A Pilot Study Evaluating the Feasibility, Acceptability, and Preliminary Evidence of Efficacy of the Families Addressing Cancer Together (FACT) Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 4
- 主要终点
- Acceptability of the Intervention Assessed Via Semi-structured Interviews
研究概览
简要总结
This is a pilot feasibility and acceptability study to inform the development and testing of a novel communication intervention to support parents in their communication with children about cancer. The research questions to be answered by this study are whether the intervention being tested can be feasible and acceptable, and provide preliminary estimates of improvement in parental psychological distress.
详细描述
This is a single-arm, single center pilot study using a pretest-posttest design to evaluate the feasibility and acceptability of a psychosocial intervention, Families Addressing Cancer Together (FACT). The purpose of the intervention is to decrease parental anxiety by facilitating parental communication about cancer with their children. The primary hypothesis being tested is that an intervention that assists parents with their communication needs with their children can be feasible, acceptable, and reduce parental psychological distress. Findings from this study will inform a future grant application to further test this intervention in a randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Informed consent reviewed and signed;
- •Age equal to or above 18 years;
- •Ability to understand and comply with study procedures;
- •Be a parent, primary caregiver, or guardian of at least one child between the ages of 3-19 years old with whom the subject has regular contact. The child must have cognitive ability to understand verbal communication;
- •Have a new or recurrent diagnosis of invasive solid tumor malignancy within the past 6 months or have a solid tumor cancer diagnosis with disease that is either stage IV or equivalent;
- •Have a cancer diagnosis that is likely to require systemic anti-neoplastic therapy, non-office based surgical intervention, radiation therapy, or palliative care/hospice within the next three months.
排除标准
- •Unable to complete self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes.
结局指标
主要结局
Acceptability of the Intervention Assessed Via Semi-structured Interviews
时间窗: 14 days
Participants were interviewed about their experiences with the study intervention using semi-structured interviews. Parents' comments on the intervention "helped them feel more comfortable and prepared to talk with their children about their illness" were graded as participants overall intervention satisfaction.
Acceptability of the Intervention Measured by the Study Visit Satisfaction Form- Overall Satisfaction
时间窗: 14 days
Acceptability of the intervention will be assessed through participants' satisfaction ratings used a study-specific satisfaction scale, "Families Addressing Cancer Together (FACT) satisfaction scale." Four-items (0=not at all, 3=very), higher scores indicate more satisfaction.
Acceptability of the Intervention Measured by the Study Visit Satisfaction Form-FACT Was Useful
时间窗: 14 days
Acceptability of the intervention will be assessed through participants' satisfaction ratings used a study-specific satisfaction scale, "Families Addressing Cancer Together (FACT) satisfaction scale." Four-items (0=not at all, 3=very), higher scores indicate more satisfaction.
Acceptability of the Intervention Measured by the Study Visit Satisfaction Form FACT Was Helpful
时间窗: 14 days
Acceptability of the intervention will be assessed through participants' satisfaction ratings used a study-specific satisfaction scale, "Families Addressing Cancer Together (FACT) satisfaction scale." Four-items (0=not at all, 3=very), higher scores indicate more satisfaction.
Acceptability of the Intervention Measured by the Study Visit Satisfaction Form Content Was Important
时间窗: 14 days
Acceptability of the intervention will be assessed through participants' satisfaction ratings used a study-specific satisfaction scale, "Families Addressing Cancer Together (FACT) satisfaction scale." Four-items (0=not at all, 3=very), higher scores indicate more satisfaction.
次要结局
- Feasibility of Screening(Baseline)
- Feasibility of Recruitment(Baseline)
- Communication Self-efficacy Measured by the Adapted Communication Self-Efficacy Scale(Baseline, 14 days, 84 days)