A Prolonged Nightly Fasting Plus Telehealth Coaching Intervention (PNF+) for Men on Androgen Deprivation Therapy for PCa: A Pilot Feasibility Randomized Controlled Trial

一项针对接受雄激素剥夺疗法治疗前列腺癌的男性患者的延长夜间禁食加远程医疗指导干预(PNF+):一项试点可行性随机对照试验

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Abstract

Background/Objectives: This study aimed to assess the feasibility and acceptability of a 3-month health coaching intervention to promote PNF and healthy diet for men on ADT for PCa. Methods: The study was carried out via a two-armed randomized controlled trial including 40 patients with PCa at a medical center in Philadelphia. During the 3-month period, the intervention group (PNF+) received health coaching utilizing an interactive text message system, and the control group received healthy eating text messages for the same duration. The outcome variables were feasibility and acceptability. Results: The PNF+ group (n = 27) had high adherence to health coaching (82%), picture response (85%) and moderate adherence to the PNF window (69%). The intervention was rated highly acceptable with no reported A/E associated with the intervention, and most participants planning to continue in some capacity. At 3 months, the PNF+ group had numerically lower BMI (29.1) and body weight (195.2 lbs) compared to the control group (n = 13; BMI 31.6, weight 223.3 lbs). Improvements in patient-reported outcomes were observed in both groups. FACIT-F scores (higher scores indicate less fatigue) increased in the PNF+ group (43.6 to 45.2) and in the control group (42.5 to 45.5). FACT-P scores (higher scores indicate better quality of life) increased in the PNF+ group (121.3 to 125.5) but decreased slightly in the control group (121.1 to 119.8). Between-group comparisons of change from baseline showed no statistically significant differences across outcomes (all p > 0.05). Conclusions: The intervention demonstrated partial feasibility and high acceptability. It was associated with numerically lower BMI and body weight and favorable changes in patient-reported outcomes, particularly quality of life; however, no statistically significant differences were observed between groups. These findings should be interpreted cautiously given the small sample size and require confirmation in larger, adequately powered trials.

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