scholarly journals Protocol for GET FIT Prostate: a randomized, controlled trial of group exercise training for fall prevention and functional improvements during and after treatment for prostate cancer

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Kerri M. Winters-Stone ◽  
Fuzhong Li ◽  
Fay Horak ◽  
Nathan Dieckmann ◽  
Arthur Hung ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Cancer Survivors ◽  
Strength Training ◽  
Physical Functioning ◽  
Control Group ◽  
Relative Efficacy ◽  
Prostate Cancer Survivors ◽  
Group Randomized Trial ◽  
Tai Ji ◽  
Secondary Outcomes

Abstract Background Many prostate cancer survivors are treated with androgen deprivation therapy (ADT), but these therapies may increase frailty, worsen physical functioning, and increase fall risk. While exercise may counter functional declines associated with ADT, no studies have tested whether and which type of exercise may reduce falls and frailty. The purpose of this trial is to compare the relative efficacy of strength training versus tai ji quan training against each other and to a stretching control group on falls, frailty, and physical functioning in men expose to ADT for prostate cancer. Methods Prostate cancer survivors treated with ADT (N = 360) who have fallen in the past year or are at risk of a fall based on validated risk factors will be recruited to participate in this single-blind, parallel group, randomized trial. Participants will be randomized to one of three supervised, group training programs: (i) strength training, (ii) tai ji quan training, or (iii) stretching (control), that train 3×/week for 6 months. Outcomes are assessed at baseline, 3 (mid-intervention), 6 (immediately post-intervention), and 12 (follow-up) months. The primary outcome is falls assessed by monthly self-report. Secondary outcomes include the following: frailty (low lean body mass (by bioelectrical impedance analysis), exhaustion (by SF-36 vitality scale), low activity (by CHAMPS physical activity survey), slowness (by 4 m usual walk speed), and weakness (by chair stand time)); objective and subjective measures of physical function will also be collected. Negative binomial regression models will be used to assess differences in falls between groups, while mixed effects modeling will be used to compare the relative efficacy of training group on secondary outcomes. Discussion Exercise represents a non-pharmacologic approach to mitigate the problem of falls experienced among men treated with ADT. By engaging in appropriate exercise, men may be able to avoid or delay falls, frailty, and disability associated with their cancer treatment. Findings of the trial are expected to inform clinical practice about how exercise could be prescribed as part of cancer care for prostate cancer survivors prescribed ADT. Trial registration ClinicalTrials.gov NCT03741335. Registered on November 18, 2018.

scholarly journals Protocol for GET FIT Prostate: A Randomized, Controlled Trial of Group Exercise Training for Fall Prevention and Functional Improvements During and After Treatment for Prostate Cancer

2021 ◽  
Author(s):  
Kerri Winters-Stone ◽  
Fuzhong Li ◽  
Fay Horak ◽  
Nathan Dieckmann ◽  
Arthur Hung ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Cancer Survivors ◽  
Strength Training ◽  
Physical Functioning ◽  
Control Group ◽  
Relative Efficacy ◽  
Prostate Cancer Survivors ◽  
Group Randomized Trial ◽  
Tai Ji ◽  
Secondary Outcomes

Abstract BackgroundMany prostate cancer survivors are treated with androgen deprivation therapy (ADT), but these therapies may increase frailty, worsen physical functioning, and increase fall risk. While exercise may counter functional declines associated with ADT, no studies have tested whether and which type of exercise may reduce falls and frailty. The purpose of this trial is to compare the relative efficacy of strength training versus tai ji quan training against each other and to a stretching control group on falls, frailty and physical functioning in men expose to ADT for prostate cancer.MethodsProstate cancer survivors treated with ADT (N = 360) who have fallen in the past year or are at risk of a fall based on validated risk factors will be recruited to participate in this single-blind, parallel group, randomized trial. Participants will be randomized to one of three supervised, group training programs: i) strength training, ii) tai ji quan training, or iii) stretching (control), that train 3x/week for 6 months. Outcomes are assessed at baseline, 3 (mid-intervention), 6 (immediately post-intervention) and 12 (follow-up) months. The primary outcome is falls assessed by monthly self-report. Secondary outcomes include the following: Frailty (low lean body mass (by bioelectrical impedance analysis), exhaustion (by SF-36 vitality scale), low activity (by CHAMPS physical activity survey), slowness (by 4 m usual walk speed), and weakness (by chair stand time)); Objective and subjective measures of physical function will also be collected. Negative binomial regression models will be used to assess differences in falls between groups, while mixed-effects modeling will be used to compare the relative efficacy of training group on secondary outcomes.DiscussionExercise represents a non-pharmacologic approach to mitigate the problem of falls experienced among men treated with ADT. By engaging in appropriate exercise men may be able to avoid or delay falls, frailty and disability associated with their cancer treatment. Findings of the trial are expected to inform clinical practice about how exercise could be prescribed as part of cancer care for prostate cancer survivors prescribed ADT.Trial Registration: ClinicalTrials.gov NCT03741335. Registered November 18, 2018. https://clinicaltrials.gov/ct2/show/NCT03741335

scholarly journals Effects of and Lessons Learned from an Internet-Based Physical Activity Support Program (with and without Physiotherapist Telephone Counselling) on Physical Activity Levels of Breast and Prostate Cancer Survivors: The PABLO Randomized Controlled Trial

