Multi-level Intervention to Successfully Transition to Adult Care for Survivors of Childhood and Adolescent Cancers: The BRIDGES-YAS! Study

Keywords

• childhood cancer survivors
• survivorship care
• randomized controlled trial
• young adults

Lead sponsor

Georgetown University is the lead sponsor of 292 studies on the registry; 40 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 20 (71%) have results posted.

Study arms

• Experimental
  Structured Transition to primary care provider (PCP)

  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.

  Behavioral: Structured Transition to PCP

• Active comparator
  Usual Care

  In-person visit at CTC survivorship clinic.

  Behavioral: Comparison Arm

Interventions

• BehavioralStructured Transition to PCP

  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.

• BehavioralComparison Arm

  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.

Primary outcomes

1. 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.

   Time frame: 1 year post-randomization

Secondary outcomes

1. 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.

   Time frame: Baseline and 1 year post-randomization

2. 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.

   Time frame: Baseline and 1 year post-randomization

3. 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.

   Time frame: 1 year post-randomization

4. 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.

   Time frame: 1 year post-randomization

5. 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.

   Time frame: 1 year post-randomization

6. 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.

   Time frame: 1 year post-randomization

7. 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.

   Time frame: Baseline and 1 year post-randomization

Related links

• NIH Reporter listing of this funded study by the National Cancer Institute ↗

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: After analysis and publication of data addressed in the aims set forth in R01CA303073.

Access criteria: De-identified data will be deposited into the Harvard Dataverse repository.