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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-01196 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| HUM00254795 | Other Identifier | University of Michigan |
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| Name | Class |
|---|---|
| Children's Cancer Research Fund | OTHER |
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This clinical trial evaluates the how well a virtually delivered solution-focused brief therapy (SFBT-C) works to decrease adolescent and young adult cancer survivors' psychological distress in comparison to enhanced treatment-as-usual care. Cancer and its treatment can have immediate and long-term impacts on adolescent and young adult cancer survivor's lives, including education and employment, financial stability, sexual health, and social, romantic, and family relationships. Consequently, many adolescent and young adult cancer survivors report psychological distress, often manifesting as depression and anxiety, and may benefit from psychotherapy to improve their engagement with medical treatment and overall quality of life. SFBT-C is a theory-driven and brief hope-based psychotherapy designed for the unique psychosocial needs facing adolescent and young adult cancer survivors. Undergoing SFBT-C may work better than treatment-as-usual care for the support of psychological distress in adolescent and young adult cancer survivors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive Care (eTAU) | Active Comparator | Patients receive eTAU and receive an educational book to address emotional challenges associated with cancer and strategies and resources to address these challenges over 4-8 weeks on study. Additionally, patients receive check in calls from clinicians QW to answer any questions patients may have about the book. |
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| Supportive Care (SFBT-C) | Experimental | Patients undergo virtual SFBT sessions over 30 minutes each QW over 4-8 weeks on study. Patients also receive an educational manual and participate in discussions after each session on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Intervention | Behavioral | Undergo SFBT-C |
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| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of solution-focused brief therapy in cancer survivors (SFBT-C) | The primary analysis will be a linear regression model with the change score from baseline (T1) to 4 weeks post-intervention completion (T3) in participants' Brief Symptom Inventory, 18-item (BSI-18) t-score as the dependent variable, the intervention assignment, and the randomization strata (age and sex) as the independent variables, i.e., covariates to control for. | At baseline, immediate post-intervention, and 4 and 8 weeks post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's level of hope | Will be measured using Snyder's Hope Scale (SHS). Will use structural equation modeling (in Mplus) to perform mediation analysis. The primary analysis will be a simple mediation model with the T1 to 8 weeks post-intervention (T4) BSI-18 change score as the dependent variable, treatment assignment as the independent variable, and SHS at immediate post-intervention (T2) as the mediator. An estimated indirect effect (i.e., joint significance testing with bootstrapped standard error) will be computed, and its corresponding 95% confidence interval will determine if hope is a significant treatment mediator. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cancer AnswerLine | Contact | 1-800-865-1125 | CancerAnswerLine@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Anao Zhang | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Comprehensive Cancer Center | Recruiting | Ann Arbor | Michigan | 48109 | United States |
We will share the study protocol, statistical analysis plan, and analytic codes after a reasonable request and with the discretion of the PI
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| Best Practice | Other | Receive eTAU |
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| Communication Intervention | Other | Receive check in calls from clinician |
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| Discussion | Other | Participate in discussions |
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| Health Promotion and Education | Other | Receive educational manual |
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| Health Promotion and Education | Other | Receive educational book |
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| Interview | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Baseline to 8 weeks |
| Quality of life | Measured by Patient Reported Outcomes Measurement Information System-29 Profile version 2.0. The primary analysis will be a linear regression model with the change score from T1 to T3 (4-week post) in participants' BSI-18 t-score as the dependent variable, the intervention assignment, and the randomization strata (age and sex) as the independent variables, i.e., covariates to control for. | At baseline, immediate post-intervention, and 4 and 8 weeks post intervention |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D006293 | Health Promotion |
| D004522 | Educational Status |
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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