Clinical trial NCT02578888: Palliative Care in Improving Quality of Life in Patients With High Risk Primary or Recurrent Gynecologic Malignancies
Official title: Early Palliative Medicine Intervention Using Idiographic Assessment for Women With High Risk Gynecologic Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Carcinoma
Ovarian Carcinoma
Primary Peritoneal Carcinoma
Recurrent Cervical Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Uterine Corpus Carcinoma
Recurrent Vulvar Carcinoma
Uterine Corpus Cancer
Vulvar Carcinoma
Peritoneal Neoplasms
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-10-19
Enrollment: 95
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized clinical trial studies a palliative care program in improving the quality of life of patients with high-risk gynecologic malignancies that is original or first tumor in the body (primary) or has come back (recurrent). Palliative care is care given to patients and their families facing the problems associated with life-threatening illness, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial and spiritual. Studying a palliative care program may help doctors learn more about patients quality of life, use of healthcare services, and the relief of pain.

Detailed description: PRIMARY OBJECTIVES:

I. Validate a model of proactive palliative medicine referral. II. Quantify the impact of palliative care aggressive care at the end-of-life (PCARE) versus PCARE + idiographic assessment on quality of care and patient satisfaction.

III. Utilizing CMO data Investigators will create a cost model for patients randomized to PCARE versus patients refusing randomization.

IV. Determine the impact of a proactive model of palliative care consultation at the time of diagnosis on family/caregivers.

OUTLINE: Patients are randomized 1 of 2 arms.

GROUP I (usual PCARE): Patients complete European Organization for Research and Treatment of Cancer quality of life-30 (EORTCQLQ-30) and Family Satisfaction with Advanced Cancer Care (FAMCARE) questionnaire every 6 weeks for 3 visits.

GROUP II: (usual PCARE + idiographic assessment): Patients complete EORTC QLQ-30, and FAMCARE questionnaire as in Group I and undergo idiographic assessment. Beginning within 4 weeks of their visit with the gynecologic oncologist, patients are referred to outpatient palliative medicine consultation.

After completion of study, patients are followed up periodically .

Eligibility criteria: Inclusion Criteria:

* Women with of primary or recurrent diagnosis of ovarian, uterine, peritoneal, cervical or vulvar cancer with any of the following:

  * \< 30 % projected 5 year survival based on histopathological stage
  * Non-pelvic recurrent malignancy
  * Persistent or progressive disease despite primary treatment with surgery, chemotherapy or
  * Palliative performance scale \< 60
* Enrollment within 6 weeks of tumor board review

Primary outcomes:
measure: Measure increased utilization (move from 18% to over 50%) of palliative medicine and increased proportion of patients receiving services more then 30 days before death as compared to historical controls.
timeFrame: Baseline
measure: Measured by differential in aggresive care at end-of-life from direct hospital costs in the last 6 months of life between patients that are randomized and refuse randomization.
timeFrame: Up to 3 years
measure: Evaluate costs related to procedures, laboratories, radiographic studies, intensive care admission, and blood transfusion to create a model of potential cost savings as generalized to patients with non-gynecologic cancers within the CMO.
timeFrame: Up to 3 years
measure: FAMCARE Survey will be administered, a 20 item scale measuring the degree to which family members are satisfied with the healthcare providers' behaviors. Comparison of family member scores between 2 arms, as well as at face value will be evaluated.
timeFrame: up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Nicole Nevadunsky
role: PRINCIPAL_INVESTIGATOR
References: