Trial Title:
Virtual Rehabilitation for Cancer Survivors
NCT ID:
NCT05898789
Condition:
Breast Cancer, Stage 0
Colorectal Cancer Stage I
Head and Neck Cancer Stage I
Lymphoma
Breast Cancer Stage I
Breast Cancer Stage II
Breast Cancer Stage III
Colorectal Cancer Stage II
Colorectal Cancer Stage III
Head and Neck Cancer Stage II
Head and Neck Cancer Stage III
Lymphoproliferative Disorders
Conditions: Official terms:
Breast Neoplasms
Colorectal Neoplasms
Head and Neck Neoplasms
Breast Carcinoma In Situ
Lymphoproliferative Disorders
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
CaRE@Home intervention
Description:
participants randomized to the intervention arm will complete a virtual 8 week exercise
and education program.
Arm group label:
CaRE@Home intervention
Summary:
Pragmatic hybrid type 1 effectiveness-implementation (E-I) trial of a virtual cancer
rehabilitation program: The study team will conduct a multi-center hybrid type I
effectiveness-implementation study to examine the clinical effectiveness and
implementation potential of an 8-week multidimensional virtual cancer rehabilitation
intervention (CaRE@Home) for cancer survivors with identified cancer-related impairments
on level of overall disability (primary outcome) and patient reported physical and social
functioning, anxiety, work status, quality of life, and physiologic changes (secondary
outcomes). The study team will conduct a multi-centre pragmatic randomized controlled
trial (RCT) (Vancouver, Toronto, Saint John and St. John's) to evaluate effectiveness and
using the CIFR, the study team will identify potential factors that may affect successful
implementation and integration of CaRE@Home in different cancer settings.
Detailed description:
Comprehensive multidimensional rehabilitation programs that include both exercise and
self management education have the potential to concurrently improve a wide range of post
treatment side-effects and overall patient function. In 2017, the Cancer Rehabilitation
and Canadian Cancer Rehabilitation (CanRehab) Team: Improving the systematic
identification, management, and treatment of the adverse effects of cancer.
Survivorship program at Princess Margaret Cancer Centre launched an evidence driven group
based multidimensional Cancer Rehabilitation and Exercise program (CaRE@ELLICSR) for
patients who have identified cancer-related impairments. The 8-week program integrates a
number of evidence-based techniques to sustain behavioural change and consists of
weekly1-hr group exercise classes followed by 1-hr self-management skills education
delivered by a rehabilitation expert. Participants return for follow-up at 3 and 6 months
post-intervention to monitor progress and adapt exercise as needed. CaRE@ELLICSR has
resulted in improvements in overall levels of disability, social functioning, distress,
and physical activity. Program satisfaction is high, and wait times are within the target
of <1 month. However, access is an issue with ~50% of referred patients unable to
participate due to travel distance, transportation costs or competing obligations
(unpublished data).
To increase access, a virtual on-line version of the CaRE program (CaRE@Home) was
developed using a series of iterative steps proposed by the NCI Research-Tested
Intervention Programs.
The CaRE@Home program is currently undergoing single-group feasibility pilot testing
(completion Oct 2019, funded by Ontario Institute for Cancer Research). Feasibility
outcomes collected to date demonstrate high program acceptability with 95% of referred
patients enrolled and 94% program adherence. The final steps of this process are to
formally evaluate effectiveness and prepare for real-world implementation, which is the
focus of Project Two of this application. If effective, the virtual CaRE@Home program has
the potential to extend access to critical cancer rehabilitation services to a greater
number of cancer survivors in need. It also has immense potential to be adapted and
scaled to other centres that lack the resources required to deliver in-house cancer
rehabilitation services. In Project Two the study team will conduct a multi-center hybrid
type I effectiveness-implementation study to examine the clinical effectiveness and
implementation potential of CaRE@Home for cancer survivors with identified cancer-related
impairments.
Principal Research Aims:
Aim 2.1: Test the effectiveness of CaRE@Home vs. usual care (UC) on disability (primary
outcome) and patient reported and physiological outcomes (secondary outcomes) at 3-months
post-intervention.
