Support and Healing Intervention for Adolescents With a Parent Diagnosed With Cancer (SHINE)

Официальное название

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

Обзор

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.

Подробное описание

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.

Primary objectives are to evaluate the feasibility of recruitment, retention, and intervention adherence, as well as participant acceptability and satisfaction. Secondary objectives are to estimate the preliminary effects of SHINE on adolescent psychosocial outcomes, including illness perceptions, coping, resilience, stress, depression, anxiety, peer relationships, family functioning, and communication. Outcomes will be assessed at baseline, immediately following the intervention, and at 3-month follow-up using validated patient-reported outcome measures.

The results of this pilot study will provide feasibility data and preliminary effect size estimates to support future fully powered clinical trials evaluating psychosocial interventions for families affected by parental cancer.

Вмешательства

• Поведенческое SHINE Psychosocial Intervention
  The SHINE (Support and Healing Intervention for Navigating Parental Cancer Experiences) intervention is a family-centered, modular behavioral intervention designed to improve psychosocial outcomes among adolescents with a parent diagnosed with cancer. The intervention consists of approximately four sessions delivered over an 8-week period, either in person or remotely using HIPAA-compliant platforms. Intervention modules address age-appropriate cancer education, family communication, coping skil
• Поведенческое Usual Supportive Care
  Participants assigned to this group will receive the standard supportive care services routinely available through UT Southwestern Simmons Comprehensive Cancer Center. These services may include access to oncology social work, counseling, patient navigation, educational resources, and community support programs as clinically indicated. Participants will not receive the SHINE intervention during the study period but will complete the same study assessments as the intervention group.

Первичные конечные точки

• Recruitment Rate [Срок оценки: From study initiation through completion of participant enrollment (approximately 36 months).]
• Retention Rate [Срок оценки: Baseline through 3-month follow-up.]
• Intervention Adherence Rate [Срок оценки: Baseline through completion of the 8-week intervention.]
• Participant Satisfaction and Acceptability Questionnaire Total Score [Срок оценки: Immediately following the 8-week intervention]

Вторичные конечные точки (8)

• Perceptions of Parental Illness Questionnaire for Cancer (PPIQ-C) [Срок оценки: Baseline, 8 weeks, and 3 months]
• Communication Self-Efficacy Scale [Срок оценки: Baseline, 8 weeks, and 3 months]
• Connor-Davidson Resilience Scale (CD-RISC-25) Total Score [Срок оценки: Baseline, 8 weeks, and 3 months]
• Perceived Stress Scale (PSS-10) [Срок оценки: Baseline, 8 weeks, and 3 months]
• Patient Health Questionnaire for Adolescents (PHQ-A) [Срок оценки: Baseline, 8 weeks, and 3 months]
• Generalized Anxiety Disorder 7-item Scale (GAD-7) [Срок оценки: Baseline, 8 weeks, and 3 months]
• PROMIS Pediatric Peer Relationships Short Form [Срок оценки: Baseline, 8 weeks, and 3 months]
• McMaster Family Assessment Device - General Functioning Subscale [Срок оценки: Baseline, 8 weeks, and 3 months]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• UT Southwestern Simmons Comprehensive Cancer Center — Dallas

Идентификаторы

NCT: NCT07751185 · STU20251757

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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