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Trial record 1 of 1 for:    GOG 0259
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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:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00958698
First received: August 12, 2009
Last updated: August 1, 2017
Last verified: August 2017
August 12, 2009
August 1, 2017
January 2010
January 8, 2017   (Final data collection date for primary outcome measure)
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 ]
Severity, distress, consequences, and control of symptoms as measured by the Symptom Representation Questionnaire at baseline and at 4, 8, and 12 weeks
Complete list of historical versions of study NCT00958698 on ClinicalTrials.gov Archive Site
  • Barriers to symptom management as measured by the Symptom Management Barriers Questionnaire [ Time Frame: Baseline and at 4, 8, and 12 weeks ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Implementation and perceived effectiveness of new symptom management strategies assessed by questionnaire [ Time Frame: Baseline and at 4, 8, and 12 weeks ]
  • 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
  • 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
  • Barriers to symptom management as measured by the Symptom Management Barriers Questionnaire at baseline and at 4, 8, and 12 weeks
  • Communication with health care providers as measured at baseline and at 4, 8, and 12 weeks
  • Change, use, and effectiveness of symptom management strategies as measured at baseline and at 4, 8, and 12 weeks
  • Mini-assessment of non-target symptoms as measured at baseline, at 4, 8, and 12 weeks, and then every 4 weeks for 1 year
Not Provided
Not Provided
 
Symptom Management in Patients With Recurrent or Persistent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
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
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Fallopian Tube Carcinoma
  • Primary Peritoneal Carcinoma
  • Psychological Impact of Cancer
  • Recurrent Ovarian Carcinoma
  • 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 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.
    Interventions:
    • Other: Communication Intervention
    • Other: Educational Intervention
    • Other: Internet-Based Intervention
    • Procedure: Psychosocial Assessment and Care
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
  • 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.
    Interventions:
    • Other: Educational Intervention
    • Other: Internet-Based Intervention
    • Procedure: Psychosocial Assessment and Care
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
  • 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.
    Interventions:
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
480
Not Provided
January 8, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00958698
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 )
Not Provided
Not Provided
Not Provided
Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Heidi Donovan Gynecologic Oncology Group
Gynecologic Oncology Group
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP