Entry for:You Can Innovate Award
1. Summary of your project
Adolescents and young adults (AYA) are a biologically, physically and psychosocially unique population, and are a significantly understudied in exercise and cancer research. Current research in adult and paediatric cohorts has demonstrated that exercise integrated as an adjunct therapy during cancer treatments is safe, tolerable and can improve physical functioning, fatigue and psychosocial distress. However, to date there are no rigorous randomised controlled trials investigating the impact of structured supervised exercise programs in AYA cancer patients. This study will prospectively examine the impact of an individualised supervised exercise program on functional decline, fatigue and quality of life in adolescents and young adults during treatment for cancer. This randomised controlled trial will assess patients at baseline (within 2 weeks of diagnosis), 10 weeks and 20 weeks evaluating physical functional capacity, psychological functioning and quality of life. Forty participants will be randomised to an immediate start intervention group or a delayed start control group and the cross over design will see each group undergo both exercise intervention and usual care. The study design will determine the impact of the exercise program on rate of decline in physical functioning and whether outcomes derived from the intervention are sustained at 20 weeks. Participants in the intervention group will be required to complete two supervised exercise sessions per week as either inpatients or outpatients, depending on their treatment schedule. Exercise sessions will be mixed modal, comprising of aerobic and resistance based exercises within patients’ limits. Secondary outcomes will investigate the optimal timing of exercise programming and tolerability in AYA patients on treatment. Additionally, participants’ treatment-related toxicities and dose adjustments will also be recorded following the completion of the program to determine any impact exercise may have on these variables.
2. Describe your approach and any preliminary findings.
Potential study participants will be identified by the WA Youth Cancer Service, invited to participate, consented into the study and have a baseline functional test performed at Edith Cowan University or the University of Western Australia testing facilities. Comprehensive functional and psychosocial assessment will be undertaken at three time points; baseline, 10 weeks and 20 weeks by blind assessors (to minimise bias). The testing will include gold standard cardiopulmonary testing (CPX), strength and functional measures, body composition scanning using dual-energy X-ray absorptiometry (DXA) and the use of psychosocial assessment tools. The study design is a randomised controlled crossover trial. Two research groups will be recruited for direct comparison: an immediate start exercise intervention group and a delayed start control group. All participants will be exposed to exercise over the course of the program. Following baseline assessment, participants will be stratified into high-intensity and low-intensity treatment groups according to their diagnosis and prescribed treatments. All stratified participants will be be randomly allocated to either the delayed or immediate start exercise groups.
The delayed-start group will act as the control group for the initial 10 week period. Following a post-intervention assessment at 10 weeks, the delayed start group will commence the exercise program and the immediate start group will then proceed with no intervention to 20 weeks. All participants will undergo a final assessment at 20 weeks.
Each participant will be prescribed a tailored exercise program by an accredited exercise physiologist. In order to ensure consistency across the cohort, the programs will be designed to address specific cardiovascular and resistance-based criteria. Participants undergoing the exercise program will be required to attend two supervised exercise sessions per week with an exercise physiologist in an outpatient gym within the WA You Can Centre at Sir Charles Gairdner Hospital. Inpatients will be treated on the wards in their respective hospital rooms. Participant attendance will be recorded to identify the tolerability and acceptability of the program. In order to ensure participant safety, a brief assessment will be conducted prior to the commencement of each session, including review of basic vital signs and blood markers.
To date there are no published studies investigating the impact of an exercise program on AYA cancer patients on treatment. Previous research however in adult and paediatric populations has demonstrated that early integration of exercise during treatment is safe and tolerable, as well as maintaining functional measures such strength, cardiovascular fitness and fatigue. A recent pilot project conducted by this research team evaluating the impact of a supervised exercise program in AYA patients in the post-treatment setting demonstrated an average of 26% increase in strength and 6% increase in cardiovascular fitness. Additional improvements were evident in body composition; percentage fat mass and bone mineral density and functional measures. While these results should be interpreted with caution due to the small sample size, they did identify that patients are significantly deconditioned post-treatment and raise the question of whether earlier integration of exercise during treatment may prevent this decline and result in similar improvements.
3. What is the impact of your research to help cancer patients?
This project will be the first of its kind to recruit and implement a structured exercise program within AYA oncology. It is not currently standard care for AYA patients to be offered exercise during treatment nationally. This study will contribute evidence to establish best practice guidelines supporting the necessity of such programs and potentially leading to exercise being supported within hospital systems Australia wide.
Currently a majority of the research into AYA cancer patients identifies the long term effects of cancer treatments. While efficacious in improving survival rates, cancer therapies often leave patients with significant long term toxicities including cardiovascular disease, obesity, metabolic syndrome and osteoporosis which may last well into survivorship for AYA patients. Previous research in adult and paediatric cohorts has demonstrated that an exercise program during treatment reduces functional decline, assists with weight management and preserves body composition, leading to a reduced severity in long term treatment related effects. To date no research has investigate the impact of earlier integration of exercise in AYA patients, and its potential to negate late effects.
It is expected that this program, which will expose all study participants to exercise during treatment will help mitigate the known negative side effects associated with cancer and its treatment. At recruitment, participants will undergo thorough assessment utilising gold standard cardiopulmonary exercise, strength and functional testing as well as body composition scanning to identify their functional capacity and psychosocial status at baseline. This comprehensive testing, not routinely offered to patients, will allow for robust monitoring of the negative effects associated with cancer and its treatment. Early identification of treatment-related toxicities, cardiovascular complications, drastic body composition or strength changes will enable earlier medical intervention and improved outcomes for the participants.
