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

Not Applicable

• Conditions: Recurrent Ovarian Carcinoma; Fallopian Tube Carcinoma; Primary Peritoneal Carcinoma; Psychological Impact of Cancer

• Registration Number: NCT00958698
• Lead Sponsor: Gynecologic Oncology Group

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2009-08-12
• Study First Submitted QC: 2009-08-12
• Study First Posted: 2009-08-13
• Study Start: 2010-01-19
• Primary Completion: 2017-01-08
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-08
• Last Update Posted: 2019-03-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 485

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
Communication with health care providers and use of self-care strategies assessed by investigator-developed survey	Baseline and at 4, 8, and 12 weeks
Implementation and perceived effectiveness of new symptom management strategies assessed by questionnaire	Baseline and at 4, 8, and 12 weeks
Barriers to symptom management as measured by the Symptom Management Barriers Questionnaire	Baseline and at 4, 8, and 12 weeks

Trial Locations

Locations (144)

Gynecologic Oncology Group of Arizona; 🇺🇸 Phoenix, Arizona, United States

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

UCLA / Jonsson Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

Palo Alto Medical Foundation-Gynecologic Oncology; 🇺🇸 Mountain View, California, United States

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

The Hospital of Central Connecticut; 🇺🇸 New Britain, Connecticut, United States

Queen's Medical Center; 🇺🇸 Honolulu, Hawaii, United States

University of Hawaii Cancer Center; 🇺🇸 Honolulu, Hawaii, United States

Kapiolani Medical Center for Women and Children; 🇺🇸 Honolulu, Hawaii, United States

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