Symptom Management in Patients With Recurrent or Persistent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

Recurrent Ovarian Carcinoma Clinical Trial

Official title:

NURSE-DELIVERED WRITE SYMPTOMS vs. SELF-DIRECTED WRITE SYMPTOMS vs. CARE AS USUAL FOR OPTIMAL SYMPTOM MANAGEMENT FOR WOMEN WITH RECURRENT OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00958698
• Other study ID #: GOG-0259
• Secondary ID: NCI-2011-01950CD
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 19, 2010

Study information

• Verified date: March 2019
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized clinical trial is studying two different symptom management programs to see how well they work compared with usual care in patients with recurrent or persistent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. Developing a symptom management plan may help relieve symptoms related to cancer or cancer treatment and help improve quality of life.

Description:

PRIMARY OBJECTIVE:

I. Compare the efficacy of nurse-delivered WRITE Symptoms? and self-directed WRITE Symptoms? vs usual care interventions in improving target symptom representations (i.e., decreases in symptom severity, symptom-related distress, and symptom consequences as measured by the Symptom Representation Questionnaire [SRQ]) in patients with recurrent or persistent ovarian, fallopian tube, or primary peritoneal cancer.

SECONDARY OBJECTIVES:

I. Compare the efficacy of nurse-delivered WRITE Symptoms? vs self-directed WRITE Symptoms? vs usual care interventions in improving target symptom representations in these patients at 4 weeks.

II. Compare the efficacy of nurse-delivered WRITE Symptoms? vs self-directed WRITE Symptoms? vs usual care interventions in improving target symptom controllability in these patients at 4, 8, and 12 weeks.

III. Compare the efficacy of nurse-delivered WRITE Symptoms? vs self-directed WRITE Symptoms? vs usual care interventions in improving indicators of quality of life (QOL) of these patients as measured by the FACT-O and the CES-Depression inventory short form at 4, 8, and 12 weeks.

IV. Compare the efficacy of nurse-delivered WRITE Symptoms? vs self-directed WRITE Symptoms? vs usual care interventions in improving communication with health care providers about symptoms, implementation of new symptom management strategies (health care provider recommended as well as patient-initiated changes), and perceived effectiveness of strategies (health care provider recommended as well as patient-initiated changes) in these patients at 4, 8, and 12 weeks.

V. Compare the efficacy of nurse-delivered WRITE Symptoms? vs self-directed WRITE Symptoms? vs usual care interventions in improving patient-related barriers to symptom management as measured by the Symptom Management Barriers Questionnaire at 4, 8, and 12 weeks.

EXPLORATORY OBJECTIVES:

I. Compare trajectories of change for overall symptom severity in patients undergoing nurse-delivered WRITE Symptoms? vs self-directed WRITE Symptoms? vs usual care interventions using monthly assessments to explore potential long-term effects of the WRITE Symptoms? interventions.

II. Compare trajectories of change for QOL of patients undergoing nurse-delivered WRITE Symptoms? vs self-directed WRITE Symptoms? vs usual care interventions using monthly assessments to explore potential long-term effects of the WRITE Symptoms? interventions.

III. Compare trajectories of change for symptom severity, distress, communication, and implementation of new strategies for non-targeted symptoms in patients undergoing nurse-delivered WRITE Symptoms? vs self-directed WRITE Symptoms? vs usual care interventions using monthly assessments to explore whether patients are able to generalize the symptom management approaches taught in WRITE Symptoms? interventions to their other non-targeted symptoms.

IV. Explore whether changes in symptom representations mediate changes in QOL of these patients at 8 and 12 weeks.

V. Explore whether effects of the WRITE Symptoms? interventions on primary and secondary endpoints at 8 and 12 weeks differ based on the following patient characteristics assessed at baseline: age, education, and ethnicity; depression as measured by the CES-D short form; trait anxiety as measured by the STAI; optimism as measured by the LOT-R; social support as measured by the ISEL; and symptom severity as measured by the SRQ.

OUTLINE: This is a multicenter study. Patients are stratified according to race/ethnicity (non-Hispanic white vs Hispanic or non-white). Patients are randomized to 1 of 3 intervention arms.

