Enhancing Connections Telephone Program: A Cancer Education Program for Parents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 22
- 主要终点
- Recruitment and retention, monitored by tracking detailed recruitment spreadsheets
研究概览
简要总结
This pilot clinical trial studies the feasibility of a telephone-based educational intervention in improving communication between patients with stage 0-III cancer and their children. An educational program delivered by telephone may help parents talk with their school-age child about their cancer.
详细描述
PRIMARY OBJECTIVES:
I. Test the feasibility of the recruitment and study protocol.
II. Evaluate the short-term impact of the program on the diagnosed parents' and the parent's perceptions of their children's adjustment using a within group design (pre-posttest design).
III. To compare outcomes from the telephone-delivered program with outcomes obtained from the in-person program (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
- 18 Years 至 —（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 an initial diagnosis of non-metastatic cancer of any type (stage 0-3), including melanoma, colorectal, cervical, leukemia, lymphoma or breast cancer within the past 7 months
- •Read and write English among their languages of choice
- •Have ready access to a telephone
- •Have a child 5-12 years old living at home who has been told their parent's cancer diagnosis
- •The child is living at home and does not have learning challenges
- •No prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer
排除标准
- 未提供
结局指标
主要结局
Recruitment and retention, monitored by tracking detailed recruitment spreadsheets
时间窗: Up to 3 months
Each referral source and method of referral will be monitored, including documenting reason for refusal. Four methods of recruitment will be monitored in order to know which method yields the highest enrollment: self-referral, provider referral, passive letter opt-in, and passive letter opt-out.
Dosage and fidelity, monitored for each intervention session using Performance Checklists
时间窗: Up to 3 months
Each audio-recorded intervention session will be reviewed against these checklists. Study participants' compliance with the in-session and at-home assignments will be monitored by the audio-recorded intervention sessions.
Acceptability of the program, assessed from interview data obtained from the Exit interview and the Swanson Caring Professional Scale
时间窗: Up to 3 months
Rate of receipt of mailed materials both to participants and from participants
时间窗: Up to 3 months
Materials include signed consents, baseline data, and parent's educational materials.
Duration of phone intervention sessions
时间窗: Up to 3 months
Rate of success in scheduling and completing intervention sessions by telephone
时间窗: Up to 3 months
Quality of data on baseline and post-intervention measures
时间窗: Up to 3 months
Short-term impact of the program, evaluated by comparing the change in pre- and post-test scores on the standardized questionnaires
时间窗: Baseline up to 3 months
Analysis of covariance (ANCOVA) will be used to test for significant differences between pre- and post-test scores, assuming the data meet the statistical assumptions. Baseline scores will serve as the covariate, along with empirical variables that are known to co-vary with parent and child functioning, e.g., length of time of diagnosis, type of medical treatment, adjuvant therapy, among others). Two-tailed tests of significance will be calculated, allowing us to evaluate any potential negative effects of the intervention.
Impact of the telephone-delivered compared to the in-person delivered program
时间窗: Up to 3 months
Linear mixed modeling will be used. Random effects models are based on Maximum Likelihood Estimation in which an iterative method estimates a trajectory for each study participant based on all available data for that participant supplemented by data obtained from the total sample.
次要结局
未报告次要终点