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Purpose

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.

Conditions

Eligibility

Eligible Ages
All ages
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Palliative Therapy 		EORTCQLQ-30 and FAMCARE questionnaire every 6 weeks for 3 visits.
  • Other: Palliative Therapy
    Palliative Therapy
    Other names:
    • Palliative Care
    • Symptom Management
  • Other: Palliative Therapy + idiographic
    Ancillary studies
    Other names:
    • Quality of Life Assessment
Experimental
Palliative Therapy+ idiographic 		EORTC QLQ-30, and FAMCARE questionnaire every 6 weeks for 3 visits plus patients undergo idiographic assessment.
  • Other: Palliative Therapy
    Palliative Therapy
    Other names:
    • Palliative Care
    • Symptom Management
  • Other: Palliative Therapy + idiographic
    Ancillary studies
    Other names:
    • Quality of Life Assessment

More Details

Status
Completed
Sponsor
Albert Einstein College of Medicine

Study Contact

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 .

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.