Improving Survivorship Care Through Enhanced Communication and Coordination: Pilot Study
Condition: Cancer
Study type: Interventional

Summary: 
      Purpose: Cancer survivorship is a high clinical and research priority both nationally and at
      the University of North Carolina. The investigators propose a randomized pilot study testing
      the development, implementation and evaluation of a parallel patient and streamlined provider
      version of a personalized Survivorship Care Plan (SCP) with lung cancer patients.

      Participants: 60 lung cancer patients at Rex Cancer Center.

      Procedures (methods): Participants will be recruited and randomized to the standard of care
      (30 patients) or intervention (30 patients) arm. Patients randomized to standard of care will
      receive a tailored survivorship care plan at the end of cancer treatment. Patients randomized
      to the intervention will receive a care plan and coordinating visit with their primary care
      provider. Patients will be invited to complete baseline and follow-up assessments regarding
      care needs and confidence in post cancer care.

      All patient primary care providers will receive condensed provider versions of the care plan.
      Providers will be asked to evaluate how the SCP and coordinated care visit (intervention
      only) facilitated communication and coordination of care.
    

Detailed description: 
      Eligible participants ending or recently ending treatment will be identified weekly by the
      Rex Care Coordinator. The Rex Care Coordinator will contact eligible patients before cancer
      treatment ends to schedule an exit interview and to describe the study, get permission to
      share contact information with the program manager (PM), and provide the written consent form
      to the patient.

      Two weeks prior to the scheduled exit interview, the PM will contact the patient to provide
      additional details about the study and obtain consent from the patient. The PM will mail
      baseline data collection measures to the patient to complete and bring to exit interview
      visit.

      The PM will contact the PCP of consented patients via email or letter informing them of their
      patient's participation in the study and inviting them to participate as well. Providers will
      receive a fact sheet about the study and a confidential email link to Qualtrics to complete
      surveys regarding patient survivorship care. Their participation in the survey will convey
      consent. The link will confirm provider name and that patient is seen by the provider. A
      separate link will allow the provider to enter responses and maintain separation of patient
      identifiers and responses.

      It is possible that PCPs may see multiple patients in our study, but this will not be the
      majority of PCPs. Providers will be asked to complete a survey for each patient. It is also
      possible providers may treat patients who are randomized to both arms. Because of the small
      sample size and the focus on feasibility, we will not limit PCPs to only see survivors in one
      group. The rate of this occurrence and preliminary data obtained from this pilot study will
      inform design/sample size calculations for the Phase III trial.

      At least one week prior to the scheduled exit interview, the Rex Research Nurse will be
      informed by the PM to develop the SCP using the JourneyForward™ template. The Rex Research
      Nurse will keep a log of how long it takes to complete the SCP and any issues that arise
      preparing them. Tailored SCPs will be developed for each eligible patient using the template
      based on information on the patient's medical and cancer records.

      When the patient comes to their post-treatment exit interview, their baseline surveys will be
      collected. Patients will receive a printed copy of their SCP during the post-treatment exit
      interview with the oncology nurse navigator, nurse practitioner or physician assistant. This
      visit will include a review of the SCP and any questions or concerns the patient may have.
      The PM will then randomize the patient, stratified by tumor type, to the standard of care arm
      (SCP alone) or the coordinated care visit arm (SCP + PCP visit).

      Standard of Care Arm:

      The patient's PCP will receive an abbreviated copy of the tailored SCP electronically (if
      accessible within the Electronic Medical Record (EMR)) or by mail. This abbreviated version
      contains the same treatment summary but a more concise care plan. No attempt to influence
      regularly scheduled appointments will be made but we will document if a visit does occur
      within the study window and the reason for it from patient's self-report.

      Intervention Arm:

      Patients randomized to the coordinated care visit arm will also have an appointment scheduled
      with their PCP by the research nurse within 4 weeks of the exit interview to review and
      discuss survivorship care. The patient's PCP will receive a copy of the abbreviated SCP
      electronically (if accessible within the EMR) or by mail along with suggested talking points
      about role clarity about what type of care the PCP will provide and when the patient should
      contact the PCP or their oncologist.

      At six weeks following the exit interview (two weeks after the visit to the PCP for the
      intervention group), the PM will contact all patients to complete the follow-up measures by
      mail or by phone. Six weeks following the exit interview, all patients' PCPs will be
      contacted via phone to complete the provider measures.
    

Intervention name(s): Survivorship Care Plan (SCP); Coordinated PCP visit
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Cancer Survivorship Care Plan (SCP) adapted from JourneyForward template. Each SCP is individualized to patient's care regimen. SCP is delivered at the conclusion of cancer treatment and during the patient's transition visit with nurse practitioner or physician assistant.; Visit with PCP scheduled on behalf of patient at the conclusion of cancer treatment and patient's transition visit.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: cancer survivorship care; provider communication; provider care coordination