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The Individualized Diet and Exercise Adherence Pilot Trial (IDEA-P) in prostate cancer patients undergoing androgen deprivation therapy: study protocol for a randomized controlled trial.

ABSTRACT: Androgen deprivation therapy (ADT) is the foundation of treatment for men with metastatic prostate cancer and is now frequently incorporated into multimodality strategies for the curative treatment of locally advanced prostate cancer. Nevertheless, the catabolic effects of ADT result in meaningful adverse effects on physiological and quality of life outcomes, which may, in turn, increase the risk of functional decline, frailty, cardiovascular disease, and metabolic syndrome. Recent evidence demonstrates that lifestyle intervention promoting change in exercise and dietary behaviors is a promising approach, and may offset, or even reverse, the adverse effects accompanying ADT. Unfortunately, the limited existing studies of the effects of exercise and dietary interventions targeting patients with prostate cancer on ADT are characterized by high attrition rates and poor postintervention maintenance of treatment effects. Consequently, the Individualized Diet and Exercise Adherence Pilot Trial (IDEA-P) is designed to contrast the effects of a lifestyle intervention designed to promote independent self-management of exercise and dietary behavior with those of standard care disease management approach in the treatment of prostate cancer.A total of 40 patients with prostate cancer undergoing ADT will be randomly assigned to lifestyle intervention or standard care. Outcomes of interest in IDEA-P include changes in self-reported and objectively assessed physical function and physical activity, dietary behavior, body composition, muscular strength, and quality of life. Outcomes will be obtained at baseline, 2-month, and 3-month assessments by trial personnel blinded to participants' randomization assignment.Findings from this study will establish the feasibility and preliminary efficacy of an innovative lifestyle intervention designed to promote progressively independent self-regulated exercise and dietary behavior change in the treatment of patients with prostate cancer undergoing ADT.ClinicalTrials.gov NCT02050906.

SUBMITTER: Focht BC

PROVIDER: S-EPMC4175627 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature

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The Individualized Diet and Exercise Adherence Pilot Trial (IDEA-P) in prostate cancer patients undergoing androgen deprivation therapy: study protocol for a randomized controlled trial.

Focht Brian C BC Lucas Alexander R AR Grainger Elizabeth E Simpson Christina C Thomas-Ahner Jennifer M JM Clinton Steven K SK

Trials 20140909

<h4>Background</h4>Androgen deprivation therapy (ADT) is the foundation of treatment for men with metastatic prostate cancer and is now frequently incorporated into multimodality strategies for the curative treatment of locally advanced prostate cancer. Nevertheless, the catabolic effects of ADT result in meaningful adverse effects on physiological and quality of life outcomes, which may, in turn, increase the risk of functional decline, frailty, cardiovascular disease, and metabolic syndrome. R ...[more]

PMID: 25199619

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Project description:BackgroundAndrogen deprivation therapy (ADT) is the mainstay therapy for men with prostate cancer. However, there are musculoskeletal side effects from ADT that increase the risk for osteoporosis and fracture, and can compromise the quality of life of these individuals. The objectives of this study are to determine the efficacy of a home-based walking exercise program in promoting bone health, physical function and quality of life in men with prostate cancer receiving ADT.Methods/designA 12-month prospective, single-blinded, randomized controlled trial will be conducted to compare the Exercise Group with the Control Group. Sixty men with prostate cancer who will be starting ADT will be recruited and randomly assigned to one of the two groups: the Exercise Group will receive instructions in setting up an individualized 12-month home-based walking exercise program, while the Control Group will receive standard medical advice from the attending physician. A number of outcome measures will be used to assess bone health, physical function, and health-related quality of life. At baseline and 12 months, bone health will be assessed using dual-energy X-ray absorptiometry. At baseline and every 3 months up to 12 months, physical function will be evaluated using the Functional Assessment of Chronic Illness Therapy - Fatigue Scale, Activities-specific Balance Confidence Scale, Short Physical Performance Battery, and Six-Minute Walk Test; and health-related quality of life will be assessed using the Functional Assessment of Cancer Therapy Prostate Module and the Medical Outcomes Study 12-item Short Form Health Survey Version 2. A mixed multiple analysis of variance will be used to analyze the data.DiscussionMusculoskeletal health management remains a challenge in men with prostate cancer receiving ADT. This study addresses this issue by designing a simple and accessible home-based walking exercise program that will potentially have significant impact on reducing the risk of fracture, promoting physical function, and ultimately improving the health-related quality of life in men with prostate cancer receiving ADT.Trial registrationClinicalTrials.gov: NCT00834392.

