Hematopoietic and Lymphatic System NeoplasmNCT06941324
Solution-Focused Brief Therapy for Support of Psychological Distress in Adolescent and Young Adult Cancer Survivors
A study testing Behavioral Intervention, Best Practice and Communication Intervention in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 39 years
- Conditions the study is for
- Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Behavioral Intervention, Best Practice and Communication Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2025to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 15 - 39 years old
- Diagnosed with cancer
- Receiving active cancer care (6 weeks post initial diagnosis to control for emotional responses to normative stressors) or within 5 years of post-treatment survivorship
- Experiencing psychological distress (i.e., a t-score >= 57 on the Brief Symptom Inventory - 18 items [BSI-18])
- Fluent in English
Who cannot join
- End-of-life care
- > 5 years into the post-treatment survivorship
- Major physical challenges (e.g., hearing loss, developmental delay)
- Acute mental health conditions (e.g., active psychosis, suicide risk)
- Receiving or newly initiated psychotherapy for psychological distress during the study period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Cancer AnswerLine, 800-865-1125, CancerAnswerLine@med.umich.edu
Sunnye Mayes
About this study
Official title: SFBT for AYA Cancer Survivors' Psychological Distress: Evaluating Solution-Focused Brief Therapy as a Strength-Based Psychotherapeutic Intervention for Psychological Distress in Adolescents and Young Adults With Cancer
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.
Read the detailed description
07JUL2026- Amendment approved updating the study PI to Dr. Sunnye Mayes.
- Being tested
- Behavioral Intervention, Best Practice, Communication Intervention, Discussion, Health Promotion and Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy
Undergo SFBT-C
Best PracticeOther
Also called standard of care, standard therapy
Receive eTAU
Communication InterventionOther
Receive check in calls from clinician
DiscussionOther
Also called Discuss
Participate in discussions
Health Promotion and EducationOther
Receive educational manual
Health Promotion and EducationOther
Receive educational book
InterviewOther
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Best Practice; Other: Communication Intervention; Other: Health Promotion and Education; Other: Questionnaire Administration |
| 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. Receives: Behavioral: Behavioral Intervention; Other: Discussion; Other: Health Promotion and Education; Other: Interview; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline, immediate post-intervention, and 4 and 8 weeks post-intervention
Secondary outcomes (2)
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.
Measured: 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.
Measured: At baseline, immediate post-intervention, and 4 and 8 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start23 Jun 2025
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphatic System NeoplasmStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Cancer Research Fund
- Responsible party
- Sponsor
- Investigators
- Sunnye Mayes, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941324
- Sponsor's protocol ID
- UMCC 2024.086
- Other IDs
- NCI-2025-01196, HUM00254795
- Status last verified
- Jul 2026
- First submitted
- 15 Apr 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will share the study protocol, statistical analysis plan, and analytic codes after a reasonable request and with the discretion of the PI
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SFBT for AYA Cancer Survivors' Psychological Distress: Evaluating Solution-Focused Brief Therapy as a Strength-Based Psychotherapeutic Intervention for Psychological Distress in Adolescents and Young Adults With Cancer
- ClinicalTrials.gov ID
- NCT06941324
- Acronym / sponsor ID
- UMCC 2024.086
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- Children's Cancer Research Fund
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
07JUL2026- Amendment approved updating the study PI to Dr. Sunnye Mayes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (eTAU) | Active comparator | Other: Best Practice, Other: Communication Intervention, Other: Health Promotion and Education, Other: Questionnaire AdministrationPatients 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. |
| Supportive Care (SFBT-C) | Experimental | Behavioral: Behavioral Intervention, Other: Discussion, Other: Health Promotion and Education, Other: Interview, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 15 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 15 - 39 years old
- Diagnosed with cancer
- Receiving active cancer care (6 weeks post initial diagnosis to control for emotional responses to normative stressors) or within 5 years of post-treatment survivorship
- Experiencing psychological distress (i.e., a t-score >= 57 on the Brief Symptom Inventory - 18 items [BSI-18])
- Fluent in English
Key exclusion criteria (5 listed)
- End-of-life care
- > 5 years into the post-treatment survivorship
- Major physical challenges (e.g., hearing loss, developmental delay)
- Acute mental health conditions (e.g., active psychosis, suicide risk)
- Receiving or newly initiated psychotherapy for psychological distress during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral InterventionAlso: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior TherapyUndergo SFBT-C | Behavioural | Supportive Care (SFBT-C) |
| Best PracticeAlso: standard of care, standard therapyReceive eTAU | Other | Supportive Care (eTAU) |
| Communication InterventionReceive check in calls from clinician | Other | Supportive Care (eTAU) |
| DiscussionAlso: DiscussParticipate in discussions | Other | Supportive Care (SFBT-C) |
| Health Promotion and EducationReceive educational manual | Other | Supportive Care (SFBT-C) |
| Health Promotion and EducationReceive educational book | Other | Supportive Care (eTAU) |
| InterviewAncillary studies | Other | Supportive Care (SFBT-C) |
| Questionnaire AdministrationAncillary studies | Other | Supportive Care (SFBT-C), Supportive Care (eTAU) |
Primary outcome
Efficacy of solution-focused brief therapy in cancer survivors (SFBT-C)
Time frame: At baseline, immediate post-intervention, and 4 and 8 weeks post-intervention
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.
2 secondary outcomes
Patient's level of hope
Time frame: Baseline to 8 weeks
Quality of life
Time frame: At baseline, immediate post-intervention, and 4 and 8 weeks post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sunnye Mayes principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Intervention, Best Practice and Communication Intervention in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by University of Michigan Rogel Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cancer AnswerLine (1-800-865-1125, CancerAnswerLine@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of solution-focused brief therapy in cancer survivors (SFBT-C) (time frame: At baseline, immediate post-intervention, and 4 and 8 weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.