Breast Cancers, Cancer, Colon Cancer, Lung Cancers, Prostate Cancers
Conditions
Keywords
Exercise oncology, Exercise, Physical activity, community program, online exercise, cancer survivor, individual living with and beyond cancer, quality of life
Brief summary
EXCEL will provide online and, where feasible, in-person exercise programs to individuals living with and beyond cancer (ILWBC). Research has shown that targeted programs that include tailored exercise prescriptions are more successful in helping individuals with chronic disease to incorporate physical activity and exercise into their daily routines. While ILWBC are advised by healthcare professionals (HCPs) to engage in exercise, there is a lack of cancer-specific exercise programs and cancer-trained exercise specialists in Canada, outside of the research setting. Considering the negative impact cancer and its treatments have on fitness and physical activity levels, community-based efforts towards improving access, uptake and maintenance of exercise programming are needed. This study will evaluate the benefits of a community-based or online EXCEL exercise program for people living with and beyond cancer across Canada, using a streamlined intake process compared to the original EXCEL Study (HREBA.CC-20-0098, NCT04478851). This 8 to 12-week program (intervention) will be delivered in-person or over virtual platform. It includes twice weekly supervised exercise classes.
Detailed description
Over the past 4.5 years, the EXCEL Study (HREBA.CC-20-0098, NCT04478851) has been implemented across Canada and has recruited over 1500 individuals living with and beyond cancer. This updated study will streamline the program to essential baseline screening and testing (for safe and effective program delivery), simplify outcome assessments (for participants to see changes and for program evaluation), and increase the reach to include more urban centres to encourage more healthcare provider (HCP) buy-in with a simplified referral process (i.e. no patient screening required from HCPs to determine eligibility, based on location). This updated program is based off of the Alberta Cancer Exercise (ACE) Program (HREBA.CC-24-0252). Thus, we are modifying the original EXCEL ethics to will reduce the participant burden with less patient-reported-outcomes and fewer follow-ups, which will allow more focus on program implementation, evaluation, and sustainability. Continued effort and training to establish the clinic-to-community model will be enhanced with stronger relationships and referrals from the cancer care system and the HCPs, which will continue to work towards a 'patient-centered care approach'.
Interventions
Participants will take part in a combination of aerobic, resistance, balance, and flexibility exercises delivered in a circuit-type class setting, twice weekly for a 8-12-week period (duration of intervention depends on scheduling logistics for the coordinating hubs and their spokes sites). The exercise sessions will be conducted in groups with a ratio of up to 15 participants per instructor. The program follows exercise progression principles (i.e., frequency, intensity, time, type, overload and progression) over the 8-12-weeks, with tailoring of any exercise to meet individual participant needs as required, in order to promote fitness and wellness benefits.
Sponsors
Study design
Intervention model description
Hybrid effectiveness-implementation study
Eligibility
Inclusion criteria
* have or had a diagnosis of cancer; * be 18 years or older; * be able to participate in low-intensity levels of activity, at minimum; * be pretreatment, or receiving active cancer treatment (i.e., surgery, systemic therapy and radiation therapy), have received cancer treatment within the past 3 years, or if beyond 3 years since treatment completion, have a referral from their healthcare team indicating they have side effects from cancer treatment or the cancer itself, that could be improved or managed with exercise; * be able to provide informed written consent in English or French
Exclusion criteria
* does not or did not have a cancer diagnosis * is under the age of 18 * is unable to participate in mild exercise, at minimum * is not pretreatment, or receiving active cancer treatment (i.e., surgery, systemic therapy and radiation therapy), has not received cancer treatment within the past 3 years, or if beyond 3 years since treatment completion, doesn't have side effects from cancer treatment or the cancer itself, that could be improved or managed with exercise * unable to read/write in English * for online programs, does not have internet or computer access
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity Level | Baseline to one year | The Modified Godin Leisure Time Exercise Questionnaire is used to determine subjective levels of physical activity in each participant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost-effectiveness | Baseline to one year | Change in EuroQual - 5Dimensions (EQ-5D) tool - first section is a questionnaire; last section uses a scale from 0-100, where 0 means the worst health imaginable and 100 means the best health imaginable. |
| Fatigue | Baseline to one year | Change in Functional Assessment of Chronic Illness Therapy - Fatigue subscale - scale is from 0-4, where 0 means not at all and 4 means very much. |
| Quality of life | Baseline to one year | Single-item measure on quality of life - scale from 0 to 100, where 100 means the best Quality of Life imaginable and 0 means the worst Quality of Life imaginable. |
| Body Composition | Baseline to 12-weeks | Change in body mass index (BMI) |
| Aerobic Capactiy | Baseline to 12-weeks | Change in 6-minute walk test (m) or 2 minute step test (steps) results |
| Cancer related symptoms | Baseline to one year | Change in Edmonton Symptom Assessment Scale - revised: cancer. Scale is from 0-10, where 0 means the symptom is absent and 10 means the worst possible severity of the symptom is being experienced. |
| Upper extremity flexibility | Baseline to 12-weeks | Change in active shoulder flexion range of motion (degrees) |
| Balance | Baseline to 12-weeks | Change in one legged stance test (seconds) |
| Exercise adherence | Duration of the intervention (8-12 week exercise program) | Adherence to exercise programming (attendance at sessions) |
| Program implementation and evaluation | Baseline to one year | RE-AIM: program reach, effectiveness, adoption, implementation and maintenance |
| Lower body strength | Baseline to 12-weeks | Change in sit-to-stand (number of repetitions in 30 seconds) |
Countries
Canada