Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05323409 |
| Other study ID # |
H-49731 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2022 |
| Est. completion date |
June 2025 |
Study information
| Verified date |
July 2023 |
| Source |
Baylor College of Medicine |
| Contact |
Hoda J. Badr, PhD |
| Phone |
7137981588 |
| Email |
hoda.badr[@]bcm.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Cancer survivors have unique healthcare needs including risk for serious late effects,
ongoing surveillance, lifestyle modifications to reduce second cancer risk, and psychosocial
support. Nearly 70% have at least one comorbid chronic condition in addition to cancer.
Comorbidities pose significant challenges to the delivery of quality cancer care because they
adversely affect and are affected by cancer treatment. Medically underserved patients have
the highest burden of multiple chronic conditions and are at increased risk for poor outcomes
during and after cancer treatment. As medically underserved cancer patients may lack
healthcare knowledge and access to supportive care, their health outcomes and care
transitions might be improved by enhancing communication and collaboration between their
oncologists and primary care providers (PCPs). This study tests and evaluates a novel shared
care model for cancer survivors with chronic comorbidities, called OPTIMISE (Oncology-Primary
Care Partnership to Improve Comprehensive Survivorship Care) in the largest safety-net
healthcare system in Houston, Texas. Three-hundred newly diagnosed breast, GI, and
hematological cancer patients who are being treated with curative intent and who have
comorbidities requiring ongoing management during cancer treatment will complete baseline
surveys and be randomized to either OPTIMISE or Usual Medical Care (UMC). Patients receiving
UMC will receive their cancer treatment, as directed by their oncologist, a survivorship care
plan (SCP) at the end of active treatment, and surveillance visits with their oncologist
based on national guidelines. Patients in OPTIMISE will 1) have an oncology nurse navigator
assigned to their care team at diagnosis to facilitate oncologist-PCP communication and
continuity of care; 2) receive coordinated care between their oncologist and PCP throughout
cancer treatment and surveillance facilitated by a structured communication and referral
process; 3) receive a survivorship care plan (SCP) at the end of treatment that incorporates
comorbidity management; and, 4) receive a risk-stratified shared care model of post-treatment
surveillance where one or more routine oncologist follow-up visits is replaced by a PCP
visit. Aim 1a evaluates the impact of OPTIMISE on patient chronic disease self-management
(primary outcome) and quality of life (secondary outcome). Aim 1b explores the effects of
OPTIMISE on healthcare use and patient unmet needs during and after active cancer treatment.
Aim 2 examines the effects of OPTIMISE on oncologist and PCP attitudes and coordination of
care. Aim 3 seeks to elucidate patient- and system-level factors that may influence
implementation outcomes. OPTIMISE shifts the timing of thinking about survivorship to point
of diagnosis and seeks to develop a clinical infrastructure to support continuity of care
from cancer diagnosis through post-treatment survivorship. If found effective, OPTIMISE could
be expanded to other cancers, igniting a potentially rich area of research. It may also have
significant downstream impact in other medical settings by enhancing care transitions from
specialty to primary care.
Description:
Design Overview. This is a randomized controlled trial of a consecutive sample of 300
medically underserved breast, GI, and hematological cancer patients with comorbidities
recruited from Harris Health Ben Taub Hospital and Smith Clinic. Randomization will divide
patients into two groups. The first is those receiving UMC.
