Browsing by Author "Santa Mina, Daniel"

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    A phase II randomized controlled trial of three exercise delivery methods in men with prostate cancer on androgen deprivation therapy
    (2019-01-03) Alibhai, Shabbir M H; Santa Mina, Daniel; Ritvo, Paul; Tomlinson, George; Sabiston, Catherine; Krahn, Murray; Durbano, Sara; Matthew, Andrew; Warde, Padraig; O’Neill, Meagan; Timilshina, Narhari; Segal, Roanne; Culos-Reed, Nicole
    Abstract Background Existing evidence demonstrates that 1:1 personal training (PT) improves many adverse effects of androgen deprivation therapy (ADT). Whether less resource-intensive exercise delivery models are as effective remains to be established. We determined the feasibility of conducting a multi-center non-inferiority randomized controlled trial comparing PT with supervised group (GROUP) and home-based (HOME) exercise programs, and obtained preliminary efficacy estimates for GROUP and HOME compared to PT on quality of life (QOL) and physical fitness. Methods Men with prostate cancer on ADT were recruited from one of two experienced Canadian centres and randomized 1:1:1 to PT, GROUP, or HOME. Randomization was stratified by length of ADT use and site. Participants completed moderate intensity aerobic and resistance exercises 4–5 days per week for 6 months with a target 150 min per week of exercise. Exercise prescriptions were individualized and progressed throughout the trial. Feasibility endpoints included recruitment, retention, adherence, and participant satisfaction. The efficacy endpoints QOL, fatigue, and fitness (VO2 peak, grip strength, and timed chair stands) in GROUP and HOME were compared for non-inferiority to PT. Descriptive analyses were used for feasibility endpoints. Between-group differences for efficacy endpoints were examined using Bayesian linear mixed effects models. Results Fifty-nine participants (mean age 69.9 years) were enrolled. The recruitment rate was 25.4% and recruitment was slower than projected. Retention was 71.2%. Exercise adherence as measured through attendance was high for supervised sessions but under 50% by self-report and accelerometry. Satisfaction was high and there was no difference in this measure between all three groups. Between-group differences (comparing both GROUP and HOME to PT) were smaller than the minimum clinically important difference on most measures of QOL, fatigue, and fitness. However, two of six outcomes for GROUP and four of six outcomes for HOME had a > 20% probability of being inferior for GROUP. Conclusions Feasibility endpoints were generally met. Both GROUP and HOME interventions in men with PC on ADT appeared to be similar to PT for multiple efficacy outcomes, although conclusions are limited by a small sample size and cost considerations have not been incorporated. Efforts need to be targeted to improving recruitment and adherence. A larger trial is warranted. Trial registration ClinicalTrials.gov: NCT02046837 . Date of registration: January 20, 2014.
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    Connecting breast cancer survivors for exercise: protocol for a two-arm randomized controlled trial
    (2021-10-14) Smith-Turchyn, Jenna; McCowan, Michelle E.; O’Loughlin, Erin; Fong, Angela J.; McDonough, Meghan H.; Santa Mina, Daniel; Arbour-Nicitopoulos, Kelly P.; Trinh, Linda; Jones, Jennifer M.; Bender, Jackie L.; Culos-Reed, S. N.; Tomasone, Jennifer R.; Vani, Madison F.; Sabiston, Catherine M.
    Abstract Background Peer-based exercise interventions that cultivate new opportunities for support with a fellow cancer survivor may result in increased exercise volume. It is not clear whether adding qualified exercise professional (QEP) support to peer-based interventions improves health outcomes. Therefore, the purpose of this study is to determine whether breast cancer survivor (BCS) dyads who receive 10 weekly sessions of virtually delivered QEP support have improved outcomes compared to BCS dyads who do not receive QEP support. Methods Participants Adult BCS with medical clearance for exercise, who have an internet-connected device, and currently engage in < 150 min of moderate-intensity exercise per week. Intervention BCS will be matched using evidence-based criteria. The intervention group will receive dyadic exercise information sessions and a program tailored by a QEP for 10 weeks (intervention period) and have access to the QEP for an additional 4 weeks (tapering period). The control will not receive any QEP support. Outcomes The primary outcome is post-intervention self-reported exercise volume. Secondary outcomes include device-assessed exercise volume (i.e., Fitbit), social support, and health-related quality of life. Randomization 108 participants, matched in dyads, will be randomized 1:1 to the MatchQEP or Match groups using a web-based scheme. Statistical analysis Outcomes will be measured at baseline, post-intervention, post-tapering, and at 12 weeks post-intervention follow-up. Discussion The findings from this RCT will determine if matched BCS dyads who receive 10 weeks of virtually delivered QEP support have higher levels of self-report and device-measured exercise, social support, and health related quality of life compared to matched dyads without QEP-delivered exercise guidance. To our knowledge this will be the first study to assess the combined effect of peer- and QEP support on exercise volume. Project findings will inform and optimize intervention methods aimed to increase exercise among BCS through accessible exercise supports. Trial Registration: The study is registered on ClinicalTrials.gov (study identifier: NCT04771975, protocol Version Number: 2, date: July 22, 2021).
