Effect of Outpatient Symptom Management on Gynecologic Oncology Patients Receiving Chemotherapy

NCT02786524 | Completed DMC

• 1 other identifier: HUM00089412
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uterine Cervical Neoplasms; Ovarian Neoplasms; Gynecologic Neoplasms; Fallopian Tube Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms; Peritoneal Neoplasms

Keywords

Palliative Care; Triage; Symptom Evaluation; Chemotherapy; Patient Distress

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Baseline Symptom Burden and Palliative Care Needs

  Baseline

• Change in Patient-Reported Distress

  3 months after study start, 6 months after study start, and 9 months after study start

• Change in Symptom Burden

  6 months after study start and 9 months after study start

• Change in Patient Adherence to Symptom Management Program

  6 months after study start and 9 months after study start

• Barriers to Symptom Management and Supportive Care

  9 months after study start

Study Arms (2)

Standard of Care

NO INTERVENTION

Patients randomized to this arm receive standard symptom management care by their primary gynecologic oncologist and complete the NCCN distress thermometer and ESAS-r at each visit, every 3-4 weeks.

Symptom Management and Supportive Care

EXPERIMENTAL

Patients randomized to this arm are referred to a specialized symptom management and supportive care clinic and seen within two weeks. Patients will be seen in follow-up as recommended by the symptom management providers, and at each visit they will complete the ESAS-r and NCCN distress thermometer and return their responses either in person or by mail to the study team in a pre-addressed postage paid envelope.

Behavioral: Specialized Symptom Management and Supportive Care

Interventions

Specialized Symptom Management and Supportive Care BEHAVIORAL

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

Symptom Management and Supportive Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

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

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases; Vulvar Diseases; Vaginal Diseases; Abdominal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Katherine Harris, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Carolyn M Johnston, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gynecologic Oncology Fellow

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: June 1, 2016
• Study Start: February 15, 2016
• Primary Completion: October 31, 2017
• Study Completion: October 31, 2017
• Last Updated: March 21, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)