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Internet of things-based lifestyle intervention for prostate cancer patients on androgen deprivation therapy: a prospective, multicenter, randomized trial.

ABSTRACT: Androgen deprivation therapy (ADT) has several adverse effects including loss of libido, osteoporosis, and metabolic complications. We aim to examine whether the Smart After-Care (SAC) service, an Internet of Things (IoT)-based lifestyle intervention, affects clinical outcomes in prostate cancer (PCa) patients on ADT. A prospective, multicenter, randomized trial including 172 patients randomly assigned to the SAC or control group was conducted. The SAC group was provided with a smartphone application providing a personalized exercise program, daily activity monitoring, and diet counselling. The control group was briefly educated on the exercise program using a paper brochure. The primary endpoint was increase in cardiorespiratory endurance assessed using the 2-minute walking test (2MWT). Secondary endpoints included improved muscle strength (hand grip strength test and 30-second chair stand test), short physical performance battery, body composition, and health-related quality of life (EORTC-QLQ-C30 and PR25). Participants in both groups showed significant improvement in the 2MWT and 30-second chair stand test after 12 weeks of intervention. Greater improvement in the 2MWT was observed in the SAC group than in the control group. Significantly increased body fat ratio was observed in both groups; however, decreased skeletal muscle mass was observed only in the control group. Marginal improvement in skeletal muscle mass was observed over time in the SAC group when compared with that in the control group. Both groups showed improvement in all physical scales in the EORTC-QLQ-C30 questionnaire, and the SAC group showed a significant interaction of group and time for social functioning scales. SAC improved cardiorespiratory endurance, sarcopenic obesity, and health-related quality of life in patients with PCa on ADT.

SUBMITTER: Park YH

PROVIDER: S-EPMC8640797 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

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Internet of things-based lifestyle intervention for prostate cancer patients on androgen deprivation therapy: a prospective, multicenter, randomized trial.

Park Yong Hyun YH Lee Jong In JI Lee Ji Youl JY Cheong In Yae IY Hwang Ji Hye JH Seo Seong Il SI Lee Kang Hyun KH Yoo Ji Sung JS Chung Seung Hyun SH So Yekyeong Y

American journal of cancer research 20211115 11

Androgen deprivation therapy (ADT) has several adverse effects including loss of libido, osteoporosis, and metabolic complications. We aim to examine whether the Smart After-Care (SAC) service, an Internet of Things (IoT)-based lifestyle intervention, affects clinical outcomes in prostate cancer (PCa) patients on ADT. A prospective, multicenter, randomized trial including 172 patients randomly assigned to the SAC or control group was conducted. The SAC group was provided with a smartphone applic ...[more]

PMID: 34873475

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Project description:BackgroundCastration resistance occurs in most patients with metastatic hormone-sensitive prostate cancer who are receiving androgen-deprivation therapy. Replacing androgens before progression of the disease is hypothesized to prolong androgen dependence.MethodsMen with newly diagnosed, metastatic, hormone-sensitive prostate cancer, a performance status of 0 to 2, and a prostate-specific antigen (PSA) level of 5 ng per milliliter or higher received a luteinizing hormone-releasing hormone analogue and an antiandrogen agent for 7 months. We then randomly assigned patients in whom the PSA level fell to 4 ng per milliliter or lower to continuous or intermittent androgen deprivation, with patients stratified according to prior or no prior hormonal therapy, performance status, and extent of disease (minimal or extensive). The coprimary objectives were to assess whether intermittent therapy was noninferior to continuous therapy with respect to survival, with a one-sided test with an upper boundary of the hazard ratio of 1.20, and whether quality of life differed between the groups 3 months after randomization.ResultsA total of 3040 patients were enrolled, of whom 1535 were included in the analysis: 765 randomly assigned to continuous androgen deprivation and 770 assigned to intermittent androgen deprivation. The median follow-up period was 9.8 years. Median survival was 5.8 years in the continuous-therapy group and 5.1 years in the intermittent-therapy group (hazard ratio for death with intermittent therapy, 1.10; 90% confidence interval, 0.99 to 1.23). Intermittent therapy was associated with better erectile function and mental health (P<0.001 and P=0.003, respectively) at month 3 but not thereafter. There were no significant differences between the groups in the number of treatment-related high-grade adverse events.ConclusionsOur findings were statistically inconclusive. In patients with metastatic hormone-sensitive prostate cancer, the confidence interval for survival exceeded the upper boundary for noninferiority, suggesting that we cannot rule out a 20% greater risk of death with intermittent therapy than with continuous therapy, but too few events occurred to rule out significant inferiority of intermittent therapy. Intermittent therapy resulted in small improvements in quality of life. (Funded by the National Cancer Institute and others; ClinicalTrials.gov number, NCT00002651.).

Dataset Information

Internet of things-based lifestyle intervention for prostate cancer patients on androgen deprivation therapy: a prospective, multicenter, randomized trial.

Publications

Internet of things-based lifestyle intervention for prostate cancer patients on androgen deprivation therapy: a prospective, multicenter, randomized trial.

Similar Datasets

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