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Novel research design and methodology for evaluating effects of physical exercise in patients with cancer

Projectomschrijving

Effectiviteit van lichaamsbeweging bij patiënten met kanker wordt gemeten in studies waarbij het lot bepaalt wie de interventie ontvangt. Dit kan teleurstellend zijn; patiënten willen niet deelnemen, trekken zich alsnog terug uit de controlegroep of gaan bewegen. In dit project is een nieuwe methode toegepast, waarbij een beweegstudie binnen een cohort van borstkankerpatiënten is uitgevoerd en alleen de patiënten in de beweeggroep zijn benaderd.

Hierdoor werden bovenstaande nadelen voorkomen. Aan de zogenaamde UMBRELLA Fit studie namen 260 borstkankerpatiënten deel die hun behandeling hadden afgerond en aangaven niet te voldoen aan de Nederlandse beweegrichtlijn. Honderddertig patiënten kregen de beweeginterventie aangeboden en iets meer dan de helft besloot om mee te doen. Na afloop van de interventie waren de patiënten fysiek actiever dan de controlegroep die niet veranderde in activiteit. De beweeginterventie bleek een positief effect te hebben op de vermoeidheid van de patiënten.

Producten

Titel: Physical exercise in cancer patients
Auteur: Anne M May
Titel: Physical activity levels of breast cancer patients, a comparison with the Dutch female population – First results
Auteur: Gal R, Monninkhof EM, Hazekamp TCH, Verkooijen HM, Young Afat DA, van den Bongard HJG, van Vulpen M, Peeters PHM, May AM
Titel: Effecten van bewegen tijdens en na kanker
Auteur: Anne M May
Titel: Alternatives for conventionally randomized trials (RCT)? cmRCT/TwiCs design. First results of UMBRELLA Fit
Auteur: Anne M May
Titel: The effect of exercise on breast cancer patients’ quality of life using the cmRCT design: The UMBRELLA Fit trial
Auteur: Roxanne Gal, Evelyn M. Monninkhof, Helena M. Verkooijen, Carla H. van Gils, Rolf H.H. Groenwold, H.J.G. Desirée van den Bongard, Petra H.M. Peeters, Anne M. May
Titel: The cohort multiple randomized controlled trial (cmRCT) design in exercise-oncology: First experiences
Auteur: Roxanne Gal, Evelyn M. Monninkhof, Helena M. Verkooijen, Carla H. van Gils, Rolf H.H. Groenwold, Desirée H.J.G. van den Bongard, Petra H.M. Peeters, Anne M. May
Titel: Physical activity levels of breast cancer patients, a comparison with the Dutch female population
Auteur: Gal R, Monninkhof EM, Hazekamp TCH, Verkooijen HM, Young Afat DA, van den Bongard HJG, van Vulpen M, Peeters PHM, May AM
Titel: The UMBRELLA Fit study: the effects of exercise on breast cancer patients’ quality of life, using the cmRCT design
Auteur: R. Gal
Link: https://www.uantwerpen.be/en/conferences/weon-2017/
Titel: UMBRELLA FIT: Experience from a trial within a hospital based breast cancer cohort
Auteur: Anne M May
Link: http://www.twics.global/ethics-symposium-2016
Titel: The cohort multiple randomized controlled trial (cmRCT) design in exercise-oncology: First experiences
Auteur: Roxanne Gal, Evelyn M. Monninkhof, Carla H. van Gils, Rolf H.H. Groenwold, Desirée H.J.G. van den Bongard, Petra H.M. Peeters, Helena M. Verkooijen, Anne M. May
Titel: UMBRELLA Fit trial: An exercise intervention study within UMBRELLA
Auteur: Anne M May
Link: http://www.sheffield.ac.uk/scharr/sections/ph/conferences/twics/presentations
Titel: Physical exercise interventions in cancer survivors: Effects and methodological issues
Auteur: Anne M May
Link: http://www.worldobesity.org/what-we-do/events/hot-topics/opac2/
Titel: UMBRELLA Fit: Effects of exercise on the quality of life of inactive breast cancer survivors, using the innovative cmRCT design
Auteur: R. Gal
Link: https://www.cancer.dk/ecrs/about-the-symposium-2018/
Titel: The ethics of ‘Trials within Cohorts’ (TwiCs): 2nd international symposium
Auteur: Relton, Clare, Burbach, Maarten, Collett, Clive, Flory, James, Gerlich, Sophie, Holm, Soren, Hunn, Amanda, Kim, Scott Y., Kwakkenbos, Linda, May, Anne, Nicholl, Jon, Young-Afat, Danny, Treweek, Shaun, Uher, Rudolf, van Staa, Tjeerd, van der Velden, Joanne, Verkooijen, Helena, Vickers, Andrew, Welch, Sophie, Zwarenstein, Merrick, Zwarenstein, Merrick, Kim, Scott, Flory, James, Goodman, Zachary, Holm, Søren, Treweek, Shaun, Gerlich, Sophie, May, Anne M., Young-Afat, Danny A., Burbach, Johannes P.
Magazine: Trials
Titel: Four-year effects of exercise on fatigue and physical activity in patients with cancer
Auteur: Witlox, Lenja, Hiensch, Anouk E., Velthuis, Miranda J., Steins Bisschop, Charlotte N., Los, Maartje, Erdkamp, Frans L. G., Bloemendal, Haiko J., Verhaar, Marlies, ten Bokkel Huinink, Daan, van der Wall, Elsken, Peeters, Petra H. M., May, Anne M.
Magazine: BMC Medicine
Titel: The effects of exercise on the quality of life of patients with breast cancer (the UMBRELLA Fit study): study protocol for a randomized controlled trial
Auteur: Gal, Roxanne, Monninkhof, Evelyn M., Groenwold, Rolf H. H., van Gils, Carla H., van den Bongard, Desiree H. J. G., Peeters, Petra H. M., Verkooijen, Helena M., May, Anne M.
Magazine: Trials
Titel: Control Group Design, Contamination and Drop-Out in Exercise Oncology Trials: A Systematic Review
Auteur: Steins Bisschop, Charlotte N., Courneya, Kerry S., Velthuis, Miranda J., Monninkhof, Evelyn M., Jones, Lee W., Friedenreich, Christine, van der Wall, Elsken, Peeters, Petra H. M., May, Anne M.
Magazine: PLoS ONE
Titel: The Effect of Physical Activity Interventions Comprising Wearables and Smartphone Applications on Physical Activity: a Systematic Review and Meta-analysis
Auteur: Gal, Roxanne, May, Anne M., van Overmeeren, Elon J., Simons, Monique, Monninkhof, Evelyn M.
Magazine: Open Access Journal of Sports Medicine
Titel: The cohort multiple randomized controlled trial design: a valid and efficient alternative to pragmatic trials?
Auteur: van der Velden, Joanne M., Verkooijen, Helena M., Young-Afat, Danny A., Burbach, Johannes P.M., van Vulpen, Marco, Relton, Clare, van Gils, Carla H., May, Anne M., Groenwold, Rolf H.H.
Magazine: International Journal of Epidemiology

