NCT02578888

Palliative Care in Improving Quality of Life in Patients With High Risk Primary or Recurrent Gynecologic Malignancies

Early Palliative Medicine Intervention Using Idiographic Assessment for Women With High Risk Gynecologic Malignancies

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Albert Einstein College of Medicine · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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 .

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

Interventions

Type	Name	Description
OTHER	Palliative Therapy	Palliative Therapy
OTHER	Palliative Therapy + idiographic	Ancillary studies

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-05-01
• Completion: 2019-04-01
• First posted: 2015-10-19
• Last updated: 2019-09-17

Locations

1 site across 1 country: United States