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Trial Title:
The IMPACT Implementation-Effectiveness Trial
NCT ID:
NCT06323707
Condition:
Cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Double (Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Exercise
Description:
Eight sessions of moderate intensity aerobic exercise using recumbent bike within the
cancer institution.
Arm group label:
Exercise & Self-Management
Intervention type:
Behavioral
Intervention name:
Self-management e-module
Description:
Eight 15 minute self-management e-modules related to exercise and physical activity for
cancer survivors.
Arm group label:
Exercise & Self-Management
Arm group label:
Self-Management Only
Summary:
More Canadians are surviving cancer, however, individuals with cancer live with side
effects for years after treatments have ended. The physical and psychosocial benefits of
regular physical activity (PA) during and after cancer treatment are well established.
However, less than 30% of individuals with cancer meet current PA recommendations and PA
levels decline significantly during treatment. PA services within the cancer institution
to support well-being during treatment are not available for survivors across Ontario.
Strategies are needed within cancer centres to close the gap between the evidence and
clinical practice.
What is the purpose? To evaluate the effectiveness of a novel exercise and education
strategy for individuals with cancer during treatment.
What are we proposing to do? This project includes two parts. In Part 1 participants will
be put into one of three groups. Group 1 (Exercise & self-management) will include eight
sessions of supervised, institution-based exercise and self-management education. Group 2
(self-management only) will include eight virtual self-management education sessions with
an exercise professional. Group 3 will receive usual care (i.e., no intervention).
In Part 2 participants who attended less than 75% of their sessions will be asked to
complete an interview on the barriers to continuing with the study during cancer
treatment.
Why is this work important? Findings from this trial will inform the way PA services are
provided within cancer institutions across Ontario. This novel strategy incorporates both
institution-based and home-based exercise strategies during treatment and highlights the
importance of individuals with cancer taking an active role in managing their condition
during treatment. This can prevent future complications and decrease burden on the
individual and the healthcare system. Results will inform future decisions on PA
implementation strategies for cancer survivors with diverse needs across Ontario.
Detailed description:
Rationale:
The burden of cancer in Canada is growing. More individuals are surviving cancer,
however, individuals with cancer live with side effects for years after treatments have
ended. The physical and psychosocial benefits of regular physical activity (PA) during
and after cancer treatment are well established. However, less than 30% of individuals
with cancer meet current PA recommendations and PA levels decline significantly during
active treatment. Institution-based PA services to support wellbeing and minimize burden
during treatment are not available across Ontario. Novel implementation strategies are
needed within the institution to close the gap between the evidence and clinical
practice. Implementation research allows us to understand how to deliver interventions
effectively in diverse settings.
Aim & Objectives:
The overall aim of this project is to conduct a fully powered, multi-centred randomized
controlled trial (RCT) to evaluate the effectiveness of a novel implementation strategy
including exercise and SM versus usual care for individuals with cancer during treatment.
To do this, there are two main objectives: 1) Determine the feasibility and effectiveness
of a novel implementation strategy using exercise and SM during treatment
Methods:
Study Design: Effectiveness-Implementation RCT Participants: Adults (>18 years) with a
cancer diagnosis of any stage, currently receiving treatment, and cleared for exercise by
their oncology care team will be included in this study.
Procedure: Participants will be randomized to three groups. Group 1: Exercise & SM: Eight
sessions of supervised, in-person institution-based exercise and SM education. This group
will also receive 4 booster sessions by telephone post intervention.
Group 2: SM Only: Eight virtual sessions of SM education using video conferencing with a
qualified exercise professional. This group will also receive 4 booster sessions by phone
post intervention.
Group 3: Usual care: No intervention.
Significance:
Implementation research is crucial to improving our understanding of real-world factors
that impact successful application of research in healthcare settings. This novel
implementation strategy builds off previous work and incorporates institution-based
exercise and SM during treatment. Findings from this trial will build off our previous
work and inform the way PA services are provided within cancer institutions across
Ontario. Our goal is to make these services available to all individuals with cancer
during treatment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Community-dwelling
- English-speaking adults
- Aged over 18 years of age
- Currently undergoing adjuvant or neoadjuvant chemotherapy, radiation, or hormonal
therapy for cancer
- Cleared by their oncologist to participate in moderate intensity aerobic exercise.
Exclusion Criteria:
- Self-report on the patient intake form any chronic condition, cognitive impairment,
or injury that would prevent them from participating independently in moderate
intensity exercise
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
March 15, 2024
Completion date:
March 15, 2027
Lead sponsor:
Agency:
McMaster University
Agency class:
Other
Collaborator:
Agency:
Canadian Cancer Society (CCS)
Agency class:
Other
Collaborator:
Agency:
Hamilton Health Sciences Corporation
Agency class:
Other
Collaborator:
Agency:
Niagara Health System
Agency class:
Other
Source:
McMaster University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06323707