Patient-identified Values as Outcome Targets (PIVOT) Feasibility Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Safety and Adverse Events (AEs)
研究概览
简要总结
A behavioral trial aimed at helping patients identify what matters most to them and is part of a larger effort to pivot from disease-oriented care to whole-person care.
详细描述
Primary Objectives:
The primary objective of the pilot clinical trial is to evaluate feasibility, operationalized as attrition, acceptability, and adherence rates of the GAS measure.
Secondary Objectives:
To evaluate initial efficacy across both arms (pre-post comparison) and between arms (A-B comparison) of goal encouragement. Due to the pilot nature of this work and a lack of published effect size estimates, this trial is unlikely to be adequately powered to estimate true efficacy. However, this trial will provide a rich source of preliminary data and effect size estimates that can be utilized to conduct formal power analysis for a larger efficacy trial.
The tertiary objective will be to identify themes within the GAS measures created by participants, utilizing grounded theory inductive coding of themes into broader categories, and comparing against the common categories pre-identified within the Patient Priorities Care framework.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated electronic informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Age 18 or older.
- •Documented diagnosis of chemotherapy-induced peripheral neuropathy meeting the following criteria: 1) onset associated with timing of neurotoxic chemotherapy and 2) symptomatic reports of peripheral neuropathy.
- •Access to smartphone and internet for participating in a technology-based intervention
- •Upcoming in-person appointment in the Main Hospital Pain Management Clinic 4-6 weeks from the consent date.
- •English-speaking
- •Pain or bothersome symptoms present most days of the week at an average of ≥4/10 on the Numeric Rating Scale for the past 3 months
- •No longer receiving cancer treatment or has been on stable maintenance treatment for the past 3 months.
- •Resides in the Houston Metroplex
- •A score ≤7 on the validated Six Item Cognitive Impairment Test (6CIT) for unimpaired cognition
排除标准
- •Provision of signed and dated electronic informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Age 18 or older.
- •Documented diagnosis of chemotherapy-induced peripheral neuropathy meeting the following criteria: 1) onset associated with timing of neurotoxic chemotherapy and 2) symptomatic reports of peripheral neuropathy.
- •Access to smartphone and internet for participating in a technology-based intervention
- •Upcoming in-person appointment in the Main Hospital Pain Management Clinic 4-6 weeks from the consent date.
- •English-speaking
- •Pain or bothersome symptoms present most days of the week at an average of ≥4/10 on the Numeric Rating Scale for the past 3 months
- •No longer receiving cancer treatment or has been on stable maintenance treatment for the past 3 months.
- •Resides in the Houston Metroplex
- •A score ≤7 on the validated Six Item Cognitive Impairment Test (6CIT) for unimpaired cognition
研究组 & 干预措施
Goal Encouragement
Eligible participants will be identified using electronic health record
干预措施: Goal Attainment Scaling (GAS) (Behavioral)
No Goal Encouragement
Eligible participants will be identified using electronic health record
干预措施: Goal Attainment Scaling (GAS) (Behavioral)
结局指标
主要结局
Safety and Adverse Events (AEs)
时间窗: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点