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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10+
SponsorUniversity of Texas Southwestern Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: SHINE InterventionExperimental treatment 1 intervention
Group B: Usual Supportive CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment Rate

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

Time frame
From study initiation through completion of participant enrollment (approximately 36 months).
2

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.

Time frame
Baseline through 3-month follow-up.
3

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).

Time frame
Baseline through completion of the 8-week intervention.
4

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.

Time frame
Immediately following the 8-week intervention

Secondary outcomes

1

Perceptions of Parental Illness Questionnaire for Cancer (PPIQ-C)

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.

Time frame
Baseline, 8 weeks, and 3 months
2

Communication Self-Efficacy Scale

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.

Time frame
Baseline, 8 weeks, and 3 months
3

Connor-Davidson Resilience Scale (CD-RISC-25) Total Score

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.

Time frame
Baseline, 8 weeks, and 3 months
4

Perceived Stress Scale (PSS-10)

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.

Time frame
Baseline, 8 weeks, and 3 months

Other outcomes

Sponsors and contacts

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