Evaluation of the Impact of A Survivorship Care Plan and Embedded Navigation Tool (ASCENT) in Patients With Prostate Cancer Undergoing Curative-Intent Radiotherapy With Concurrent Androgen Deprivation Therapy (ADT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 11
- 主要终点
- Abiding by the survivorship guidelines as measured by making an appointment within 6 months of enrollment OR completing a guideline-based assessment.
研究概览
简要总结
This is a parallel group, multisite prospective clinical study. The purpose of this study is to evaluate whether ASCENT enables patients to adhere to the survivorship guidelines and improves coordination of care to address patient needs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Histologically confirmed diagnosis of prostate adenocarcinoma
- •Age ≥18 years
- •Receiving curative intent radiotherapy for prostate cancer (Note: post-operative radiotherapy [i.e., "adjuvant" or "salvage radiotherapy subsequent to prostatectomy] is allowed.)
- •Subjects will be enrolled within two weeks prior to and two weeks after the final fraction of radiotherapy.
- •Receiving androgen deprivation therapy (ADT) for a duration of ≥3 consecutive months as follows:
- •GnRH agonist or antagonist (medical castration), with or without an anti-androgen (i.e., bicalutamide, flutamide, nilutamide, etc.), OR
- •Bilateral orchiectomy (surgical castration)
- •Technology requirement: candidates must have access to the internet
- •Able to understand and willing to sign a written informed consent document.
- •Able to speak and understand English, in the opinion of the treating physician.
排除标准
- •Significant concurrent medical or psychiatric condition that would interfere with the patient's ability to abide by the study protocol or cooperate fully with the protocol requirements, including completion of survey and assessment
结局指标
主要结局
Abiding by the survivorship guidelines as measured by making an appointment within 6 months of enrollment OR completing a guideline-based assessment.
时间窗: 6 months
Abiding by the survivorship guidelines is defined as either of: Making an appointment with primary health care provider within 6 months of enrollment, OR completing a guideline-based assessment or management strategy for reducing side effects related to prostate cancer treatment.
Assess trial participants', caregivers'/family members', and staff satisfaction and experiences with the ASCENT technology and trial.
时间窗: 6 months
Focus group comments and question responses detailing trial participants', caregivers'/family members', and staff's satisfaction and experiences with ASCENT.
次要结局
- Existence and severity of depression(6 months)
- Overall health-related-quality of life including, but not limited to, mental and physical functioning as measured by the Short Form Health Survey(6 months)
- General health status(6 months)
- Prostate-cancer specific quality of life.(6 months)