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.
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
1) Impaired functional status that would preclude rehabilitation (PRFS >3)
2) Indication of major depressive disorder (> or = to 20 on PHQ-9)
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) Currently enrolled in another personalized and supervised exercise or rehabilitation program
Parallel
CaRE@Home intervention
Behavioralparticipants randomized to the intervention arm will complete a virtual 8 week exercise and education program.
Disability
measured using the 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. The average scores are comparable to the WHODAS 5-point scale, he total score for WHODAS ranges from 0-100, where a high score indicates major living limitations ((0-0.49) = none, mild (0.5-1.49), moderate (1.5-2.49), severe (2.5-3.49), or extreme (3.5-4).
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
Physical functioning
Measured using the 10-item sub-scale of the short form Health Survey (scale from 0 (negative health) to 100 (positive health))
Social functioning
Measured using the Social Difficulties Inventory. A zero score indicates perfect comparison with consensus group and \> or equal to 2 indicates unacceptable performance/remedial action required.
Anxiety
Measured using the Generalized Anxiety Disorder 7. The overall GAD 7 score ranges between 0-21, with zero meaning no anxiety and 21 meaning severe anxiety.
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University Health Network, Toronto
Lead sponsor
Horizon Health Network
Collaborator
University of British Columbia
Collaborator
Eastern Regional Health Authority
Collaborator
Alberta Health services
Collaborator
