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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00958698
First received: August 12, 2009
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

RATIONALE: Developing a symptom management plan may help relieve symptoms related to cancer or cancer treatment and help improve quality of life.

PURPOSE: 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.


Condition Intervention
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Psychosocial Effects of Cancer and Its Treatment
Other: communication intervention
Other: educational intervention
Other: internet-based intervention
Other: questionnaire administration
Other: study of socioeconomic and demographic variables
Procedure: assessment of therapy complications
Procedure: management of therapy complications
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment

Study Type: Interventional
Study Design: Allocation: Randomized
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

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Severity, distress, consequences, and control of symptoms as measured by the Symptom Representation Questionnaire at baseline and at 4, 8, and 12 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health-related quality of life as measured by the FACT-O at baseline, at 4, 8, and 12 weeks, and then every 4 weeks for 1 year [ Designated as safety issue: No ]
  • Depressive symptoms as measured by the CES-D short form at baseline, at 4, 8, and 12 weeks, and then every 4 weeks for 1 year [ Designated as safety issue: No ]
  • Barriers to symptom management as measured by the Symptom Management Barriers Questionnaire at baseline and at 4, 8, and 12 weeks [ Designated as safety issue: No ]
  • Communication with health care providers as measured at baseline and at 4, 8, and 12 weeks [ Designated as safety issue: No ]
  • Change, use, and effectiveness of symptom management strategies as measured at baseline and at 4, 8, and 12 weeks [ Designated as safety issue: No ]
  • Mini-assessment of non-target symptoms as measured at baseline, at 4, 8, and 12 weeks, and then every 4 weeks for 1 year [ Designated as safety issue: No ]

Estimated Enrollment: 480
Study Start Date: January 2010
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
  Hide Detailed Description

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00958698

  Show 145 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Heidi Donovan, RN, PhD University of Pittsburgh
  More Information

Additional Information:
No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00958698     History of Changes
Other Study ID Numbers: GOG-0259, CDR0000648729, NCI-2011-01950
Study First Received: August 12, 2009
Last Updated: August 19, 2013
Health Authority: United States: National Cancer Institute

Keywords provided by Gynecologic Oncology Group:
psychosocial effects of cancer and its treatment
recurrent ovarian epithelial cancer
recurrent fallopian tube cancer
recurrent primary peritoneal cavity cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases

ClinicalTrials.gov processed this record on April 17, 2014