Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03837132 |
| Other study ID # |
H2018:291 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 15, 2018 |
| Est. completion date |
June 30, 2021 |
Study information
| Verified date |
January 2022 |
| Source |
University of Manitoba |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The primary objective is to explore the impact of early palliative care on quality of life in
patients with advanced pancreatic cancer. The secondary objectives are to explore the impact
of early palliative care on symptom management, depression, anxiety and survival in patients
with advanced pancreatic cancer.
Description:
This is a prospective case-crossover study of patients with advanced pancreatic cancer (APC)
at CancerCare Manitoba (CCMB) with early palliative care (PALC) plus standard oncologic care.
The primary endpoint of this study is quality of life (QOL) at week 16, measured by the
Functional Assessment of Cancer Therapy - hepatobiliary (FACT-Hep). FACT-hep is a 45-item
tool, which measures physical, emotional, social and functional well-being, and has been
validated in a general population with hepatobiliary cancers, including metastatic pancreatic
cancer. FACT-Hep has strong psychometric properties, and is a reliable, comprehensive and
well-validated scale for use in patients with gastrointestinal cancers.
Secondary endpoints will include: (1) symptom control at 16 weeks as measured by the revised
Edmonton Symptom Assessment Scale (ESAS-r), (a widely used and validated tool to assess
symptom intensity, which is routinely completed by patients at all CCMB visits); (2)
depression and anxiety at 16 weeks using the Hospital Anxiety and Depression Scale (HADS),
(a-14 item scale which can be used in the outpatient setting to screen for anxiety and
depression within the previous week) and the Patient Health Questionnaire (PHQ-9), (a
sensitive (88%) and specific (88%) 9-question tool which incorporates diagnostic criteria for
major depression); and overall survival measured from date of registration to death.
Recruitment to the study will occur in a clinic staffed by medical oncologists with expertise
in gastrointestinal cancers, as this is the first point of entry into the CCMB system for
patients with APC.
Early PALC will consist of referral to PALC at the time of study enrollment. Patients will
undergo an initial consultation by the PALC team within two weeks of registration. Patients
enrolled in the study who are also receiving chemotherapy must have their initial PALC
consultation before receiving cycle 2 of chemotherapy. Baseline QoL questionnaires may be
completed any time between registration and the first PALC consultation. The PALC team will
be led by a physician with subspecialty training in PALC and an advanced practice nurse, with
the ability to involve other members of the team (dietician, pharmacist, social worker,
psychologist, psychiatrist, spiritual care, home care) as needed. The initial consultation by
the PALC team will consist of assessments as per guidelines set by the Canadian Hospice
Palliative Care Association. Patients will be followed by the PALC team at least every 2
weeks for the first month, then every 4 weeks until week 16, then at the discretion of the
PALC team thereafter. Follow-up PALC visits will occur in person or via telehealth
videoconference. A more intensive follow up regimen will occur early on, with a goal of
achieving symptom control, as APC related symptoms can result in emergency room visits and
hospitalizations. Patients will also receive regular oncologic follow up as directed by their
oncologist.
All patients will complete the FACT-hep, ESAS-r, HADS and PHQ-9 at baseline and every 4 weeks
until week 16. The data collected at these time points will provide a sense of the trajectory
of the patient experience and provide insights into the timing of interventions to improve
management of pain, symptoms, anxiety and depression in the future. Measuring QOL at these
various time points may also be useful in case we experience unexpected loss to follow up at
weeks 16, as it would provide data at intermediate time points for analysis.
Completion of QOL questionnaires will take patients approximately 15-20 minutes (10-15
minutes for FACT-hep), 1-2 minutes for ESAS, 2-3 minutes for HADS, and 1-2 minutes for
PHQ-9). Questionnaires will be completed in the outpatient clinic, at least 7 days after
receiving any chemotherapy to avoid conflation from chemotherapy side effects. All
questionnaires will be collected by a study coordinator, and the study coordinator will be
available to assist patients with questionnaire paperwork as needed. If a patient does not
have an oncology appointment, they may receive the questionnaires and a stamped return
envelope in the mail. If the questionnaires are not returned within 2 weeks, the study
coordinator will contact the patient via phone as a reminder. If necessary, the study
coordinator can complete these in an interview-style format over the telephone.
Patient and treatment characteristics will be captured at baseline, including: age, sex,
education level, height, weight, primary language spoken, Eastern Cooperative Oncology Group
(ECOG) performance status, comorbid illnesses (hypertension, dyslipidemia, diabetes, coronary
artery disease, cerebrovascular accident or transient ischemic attack, psychiatric illness,
other cancers), medications (prescribed, over the counter, alternative/complementary), use of
opioids for cancer related pain, weight loss, clinical stage (locally advanced,
unresectable/metastatic), site of primary tumour in pancreas (head or neck/body/tail), CA
19-9 (normal/elevated). Emergency room visits and hospitalizations while on study will be
captured. This data will be used to describe the study cohort. Data will be entered and
maintained in REDCap on the University of Manitoba's secure research environment.
Note: During the time of the COVID-19 response, patients are assessed over the phone by the
advanced practice nurse two days before their scheduled appointment to determine if in-person
visits are necessary. If in-person visits are necessary, follow up palliative care visits
will be done in clinic with only one support person allowed per patient and clinic visit time
limited to minimize any potential exposure time. In in-person visits not necessary, the
follow up palliative care visits are conducted over the phone until COVID-19 precautions are
lifted.
