CancerNCT02111616
Improving Survivorship Care Through Enhanced Communication and Coordination: Pilot Study
A study testing Survivorship Care Plan (SCP) and Coordinated PCP visit in people with Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Cancer
- What is being tested?
- Survivorship Care Plan (SCP) and Coordinated PCP visit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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)
Who cannot join
- patient does not meet inclusion criteria
- patient diagnosed with metastatic cancer
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Survivorship Care Plan (SCP), Coordinated PCP visit
- Keywords
- cancer survivorship care, provider communication, provider care coordination
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survivorship Care Plan (SCP)Behavioural
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.
Coordinated PCP visitBehavioural
Visit with PCP scheduled on behalf of patient at the conclusion of cancer treatment and patient's transition visit.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SCP) | Active comparator | Patient will attend a transition visit at the conclusion of cancer treatment. Patient will receive an individualized cancer survivorship care plan based on their cancer type and treatment. Receives: Behavioral: Survivorship Care Plan (SCP) |
| Intervention Arm (SCP + PCP visit) | Experimental | Patient will attend a transition visit at the conclusion of cancer treatment. Patient will receive an individualized cancer survivorship care plan based on their cancer type and treatment.
SCP plus Coordinated PCP Visit: Care coordinators will schedule patient appointment with PCP within 4 weeks of treatment. Receives: Behavioral: Survivorship Care Plan (SCP); Behavioral: Coordinated PCP visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with increased patient confidence about Survivorship Care
To compare the change in confidence about survivorship care between patients who receive a coordinated care visit with their PCP (intervention group) compared to those who do not have this visit (control group). The project will use 8 questionnaires to assess changes in patient and provider confidence and patient concerns over the course of the study. The primary objective in this one year study is to compare changes in Confidence in Survivorship Information Questionnaire (CSI) scores among patients receiving the proposed standard of care survivorship care plan (30 patients) to patients receiving care plans and a coordinated PCP visit (30 patients) to determine whether the delivery of tailored SCPs increases the confidence of survivors in receiving post treatment cancer care.
Measured: Up to six weeks
Secondary outcomes (2)
Patient Activation Score
To compare changes in survivor concerns, activation, perspective on care coordination, expectations and satisfaction between intervention and control group as measured by Patient Activation Measure (PAM).
Measured: Up to 6 weeks
Number of providers with increased confidence about survivorship
To compare the change in confidence about survivorship care between PCPs who were 1) only assigned survivors in the control group, 2) only assigned survivor in the coordinated care visit and 3) who were assigned both types of survivors. This information will be captured via questionnaires.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startDec 2013
- Primary completionMay 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Participant
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
- Investigators
- Deborah K. Mayer, PhD, RN, Principal investigator, University of North Carolina, Chapel HillDonald L Rosenstein, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111616
- Sponsor's protocol ID
- UNC HENC LCCC 1325
- Status last verified
- Jan 2016
- First submitted
- 10 Jan 2014
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Survivorship Care Through Enhanced Communication and Coordination: Pilot Study
- ClinicalTrials.gov ID
- NCT02111616
- Acronym / sponsor ID
- UNC HENC LCCC 1325
- Conditions
- Cancer
- Keywords
- cancer survivorship care, provider communication, provider care coordination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Study start
- Dec 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 11 Apr 2014 (estimated)
- 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SCP) | Active comparator | Behavioral: Survivorship Care Plan (SCP)Patient will attend a transition visit at the conclusion of cancer treatment. Patient will receive an individualized cancer survivorship care plan based on their cancer type and treatment. |
| Intervention Arm (SCP + PCP visit) | Experimental | Behavioral: Survivorship Care Plan (SCP), Behavioral: Coordinated PCP visitPatient will attend a transition visit at the conclusion of cancer treatment. Patient will receive an individualized cancer survivorship care plan based on their cancer type and treatment. SCP plus Coordinated PCP Visit: Care coordinators will schedule patient appointment with PCP within 4 weeks of treatment. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- >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-
Key exclusion criteria (2 listed)
- patient does not meet inclusion criteria
- patient diagnosed with metastatic cancer
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 |
|---|---|---|
| Survivorship Care Plan (SCP)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. | Behavioural | Intervention Arm (SCP + PCP visit), Standard of Care (SCP) |
| Coordinated PCP visitVisit with PCP scheduled on behalf of patient at the conclusion of cancer treatment and patient's transition visit. | Behavioural | Intervention Arm (SCP + PCP visit) |
Primary outcome
Number of participants with increased patient confidence about Survivorship Care
Time frame: Up to six weeks
To compare the change in confidence about survivorship care between patients who receive a coordinated care visit with their PCP (intervention group) compared to those who do not have this visit (control group). The project will use 8 questionnaires to assess changes in patient and provider confidence and patient concerns over the course of the study. The primary objective in this one year study is to compare changes in Confidence in Survivorship Information Questionnaire (CSI) scores among patients receiving the proposed standard of care survivorship care plan (30 patients) to patients receiving care plans and a coordinated PCP visit (30 patients) to determine whether the delivery of tailored SCPs increases the confidence of survivors in receiving post treatment cancer care.
2 secondary outcomes
Patient Activation Score
Time frame: Up to 6 weeks
Number of providers with increased confidence about survivorship
Time frame: Up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
- Journey Forward is a program for healthcare providers and patients who have recently completed active treatment for cancer.Link provided by the sponsor.
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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. This study is not recruiting at the moment.
Deborah K. Mayer, PhD, RN principal investigator
University of North Carolina, Chapel Hill
Donald L Rosenstein, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survivorship Care Plan (SCP) and Coordinated PCP visit in people with Cancer, run by UNC Lineberger Comprehensive 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 20 Jan 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with increased patient confidence about Survivorship Care (time frame: Up to six weeks). 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 20 Jan 2016; AzTrials last refreshed its copy on 1 Nov 2026.