Enhancing Connections Program in Palliative Care: Taking Care of the Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Rate of success in scheduling and completing intervention sessions
研究概览
简要总结
This pilot clinical trial studies the use of the Enhancing Connections Program in improving communication between patients with incurable cancer and their children. The Enhancing Connections Program is an educational program that may provide patients with new competencies to improve communication with their children and help them to cope with their parent's incurable cancer.
详细描述
PRIMARY OBJECTIVES:
I. To test the feasibility of the study protocol in advanced cancer patients (recruitment/retention, dosage and fidelity of the intervention; program acceptability of program; and logistics).
II. To evaluate the short-term impact of the program on the diagnosed parents' and children's adjustment using a within group design (pre- and post-test design).
III. To compare outcomes from the Enhancing Connections Program with outcomes obtained from the completed Phase III trial (between group design).
OUTLINE:
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
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parents will be eligible if they have a diagnosis of incurable cancer of any type
- •Read and write English among their languages of choice
- •Have a child 5-17 years old living at home who has been told their parent's cancer diagnosis
- •The child does not have learning challenges
排除标准
- •Parents will be excluded if they are enrolled in hospice at time of enrollment; (however, they will be allowed to continue in the study if they enroll in hospice after beginning the study)
- •Parents will be ineligible if their child lives in the home less than 50% of the time
研究组 & 干预措施
Supportive care (Enhancing Connections Program)
Patients participate in Enhancing Connections Program comprising of anchoring patients to help their child, adding to listening skills, building on listening skills, being a detective of their child's coping, and celebrating success for 5 sessions. Patients also receive workbook which includes text from the sessions, handouts, and at-home assignments to be completed between sessions.
干预措施: Questionnaire Administration (Other)
Supportive care (Enhancing Connections Program)
Patients participate in Enhancing Connections Program comprising of anchoring patients to help their child, adding to listening skills, building on listening skills, being a detective of their child's coping, and celebrating success for 5 sessions. Patients also receive workbook which includes text from the sessions, handouts, and at-home assignments to be completed between sessions.
干预措施: Educational Intervention (Other)
结局指标
主要结局
Rate of success in scheduling and completing intervention sessions
时间窗: At Session 5, occurring within up to 3 months
Duration of intervention sessions
时间窗: Up to 3 months
Differences between the telephone-delivered and the in-person delivered program
时间窗: Up to 3 months
Linear mixed modeling based on maximum likelihood estimation will be used to test the differences between the telephone-delivered and the in-person delivered program.
Dosage and fidelity
时间窗: Up to 3 months
Will be monitored for each intervention session using the performance checklists, the same checklists used to monitor dosage and fidelity in the Enhancing Connections (EC) trial. (Each session of the Program has its own unique Performance Checklist and each item is scored from 0-2. Performance Checklist items are specific to each session of the Program to be delivered by the patient educator. Higher scores denote higher performance by the patient educator and greater confidence that the Program was delivered as designed. The Performance Checklist is only used to monitor the performance of the
Rate of receipt of mailed materials both to participants and from participants (e.g., signed consents, baseline data; parent's materials)
时间窗: Baseline
Number of patients recruited and retained, tracked on recruitment spreadsheets
时间窗: Up to 3 months
Three methods of recruitment will be monitored: self-referral, provider referral, and recruitment letter.
Parent and child adjustment at completion of the EC-PC program, as measured by standardized questionnaire
时间窗: Up to 3 months
Will be compared with outcomes obtained from the intervention group in the EC-RCT (historical comparison group).
Program acceptability (per session, overall, duration of program, interval between intervention sessions)
时间窗: At Session 5, occurring within up to 3 months
Will be assessed from a debriefing interview in Session 5 that includes the parents' attributed gains of the program and their responses to the program's content, format, in-session, and at-home assignments.
Change in EC-palliative care (PC) parents' and children's scores (parent-reported) on standardized questionnaires from baseline to post-intervention
时间窗: Baseline to up to 3 months
Baseline scores will be compared with post-intervention scores on the same measures. Analysis of covariance will be used to test for significant differences between pre- and post-test scores.
Percentage of participants who complete both baseline and post-intervention sets of questionnaires with no missing data
时间窗: Up to 3 months
Assessed at baseline and post-intervention (up to 3 months).
Percentage of participants who return both baseline and post-intervention sets of questionnaires within 2 weeks of receipt
时间窗: Up to 14 weeks
Assessed at baseline and post-intervention (up to 3 months).
次要结局
未报告次要终点