A Prolonged Nightly Fasting Plus Telehealth Coaching Intervention (PNF+) for Men on Androgen Deprivation Therapy for PCa: A Pilot Feasibility Randomized Controlled
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Patient Satisfaction
研究概览
简要总结
This small study tested a 3-month text-based health coaching program for men with prostate cancer on hormone therapy. The program was feasible and well accepted, with participants showing good engagement and some improvements in weight and quality of life. However, differences between groups were not statistically significant, so larger studies are needed to confirm the benefits.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
- •Must be 18 years of age or older
- •Provide signed and dated informed consent form
- •Had a histological diagnosis of PCa (Stage IIA-IVB)
- •Are beginning or receiving ADT (including medical castration with LHRH-agonist-antagonist androgen receptor modulators) for PCa with an anticipated duration of ≥ 3 months. The ADT is defined as: (a) Gonadotropin Releasing Hormone (GNRH) agonist (including leuprolide [Lupron/Eligard], goserelin [Zoladex], triptorelin [Trelstar], histrelin [Vantas], and abiraterone [Zytiga]) alone; (b) GNRH agonist with oral androgen receptor blockade (including bicalutamide [Casodex], flutamide [Eulexin], and enzalutamide [Xtandi]), and (c) GNRH agonist, oral androgen receptor blockade, and 5-alpha reductase inhibitors. Patients on androgen receptor modulators and second-generation androgen receptor antagonists will qualify.
- •Intermittent ADT will be allowed as long as the overall duration is more than 3 months.
- •BMI ≥25 kg/m2
- •Radiation therapy will be allowed concurrently.
- •Willing and able to comply with the protocol for the duration of the study
- •Able to speak, read and write English
- •Has a mobile phone with TXT capability.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Inability to tolerate a normal diet (may include an active malabsorption syndrome at time of consent (i.e. Crohn's disease, major bowel resection leading to permanent malabsorption)
- •Patients on concurrent chemotherapy will be excluded.
- •ECOG score > 2
- •Medications such as finasteride/dutasteride/saw palmetto are not allowed.
- •Insulin injection or glyburide medication
研究组 & 干预措施
Healthy Diet Group
The health eating attention control group: participants will receive text messages twice a day to focus on information and tips on general healthy eating, based on AICR evidence-based materials.
干预措施: Healthy Diet Text Messaging (Behavioral)
结局指标
主要结局
Patient Satisfaction
时间窗: Approximately 3 months
Patient satisfaction, as measured from Client Satisfaction Quesionnaire-8 item version (CSQ-8), a validated measure that elicits the client's perspective on the value of serves received37. Qualitatively, a structured interview guide will be developed to assess the behavioral determinants (barriers and facilitators to adoption of the 16:8 TRE, including the usefulness and practicality of the PNF+ intervention and any specific feedback for improvement. Sample questions include: asking participants to: 1) identify the greatest benefit from PNF+ program; 2) indicate the greatest challenge from be compliant with the PNF+ program; 3) describe the way in which their neurological function or memory had changed (improved or worsened); and 4) indicate the driving force that bring them to participate in the PNF+ program.
Accrual Rate
时间窗: 12 months
Percentage of eligible participants who consent and enroll in the study.
Attrition Rate
时间窗: Approximately 3 months
Percentage of enrolled participants completing post-intervention follow-up.
Time-Restricted Eating Compliance
时间窗: Approximately 3 months
Percentage of participants compliant with 70% of the intervention days (70% of 90 days = 63 days) with suggested TRE
Number of Adverse Events
时间窗: Approximately 3 months
Number of Adverse Events
次要结局
未报告次要终点