Support and Healing Intervention for Navigating Parental Cancer Experiences (SHINE): A Mixed-Methods Study to Develop and Pilot-Test a Family-Centered Psychosocial Intervention for Adolescents With a Parent Diagnosed With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Recruitment Rate
研究概览
简要总结
e purpose of this study is to develop and evaluate SHINE (Support and Healing Intervention for Navigating Parental Cancer Experiences), a family-centered program designed to support adolescents whose parent has been diagnosed with cancer.
The study has two phases. In the first phase, parents and adolescents will participate in interviews or focus groups to help researchers understand their experiences and identify the types of support that families need. Information from these discussions will be used to refine the SHINE program.
In the second phase, families will be randomly assigned to either receive the SHINE program or continue with their usual supportive care. The SHINE program consists of approximately four sessions delivered over 8 weeks and focuses on improving communication, coping skills, resilience, and emotional well-being. Adolescents will complete questionnaires before the program begins, immediately after the 8-week intervention period, and 3 months later.
Researchers will evaluate whether SHINE is feasible to deliver, acceptable to families, and shows promise for improving psychosocial outcomes among adolescents coping with a parent's cancer diagnosis.
详细描述
A parental cancer diagnosis can significantly affect the emotional and psychological well-being of children and adolescents. Youth experiencing parental cancer are at increased risk for anxiety, depression, stress, communication difficulties, and impaired coping. Despite these challenges, relatively few evidence-based psychosocial interventions have been developed specifically for this population, and many existing interventions have not incorporated input from adolescents and families during development.
The SHINE (Support and Healing Intervention for Navigating Parental Cancer Experiences) study is a mixed-methods investigation designed to develop and pilot-test a family-centered psychosocial intervention for adolescents ages 10-17 whose parent has been diagnosed with Stage I-IV cancer.
The study consists of two sequential phases.
Aim 1 uses qualitative focus groups with parents and individual interviews with adolescents to identify priority psychosocial needs related to parental cancer, including age-appropriate information, family communication, coping strategies, peer support, emotional expression, and ongoing supportive care. Findings from these interviews will be used to refine the SHINE intervention, and a subset of families will participate in additional feedback sessions to finalize intervention materials.
Aim 2 is a pilot randomized controlled trial enrolling approximately 40 families (one parent with cancer and one adolescent child per family). Following completion of baseline assessments, families will be randomized in a 1:1 ratio to either the SHINE intervention or usual supportive care. The SHINE intervention is a modular psychosocial program delivered over approximately 8 weeks through approximately four sessions that may be conducted in person or virtually using HIPAA-compliant platforms.
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
盲法说明
None (Open Label)
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parent or caregiver aged 18 years or older with a documented diagnosis of Stage I-IV (or equivalent) cancer.
- •Parent or caregiver has at least one adolescent child between the ages of 10 and 17 years living in the household.
- •Parent/caregiver and adolescent are able to communicate in English or Spanish. Parent or caregiver is willing and able to provide informed consent, and the adolescent is willing and able to provide assent.
- •Family is willing and able to participate in study procedures, including intervention sessions and study assessments.
排除标准
- •Adolescent younger than 10 years or older than 17 years. Parent/caregiver or adolescent unable to communicate in English or Spanish. Parent/caregiver or adolescent with significant cognitive impairment or developmental delay that would prevent meaningful participation in study procedures.
- •Family unable or unwilling to complete study procedures or follow-up assessments.
- •Parent/caregiver unwilling or unable to provide informed consent, or adolescent unwilling or unable to provide assent.
研究组 & 干预措施
SHINE Intervention
Participants randomized to this arm will receive the SHINE (Support and Healing Intervention for Navigating Parental Cancer Experiences) intervention in addition to usual supportive care. SHINE is a family-centered, modular psychosocial intervention consisting of approximately four sessions delivered over an 8-week period. Sessions focus on age-appropriate cancer education, family communication, coping skills, resilience, emotional support, and peer support. Intervention sessions may be delivered in person at UT Southwestern Simmons Cancer Center or remotely using HIPAA-compliant virtual platforms.
干预措施: SHINE Psychosocial Intervention (Behavioral)
Usual Supportive Care
Participants randomized to this arm will receive the usual supportive care available through UT Southwestern Simmons Cancer Center. Usual supportive care may include access to oncology social work services, counseling, community resources, and other supportive services routinely available to families affected by cancer. Participants in this arm will complete the same study assessments as the intervention group but will not receive the SHINE intervention during the study period.
干预措施: Usual Supportive Care (Behavioral)
结局指标
主要结局
Recruitment Rate
时间窗: From study initiation through completion of participant enrollment (approximately 36 months).
Recruitment rate will be defined as the percentage of eligible families who enroll in the study.
Retention Rate
时间窗: Baseline through 3-month follow-up.
Retention rate will be defined as the percentage of enrolled families who complete all planned study assessments through the 3-month follow-up.
Intervention Adherence Rate
时间窗: Baseline through completion of the 8-week intervention.
Intervention adherence will be defined as the percentage of participants randomized to the SHINE intervention who complete all planned intervention sessions (approximately four sessions over 8 weeks).
Participant Satisfaction and Acceptability Questionnaire Total Score
时间窗: Immediately following the 8-week intervention
Acceptability will be assessed using a study-specific Participant Satisfaction and Acceptability Questionnaire administered immediately following completion of the SHINE intervention. The questionnaire consists of Likert-scale items assessing satisfaction, perceived usefulness, and willingness to recommend the intervention. Total scores range from 1 to 5, with higher scores indicating greater acceptability and satisfaction.
次要结局
- Perceptions of Parental Illness Questionnaire for Cancer (PPIQ-C)(Baseline, 8 weeks, and 3 months)
- Communication Self-Efficacy Scale(Baseline, 8 weeks, and 3 months)
- Connor-Davidson Resilience Scale (CD-RISC-25) Total Score(Baseline, 8 weeks, and 3 months)
- Perceived Stress Scale (PSS-10)(Baseline, 8 weeks, and 3 months)
- Patient Health Questionnaire for Adolescents (PHQ-A)(Baseline, 8 weeks, and 3 months)
- Generalized Anxiety Disorder 7-item Scale (GAD-7)(Baseline, 8 weeks, and 3 months)
- PROMIS Pediatric Peer Relationships Short Form(Baseline, 8 weeks, and 3 months)
- McMaster Family Assessment Device - General Functioning Subscale(Baseline, 8 weeks, and 3 months)
研究者
Sarah Messiah
Professor, Department of Epidemiology; Associate Dean for Research, Peter O'Donnell Jr. School of Public Health, The University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center