Health Care TransitionBRIDGES-YAS!NCT07915479
Multi-level Intervention to Successfully Transition to Adult Care for Survivors of Childhood and Adolescent Cancers: The BRIDGES-YAS! Study
A study testing Structured Transition to PCP and Comparison Arm in people with Health Care Transition and Survivorship Care, run by Georgetown University at 3 sites in United States.
Trial summary
Although 95% of young adult childhood cancer survivors (YA CCS) will develop chronic health conditions, suboptimal transition to adult-oriented care leads to <20% receiving recommended lifelong survivorship care. Read more about this study
- Who is it for?
- Ages 18 to 26 years
- Conditions the study is for
- Health Care Transition, Survivorship Care, Survivors of Childhood Cancer
- What is being tested?
- Structured Transition to PCP and Comparison Arm
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Mar 2027to Aug 2030
- 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 18 to 26 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of cancer at age <19 years
- Current age 18-26.99 years (typical transition age for young adult childhood cancer survivors)
- History of chemotherapy and/or radiation
- ≥2 and <10 years post-completion of all cancer-related therapy (including oral chemotherapy)
- Cancer-free with a life expectancy of ≥2 years
- Followed at one of the 3 study sites (Yale University, University of Alabama at Birmingham, Children's Hospital Colorado)
Who cannot join
- Patients at the Children's Hospital Colorado study site who choose to participate in their cancer treatment center's structured, in-person transition program.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Monica M Gramatges, MD, PhD, (205) 638-2120, mmgramatges@uabmc.edu
Children's Hospital Colorado
Denver, Colorado, 80045
Jenna Demedis, MD, 720-777-6740, Jenna.Demedis@childrenscolorado.org
Yale University School of Medicine
New Haven, Connecticut, 06510
Rozalyn L Rodwin, MD, MHS, rozalyn.rodwin@yale.edu
About this study
Official title: Randomized Controlled Trial of a Remote, Multi-level Intervention to Successfully Transition to Adult Care for Survivors of Childhood and Adolescent Cancers: The BRIDGES-YAS! Study
Although 95% of young adult childhood cancer survivors (YA CCS) will develop chronic health conditions, suboptimal transition to adult-oriented care leads to <20% receiving recommended lifelong survivorship care. YA CCS survivorship follow-up care at the pediatric cancer treatment center is limited by organization- and patient-level barriers. This study overcomes these barriers by transitioning survivors to community adult primary care providers (PCPs) after orienting PCPs to survivors' individual survivorship care needs and educating YA CCS regarding health self-management/advocacy. This study includes a remote transition approach for YA survivorship care that leverages community PCPs, telehealth, and nurse navigators (NNs). BRIDGES-YAS! will investigate a novel, remote, multi-level intervention to transition YA CCS to community adult PCPs for a survivorship visit versus usual cancer treatment center (CTC) based follow-up care (plus educational handout about transition). The 1-year intervention includes: 1) tailored telehealth CCS education and resource navigation with self-management and self-advocacy skills training by a CTC NN, 2) brief, structured, interactive phone handoff by CTC NN to the community PCP conveying the CCS's individualized survivorship care needs, 3) secure electronic storage on CCS' smartphone (or other device) of Survivorship Care Plan and established health education materials, and 4) ongoing NN support and communication between CCS, CTC, and PCP. If successful, this intervention strategy could readily be deployed in cancer treatment centers to improve adult survivor access to quality, community-based survivorship care.
- Conditions
- Health Care Transition, Survivorship Care, Survivors of Childhood Cancer, Patient Navigation
- Being tested
- Structured Transition to PCP, Comparison Arm
- Keywords
- childhood cancer survivors, survivorship care, randomized controlled trial, young adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Transition to PCPBehavioural
Transition of young adult childhood cancer survivors (YA CCS) to adult primary care providers (PCPs) in the community for a survivorship care visit. The one-year intervention includes: I) Tailored, telehealth-supported CCS education regarding their Survivorship Care Plan that includes self-management and self-advocacy skills training and resource navigation by a cancer treatment center (CTC) nurse navigator (NN), II) Brief, interactive phone handoff by the CTC NN to the community PCP conveying the CCS' individualized survivorship care needs, III) Secure electronic storage of key health care materials (e.g., Survivorship Care Plan, health self-management tools) on the patient's smartphone, and IV) Ongoing CTC NN support and facilitation of communication between the patient, CTC, and PCP.