ARM I (nurse-delivered intervention): Patients are given password-protected access to their own web-based message board to communicate with a research nurse. The nurse leads the patient through the WRITE Symptoms? intervention module comprising representational assessment; exploring concerns/misconceptions/gaps/confusions; creating conditions for conceptual change; introducing new information, goal setting, and development of a symptom management plan; and summary via asynchronous postings to the patient's message board. Patients work through 3 selected symptoms using the nurse-delivered WRITE Symptoms? intervention module over approximately 4 weeks. Two weeks later, the patient's symptom management strategy and their desire to make further changes are evaluated by additional interaction with the nurse via the message board. The nurse will encourage the patient to try new selected strategies, continue with effective strategies, and work with local health care providers in an ongoing process to improve symptom management. Patients are given access to a resource guide that includes self-care guides for 26 symptoms. They are encouraged to use the same process taught for their 3 selected symptoms for any other symptoms that arise after the course of the intervention.

ARM II (self-directed intervention): Patients are given password-protected access to an interactive web-based computer program that will lead them through a modified WRITE Symptoms? intervention module (comprising the same elements as in arm I) without guidance and individualized recommendations from a nurse. Patients work through 3 selected symptoms using the WRITE Symptoms? intervention module over approximately 4 weeks. Two weeks later, patients are prompted by the computer program to respond to questions about their symptom management strategy and their desire to make further changes. The program will generate an encouragement for the patient to try new selected strategies, continue with effective strategies, and continue the new approach to symptom management with local health care providers in an ongoing process to improve symptom management. Patients are given access to a resource guide that includes self-care guides for 26 symptoms. They are encouraged to use the same process taught for their 3 selected symptoms for any other symptoms that arise after the course of the intervention.

ARM III (usual care): Patients are given password-protected access to online questionnaires. Patients are prompted monthly to complete online questionnaires. Patients receive standard symptom management from their local health care providers.

In all arms, patients complete online questionnaires to assess outcome measures at baseline, at 4, 8, and 12 weeks, and then every 4 weeks for 1 year.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 485
• Est. primary completion date: January 8, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of ovarian, fallopian tube, or primary peritoneal cancer that has recurred or persisted following primary therapy

• Active disease or current treatment are not required

• Must be experiencing ? 3 symptoms associated with ovarian cancer or cancer treatment, including, but not limited to, any of the following:

• Abdominal bloating or cramping

• Nausea, vomiting, or diarrhea

• Constipation

• Anorexia

• Anxiety

• Depression

• Dizziness

• Drowsiness

• Dry mouth

• Fatigue

• Headaches

• Hair loss

• Hot flashes

• Memory concerns

• Mood swings

• Mouth sores

• Pain

• Peripheral neuropathies

• Sexuality concerns

• Sleep disturbances

• Shortness of breath

• Skin rash or palmar-plantar erythrodysesthesia

• Urinary problems

• Weight gain or loss

• GOG performance status 0-2

• Able to read and write English

• Access to computer and the Internet required

• Concurrent treatment on other clinical trials allowed

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Ovarian Epithelial
• Fallopian Tube Carcinoma
• Fallopian Tube Neoplasms
• Ovarian Neoplasms
• Primary Peritoneal Carcinoma
• Psychological Impact of Cancer
• Recurrent Ovarian Carcinoma

Intervention

Other:
• Communication Intervention
Ancillary studies
• Educational Intervention
Ancillary studies
• Internet-Based Intervention
Ancillary studies

