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Effect of Outpatient Symptom Management on Gynecologic Oncology Patients Receiving Chemotherapy

NCT02786524CompletedNAINTERVENTIONAL

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.

Key Facts

Lead Sponsor

University of Michigan

Enrollment

107

Start Date

2016-02-15

Completion Date

2017-10-31

Study Type

INTERVENTIONAL

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

Interventions

Specialized Symptom Management and Supportive Care

Conditions

Uterine Cervical NeoplasmsOvarian NeoplasmsGynecologic NeoplasmsFallopian Tube NeoplasmsVulvar NeoplasmsVaginal NeoplasmsPeritoneal Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

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.

Time frame: Baseline and 3 months after study start

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.

Time frame: Baseline and 3 months after study start

Secondary Outcomes

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.

Time frame: Baseline

Change in Patient-Reported Distress

Measure changes in patient-reported distress using the NCCN Distress Thermometer

Time frame: 3 months after study start, 6 months after study start, and 9 months after study start

Change in Symptom Burden

Evaluate changes in patients' symptom burden with the ESAS-r to evaluate the ongoing sustained effect of the intervention.

Time frame: 6 months after study start and 9 months after study start

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.

Time frame: 6 months after study start and 9 months after study start

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.

Time frame: 9 months after study start

Overall Survival Rate

Overall survival will be compared between the two study arms.

Time frame: Upon study completion, an average of 1 year

Locations

University of Michigan Comprehensive Cancer Center, Ann Arbor, United States

Linked Diseases

Uterine Cervical Neoplasms

Uterine Cervical Neoplasms — a type of gynecological cancer.

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.

Vulvar Neoplasms

Vulvar Neoplasms — a type of gynecological cancer.

Vaginal Neoplasms

Vaginal Neoplasms — a type of gynecological cancer.