Parenting Support Intervention for Families Coping With an Advanced Cancer Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Examine the feasibility of implementing a parenting support intervention in 50 patients with an incurable cancer and their spousal caregivers.
研究概览
简要总结
This clinical trial examines the acceptability and effect of a parenting support intervention for families coping with solid tumor that has spread to other places in the body (metastatic) or has come back (recurrent). Parenting support program may help to reduce common parenting concerns, improve communication between parents and children about cancer, and improve the overall psychological wellbeing of parents.
详细描述
PRIMARY OBJECTIVES:
I. Examine the acceptability a parenting support intervention in 10 patients with an incurable cancer and their spousal caregivers. (Trial 1) II. Examine the feasibility of implementing a parenting support intervention in 50 patients with an incurable cancer and their spousal caregivers. (Trial 2) III. Evaluate the initial evidence for intervention efficacy relative to waitlist control (WLC) group regarding patient and spousal caregiver psychological symptoms (primary outcome) and parenting concerns and parenting efficacy (secondary outcomes) and patient end of life (EOL) healthcare utilization (exploratory outcome). (Trial 2) IV. Understand the patients and caregivers' experiences using qualitative methods regarding participation in this study and explore emerging themes as possible intervention mediators/moderators to be examined in future research. (Trial 2)
OUTLINE:
TRIAL 1: Participants receive education materials (brochure and a video) and attend 2 weekly videoconference intervention sessions over 45 minutes each. Caregivers attend 2 additional weekly intervention sessions over 45 minutes each.
TRIAL 2: Participants are randomized to 1 of 2 groups.
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
- 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
- 是
入选标准
- •Participants must (1) be diagnosed with a metastatic or locally recurrent solid malignant tumor and on active treatment; (2) be at least 18 years old; (3) have at least one dependent child between the ages of 4 and 16 and currently living with the parent; (4) be able to provide informed consent and (5) have a spousal caregiver over the age of 18 who co-parents the child(ren) (i.e. share custody) and is willing and able to consent to participate.*
排除标准
- •Participants and caregivers who do not read and speak English and who do not have access to the internet.
研究组 & 干预措施
Group I (education material, videoconference session)
Examine the acceptability of a parenting support intervention in 10 patients with an incurable cancer and their spousal caregivers (cohort A) and 10 patients with an advanced cancer diagnosis and their family caregivers (cohort B).
干预措施: Educational Intervention (Other)
Group I (education material, videoconference session)
Examine the acceptability of a parenting support intervention in 10 patients with an incurable cancer and their spousal caregivers (cohort A) and 10 patients with an advanced cancer diagnosis and their family caregivers (cohort B).
干预措施: Questionnaire Administration (Other)
Group II (waitlist control)
Participants receive standard of care.
干预措施: Best Practice (Other)
Group II (waitlist control)
Participants receive standard of care.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Examine the feasibility of implementing a parenting support intervention in 50 patients with an incurable cancer and their spousal caregivers.
时间窗: Through study completion, an average of 1 year
次要结局
未报告次要终点