Effect of Outpatient Symptom Management on Gynecologic Oncology Patients Receiving Chemotherapy

Ovarian Neoplasms Clinical Trial

Official title:

A Randomized Study to Evaluate the Effect of Outpatient Symptom Management on Symptom Burden in Advanced Stage or Recurrent Gynecologic Oncology Patients Receiving Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02786524
• Other study ID #: HUM00089412
• Status: Completed
• Phase: N/A
• Start date: February 15, 2016
• Est. completion date: October 31, 2017

Study information

• Verified date: March 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate whether formal referral to The Symptom Management and Supportive Care Clinic improves symptom burden in advanced stage or recurrent gynecologic oncology chemotherapy patients compared with symptom management performed by the primary gynecologic oncologist.

Description:

Patients with gynecologic malignancies often have a high prevalence of symptoms throughout their disease course including fatigue, pain, anxiety and depression. Palliative care is defined by the World Health Organization (WHO) as "an approach that improves the quality of life of 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."

The University of Michigan Symptom Management and Supportive Care Program works together with patient's oncology team to manage cancer related and treatment related symptoms. They offer a wide range of services including: pain and symptom management, medication management, nutritional counseling, expedited access to psychiatric oncology, anesthesia pain service and physical medicine and rehabilitation. Studies have demonstrated an improvement in quality of life, symptom burden and patient/care giver satisfaction when palliative care is part of routine oncologic care. Currently, in gynecologic oncology, palliative care is incorporated on a case by case basis, instead of in a standardized approach. We hope this study will provide a standardized tool to identify gynecologic oncology patients receiving chemotherapy who would benefit from a referral to a symptom management clinic.

This study will provide a screening mechanism to identify advanced stage or recurrent gynecologic oncology chemotherapy patients with palliative care needs and determine which symptom management option provides the best improvement in symptom burden, that performed by a specialty clinic staffed by providers formally trained in palliative care or that provided by the patient's gynecologic oncologist. This study has the potential to change practice by providing a triage tool that will identify patients that will most benefit from specialty palliative care services and could result in improved quality of life for our patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female

• 18 years of age or older

• Diagnosis of Stage III, IV, or recurrent gynecologic malignancy (Uterine, Ovarian, Cervical, Vulvar, Vaginal, Fallopian Tube, Primary Peritoneal)

• Receiving active intravenous, intraperitoneal, or oral chemotherapy

• Patient at University of Michigan Gynecologic Oncology Clinic

Exclusion Criteria:

• Male

• Less than 18 years of age

• Patients without a diagnosis of a gynecologic malignancy

• Patients not receiving intravenous, intraperitoneal or oral chemotherapy at the time of enrollment

• Patients receiving radiation therapy with chemo-sensitization.

Related Conditions & MeSH terms

• Fallopian Tube Neoplasms
• Genital Neoplasms, Female
• Gynecologic Neoplasms
• Neoplasms
• Ovarian Neoplasms
• Peritoneal Neoplasms
• Uterine Cervical Neoplasms
• Vaginal Neoplasms
• Vulvar Neoplasms

Intervention

Behavioral:
• Specialized Symptom Management and Supportive Care
Based on Patients who score 5 or higher on the Baseline Patient Palliative Care Survey that will identify patients that will most benefit from specialty palliative care

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Patient-Reported Symptom Burden as Determined by the Edmonton Symptom Assessment System	To determine if referral to a symptom management clinic improves the symptom burden quantified by the patients' Edmonton Symptom Assessment System (ESAS) scores.	Baseline and 3 months after study start
Primary	Change in Patient-Reported Symptom Burden as Determined by the National Comprehensive Cancer Network Distress Screening Tool	To determine if referral to a symptom management clinic improves the symptom burden quantified by the patients' National Comprehensive Cancer Network (NCCN) Distress Screening Tool scores.	Baseline and 3 months after study start
Secondary	Baseline Symptom Burden and Palliative Care Needs	To determine the baseline symptom burden and palliative care needs upon enrollment of patients with advanced stage or recurrent gynecologic malignancies receiving chemotherapy.	Baseline
Secondary	Change in Patient-Reported Distress	Measure changes in patient-reported distress using the NCCN Distress Thermometer	3 months after study start, 6 months after study start, and 9 months after study start
Secondary	Change in Symptom Burden	Evaluate changes in patients' symptom burden with the ESAS-r to evaluate the ongoing sustained effect of the intervention.	6 months after study start and 9 months after study start
Secondary	Change in Patient Adherence to Symptom Management Program	To analyze patients in the symptom management arms with a 3-item questionnaire to determine what factors are associated with adherence to a symptom management program.	6 months after study start and 9 months after study start
Secondary	Barriers to Symptom Management and Supportive Care	Analyze barriers that prevented patients from attending the Symptom Management and Supportive Care Clinic, as identified in a 3-item questionnaire.	9 months after study start
Secondary	Overall Survival Rate	Overall survival will be compared between the two study arms.	Upon study completion, an average of 1 year