The second is those receiving OPTIMISE. Grounded by the Collaborative Chronic Care Model
(CCM), OPTIMISE targets patients, providers, and systems of care. Key components are 1) a
bilingual ONN, 2) culturally tailored self management action planning, 3) a referral schedule
and structured communication between oncologists and PCPs, 3) an EHR generated SCP, and 4) a
risk stratified shared care model for cancer surveillance. Patients in both arms will
complete surveys at baseline (cancer treatment planning visit), during routine clinic visits
at 2 and 4 months after cancer treatment initiation/study enrollment, the time of SCP
delivery, and 3, 6, and 12 months after SCP delivery. Healthcare providers complete surveys
upon enrollment and study completion. We will also interview patients and providers to
understand experiences with comorbidity management and care transitions and identify
individual and system barriers to future adoption, implementation, and sustainability of
OPTIMISE. Recruitment and Baseline Assessment. Provider Recruitment. Before starting patient
recruitment, the research assistant (RA) will work with Drs. Mims and Lu to consent
oncologists and PCPs using a blanket consent. Reasons for refusal will be tracked. All
providers will complete a short baseline survey to assess collaboration, satisfaction with
comorbidity care management and care transitions. Patient Recruitment. New cancer patients
who are within 3 months of treatment initiation will complete medical history forms about
comorbidities, PCP status, distress, lifestyle behaviors, and weight and height at their
initial consult visit. The ONN will review these forms and notify the RA if a patient is
eligible. The research assistant will approach the patient at the initial consult visit,
introduce the study, and obtain informed consent. Then, at the next clinic visit for
treatment planning, consenting patients will be asked to complete the baseline survey on
tablet computers using REDCap in the waiting room. Surveys are brief (30 minutes) to minimize
burden. As wait times are usually more than 1 hour, patients should have ample time to
complete the survey. Patients will then be randomized to UMC or OPTIMISE. If patients do not
have a PCP and are randomized to OPTIMISE after completing the baseline survey, a
participating Smith Clinic PCP will be assigned to them by the ONN. Study Arms. UMC consists
of standard oncologic care from point of diagnosis. Cancer patients with comorbidities are
encouraged by their oncologist to follow up with their PCP regarding comorbidity management
but no formal referral process is in place. At the end of cancer treatment (~6 8 months for
those treated with standard, definitive therapies), patients meet with a nurse (Survivorship
Nurse Practitioner, NP) to review the SCP, which is populated from the electronic health
record. The Survivorship NP also reviews therapies received, recommended surveillance, common
late effects, and recommended lifestyle behaviors. Patients are given a printed copy of the
SCP and are encouraged to share this information with their PCP. Cancer surveillance follows
the traditional oncologist led model regardless of patient risk for recurrence. OPTIMISE
seeks to improve comprehensive care and outcomes for underserved cancer patients with
comorbidities from diagnosis to survivorship. It is based on IOM recommendations, our
preliminary data, and the Collaborative Chronic Care Model (CCM). The CCM seeks to optimize 6
elements of care 1) self management support, 2) provider decision support, 3) use of clinical
information systems, 4) delivery system redesign, 5) linkages to community resources, and 6)
organizational support. We chose the CCM because 1) it promotes supportive, evidence based
interactions between more empowered patients and more proactive healthcare teams, 2) elements
are flexibly implemented according to local needs and priorities, 3) it has been effective in
addressing disparities in chronic disease self management, and, 4) redesigning care using the
CCM improves patient care and outcomes. OPTIMISE components organized by CCM elements are
described below. Patient Self management Support. ONN care coordination. At the treatment
planning visit, the ONN will meet with the patient to 1) explain the navigator role, 2)
answer questions about cancer treatment and next steps, and, 3) provide a resource list of
hospital and community resources (e.g., counselors, translators) based on stated needs. The
ONN will also coordinate a referral to a Harris Health PCP for comorbidity management. The
ONN will follow up with the patient and PCP to ensure the visit occurs within 1 month of
referral. Distress screening. At the initial oncology consult, patients will complete the
NCCN Distress Thermometer and problem checklist. All distressed patients (scores greater than
5 out of 10) are referred to social work and receive a mental health resource list. For those
receiving OPTIMISE, the ONN will additionally notify the PCP so causes of distress can be
further explored and the patient connected to appropriate support resources. Culturally
tailored comorbidity self management action planning. After the patients initial PCP consult,
the ONN will review the PCPs progress notes in EPIC regarding the recommended comorbidity
management plan. The ONN will send a memo to the PCP via his or her EPIC mailbox requesting
clarifications as needed. Based on this, at the patients next routine oncology clinic visit,
the ONN and patient will collaborate on a comorbidity self management action plan. A brief
action planning approach will be employed whereby the patient identifies a specific,
actionable self management goal (e.g., diet change, medication adherence), actions to work
toward achieving the goal, possible barriers and solutions, where, how much, how often, and
when the action will occur, and how and when the patient will self check progress.
Action planning will be culturally tailored by the bilingual ONN through linguistic (i.e.,
action plan worksheet translation and delivery in English or Spanish), evidential (presenting
evidence on the importance of comorbidity management during cancer treatment), and
sociocultural strategies (i.e., integrating cultural values and religious beliefs when
addressing barriers and facilitators to behavior change). Afterwards, the ONN will check in
with the patient at his or her routine 2 and 4 month clinic visits to follow up on action
plan progress, address concerns, and confirm survey completion.
Culturally tailored survivorship action planning. After cancer treatment completion, as per
UMC, the Survivorship NP will schedule a transition review appointment where he or she will
review the SCP and educate patients about prevention and surveillance guidelines, long term
and late effects, and recommended lifestyle modifications. After this, the ONN will meet with
the patient to reinforce the SCP, and provide him or her with a referral to the PCP (to
conduct a physical exam, discuss any adjustments to the comorbidity management plan that may
be needed in light of cancer treatment completion, and coordinate specialty care referrals),
discuss different roles and responsibilities of the oncologist and PCP post treatment, and
provide the patient with hospital and community resources for cancer survivors. The ONN and
patient will collaborate to develop a culturally tailored survivorship self management action
plan. Afterwards, patients will complete the next scheduled assessment survey and the RA will
gauge patient interest in participating in an additional optional interview within 1 month of
SCP delivery. The purpose is to obtain a more in depth perspective regarding patient
knowledge and understanding of the SCP, unmet needs, and experiences with comorbidity
management during cancer treatment. Recruitment for the qualitative interviews will continue
until we have reached 30 patients (N=15 for each study arm) or saturation has been achieved.
