Rehabilitation for People With Advanced Cancer

Advanced Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05424068
• Other study ID #: 21-5539
• Status: Recruiting
• Phase: N/A
• Start date: December 2, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2024
• Source: University Health Network, Toronto
• Contact: Charmaine Silva, MSc
• Phone: 4165818453
• Email: charmaine.silva[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 117
• Est. completion date: September 30, 2024
• Est. primary completion date: September 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Advanced Colorectal Cancer
• Cancer Rehabilitation
• Colorectal Neoplasms

Intervention

Behavioral:
• In-person rehabilitaiton group
participants who have chosen to complete the study intervention by coming in for their 8 week education and exercise sessions.
• Virtual rehabilitation group
Participants who have chosen to complete the study virtually instead of in-person sessions.

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Performance Status	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.	6 months
Other	Measure of performance status	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.	6 months
Primary	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.	6 months
Primary	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.	6 months
Primary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	Physical functioning	Measured using the 10 item physical function subscale of Short-Form Health Survey (scale from 0 (negative health) to 100 (positive health) ).	6 months
Secondary	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	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	Physicial activity	Measured using the modified Godin Leisure Score Index (LSI) of the Godin and Shepherd Leisure Time Exercise Questionnaire (GLTEQ)	6 months
Secondary	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	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	8 weeks
Secondary	Physiological measure of height	Participant height at baseline	6 months
Secondary	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.	6 months
Secondary	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).	6 months
Secondary	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).	6 months
Secondary	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).	6 months
Secondary	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).	6 months
Secondary	Physiological measures of cardiorespiratory fitness	Measured with the six minute walk test (6MWT)	6 months
Secondary	Physiological measures of muscular strength	Measured with hand grip strength for upper body	6 months
Secondary	Physiological measures of endurance	Measured with 30-second sit to stand test for lower body strength	6 months
Secondary	Physiological measures of balance	Measured with the Balance test	6 months
Secondary	Physiological measures of Performance	Measured with the 4-meter Gait speed test	6 months