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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00958698
Recruitment Status : Active, not recruiting
First Posted : August 13, 2009
Last Update Posted : March 12, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
GOG Foundation ( Gynecologic Oncology Group )

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Fallopian Tube Carcinoma Primary Peritoneal Carcinoma Psychological Impact of Cancer Recurrent Ovarian Carcinoma Other: Communication Intervention Other: Educational Intervention Other: Internet-Based Intervention Procedure: Psychosocial Assessment and Care Other: Quality-of-Life Assessment Other: Questionnaire Administration Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 485 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : January 19, 2010
Actual Primary Completion Date : January 8, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I (nurse-assisted intervention module)
Patients are given password-protected access to their own web-based message board to communicate with a research nurse. The nurse leads patients through WRITE Symptoms? intervention module, with personalized support and advice. 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.
 Other: Communication Intervention
Ancillary studies

Other: Educational Intervention
Ancillary studies
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

Other: Internet-Based Intervention
Ancillary studies

Procedure: Psychosocial Assessment and Care
Ancillary studies
Other Name: Psychosocial Care/Assessment

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies
Experimental: Arm II (self-directed intervention module)
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. 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.
 Other: Educational Intervention
Ancillary studies
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

Other: Internet-Based Intervention
Ancillary studies

Procedure: Psychosocial Assessment and Care
Ancillary studies
Other Name: Psychosocial Care/Assessment

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies
Active Comparator: Arm III (standard care from local provider)
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.
 Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. Symptom severity, symptom-related distress, consequences, and control of symptoms as measured by the Symptom Representation Questionnaire [ Time Frame: Baseline and at 4, 8, and 12 weeks ]

Secondary Outcome Measures :
  1. Health-related quality of life as measured by the FACT-O [ Time Frame: Baseline and at 4, 8, and 12 weeks, and every 4 weeks for 1 year ]
  2. Depressive symptoms as measured by the CES-D short form [ Time Frame: Baseline and at 4, 8, and 12 weeks, and every 4 weeks for 1 year ]
  3. Communication with health care providers and use of self-care strategies assessed by investigator-developed survey [ Time Frame: Baseline and at 4, 8, and 12 weeks ]
  4. Implementation and perceived effectiveness of new symptom management strategies assessed by questionnaire [ Time Frame: Baseline and at 4, 8, and 12 weeks ]
  5. Barriers to symptom management as measured by the Symptom Management Barriers Questionnaire [ Time Frame: Baseline and at 4, 8, and 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00958698


Locations
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Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Heidi Donovan Gynecologic Oncology Group
More Information
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Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00958698    
Other Study ID Numbers: GOG-0259
NCI-2011-01950 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000648729
GOG-0259 ( Other Identifier: Gynecologic Oncology Group )
GOG-0259 ( Other Identifier: DCP )
GOG-0259 ( Other Identifier: CTEP )
U10CA101165 ( U.S. NIH Grant/Contract )
First Posted: August 13, 2009    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms