Improving Survivorship Care Through Enhanced Communication and Coordination: Pilot Study
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - 90 |
| Updated: | 4/21/2016 |
| Start Date: | December 2013 |
| End Date: | August 2015 |
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.
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.
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.
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.
Inclusion Criteria:
- >21 years
- Able to read and speak English will be eligible to participate
- Diagnosed with a smoking-related cancer (initial accrual priority is lung cancer,
followed by head and neck, esophageal and cervical cancer)
- Treated at Rex Cancer Center for cancer
- Completed treatment within the past three months-
- Have a designated primary care provider (PCP)
Exclusion Criteria:
- patient does not meet inclusion criteria
- patient diagnosed with metastatic cancer
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