Adaptation, Psychological, Cancer, Psychological Distress
Conditions
Keywords
Parental cancer, Adolescents, Family-centered intervention, Psychosocial intervention, Supportive care, Cancer survivorship, Family communication, Coping, Resilience, Peer support, Pediatric psychosocial oncology, Behavioral intervention, Mixed-methods, Randomized controlled trial, SHINE
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALSHINE 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 skills, resilience, peer support, and emotional well-being. Content is informed by qualitative input from adolescents, parents, and clinical providers and may be tailored to family needs while maintaining a standardized intervention framework.
BEHAVIORALUsual 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.
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
None (Open Label)
Intervention model description
Participants will be randomized in a 1:1 ratio to either the SHINE intervention or usual supportive care. The SHINE intervention consists of approximately four family-centered psychosocial sessions delivered over an 8-week period. The control group will receive usual supportive care available through the cancer center. Participants will complete assessments at baseline, post-intervention (8 weeks), and 3-month follow-up.
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceptions of Parental Illness Questionnaire for Cancer (PPIQ-C) | Baseline, 8 weeks, and 3 months | Perceptions of Parental Illness Questionnaire for Cancer (PPIQ-C) Coherence Subscale Score. The Coherence subscale measures adolescents' understanding of their parent's cancer. Scores range from 1 to 5, with higher scores indicating greater illness understanding. |
| Communication Self-Efficacy Scale | Baseline, 8 weeks, and 3 months | Change in communication self-efficacy measured using the Communication Self-Efficacy Scale (CSES). Total scores range from 10 to 50. Higher scores indicate greater communication self-efficacy. |
| Connor-Davidson Resilience Scale (CD-RISC-25) Total Score | Baseline, 8 weeks, and 3 months | Change in resilience measured using the Connor-Davidson Resilience Scale (CD-RISC-25). The Connor-Davidson Resilience Scale consists of 25 items with total scores ranging from 0 to 100. Higher scores indicate greater resilience. |
| Perceived Stress Scale (PSS-10) | Baseline, 8 weeks, and 3 months | Change in stress measured using the Perceived Stress Scale (PSS-10). The Perceived Stress Scale (10-item) total score ranges from 0 to 40. Higher scores indicate greater perceived stress. |
| Patient Health Questionnaire for Adolescents (PHQ-A) | Baseline, 8 weeks, and 3 months | Change in depressive symptoms measured using the Patient Health Questionnaire for Adolescents (PHQ-A). Total scores range from 0 to 27. Higher scores indicate more severe depressive symptoms. |
| Generalized Anxiety Disorder 7-item Scale (GAD-7) | Baseline, 8 weeks, and 3 months | Change in anxiety measured using the Generalized Anxiety Disorder Scale (GAD-7). Total scores range from 0 to 21. Higher scores indicate more severe anxiety symptoms. |
| PROMIS Pediatric Peer Relationships Short Form | Baseline, 8 weeks, and 3 months | Change in peer relationships measured using the PROMIS Pediatric Peer Relationships Short Form. Scores are converted to standardized T-scores (mean = 50; standard deviation = 10). Higher T-scores indicate better peer relationships. |
| McMaster Family Assessment Device - General Functioning Subscale | Baseline, 8 weeks, and 3 months | Change in family functioning measured using the McMaster Family Assessment Device - General Functioning (FAD-GF). Mean scores range from 1.0 to 4.0. Higher scores indicate poorer family functioning. |
Countries
United States
Contacts
CONTACTSophia Ngenge, BS, MPH
PRINCIPAL_INVESTIGATORSarah E Messiah, MPH, PhD
University of Texas Southwestern Medical Center
Outcome results
None listed