Pilot Study of a Rapid Triadic Communication Intention Elicitation Intervention (PRECursOr) to Improve Supportive Oncology Care Delivery for Patients with Advanced, Incurable Cancer and Their Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Identify intervention approaches in exit interview that contributed to positive and/or negative outcomes
研究概览
简要总结
The purpose of this study is to help test an idea designed to foster more supportive talk between providers (doctors or nurse practitioners), patients, and caregivers during an outpatient oncology appointment. A caregiver is the person the patient identifies is primarily involved in their healthcare. This study is collecting your reaction to this idea in order to understand needed changes before we introduce the idea to a larger group of patients.
详细描述
This pilot study focuses on an intervention (freelisting) designed to elicit supportive oncology communication intentions among the patient-caregiver-provider triad prior to an outpatient oncology encounter. The goal is to shape communication behaviors during the encounter to improve outcomes of the encounter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •patients will:
- •be adult women with an incurable gynecologic cancer (i.e., evidence of refractory/progressive disease after first-line treatment or recurrent disease),
- •not be receiving specialty palliative care or hospice,
- •read/speak English, and
- •be able to provide written informed consent.
- •caregivers will:
- •identify as the individual who is primarily involved in the patient's care,
- •be able to attend the oncology encounter,
- •read/speak English, and
- •be able to provide written informed consent.
- •providers will:
- •specialize in gynecologic oncology, and
- •provide outpatient care at IUSCCC gynecologic oncology clinic.
排除标准
- •patients and/or caregivers will be excluded if either one or both demonstrate:
- •cognitive impairment, or
- •speech/hearing difficulties precluding participation.
研究组 & 干预措施
Control group triads
Intervention group triads
干预措施: Intervention group triads (Behavioral)
结局指标
主要结局
Identify intervention approaches in exit interview that contributed to positive and/or negative outcomes
时间窗: Once all surveys in the sample size are completed, 9 months anticipated
Identify intervention approaches that contributed to positive and/or negative outcomes to inform intervention refinement using qualitative research methods.
Evaluate overall participant satisfaction surveys.
时间窗: Once all surveys in the sample size are completed, 9 months anticipated
PRECursOr will meet or exceed acceptability (satisfaction, acceptability of approach) benchmarks per patient and caregiver questionnaire.
Explore group differences in exit interview outcomes following the encounters.
时间窗: Once all encounters in the sample size are completed and transcribed and survey/interview completion, 9 months anticipated
The intervention group will demonstrate increased communication behaviors and a trend toward greater benefits in the immediate (e.g., quality of communication) and proximal (e.g., shared understanding of treatment goals, distress, anxiety) outcomes of communication.
Evaluate overall recruitment rates.
时间窗: Once all surveys in the sample size are completed, 9 months anticipated
PRECursOr will meet or exceed feasibility (overall recruitment, recruitment rate, measure completion, encounter duration).
Explore group differences in communication behaviors during the audio-recorded encounters.
时间窗: Once all encounters in the sample size are completed and transcribed, 9 months anticipated
The intervention group will demonstrate increased communication behaviors during the encounter (i.e., breadth of supportive oncology domains discussed) and a trend toward greater benefits in the immediate (e.g., quality of communication) and proximal (e.g., shared understanding of treatment goals, distress, anxiety) outcomes of communication.
次要结局
未报告次要终点
研究者
Kristin Levoy
Assistant Professor
Indiana University