Comparison ArmBehavioural
Usual follow-up care as per their CTC in real world settings, including elements of recommended care such as the individualized Survivorship Care Plan and educational handout on transition to adult care.
| Study group | Role | What they receive |
|---|---|---|
| Structured Transition to primary care provider (PCP) | Experimental | Multi-level intervention including telehealth patient education by a nurse navigator (NN) from the patient's cancer treatment center (CTC), handoff from the CTC NN to the patient's primary care provider (PCP) conveying the patient's individualized survivorship care needs, secure electronic storage of established health care materials on the patient's smartphone, and ongoing CTC NN support and facilitation of communication between the patient, CTC, and PCP. Receives: Behavioral: Structured Transition to PCP |
| Usual Care | Active comparator | In-person visit at CTC survivorship clinic. Receives: Behavioral: Comparison Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Survivorship Care Composite Score
A single Quality of Survivorship Care Composite Score will be calculated from completion rates in 5 prioritized categories from the 2024 United States National Standards for Cancer Survivorship Care set forth by the National Cancer Institute: 1) physical effects, 2) chronic conditions, 3) new cancers (including genetic risk), 4) psychosocial effects (including financial hardship), and 5) health behaviors. Each category's completion rate will be converted to a z-score using the comparison arm's mean and standard deviation; the composite score is the average of the 5 z-scores, with higher scores indicating higher quality of care. Assessments include physical exam, history, tests, and/or referrals individualized to treatment exposures per the Children's Oncology Group Long-Term Follow-Up Guidelines Version 6.0, as delineated in the Survivorship Care Plan. Research staff not involved in patient care will abstract data and determine completion of recommended assessments.
Measured: 1 year post-randomization
Secondary outcomes (7)
Patient Self-Management and Self-Advocacy Skills, Measured by the Transition Readiness Assessment Questionnaire Version 5.0
Self-management and self-advocacy skills will be assessed with the validated 20-item Transition Readiness Assessment Questionnaire Version 5.0. The questionnaire includes 5 subscales: managing medications, appointment keeping, and tracking health issues (self-management), and talking with providers and managing daily activities (self-advocacy). Items are rated on a 5-point Likert scale, and the total score is the mean of all item responses (range 1 to 5). Higher scores indicate greater self-management and self-advocacy, respectively.
Measured: Baseline and 1 year post-randomization
Trust in Provider, Measured by the Wake Forest Physician Trust Scale
Trust in the provider delivering survivorship care will be assessed with the validated 10-item Wake Forest Physician Trust Scale. Items are rated on a 5-point Likert scale and summed for a total score (range 10 to 50). Higher values indicate greater trust.
Measured: Baseline and 1 year post-randomization
Feasibility of the Intervention, Measured by the Feasibility of Intervention Measure
Among participants randomized to the intervention arm, intervention feasibility will be assessed with the validated 4-item Feasibility of Intervention Measure. Items are rated on a 5-point Likert scale, and the total score is the mean of item responses (range 1 to 5). Higher scores indicate greater feasibility.
Measured: 1 year post-randomization
Acceptability of the Intervention, Measured by the Acceptability of Intervention Measure
Among participants randomized to the intervention arm, intervention acceptability will be measured using the validated 4-item Acceptability of Intervention Measure. Items are rated on a 5-point Likert scale, and the total score is the mean of item responses (range 1 to 5). Higher scores indicate greater acceptability.
Measured: 1 year post-randomization
Fidelity of Intervention
Fidelity will be measured as the percentage of the 4 intervention components delivered per protocol for each intervention-arm participant: telehealth education, the structured phone handoff to the primary care provider (PCP), smartphone storage of the Survivorship Care Plan, and ongoing nurse navigator support. Completion will come from nurse navigator and research staff tracking logs.
Measured: 1 year post-randomization
Cost of Survivorship Care
Cost of survivorship care during the study period will be estimated for each participant and compared between randomization arms. Costs will be combined into a single total per participant from three components: 1) Nurse navigator time, from nurse navigator time logs, 2) Survivorship care visit costs at the cancer treatment centers and primary care provider clinics, based on billing codes, reimbursement rates, time per patient, and additional services or staffing per visit, and 3) Participant-reported out-of-pocket survivorship care expenses, measured with the Costs for Patients Questionnaire. Higher values will indicate greater cost.