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    Factors related to dropout in integrative oncology clinical trials: interim analysis of an ongoing comparative effectiveness trial of mindfulness-based cancer recovery and Tai chi/Qigong for cancer health (The MATCH study)
    (2020-07-17) Oberoi, Devesh; Piedalue, Katherine-Ann L; Pirbhai, Hassan; Guirguis, Steven; Santa Mina, Daniel; Carlson, Linda E
    Abstract Objective To examine the factors associated with loss to follow-up (LTFU) in an ongoing preference-based randomized waitlist controlled trial of mindfulness-based cancer recovery (MBCR) and Taichi/Qigong (TCQ) for cancer survivors (the MATCH Study). Hierarchical logistic regression was used to determine the factors associated with LTFU. Predictors included adherence to treatment, preference vs. randomized, type of intervention (MBCR vs. TCQ) and program timing (immediate {IM} vs. waitlist control {WLC} group). Results Data indicated that randomization to the WLC group and, once in the intervention, low adherence were the main predictors of LTFU. Participants in the WLC group were 4 times more likely to be LTFU post-randomization [OR 3.96, 95% CI 2.08–7.56, p < 0.005] than those in the IM group. Participants showing low adherence to treatment were 6 times more likely for LTFU post-intervention [5.87 (2.57–13.400; p < 0.005] and 4 times more likely for LTFU 6 months post-intervention [OR 3.93, 95% CI 1.53–10.02, p = 0.01].
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    Protocol for a phase III RCT and economic analysis of two exercise delivery methods in men with PC on ADT
    (2018-10-23) Alibhai, Shabbir M H; Ritvo, Paul; Santa Mina, Daniel; Sabiston, Catherine; Krahn, Murray; Tomlinson, George; Matthew, Andrew; Lukka, Himu; Warde, Padraig; Durbano, Sara; O’Neill, Meagan; Culos-Reed, S. N
    Abstract Background Androgen deprivation therapy (ADT) is commonly used to treat prostate cancer. However, side effects of ADT often lead to reduced quality of life and physical function. Existing evidence demonstrates that exercise can ameliorate multiple treatment-related side effects for men on ADT, yet adherence rates are often low. The method of exercise delivery (e.g., supervised group in-centre vs. individual home-based) may be important from clinical and economic perspectives; however, few studies have compared different delivery models. Additionally, long-term exercise adherence and an understanding of predictors of adherence are critical to achieving sustained benefits, but such data are lacking. The primary aim of this multi-centre phase III non-inferiority randomized controlled trial is to determine whether a home-based delivery model is non-inferior to a group-based delivery model in terms of benefits in fatigue and fitness in this population. Two other key aims include examining cost-effectiveness and long-term adherence. Methods Men diagnosed with prostate cancer of any stage, starting or continuing on ADT for at least 6 months, fluent in English, and living close to a study centre are eligible. Participants complete five assessments over 12 months (baseline and every 3 months during the 6-month intervention and 6-month follow-up phases), including a fitness assessment and self-report questionnaires. Biological outcomes are collected at baseline, 6, and 12 months. A total of 200 participants will be randomized in a 1:1 fashion to supervised group training or home-based training supported by smartphones, health coaches, and Fitbit technology. Participants are asked to complete 4 to 5 exercise sessions per week, incorporating aerobic, resistance and flexibility training. Outcomes include fatigue, quality of life, fitness measures, body composition, biological outcomes, and program adherence. Cost information will be obtained using patient diary-based self-report and utilities via the EQ-5D. Discussion To disseminate publicly funded exercise programs widely, clinical efficacy and cost-effectiveness have to be demonstrated. The goals of this trial are to provide these data along with an increased understanding of adherence to exercise among men with prostate cancer receiving ADT. Trial registration The trial has been registered at clinicaltrials.gov (Registration # NCT02834416 ). Registration date was June 2, 2016.