Procedure:
• Psychosocial Assessment and Care
Ancillary studies

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Cleveland Clinic Akron General	Akron	Ohio
United States	Summa Akron City Hospital/Cooper Cancer Center	Akron	Ohio
United States	Southwest Gynecologic Oncology Associates Inc	Albuquerque	New Mexico
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico
United States	Lehigh Valley Hospital-Cedar Crest	Allentown	Pennsylvania
United States	University of Colorado Hospital	Aurora	Colorado
United States	Johns Hopkins University/Sidney Kimmel Cancer Center	Baltimore	Maryland
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Billings Clinic Cancer Center	Billings	Montana
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Island Gynecologic Oncology	Brightwaters	New York
United States	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania
United States	Fairview Ridges Hospital	Burnsville	Minnesota
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Case Western Reserve University	Cleveland	Ohio
United States	Cleveland Clinic Cancer Center/Fairview Hospital	Cleveland	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	Medical Oncology and Hematology Associates-West Des Moines	Clive	Iowa
United States	Mercy Cancer Center-West Lakes	Clive	Iowa
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	Mercy Hospital	Coon Rapids	Minnesota
United States	Miami Valley Hospital	Dayton	Ohio
United States	Decatur Memorial Hospital	Decatur	Illinois
United States	Iowa Lutheran Hospital	Des Moines	Iowa
United States	Iowa Methodist Medical Center	Des Moines	Iowa
United States	Iowa-Wide Oncology Research Coalition NCORP	Des Moines	Iowa
United States	Medical Oncology and Hematology Associates-Des Moines	Des Moines	Iowa
United States	Medical Oncology and Hematology Associates-Laurel	Des Moines	Iowa
United States	Mercy Medical Center - Des Moines	Des Moines	Iowa
United States	Wayne State University/Karmanos Cancer Institute	Detroit	Michigan
United States	Marshfield Clinic Cancer Center at Sacred Heart	Eau Claire	Wisconsin
United States	Fairview-Southdale Hospital	Edina	Minnesota
United States	Elkhart Clinic	Elkhart	Indiana
United States	Elkhart General Hospital	Elkhart	Indiana
United States	Michiana Hematology Oncology PC-Elkhart	Elkhart	Indiana
United States	Green Bay Oncology - Escanaba	Escanaba	Michigan
United States	Unity Hospital	Fridley	Minnesota
United States	Spectrum Health at Butterworth Campus	Grand Rapids	Michigan
United States	Green Bay Oncology at Saint Vincent Hospital	Green Bay	Wisconsin
United States	Green Bay Oncology Limited at Saint Mary's Hospital	Green Bay	Wisconsin
United States	Saint Vincent Hospital Cancer Center at Saint Mary's	Green Bay	Wisconsin
United States	Saint Vincent Hospital Cancer Center Green Bay	Green Bay	Wisconsin
United States	Hartford Hospital	Hartford	Connecticut
United States	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii
United States	Queen's Medical Center	Honolulu	Hawaii
United States	University of Hawaii Cancer Center	Honolulu	Hawaii
United States	The Methodist Hospital System	Houston	Texas
United States	Hutchinson Area Health Care	Hutchinson	Minnesota
United States	Indiana University/Melvin and Bren Simon Cancer Center	Indianapolis	Indiana
United States	University of Iowa/Holden Comprehensive Cancer Center	Iowa City	Iowa
United States	Green Bay Oncology - Iron Mountain	Iron Mountain	Michigan
United States	Borgess Medical Center	Kalamazoo	Michigan
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Heartland Hematology and Oncology Associates Incorporated	Kansas City	Missouri
United States	North Kansas City Hospital	Kansas City	Missouri
United States	Providence Medical Center	Kansas City	Kansas
United States	Research Medical Center	Kansas City	Missouri
United States	Saint Joseph Health Center	Kansas City	Missouri
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri
United States	Truman Medical Center	Kansas City	Missouri
United States	Community Howard Regional Health	Kokomo	Indiana
United States	IU Health La Porte Hospital	La Porte	Indiana
United States	Memorial Medical Center - Las Cruces	Las Cruces	New Mexico
United States	Saint Luke's East - Lee's Summit	Lee's Summit	Missouri
United States	Liberty Radiation Oncology Center	Liberty	Missouri
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin
United States	Holy Family Memorial Hospital	Manitowoc	Wisconsin
United States	Minnesota Oncology Hematology PA-Maplewood	Maplewood	Minnesota
United States	Saint John's Hospital - Healtheast	Maplewood	Minnesota
United States	Bay Area Medical Center	Marinette	Wisconsin
United States	Marshfield Medical Center-Marshfield	Marshfield	Wisconsin
United States	Hillcrest Hospital Cancer Center	Mayfield Heights	Ohio
United States	UH Seidman Cancer Center at Lake Health Mentor Campus	Mentor	Ohio
United States	Aurora Saint Luke's Medical Center	Milwaukee	Wisconsin
United States	Abbott-Northwestern Hospital	Minneapolis	Minnesota
