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

Albert Einstein College of Medicine logo

Albert Einstein College of Medicine

Status

Completed

Conditions

Vulvar Carcinoma
Recurrent Vulvar Carcinoma
Uterine Corpus Cancer
Primary Peritoneal Carcinoma
Peritoneal Neoplasms
Recurrent Ovarian Carcinoma
Recurrent Cervical Carcinoma
Ovarian Carcinoma
Recurrent Uterine Corpus Carcinoma
Cervical Carcinoma

Treatments

Other: Palliative Therapy + idiographic
Other: Palliative Therapy

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02578888
P30CA013330 (U.S. NIH Grant/Contract)
2014-4421 (Other Identifier)
NCI-2015-00729 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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 .

Enrollment

95 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

95 participants in 2 patient groups

Palliative Therapy
Active Comparator group
Description:
EORTCQLQ-30 and FAMCARE questionnaire every 6 weeks for 3 visits.
Treatment:
Other: Palliative Therapy
Other: Palliative Therapy + idiographic
Palliative Therapy+ idiographic
Experimental group
Description:
EORTC QLQ-30, and FAMCARE questionnaire every 6 weeks for 3 visits plus patients undergo idiographic assessment.
Treatment:
Other: Palliative Therapy
Other: Palliative Therapy + idiographic

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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