Project description:BackgroundAndrogen deprivation therapy (ADT) is an effective prostate cancer (PCa) treatment strategy that can curb the development or progression of the disease. This review aimed to examine and summarize available systematic reviews/meta-analyses (SRs/MAs) of exercise training on physical condition of PCa patients undergoing ADT.MethodsA comprehensive search of 8 databases was conducted for relevant literature published before April 25, 2022 with the language restrictions of Chinese and English. Two reviewers independently assessed the methodological quality, risk of bias, reporting quality, and evidence quality of the included SRs/MAs using a range of evaluation tools, including A Measurement Tool to Assess Systematic Reviews (AMSTAR) 2, Risk of Bias in Systematic Reviews (ROBIS), the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA), and Grades of Recommendations, Assessment, Development and Evaluation (GRADE).ResultsThis review included 8 SRs/MAs which included a total of 94 studies. Ultimately, A total of 51 outcomes was included, regarding 11 different outcome categories. The AMSTAR-2 tool showed that 3 SRs/MAs had moderate methodological quality, 4 SRs/MAs had very low quality, and the remaining 1 had low quality. According to the ROBIS scale, 3 SRs/MAs had a high risk of bias. The PRISMA checklist showed that the primary reporting faults were protocol registration and funding source. The GRADE system was used to analyze the evidence quality of the 51 outcomes, and no high-quality evidence was found. However, moderate-quality evidence indicated that exercise training may improve body composition [by lowering body fat mass (BFM) and body fat rate (BFR)], muscular strength, and quality of life (QoL) in PCa patients undergoing ADT. Low-quality evidence demonstrated that exercise training could improve such symptoms as fatigue, depression, sexual function, and cardiometabolic changes.ConclusionsAvailable evidence suggests that exercise training may be used as an adjuvant treatment for PCa patients undergoing ADT to improve several aspects of general health. Studies with more rigorous designs and larger sample sizes are needed to support our findings with more robust evidence.

Project description:BackgroundThe purpose of this study was to assess the effect of preoperative physiotherapy (PT) on functional, subjective and socio-economic parameters after total knee arthroplasty (TKA).Methods20 patients (mean ± SD: age 67 ± 7 years) scheduled for TKA at Balgrist University Hospital between July 2016 and March 2017 were randomly assigned to a control (CG) or intervention (IG) group. 3 to 4 weeks prior to surgery the IG completed 5 to 9 sessions of PT containing proprioceptive neuromuscular facilitation (PNF) techniques, endurance training and individually indicated interventions. Measurements were executed at baseline, preoperative and 3 months after TKA. The primary outcome measure was the Stair Climbing Test (SCT), secondary outcome measures were the knee range of motion (ROM) and the level of physical activity using Lysholm Score (LS) and Tegner Activity Scale (TAS). The subjective and socio-economic parameters were the Patients' Global Impression of Change (PGIC) scale, inpatient rehabilitation time, preoperative pain levels and metabolic equivalent (MET), postoperative intake of analgesics and overall costs.ResultsNo difference between IG and CG was found for SCT (F (2/36) = 0.016, p = 0.984, η2 = 0.004). An interaction between group and time was shown for TAS (F (18/1) = 13.890) with an increase in the IG (p = 0.002, η2 = 0.536). The sub-item "pain" within the LS presented a higher pain-level in CG (F (18/1) = 4.490, p = 0.048, η2 = 0.974), while IG showed a higher preoperative MET compared to CG (p = 0.035). There were no other significant changes. The CG produced 21.4% higher overall costs, took more analgesics and showed higher preoperative pain levels than the IG.ConclusionsFindings show that preoperative therapy improved the level of physical activity before and after TKA and resulted in a clinically relevant gain in TAS.Trial registrationClinicalTrials.gov Identifier; NCT03160534. Registered 19 May 2017.

Project description:BackgroundTreatment decision-making regarding immunosuppressive therapy is challenging for individuals with lupus. We assessed the effectiveness of a decision aid for immunosuppressive therapy in lupus nephritis.Methods and findingsIn a United States multicenter, open-label, randomized controlled trial (RCT), adult women with lupus nephritis, mostly from racial/ethnic minority backgrounds with low socioeconomic status (SES), seen in in- or outpatient settings, were randomized to an individualized, culturally tailored, computerized decision aid versus American College of Rheumatology (ACR) lupus pamphlet (1:1 ratio), using computer-generated randomization. We hypothesized that the co-primary outcomes of decisional conflict and informed choice regarding immunosuppressive medications would improve more in the decision aid group. Of 301 randomized women, 298 were analyzed; 47% were African-American, 26% Hispanic, and 15% white. Mean age (standard deviation [SD]) was 37 (12) years, 57% had annual income of <$40,000, and 36% had a high school education or less. Compared with the provision of the ACR lupus pamphlet (n = 147), participants randomized to the decision aid (n = 151) had (1) a clinically meaningful and statistically significant reduction in decisional conflict, 21.8 (standard error [SE], 2.5) versus 12.7 (SE, 2.0; p = 0.005) and (2) no difference in informed choice in the main analysis, 41% versus 31% (p = 0.08), but clinically meaningful and statistically significant difference in sensitivity analysis (net values for immunosuppressives positive [in favor] versus negative [against]), 50% versus 35% (p = 0.006). Unresolved decisional conflict was lower in the decision aid versus pamphlet groups, 22% versus 44% (p < 0.001). Significantly more patients in the decision aid versus pamphlet group rated information to be excellent for understanding lupus nephritis (49% versus 33%), risk factors (43% versus 27%), medication options (50% versus 33%; p ≤ 0.003 for all); and the ease of use of materials was higher in the decision aid versus pamphlet groups (51% versus 38%; p = 0.006). Key study limitations were the exclusion of men, short follow-up, and the lack of clinical outcomes, including medication adherence.ConclusionsAn individualized decision aid was more effective than usual care in reducing decisional conflict for choice of immunosuppressive medications in women with lupus nephritis.Trial registrationClinicaltrials.gov, NCT02319525.

Dataset Information

The Individualized Diet and Exercise Adherence Pilot Trial (IDEA-P) in prostate cancer patients undergoing androgen deprivation therapy: study protocol for a randomized controlled trial.

Publications

The Individualized Diet and Exercise Adherence Pilot Trial (IDEA-P) in prostate cancer patients undergoing androgen deprivation therapy: study protocol for a randomized controlled trial.

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