Aim 2.2: Conduct a descriptive implementation-focused process evaluation to inform future
implementation efforts
Methods The project is a hybrid type 1 effectiveness-implementation (E-I) study. The aim
of hybrid trials are to better align research and practice and to provide a pathway for
rapidly moving knowledge from research to implementation. In hybrid type 1 studies, the
primary aim is to determine effectiveness in the setting where it will be implemented and
the secondary aim is to better understand the context for implementation. This
methodology promotes the study of implementation as early as possible in the research
process and can serve a dual purpose in helping to explain effectiveness results and
informing future implementation efforts.
Aim 2.1: Effectiveness evaluation of CaRE@Home (months 36-58) Design: The study team will
conduct a multi-centre pragmatic RCT (Vancouver, Toronto, Saint John and St. John's) to
evaluate effectiveness. Clinical effectiveness studies place a greater emphasis on
external validity and generalizability than efficacy trials and typically include
heterogeneous patient populations and settings. Participants will be randomized into
CaRE@Home or UC.
Recruitment and Data Collection: Eligible participants will be identified by their
oncology team, and provided information about the study along with contact information
for the local study team. Depending on timing, the ePSM platform (Project One) may also
be used to identify and invite potential participants. Interested patients will be
pre-screened by telephone (eligibility tools above), and those who are eligible will be
invited to an in-person baseline assessment (T1). Site-specific screening logs will be
maintained. At the baseline assessment, participants will provide consent and complete
PRO and physiological measures (see below) with a trained assessor. Following the
assessment, the research assistant will obtain the randomization assignment. Those
assigned to CaRE@Home will be registered into the CaRE@Home platform.
Follow-up assessment for both groups will occur at 8-weeks (T2 immediate post
intervention) and 3 months post-intervention (T3). The CaRE@Home group will have an
additional 6 months post-intervention (T4) to assess maintenance. Randomization: Permuted
block randomization, with stratification by center and on/finished treatment will
allocate participants to either CaRE@Home or UC. Randomization will be computer-generated
and managed by the Department of Biostatistics at Princess Margaret Cancer Centre.
Description of Study Arms: i) Care@Home is an 8-week program comprised of: 1) weekly
e-modules providing interactive education to promote self-management skills; 2)
individualized progressive exercise prescription supported with mobile application
(PhysitrackTM); 3) wearable technology (FitbitTM) to track activity and sleep; and 4)
weekly brief telephone counselling with a member of the rehabilitation team (see Appendix
4 CaRE@Home program elements). Informed by behavior change theory, the program elements
aim to provide patients with the knowledge and tools needed to reach and maintain their
wellness and exercise goals. Training for health professionals: In person assessments and
weekly phone calls will be delivered by a rehabilitation/exercise professional who has
experience working with cancer survivors. The exercise professionals will receive
comprehensive training and ongoing supervision. Training will be provided by a
Motivational Interviewing Network of Trainers certified trainer (Dr. M. Obadia). The
training will be videotaped and an online tool box with training resources will be
developed to support future scalability. ii) UC will receive usual care and will be asked
to complete in-person assessment at T2 and T3. Following T3 assessment, the UC group will
be offered the CaRE@Home program.
Data analysis: Demographic and clinical information across all time points will be
summarised using descriptive statistics and plotted across all time points. Effectiveness
will be assessed on the full set of consented participants in accordance with the
intention to treat principle. The primary outcome is the difference in WHODAS 2.0 mean
score between CaRE@Home and UC at T3. Differences on secondary outcomes at T3 will also
be compared between the two treatment arms using paired t test or paired Wilcoxon
rank-sum test. Maintenance of treatment gains in the CaRE@Home group will be analyzed at
T4. An estimate of the effect size and parameters and corresponding confidence intervals
will be calculated between groups at T3 and over time (within groups). Variability of the
main and interaction effects will be examined on the primary clinical outcome (WHODAS
2.0) and each of the secondary outcomes using separate longitudinal analysis models such
as mixed model regression and generalized estimating equation models. Sensitivity
analysis will be conducted, adjusting for important clinical factors using the regression
model. Finally, a cost-utility analysis will be undertaken to estimate the incremental
cost per quality-adjusted life year (QALY) of the intervention arm compared to the
control arm.