Interviews will be conducted by phone, last 60 minutes, and be digitally recorded and
transcribed. Surveillance reminders and follow up. Patients will receive reminders of
upcoming surveillance visits via phone or text message to encourage adherence. The ONN will
meet with patients after their oncology surveillance visits to 1) ensure ongoing care
management with the PCP, 2) follow up on action plan progress, 3) answer questions, and 4)
confirm survey completion. After surveillance visits with the PCP, the ONN will review
progress reports and relevant test results, report them to the oncologist, and follow up by
sending a memo via EPIC to request clarifications if needed. Provider Decision Support.
Treatment plan and concerns. When the initial PCP referral is made, the ONN will send the PCP
treatment plan summary (based on the ASCO treatment plan template) and standardized fact
sheets on treatment toxicities that we will develop.
Bi directional and structured communication between oncologist and PCP. Throughout cancer
treatment, the ONN will be available to answer questions from PCP staff and facilitate prompt
communication between the oncologist and PCP as questions arise. As the number of PCP visits
will vary based on the patients comorbidity(ies), the ONN will review PCP progress notes in
EPIC every 2 months during treatment, collect data on comorbidity management using a
structured template with fields for the number of visits, progress notes, and relevant test
results, and inform the oncologist. If questions or concerns arise, the ONN will send a memo
to the PCPs EPIC mailbox requesting clarification. Using a similar structured template, the
ONN will send updates to the PCP regarding the patients cancer treatment progress and
relevant changes in the treatment plan. Surveillance guidelines and summary of late effects.
The ONN will send the SCP to the PCP via the EHR, along with a memo detailing surveillance
guidelines, oncologist concerns related to the management of treatment toxicities and late
effects, and recommendations for specialty care referrals (e.g., cardiology, nutrition,
physical therapy). The ONN will also field questions from PCP staff and ensure a prompt
response to PCP questions as they arise during the first year post treatment to facilitate
the transition of care. Clinical Information Systems. EHR enhancements. We will work with the
Harris Health EPIC Information Technology (IT) group to create and streamline templates for
treatment summaries and to generate standardized toxicity and concern lists to facilitate
coordination of care between oncologists and PCPs. EHR generated SCP. After treatment
completion, the oncologist will classify the patient as low , moderate or high risk for
recurrence based on the treatment received, presence and degree of persistent therapy
toxicity, presence and degree of organ dysfunction, and risk of developing serious late
effects. This will be entered in the EHR and used to populate surveillance visit
recommendations in the SCP.
Delivery System Redesign. OPTIMISE will adopt a risk stratified shared care model of post
treatment survivorship care. As patients typically see their oncologist for surveillance 4 5
times in the first year post treatment, OPTIMISE participants will undergo a risk stratified
shared care model in which a certain number of oncologist surveillance visits are replaced by
PCP visits. Low risk patients are those who had surgery only or chemotherapy that did not
include alkylating agents, anthracycline, bleomycin, or epipodophyllotoxin, no radiation, low
risk of recurrence, or mild or no persistent therapy toxicity. For low risk patients, two
oncologist visits will be replaced by PCP visits (at 3 and 9 months). Moderate risk patients
received an autologous stem cell transplant or a low or moderate dose of an alkylating agent,
anthracycline, bleomycin, epipodophyllotoxin, or radiation, who are at moderate risk of
recurrence, or experienced moderate persistent toxicity of therapy. For these patients, one
oncologist visit will be replaced by a PCP visit (at 6 months). Finally, high risk patients
received an allogenic stem cell transplant or high doses of an alkylating agent,
anthracycline, bleomycin, epipodophyllotoxin, or radiation, are at high risk of recurrence,
or experienced multi organ persistent therapy toxicity. These patients will receive all
surveillance visits from the oncologist (none replaced). All patients will complete follow up
surveys at 3, 6, and 12 months post SCP delivery in the clinic or by mail.
Linkages to Community Resources. Patients will receive resource lists linking them to
healthcare and community resources at diagnosis, during treatment, and at SCP delivery.
Provider interviews will elucidate opportunities for increased community linkages that will
inform future scale out efforts. Healthcare Organization Support. To inform strategies to
support future scale up, we will conduct interviews with providers to identify factors
affecting care coordination, SCP delivery, and care transitions.
