complete the study virtually instead of in-person sessions.
Time frame: 6 months
Number of patients who complete the study/ drop-out will be used to identify feasibility of the intervention.
Time frame: 6 months
Check-ins with Kinesiologist during assessments will be used to identify intervention acceptability/preference.
Time frame: 6 months
Completed over MS Teams/in-person and will be a conversational question and answer format.
Time frame: 6 months
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
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
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
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
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
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
Measured using the modified Godin Leisure Score Index (LSI) of the Godin and Shepherd Leisure Time Exercise Questionnaire (GLTEQ)
Time frame: 6 months
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
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
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
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: 8 weeks
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: 6 months
Participant height at baseline
Time frame: 6 months
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
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
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
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
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
Measured with the six minute walk test (6MWT)
Time frame: 6 months
Measured with hand grip strength for upper body
Time frame: 6 months
Measured with 30-second sit to stand test for lower body strength
Time frame: 6 months
Measured with the Balance test
Time frame: 6 months
Measured with the 4-meter Gait speed test
Time frame: 6 months
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
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.
University Health Network, Toronto
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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