Cancers ◽  
2021 ◽  
Vol 13 (15) ◽  
pp. 3665
Author(s):  
H. J. van de Wiel ◽  
M. M. Stuiver ◽  
A. M. May ◽  
S. van Grinsven ◽  
N. K. Aaronson ◽  
...  
Keyword(s):  
Physical Activity ◽  
Prostate Cancer ◽  
Cancer Survivors ◽  
Lessons Learned ◽  
Support Program ◽  
Control Group ◽  
Telephone Counselling ◽  
Prostate Cancer Survivors ◽  
Secondary Outcomes ◽  
Blended Care

Background: We developed an Internet-based physical activity (PA) support program (IPAS), which is embedded in a patient portal. We evaluated the effectiveness and costs of IPAS alone (online only) or IPAS combined with physiotherapist telephone counselling (blended care), compared to a control group. Methods: Breast or prostate cancer survivors, 3–36 months after completing primary treatment, were randomized to 6-months access to online only, blended care, or a control group. At baseline and 6-month post-baseline, minutes of moderate-to-vigorous PA (MVPA) were measured by accelerometers. Secondary outcomes were self-reported PA, fatigue, mood, health-related quality of life, attitude toward PA, and costs. (Generalized) linear models were used to compare the outcomes between groups. Results: We recruited 137 survivors (participation rate 11%). We did not observe any significant between-group differences in MVPA or secondary outcomes. Adherence was rather low and satisfaction scores were low to moderate, with better scores for blended care. Costs for both interventions were low. Conclusions: Recruitment to the study was challenging and the interventions were less efficacious than anticipated, which led to lessons learned for future trials. Suggestions for future research are as follows: improved accessibility of the support program, increased frequency of support, and use of activity trackers.

The GET FIT trial (NCT01635413): A randomized controlled trial of strength training versus Tai Ji Quan for fall prevention among female cancer survivors.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 12059-12059
Author(s):  
Kerri M. Winters-Stone ◽  
Fuzhong Li ◽  
Fay B. Horak ◽  
Sydnee Stoyles ◽  
Nathan Dieckmann ◽  
...  
Keyword(s):  
Postural Control ◽  
Cancer Survivors ◽  
Strength Training ◽  
Fall Prevention ◽  
Controlled Trial ◽  
Control Group ◽  
Placebo Control ◽  
Leg Strength ◽  
Tai Ji

12059 Background: Women with cancer are significantly more likely to fall than women without cancer but there are not yet any evidence-based fall prevention strategies that specifically target cancer survivors. The GET FIT trial compares the efficacy of two distinct types of exercise, strength training vs. tai ji quan, to prevent falls in women finished with chemotherapy. Methods: We conducted a 3 group, single-blind, parallel design, randomized controlled trial in older, inactive women cancer survivors treated with chemotherapy. Women were randomly assigned to 1 of 3 intervention groups: 1) strength training, 2) tai ji quan or 3) a placebo control group (stretching) that trained 2x/week for 6 months. Additional follow-up occurred 6 months after formal training stopped. The primary outcome was fall rate across 6-and 12 months; secondary outcomes, reflective of training fidelity, were maximal leg strength (by 1-repetition maximum) and dynamic postural control (by computerized dynamic posturography), collected at 0, 3, and 6 months. Results: 442 women (mean age 62.4 + 6.3 yrs.) were enrolled and randomly assigned to study groups. Over the 6 months prior to enrollment, 21% of the sample (n = 94) reported at least one fall (of which, 37% (n = 35) reported two or more falls)), and 12% (n = 51) reported at least one injurious fall. Retention across the 12 months study period was 88%, while adherence to the study interventions over 6 months averaged 73%, 71%, and 74% for the strength, tai ji quan and stretching (control) groups, respectively. 26% of the sample (n = 99 of 382) reported at least one fall during the intervention and 27% (n = 102) reported falls during follow up. Using regression models, there were no significant differences in the odds of having at least one fall during the intervention period (1-6 months) or across the entire follow-up period (1-12 months) between the control and either the strength or tai ji quan groups. At 6 months, the strength group showed a greater increase from baseline in maximal leg strength (+14.3 kg, 95% CI: 11.4-17.1) than the control group (+7.5 kg, 95% CI: 4.6-10.4, p = 0.002). Whereas, the tai ji quan group showed a greater increase in dynamic postural control (+2.42%, 95% CI: 1.36-3.48) compared to the control group (+0.35%, 95% CI: -0.69-1.38, p = 0.007). Conclusions: Despite evidence for fidelity of strength and tai ji quan training to improve muscle strength and postural control, respectively, neither program significantly lowered fall rates over a placebo control group. It is possible that the dose of exercise was too low and/or the sample was not at high risk of falls. The etiology of fall risk in women cancer survivors needs to be better understood as it may differ from risk factors in older adults. Future trials should consider patient-centered, tailored fall-prevention interventions for cancer survivors based on identified fall risk factors. Clinical trial information: NCT01635413.

