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

NCT07751185 | Not Yet Recruiting

• 1 other identifier: STU20251757
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Psychological Distress; Adaptation, Psychological

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

Outcome Measures

Primary Outcomes (4)

• Recruitment Rate

  Recruitment rate will be defined as the percentage of eligible families who enroll in the study.

  From study initiation through completion of participant enrollment (approximately 36 months).

• Retention Rate

  Retention rate will be defined as the percentage of enrolled families who complete all planned study assessments through the 3-month follow-up.

  Baseline through 3-month follow-up.

• Intervention Adherence Rate

  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).

  Baseline through completion of the 8-week intervention.

• Participant Satisfaction and Acceptability Questionnaire Total Score

  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.

  Immediately following the 8-week intervention

Secondary Outcomes (8)

• 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

Study Arms (2)

SHINE Intervention

EXPERIMENTAL

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.

Behavioral: SHINE Psychosocial Intervention

Usual Supportive Care

ACTIVE COMPARATOR

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.

Behavioral: Usual Supportive Care

Interventions

SHINE Psychosocial Intervention BEHAVIORAL

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.

SHINE Intervention

Usual Supportive Care BEHAVIORAL

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.

Usual Supportive Care

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Simmons Comprehensive Cancer Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Sarah E Messiah, MPH, PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophia Ngenge, BS, MPH

CONTACT

214-645-8226; Sophia.Ngenge@UTSouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Epidemiology; Associate Dean for Research, Peter O'Donnell Jr. School of Public Health, The University of Texas Southwestern Medical Center

Model Details: 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.

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 7, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning approximately 12 months after publication of the primary study results and continuing for up to 5 years following publication.
• Access Criteria: De-identified data will be made available to qualified researchers whose proposed use of the data has been reviewed and approved by the study investigators and is consistent with participant consent, institutional policies, and applicable regulations. Data will be shared under an appropriate data use agreement.

Locations

US (1)