Families Addressing Cancer Together (FACT): A Pilot Randomized Trial
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
- Families Addressing Cancer Together (FACT) Satisfaction Scale
研究概览
简要总结
The proposed pilot randomized controlled trial will test the FACT (Families Addressing Cancer Together) intervention designed to improve parents' confidence and ability to talk about their cancer with their minor children. We will enroll 40 patients with cancer who have a minor child to participate in this single site, 6-week study. The primary hypothesis being tested is that an intervention that assists parents with their communication needs with their children can be feasible and acceptable when compared with a wait-list control condition.
详细描述
Parents with cancer are encouraged to be "honest and open" with their minor children about their illness. However, many lack access to professional support for their communication needs. Without this support, parents with cancer and their children experience avoidable psychosocial distress. In order to better support parental communication needs in cancer, psychosocial interventions that can be implemented across clinical practice settings are needed. To address this gap, we developed and pilot-tested FACT (Families Addressing Cancer Together) - a theory-guided, web-based psycho-educational intervention to help parents with cancer talk about their illness with their children in a developmentally appropriate way.
The proposed pilot randomized controlled trial will test the feasibility and acceptability of the FACT intervention. We will enroll 40 patients with cancer who have a minor child to participate in this single site, 6-week study. The primary hypothesis being tested is that an intervention that assists parents with their communication needs with their children can be feasible and acceptable when compared with a wait-list control condition. We will also explore preliminary effects of the intervention on parental communication and psychological outcomes.
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
- Single (Investigator)
盲法说明
Biostatistician
入排标准
- 年龄范围
- 18 Years 至 99 Years（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;
- •Able to complete all study measures and visits in English;
- •Be a parent (defined as biological, adoptive, foster, or step-parent), kin caregiver (defined as a relative or someone with a significant emotional relationship who provides full-time care and nurturing of a child), or legal guardian of a child age 3 to 17 years of age who can speak and understand English;
- •Have a diagnosis of Stage II-IV (or equivalent) invasive solid tumor not in surveillance or survivorship
排除标准
- •Unable to complete self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes;
- •Prior participation in the pilot trial or development and user testing protocol preliminary to this study;
- •No current or expected contact with their child; or
- •Existence of other co-morbid disease, which in the opinion of the investigator, prohibits participation in the protocol.
结局指标
主要结局
Families Addressing Cancer Together (FACT) Satisfaction Scale
时间窗: 3 weeks
Acceptability was measured by the FACT satisfaction scale in the intervention group using the study-specific, 6-item FACT satisfaction scale. The total score range is 0-18 with higher scores indicating more satisfaction.
Acceptability as Assessed by a Semi-structured, Post-intervention Interview
时间窗: 6 weeks
Satisfaction with FACT will be assessed via semi-structured, post-intervention interviews. Regarding n's, these interviews were offered as an optional part of participation among those randomized to the intervention (FACT). 12 participants agreed to participate in the interviews.
Acceptability as Measured by FACT Satisfaction Scale
时间窗: 6 weeks
Satisfaction with FACT will be measured in the intervention group using the study-specific, 6-item FACT satisfaction scale. Total score range is 0-18 with higher scores indicating more satisfaction.
次要结局
- Recruitment Feasibility as Measured by Rate of Eligible Patients Who Consent to Study Participation(6 weeks)
- Change From Baseline Communication Self-efficacy Using the CSES(Baseline, 6 weeks)
- Feasibility of Participant Retention as Measured by Percentage of Participants Who Complete Survey(3 weeks)
- Feasibility of Participant Retention as Measured by Percentage of Participants Who Complete Survey Assessments at 6 Weeks.(6 weeks)