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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


N/A
18 Years
N/A
Open (Enrolling)
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer, Psychosocial Effects of Cancer and Its Treatment

Thank you

Trial Information

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


OBJECTIVES:

Primary

- 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

- 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.

- 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.

- 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.

- 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.

- 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

- 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.

- 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.

- 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.

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

- 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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

- GOG performance status 0-2

- Able to read and write English

- Access to computer and the Internet required

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Concurrent treatment on other clinical trials allowed

Type of Study:

Interventional

Study Design:

Allocation: Randomized

Outcome Measure:

Severity, distress, consequences, and control of symptoms as measured by the Symptom Representation Questionnaire at baseline and at 4, 8, and 12 weeks

Safety Issue:

No

Principal Investigator

Heidi Donovan, RN, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Pittsburgh

Authority:

Unspecified

Study ID:

CDR0000648729

NCT ID:

NCT00958698

Start Date:

January 2010

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • Psychosocial Effects of Cancer and Its Treatment
  • psychosocial effects of cancer and its treatment
  • recurrent ovarian epithelial cancer
  • recurrent fallopian tube cancer
  • recurrent primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

National Naval Medical CenterBethesda, Maryland  20889
MBCCOP - HawaiiHonolulu, Hawaii  96813
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut  06050
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
MetroHealth Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44109
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Marshfield Clinic - Indianhead CenterRice Lake, Wisconsin  54868
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
UMASS Memorial Cancer Center - University CampusWorcester, Massachusetts  01605-2982
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical CenterMilwaukee, Wisconsin  53201-2901
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
St. John's Regional Health CenterSpringfield, Missouri  65804
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Lake/University Ireland Cancer CenterMentor, Ohio  44060
Women and Infants Hospital of Rhode IslandProvidence, Rhode Island  02905
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Green Bay Oncology, Limited - EscanabaEscanaba, Michigan  49431
Dickinson County Healthcare SystemIron Mountain, Michigan  49801
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon BaySturgeon Bay, Wisconsin  54235
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota  55455
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Helen and Harry Gray Cancer Center at Hartford HospitalHartford, Connecticut  06102-5037
Elkhart General HospitalElkhart, Indiana  46515
Howard Community HospitalKokomo, Indiana  46904
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Cleveland Clinic Cancer Center at Fairview HospitalCleveland, Ohio  44111
Hillcrest Cancer Center at Hillcrest HospitalMayfield Heights, Ohio  44124
Cancer Care Associates - Saint Francis CampusTulsa, Oklahoma  74136-1929
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Morgan Cancer Center at Lehigh Valley Hospital - Cedar CrestAllentown, Pennsylvania  18105
UPMC Cancer CentersPittsburgh, Pennsylvania  15232
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des MoinesWest Des Moines, Iowa  50266
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Holy Family Memorial Medical Center Cancer Care CenterManitowoc, Wisconsin  54221-1450
Palo Alto Medical FoundationPalo Alto, California  94301
Western Pennsylvania Cancer Institute at Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224-1791
Michiana Hematology-Oncology, PC - ElkhartElkhart, Indiana  46514
Elkhart Clinic, LLCElkhart, Indiana  46514-2098
Michiana Hematology Oncology PC - La PorteLa Porte, Indiana  46350
Michiana Hematology-Oncology, PC - South BendMishawaka, Indiana  46545-1470
Michiana Hematology Oncology PC - PlymouthPlymouth, Indiana  46563
Menorah Medical CenterOverland Park, Kansas  66209
Saint Luke's Hospital - SouthOverland Park, Kansas  66213
Lakeside Cancer Specialists, PLLCSaint Joseph, Michigan  49085
Willmar Cancer Center at Rice Memorial HospitalWillmar, Minnesota  56201
Heartland Hematology Oncology Associates, IncorporatedKansas City, Missouri  64118
North Kansas City HospitalKansas City, Missouri  64116
Saint Luke's Cancer Institute at Saint Luke's HospitalKansas City, Missouri  64111
Research Medical CenterKansas City, Missouri  64132
Saint Luke's East - Lee's SummitLee's Summit, Missouri  64086
Heartland Regional Medical CenterSaint Joseph, Missouri  64506
Saint Joseph Oncology, IncorporatedSaint Joseph, Missouri  64507
Billings Clinic - DowntownBillings, Montana  59107-7000
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Marshfield Clinic Cancer Care at Regional Cancer CenterEau Claire, Wisconsin  54701
Marshfield Clinic - Lakeland CenterMinocqua, Wisconsin  54548
Marshfield Clinic - Weston CenterWeston, Wisconsin  54476
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Queen's Cancer Institute at Queen's Medical CenterHonolulu, Hawaii  96813
Parvin Radiation OncologyKansas City, Missouri  64116
Kapiolani Medical Center for Women and ChildrenHonolulu, Hawaii  96826
Cancer Center of Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
CCOP - Main Line HealthWynnewood, Pennsylvania  19096
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045
Minnesota Oncology - MaplewoodMaplewood, Minnesota  55109
Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
Lakeview HospitalStillwater, Minnesota  55082
Minnesota Oncology - WoodburyWoodbury, Minnesota  55125
CCOP - Kansas CityPrairie Village, Kansas  66208
Southwest Gynecologic Oncology Associates, IncorporatedAlbuquerque, New Mexico  87102
Aurora Women's Pavilion of West Allis Memorial HospitalWest Allis, Wisconsin  53227
University of New Mexico Cancer Center - SouthLas Cruces, New Mexico  88011
New Ulm Medical CenterNew Ulm, Minnesota  56073
Mercy Cancer Center - West LakesClive, Iowa  50325
Methodist West HospitalWest Des Moines, Iowa  50266-7700