Measured: 1 year post-randomization
Perceived Financial Toxicity, Measured by the COmprehensive Score for financial Toxicity
Perceived financial toxicity will be assessed with the validated COmprehensive Score for financial Toxicity measure. Items are rated on a 5-point Likert scale and summed for a total score ranging from 0 to 44. Lower scores indicate greater financial toxicity.
Measured: Baseline and 1 year post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start9 Mar 2027 (estimated)
- Primary completionAug 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Care TransitionStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Colorado, Yale University, National Cancer Institute (NCI), University of Alabama at Birmingham, NYU Langone Health
- Responsible party
- Principal investigator, Nina Kadan-Lottick, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915479
- Sponsor's protocol ID
- The BRIDGES-YAS! Study
- Other IDs
- R01CA303073
- Acronym
- BRIDGES-YAS!
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study will include data from 240 young adult survivors of childhood cancer. Expected data: human medical record data and human self-reported data from surveys (including validated instruments). Data will be formatted in tabular comma-separared values (.csv) files. De-identified data will be deposited into the Harvard Dataverse repository.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of a Remote, Multi-level Intervention to Successfully Transition to Adult Care for Survivors of Childhood and Adolescent Cancers: The BRIDGES-YAS! Study
- ClinicalTrials.gov ID
- NCT07915479
- Acronym / sponsor ID
- BRIDGES-YAS! / The BRIDGES-YAS! Study
- Conditions
- Health Care Transition, Survivorship Care, Survivors of Childhood Cancer, Patient Navigation
- Keywords
- childhood cancer survivors, survivorship care, randomized controlled trial, young adults
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- Children's Hospital Colorado, Yale University, National Cancer Institute (NCI), University of Alabama at Birmingham, NYU Langone Health
- Study start
- 9 Mar 2027 (estimated)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 4 Nov 2026 (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.
Although 95% of young adult childhood cancer survivors (YA CCS) will develop chronic health conditions, suboptimal transition to adult-oriented care leads to <20% receiving recommended lifelong survivorship care. YA CCS survivorship follow-up care at the pediatric cancer treatment center is limited by organization- and patient-level barriers. This study overcomes these barriers by transitioning survivors to community adult primary care providers (PCPs) after orienting PCPs to survivors' individual survivorship care needs and educating YA CCS regarding health self-management/advocacy. This study includes a remote transition approach for YA survivorship care that leverages community PCPs, telehealth, and nurse navigators (NNs). BRIDGES-YAS! will investigate a novel, remote, multi-level intervention to transition YA CCS to community adult PCPs for a survivorship visit versus usual cancer treatment center (CTC) based follow-up care (plus educational handout about transition). The 1-year intervention includes: 1) tailored telehealth CCS education and resource navigation with self-management and self-advocacy skills training by a CTC NN, 2) brief, structured, interactive phone handoff by CTC NN to the community PCP conveying the CCS's individualized survivorship care needs, 3) secure electronic storage on CCS' smartphone (or other device) of Survivorship Care Plan and established health education materials, and 4) ongoing NN support and communication between CCS, CTC, and PCP. If successful, this intervention strategy could readily be deployed in cancer treatment centers to improve adult survivor access to quality, community-based survivorship care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured Transition to primary care provider (PCP) | Experimental | Behavioral: Structured Transition to PCPMulti-level intervention including telehealth patient education by a nurse navigator (NN) from the patient's cancer treatment center (CTC), handoff from the CTC NN to the patient's primary care provider (PCP) conveying the patient's individualized survivorship care needs, secure electronic storage of established health care materials on the patient's smartphone, and ongoing CTC NN support and facilitation of communication between the patient, CTC, and PCP. |
| Usual Care | Active comparator | Behavioral: Comparison ArmIn-person visit at CTC survivorship clinic. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Diagnosis of cancer at age <19 years
- Current age 18-26.99 years (typical transition age for young adult childhood cancer survivors)
- History of chemotherapy and/or radiation
- ≥2 and <10 years post-completion of all cancer-related therapy (including oral chemotherapy)
- Cancer-free with a life expectancy of ≥2 years
Key exclusion criteria (1 listed)
- Patients at the Children's Hospital Colorado study site who choose to participate in their cancer treatment center's structured, in-person transition program.