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Samenvatting van de aanvraag

My proposal is the proof-of-principle of an innovative trial design: the cohort Randomized Controlled Trial (cRCT), as an alternative for conventional pragmatic RCTs when blinding is impossible. I will also develop statistical methods for sample size calculation as well as methods for cRCT analyses, ultimately resulting in a practical cRCT guideline. RCTs are the gold standard in evidence based medicine. However, evaluating interventions that cannot be blinded has the possible disadvantage of difficult accrual, drop-out after randomization to control, and contamination between study groups (mainly non-compliance in controls) resulting in biased results and decreased power and consequently impeding evidence based medicine. A cRCT is embedded in an ongoing prospective cohort study with regular follow-up measures. A subcohort of eligible patients is defined and a random sample of the subcohort will be offered the intervention and outcomes will be compared to outcomes in randomly selected eligible controls from the subcohort. This design overcomes the above mentioned disadvantages and might be a promising alternative when investigating lifestyle interventions or medical treatments, when blinding is difficult. I propose to set up a cRCT investigating the effect of exercise on quality of life in 150 breast cancer patients participating in the UMBRELLA cohort (UMCU, Utrecht). Exercise-oncology is an ideal setting to prove the cRCT principle since blinding is not feasible and in previous conventional RCTs contamination was high. Primary outcome will be contamination, specific PA levels in controls; and participation rate and participant retention compared to previous exercise-oncology trials. In addition adequate methods for sample size calculations and statistical analyses will be developed. For this, data of the proposed cRCT will be used as well as simulations in individual patient data of 36 international exercise-oncology trials (4,888 patients) available in the POLARIS database. Finally, this will result in a guideline for future cRCTs.

Onderwerpen

Kenmerken

Projectnummer:
91615050
Looptijd: 100%
Looptijd: 100 %
2015
2018
Gerelateerde subsidieronde:
Projectleider en penvoerder:
Prof. dr. A.M. May
Verantwoordelijke organisatie:
Universitair Medisch Centrum Utrecht