Sample Size: Our sample size calculations is based on 80% power with a two-sided
alpha-level at 0.05 and an estimated effect size of 0.4 standard deviation of the primary
endpoint.
Assuming attrition of up to 30% and adherence to be 80%, 388 patients will be recruited
(or 194 patients per arm). The number of potentially eligible patients across sites is
estimated to be 170 patients per month. Based on proposed staffing per site, a maximum of
20 patients can be enrolled per month in Toronto/Vancouver and 10 per site in NB/NFLD.
Enrollment is estimated to take 6-7 months. The study team will use multiple strategies
to promote retention and prevent attrition.
Aim 2.2: Implementation-focused Process Evaluation (months 30-52) Design: In order to
inform the implementation of CaRE@Home, a process evaluation will be conducted and guided
by the RE-AIM framework[88]. The CFIR will be used to examine context and understand
relevant barriers and facilitators across and within CanRehab sites. See Table 3 for
Implementation Framework/Process Evaluation Questions and Tools.
Data Collection Tools: Data tools will include interviews/focus groups, surveys,
screening logs, observational notes, technical reports, infrastructure review to inform
costs as well as staffing and infrastructure requirements. The study team will
triangulate the data from the different quantitative and qualitative sources to answer
questions developed based on elements of the selected frameworks and summarize our
findings.
Data Analysis: Descriptive variables will be presented as means, distributions, and
proportions with differences between subgroups compared. Qualitative information from
open-ended survey questions, interviews, and research log entries will be transcribed and
analyzed using common deductive qualitative analysis techniques[133] following the CFIR
qualitative data analysis templates. Following this, all transcripts will be coded and
additional inductive codes will be added.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1) Age 18 years or older
-
2) Diagnosed with breast (stage 0-III), colorectal (stage I-III), head and neck
(stage I-III), or lymphoma/lymphoproliferative disorder (excluded: recurrent,
refractory, progressive, received or planning to receive transplant)
-
3) Completed a primary treatment (i.e. surgery and/or radiation and/or systemic
therapy of any kind) within the last 24 months
-
4) If patients received systemic therapy of a fixed duration with
adjuvant/curative intent, the main part should be completed, but patients are
eligible if on primary, maintenance, or other adjuvant systemic therapy (e.g.
eligible while on trastuzumab, immunotherapy, rituximab, oral endocrine or
targeted therapy - ie ibrutinib). Indolent non-curative lymphoma patients are
eligible if they have response to systemic therapy
-
5) Communicate sufficiently in English to complete intervention and questionnaires
-
6) Willing to be randomized and participate in the intervention and in-person
assessments; 6) Internet access
-
7) An indication for cancer rehabilitation (WHO-DAS score >5).
Exclusion Criteria:
-
1) Impaired functional status that would preclude rehabilitation (PRFS >3)
-
2) Indication of major depressive disorder (PHQ-2 >3)
-
3) Diagnosis of neurological disease or condition significantly limiting cognitive
functioning, such as language or memory (e.g., Alzheimer's disease or other
dementia, severe traumatic brain injury);
-
4) Conditions or current injuries which are not appropriate for distance based
exercise
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Princess Margaret Cancer Centre
Address:
City:
Toronto
Zip:
M5G 2N2
Country:
Canada
Status:
Recruiting
Contact:
Last name:
charmaine silva, MSc
Phone:
4165818543
Email:
charmaine.silva@uhn.ca
Contact backup:
Last name:
Jennifer Jones, PhD
Phone:
4165818603
Email:
jennifer.jones@uhn.ca
Start date:
July 7, 2023
Completion date:
August 31, 2025
Lead sponsor:
Agency:
University Health Network, Toronto
Agency class:
Other
Source:
University Health Network, Toronto
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05898789