scholarly journals Optimising Web-Based Computer-Tailored Physical Activity Interventions for Prostate Cancer Survivors: A Randomised Controlled Trial Examining the Impact of Website Architecture on User Engagement

2020 ◽  
Vol 17 (21) ◽  
pp. 7920
Author(s):  
Amy Finlay ◽  
Holly Evans ◽  
Andrew Vincent ◽  
Gary Wittert ◽  
Corneel Vandelanotte ◽  
...  
Keyword(s):  
Physical Activity ◽  
Prostate Cancer ◽  
Cancer Survivors ◽  
Behaviour Change ◽  
Free Choice ◽  
Self Monitoring ◽  
Web Based ◽  
Prostate Cancer Survivors ◽  
Secondary Outcomes ◽  
The Impact

Background: Web-based computer-tailored interventions can assist prostate cancer survivors to become more physically active by providing personally relevant behaviour change support. This study aimed to explore how changing the website architecture (free choice vs. tunnelled) impacted engagement within a physical activity computer-tailored intervention targeting prostate cancer survivors. Methods: On a 2:2:1 ratio, 71 Australian prostate cancer survivors with local or locally advanced disease (mean age: 66.6 years ± 9.66) were randomised into either a free-choice (N = 27), tunnelled (N = 27) or minimal intervention control arm (N =17). The primary outcome was differences in usage of the physical activity self-monitoring and feedback modules between the two intervention arms. Differences in usage of other website components between the two intervention groups were explored as secondary outcomes. Further, secondary outcomes involving comparisons between all study groups (including the control) included usability, personal relevance, and behaviour change. Results: The average number of physical activity self-monitoring and feedback modules accessed was higher in the tunnelled arm (M 2.6 SD 1.3) compared to the free-choice arm (M 1.5 SD 1.4), p = 0.01. However, free-choice participants were significantly more likely to have engaged with the social support (p = 0.008) and habit formation (p = 0.003) ‘once-off’ modules compared to the standard tunnelled arm. There were no other between-group differences found for any other study outcomes. Conclusion: This study indicated that website architecture influences behavioural engagement. Further research is needed to examine the impact of differential usage on mechanisms of action and behaviour change.

scholarly journals Self-Management in Long-Term Prostate Cancer Survivors: A Randomized, Controlled Trial

2019 ◽  
Vol 37 (15) ◽  
pp. 1326-1335 ◽  
Author(s):  
Ted A. Skolarus ◽  
Tabitha Metreger ◽  
Daniela Wittmann ◽  
Soohyun Hwang ◽  
Hyungjin Myra Kim ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Cancer Survivors ◽  
Symptom Management ◽  
Intervention Group ◽  
Symptom Burden ◽  
Self Management ◽  
Prostate Cancer Survivors ◽  
Secondary Outcomes ◽  
Long Term Survivors

PURPOSE This randomized clinical trial compared a personally tailored, automated telephone symptom management intervention to improve self-management among long-term survivors of prostate cancer with usual care enhanced with a nontailored newsletter about symptom management. We hypothesized that intervention-group participants would have more confident symptom self-management and reduced symptom burden. METHODS A total of 556 prostate cancer survivors who, more than 1 year after treatment, were experiencing symptom burden were recruited from April 2015 to February 2017 across four Veterans Affairs sites. Participants were randomly assigned to intervention (n = 278) or usual care (n = 278) groups. We compared differences in the primary (symptom burden according to Expanded Prostate Cancer Index Composite-26 [EPIC], confidence in self-management) and secondary outcomes between groups using intent-to-treat analyses. We compared domain-specific changes in symptom burden from baseline to 5 and 12 months among the intervention group according to the primary symptom focus area (urinary, bowel, sexual, general) of participants. RESULTS Most of the prostate cancer survivors in this study were married (54.3%), were white (69.2%), were retired (62.4%), and underwent radiation therapy (56.7% v 46.2% who underwent surgery), and the mean age was 67 years. There were no baseline differences in urinary, bowel, sexual, or hormonal domain EPIC scores across groups. We observed higher EPIC scores in the intervention arm in all domain areas at 5 months, though differences were not statistically significant. No differences were found in secondary outcomes; however, coping appraisal was higher (2.8 v 2.6; P = .02) in intervention-arm patients at 5 months. In subgroup analyses, intervention participants reported improvement from baseline at 5 and 12 months in their symptom focus area domains. CONCLUSION This intervention was well received among veterans who were long-term survivors of prostate cancer. Although overall outcome differences were not observed across groups, the intervention tailored to symptom area of choice may hold promise to improve associated burden.

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