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	University of Minnesota/Masonic Cancer Center	Minneapolis	Minnesota
United States	Marshfield Clinic-Minocqua Center	Minocqua	Wisconsin
United States	Michiana Hematology Oncology PC-Mishawaka	Mishawaka	Indiana
United States	Saint Joseph Regional Medical Center-Mishawaka	Mishawaka	Indiana
United States	Palo Alto Medical Foundation-Gynecologic Oncology	Mountain View	California
United States	The Hospital of Central Connecticut	New Britain	Connecticut
United States	New Ulm Medical Center	New Ulm	Minnesota
United States	Lakeland Hospital Niles	Niles	Michigan
United States	Saint Vincent Hospital Cancer Center at Oconto Falls	Oconto Falls	Wisconsin
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Nebraska Methodist Hospital	Omaha	Nebraska
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Menorah Medical Center	Overland Park	Kansas
United States	Saint Luke's South Hospital	Overland Park	Kansas
United States	Paoli Memorial Hospital	Paoli	Pennsylvania
United States	Gynecologic Oncology Group of Arizona	Phoenix	Arizona
United States	University of Pittsburgh Cancer Institute (UPCI)	Pittsburgh	Pennsylvania
United States	UPMC-Magee Womens Hospital	Pittsburgh	Pennsylvania
United States	West Penn Hospital	Pittsburgh	Pennsylvania
United States	Michiana Hematology Oncology PC-Plymouth	Plymouth	Indiana
United States	Kansas City NCI Community Oncology Research Program	Prairie Village	Kansas
United States	Women and Infants Hospital	Providence	Rhode Island
United States	Marshfield Medical Center-Rice Lake	Rice Lake	Wisconsin
United States	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia
United States	North Memorial Medical Health Center	Robbinsdale	Minnesota
United States	William Beaumont Hospital-Royal Oak	Royal Oak	Michigan
United States	Heartland Regional Medical Center	Saint Joseph	Missouri
United States	Lakeland Medical Center Saint Joseph	Saint Joseph	Michigan
United States	Marie Yeager Cancer Center	Saint Joseph	Michigan
United States	Saint Joseph Oncology Inc	Saint Joseph	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Metro Minnesota Community Oncology Research Consortium	Saint Louis Park	Minnesota
United States	Park Nicollet Clinic - Saint Louis Park	Saint Louis Park	Minnesota
United States	Regions Hospital	Saint Paul	Minnesota
United States	United Hospital	Saint Paul	Minnesota
United States	Saint Francis Regional Medical Center	Shakopee	Minnesota
United States	Shawnee Mission Medical Center-KCCC	Shawnee Mission	Kansas
United States	CHRISTUS Highland Medical Center	Shreveport	Louisiana
United States	Memorial Hospital of South Bend	South Bend	Indiana
United States	Michiana Hematology Oncology PC-South Bend	South Bend	Indiana
United States	Northern Indiana Cancer Research Consortium	South Bend	Indiana
United States	South Bend Clinic	South Bend	Indiana
United States	CoxHealth South Hospital	Springfield	Missouri
United States	Memorial Medical Center	Springfield	Illinois
United States	Mercy Hospital Springfield	Springfield	Missouri
United States	Lakeview Hospital	Stillwater	Minnesota
United States	Green Bay Oncology - Sturgeon Bay	Sturgeon Bay	Wisconsin
United States	Oklahoma Cancer Specialists and Research Institute-Tulsa	Tulsa	Oklahoma
United States	Carle Cancer Center	Urbana	Illinois
United States	Ridgeview Medical Center	Waconia	Minnesota
United States	Aurora West Allis Medical Center	West Allis	Wisconsin
United States	Mercy Medical Center-West Lakes	West Des Moines	Iowa
United States	Methodist West Hospital	West Des Moines	Iowa
United States	Marshfield Clinic - Weston Center	Weston	Wisconsin
United States	Michiana Hematology Oncology PC-Westville	Westville	Indiana
United States	Rice Memorial Hospital	Willmar	Minnesota
United States	Minnesota Oncology Hematology PA-Woodbury	Woodbury	Minnesota
United States	University of Massachusetts Medical School	Worcester	Massachusetts
United States	University of Massachusetts Memorial Health Care	Worcester	Massachusetts
United States	Lankenau Medical Center	Wynnewood	Pennsylvania
United States	Main Line Health NCORP	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom severity, symptom-related distress, consequences, and control of symptoms as measured by the Symptom Representation Questionnaire		Baseline and at 4, 8, and 12 weeks
Secondary	Health-related quality of life as measured by the FACT-O		Baseline and at 4, 8, and 12 weeks, and every 4 weeks for 1 year
Secondary	Depressive symptoms as measured by the CES-D short form		Baseline and at 4, 8, and 12 weeks, and every 4 weeks for 1 year
Secondary	Communication with health care providers and use of self-care strategies assessed by investigator-developed survey		Baseline and at 4, 8, and 12 weeks
Secondary	Implementation and perceived effectiveness of new symptom management strategies assessed by questionnaire		Baseline and at 4, 8, and 12 weeks
Secondary	Barriers to symptom management as measured by the Symptom Management Barriers Questionnaire		Baseline and at 4, 8, and 12 weeks