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 |
|---|---|---|
| Structured Transition to PCPTransition of young adult childhood cancer survivors (YA CCS) to adult primary care providers (PCPs) in the community for a survivorship care visit. The one-year intervention includes: I) Tailored, telehealth-supported CCS education regarding their Survivorship Care Plan that includes self-management and self-advocacy skills training and resource navigation by a cancer treatment center (CTC) nurse navigator (NN), II) Brief, interactive phone handoff by the CTC NN to the community PCP conveying the CCS' individualized survivorship care needs, III) Secure electronic storage of key health care materials (e.g., Survivorship Care Plan, health self-management tools) on the patient's smartphone, and IV) Ongoing CTC NN support and facilitation of communication between the patient, CTC, and PCP. | Behavioural | Structured Transition to primary care provider (PCP) |
| Comparison ArmUsual follow-up care as per their CTC in real world settings, including elements of recommended care such as the individualized Survivorship Care Plan and educational handout on transition to adult care. | Behavioural | Usual Care |
Primary outcome
Quality of Survivorship Care Composite Score
Time frame: 1 year post-randomization
A single Quality of Survivorship Care Composite Score will be calculated from completion rates in 5 prioritized categories from the 2024 United States National Standards for Cancer Survivorship Care set forth by the National Cancer Institute: 1) physical effects, 2) chronic conditions, 3) new cancers (including genetic risk), 4) psychosocial effects (including financial hardship), and 5) health behaviors. Each category's completion rate will be converted to a z-score using the comparison arm's mean and standard deviation; the composite score is the average of the 5 z-scores, with higher scores indicating higher quality of care. Assessments include physical exam, history, tests, and/or referrals individualized to treatment exposures per the Children's Oncology Group Long-Term Follow-Up Guidelines Version 6.0, as delineated in the Survivorship Care Plan. Research staff not involved in patient care will abstract data and determine completion of recommended assessments.
7 secondary outcomes
Patient Self-Management and Self-Advocacy Skills, Measured by the Transition Readiness Assessment Questionnaire Version 5.0
Time frame: Baseline and 1 year post-randomization
Trust in Provider, Measured by the Wake Forest Physician Trust Scale
Time frame: Baseline and 1 year post-randomization
Feasibility of the Intervention, Measured by the Feasibility of Intervention Measure
Time frame: 1 year post-randomization
Acceptability of the Intervention, Measured by the Acceptability of Intervention Measure
Time frame: 1 year post-randomization
Fidelity of Intervention
Time frame: 1 year post-randomization
Cost of Survivorship Care
Time frame: 1 year post-randomization
Perceived Financial Toxicity, Measured by the COmprehensive Score for financial Toxicity
Time frame: Baseline and 1 year post-randomization
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 4 Nov 2026.
- NIH Reporter listing of this funded study by the National Cancer InstituteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. This study will include data from 240 young adult survivors of childhood cancer. Expected data: human medical record data and human self-reported data from surveys (including validated instruments). Data will be formatted in tabular comma-separared values (.csv) files. De-identified data will be deposited into the Harvard Dataverse repository.
Related trials for Health Care Transition
Not yet recruiting
Prevention and Rapid Outreach for Treatment, Engagement, and Care Transition From the Emergency Department
Opioid Overdose Prevention, HIV Prevention and Care
Not yet recruiting
Optimizing Care Transitions in CHD
Congenital Heart Disease (CHD), Mentorship
Recruiting
Wichitasowin: Indigenous Patient Navigator for Young Adults Study
Chronic Diseases in Adolescence
Enrolling by invitation
Attitudes, Experience and Adaptation to Family Presence in the ICU
ICU Staff Attitudes Toward Family Presence, ICU Staff Experience of Family Presence
Active, not recruiting
Celiac Disease in Childhood-Adulthood Transition
Celiac Disease, Celiac Disease in Children
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Transition to PCP and Comparison Arm in people with Health Care Transition and Survivorship Care, run by Georgetown University at 3 sites 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 6 inclusion and 1 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: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Nina S Kadan-Lottick, MD, MSPH (202-444-7599, nk873@georgetown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Survivorship Care Composite Score (time frame: 1 year post-randomization). 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 4 Nov 2026.