It is expected that the exercise program will deliver similar physiological and psychosocial benefits to those seen in other cohorts in previous research. We expect the combined resistance and aerobic program will prevent cardiovascular decline, reduce weight loss/gain, reduce the loss of lean muscle mass and strength as well as reduce fatigue in the AYA cohort. We also anticipate the exercise program will prevent or reduce the severity of treatment-related toxicities. Through close monitoring of patient blood markers and completion rates for each chemotherapy cycle, we anticipate seeing a positive impact on these factors in the exercising group. Through mitigation of treatment-related toxicities, we hope to see a reduction in the number of chemotherapy dosage adjustments and possibly improve chemotherapy completion rates.
The study will aim to formally support the necessary integration of exercise as an adjunct therapy for this cohort from diagnosis. The cross over design will identify the optimal time for intervention and results will demonstrate the appropriate best practice to be integrated for AYA patients. If the project demonstrates reductions in dose adjustments and improvements in chemotherapy completion rates this may lead to improvements in overall survival in this patient cohort long term.
4. What ideas would you like to explore, or currently are exploring, to take this research further?
The research team is currently conducting a longitudinal exercise trial in AYA cancer survivors; patients who have completed treatment in the previous two years. The pilot project conducted last year involving 10 AYA patients, demonstrated significant improvements in strength, cardiovascular fitness, functional measures and quality of life. The pilot study involving AYA cancer survivors identified the significant negative impact that cancer and its treatment has on physical function and quality of life for AYA patients after completing treatment. Preliminary results were positive however, given the small number of participants, the results were interpreted with caution, leading to the development of the larger scale study being conducted over three years. This notion led to the development of the current research question of whether an exercise program integrated during treatment could reduce the negative impacts previously identified in the cohort of survivors.
Given the paucity of research in AYA oncology, our proposed project will provide an innovative approach to help mitigate the negative treatment-related side effects. If the exercise intervention does reduce treatment-related toxicities and reduce the need for chemotherapy dose adjustments, it will support the integration of exercise as an adjunct therapy for all AYA patients undergoing treatment. The results will provide the basis for further research to determine the optimal dose, intensity and mode of exercise to elicit further improvements in treatment adherence; the completion of planned treatment doses. Improvements in treatment adherence are correlated with improved disease-free and long term survival. Further research could involve larger-scale longitudinal studies to determine disease-free and long term survival rates in AYA patients who have followed an exercise program during their treatment. Related research could also involve determining the impact, if any, of exercise programs integrated during cancer treatment on reducing the severity of late effects; treatment-related long-term side effects which can present some time after the completion of cancer treatment.
5. Please demonstrate your track-record. Share a selection of publications, citations, awards etc.
Principal Investigator - Claire Munsie
The Principal Investigator (PI) attained a Masters of Science (research) from the University of Western Australia (UWA) culminating in a publication in the Archives of Physical Medicine and Rehabilitation in 2014, titled 'Guidelines for the early restoration of active knee flexion after total knee arthroplasty: Implications for rehabilitation and early intervention.' The PI has since been involved in a number of research projects related to the field of exercise oncology, with current research roles including PI on ‘WA Youth Cancer Service Adolescent and Young Adult (AYA) Life Now Group Exercise Program’ and Coordinating PI on ‘Concept Development: Improving functional outcomes and quality of life in adolescent and young adult patients undergoing haematopoietic stem cell transplant.’ The PI is also the recipient of a number of research grants, including Cancer Australia, Supporting people with Cancer Grant for $112,462, the Emma Pauley Research Grant from ‘Sock it to Sarcoma!’ for $10,000 and the Hannah's Chance Foundation Research Grant for $15, 000.
Professor Rob Newton
Professor Newton has over 30 years of academic and professional experience in the field of exercise and sports science. He has published 318 articles, with over 25,000 citations in high impact peer reviewed journals. Current major research directions for Rob and his team include: reducing decline in strength, body composition and functional ability in cancer patients; cancer related fatigue and the influence of exercise; exercise medicine and tumor biology.
Professor Tim Ackland
Professor Ackland has 130 peer reviewed papers, 3522 citations, 5 books and 30 book chapters in the field of musculoskeletal rehabilitation, physical performance and ergonomics and cancer research. His keen interest in biomechanics and anatomy, as well as broad knowledge on exercise physiology will provide essential support for this project.
Dr Carolyn McIntyre
Dr McIntyre is a postdoctoral research fellow at the Exercise Medicine Research Institute at Edith Cowan University. Currently she has 39 publications, and 1310 citations predominantly in the field of exercise oncology. Her interests in the role of exercise as medicine for cancer and experience within the field will be invaluable for this current research project.
Dr Jay Ebert
Dr Ebert has over 15 years clinical and research experience in musculoskeletal rehabilitation. He has published 57 articles, with 552 citations, primarily in orthopaedic and musculoskeletal rehabilitation. Dr Ebert’s clinical experience will provide essential insight for exercise program development.
Dr Rachel Hughes
Dr Hughes is the Lead Clinician at the WA Youth Cancer Service and has over 6 years experience in the field of AYA oncology. Dr Hughes clinical experience will provide medical oversight for the project.
Ms Meg Plaster
Ms Plaster is the Service Manager of the WA Youth Cancer Service and an AYA Cancer Nurse Coordinator. Meg has over 20 years experience in AYA oncology, and endorses the project from management level within the service.
Ms Jo Collins
Ms Collins is the Research Coordinator for the WA Youth Cancer Service and has more than 15 years experience in AYA oncology and clinical research.