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Symptom Management for Ovarian Cancer
N/A
Waitlist Available
Led By Heidi Donovan
Research Sponsored by Gynecologic Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hair loss
Peripheral neuropathies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and at 4, 8, and 12 weeks
Awards & highlights
Study Summary
This trial is studying two different symptom management programs to see how well they work compared with usual care in patients with ovarian cancer.
Who is the study for?
This trial is for individuals with recurrent or persistent ovarian, fallopian tube, or primary peritoneal cancer. Participants must be experiencing at least three symptoms like pain, mood swings, or fatigue and have access to a computer and the Internet. They should be able to read/write in English and can have any performance status from 0-2.Check my eligibility
What is being tested?
The study compares two symptom management programs against usual care for patients with certain types of cancer. It aims to see which method better relieves symptoms caused by the disease or its treatment and improves life quality.See study design
What are the potential side effects?
Since this trial focuses on non-medical interventions like educational materials and psychosocial support rather than drugs, traditional side effects are not expected. However, participants may experience emotional discomfort when discussing their condition.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am experiencing hair loss.
Select...
I have nerve damage in my hands or feet.
Select...
I have a dry mouth.
Select...
I have a significantly reduced appetite or desire to eat.
Select...
I have a skin rash or redness and swelling of my palms or soles.
Select...
My ovarian, fallopian tube, or peritoneal cancer has come back or didn't go away after initial treatment.
Select...
I have mouth sores.
Select...
I have been diagnosed with depression.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and at 4, 8, and 12 weeks, and every 4 weeks for 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and at 4, 8, and 12 weeks, and every 4 weeks for 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Symptom severity, symptom-related distress, consequences, and control of symptoms as measured by the Symptom Representation Questionnaire
Secondary outcome measures
Barriers to symptom management as measured by the Symptom Management Barriers Questionnaire
Communication with health care providers and use of self-care strategies assessed by investigator-developed survey
Depressive symptoms as measured by the CES-D short form
+2 moreSide effects data
From 2022 Phase 3 trial • 87 Patients • NCT0206618173%
Fatigue
71%
Palmar-plantar erythrodysesthesia syndrome
63%
Hypertension
61%
Papulopustular rash
55%
Diarrhea
51%
Nausea
39%
Myalgia
37%
Alopecia
35%
Arthralgia
33%
Abdominal pain
31%
Anorexia
27%
Vomiting
22%
Mucositis oral
22%
Constipation
18%
Anemia
18%
Alanine aminotransferase increased
16%
Platelet count decreased
14%
Pruritus
14%
Hyperglycemia
14%
Rash maculo-papular
14%
Skin and subcutaneous tissue disorders - Other, specify
12%
Aspartate aminotransferase increased
12%
Rash acneiform
12%
Peripheral sensory neuropathy
10%
Investigations - Other, specify
10%
Dry skin
10%
Neutrophil count decreased
10%
Blood bilirubin increased
8%
Back pain
8%
Headache
8%
Nervous system disorders - Other, specify
8%
Pain in extremity
6%
General disorders and administration site conditions - Other, specify
6%
Skin infection
6%
White blood cell decreased
6%
Hypercalcemia
6%
Hypokalemia
6%
Musculoskeletal and connective tissue disorder - Other, specify
6%
Dizziness
6%
Respiratory, thoracic and mediastinal disorders - Other, specify
6%
Eye disorders - Other, specify
6%
Hyperkalemia
6%
Pain
6%
Alkaline phosphatase increased
6%
Hypocalcemia
6%
Cough
4%
Flushing
4%
Tinnitus
4%
Dental caries
4%
Gastrointestinal disorders - Other, specify
4%
Hemoglobin increased
4%
Weight loss
4%
Metabolism and nutrition disorders - Other, specify
4%
Dysgeusia
4%
Anxiety
4%
Irregular menstruation
4%
Menorrhagia
4%
Sore throat
4%
Lymphocyte count decreased
4%
Hyperuricemia
4%
Non-cardiac chest pain
4%
Infections and infestations - Other, specify
4%
Hypernatremia
4%
Hypoglycemia
4%
Scalp pain
4%
Dry mouth
2%
Blurred vision
2%
Acute kidney injury
2%
Hemorrhoids
2%
Hypothyroidism
2%
Urticaria
2%
Palpitations
2%
Leukocytosis
2%
Myocardial infarction
2%
Vertigo
2%
Anal hemorrhage
2%
Dysphagia
2%
Esophageal pain
2%
Periodontal disease
2%
Fever
2%
Sinusitis
2%
Urinary tract infection
2%
Bruising
2%
Dermatitis radiation
2%
Cholesterol high
2%
Creatinine increased
2%
Neck pain
2%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
2%
Concentration impairment
2%
Memory impairment
2%
Spasticity
2%
Depression
2%
Insomnia
2%
Allergic rhinitis
2%
Productive cough
2%
Sleep apnea
2%
Pregnancy, puerperium and perinatal conditions - Other, specify
2%
Dry eye
2%
Lymphedema
2%
Chest pain - cardiac
2%
Heart failure
2%
Gastric perforation
2%
Hypertriglyceridemia
2%
Dyspnea
2%
Cardiac disorders - Other, specify
2%
Gastroesophageal reflux disease
2%
Oral dysesthesia
2%
Chills
2%
Hypophosphatemia
2%
Chest wall pain
2%
Psychiatric disorders - Other, specify
2%
Hematuria
2%
Urinary tract obstruction
2%
Dysmenorrhea
2%
Skin hypopigmentation
2%
Unintended pregnancy
2%
Flu like symptoms
2%
Nail infection
2%
Pancreatitis
2%
Blood and lymphatic system disorders - Other, specify
2%
Oral pain
2%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Sorafenib Tosylate)
Arm II (Placebo)
Crossover Group
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (self-directed intervention module)Experimental Treatment5 Interventions
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.
Group II: Arm I (nurse-assisted intervention module)Experimental Treatment6 Interventions
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.
Group III: Arm III (standard care from local provider)Active Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psychosocial Assessment and Care
2007
Completed Phase 3
~370
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,668 Total Patients Enrolled
Gynecologic Oncology GroupLead Sponsor
250 Previous Clinical Trials
70,441 Total Patients Enrolled
Heidi DonovanPrincipal InvestigatorGynecologic Oncology Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience abdominal bloating or cramping.I experience nausea, vomiting, or diarrhea.I often feel very tired.I am experiencing hair loss.You have problems with your memory.I experience hot flashes.I am experiencing pain.I have nerve damage in my hands or feet.Your sexual orientation or preferences are not relevant for this study.I have experienced recent weight changes.I have 3 or more symptoms related to ovarian cancer or its treatment.I often feel very sleepy.I have a dry mouth.I experience shortness of breath.I have a significantly reduced appetite or desire to eat.I don't need to be currently receiving treatment or have active symptoms.I experience headaches.I have a skin rash or redness and swelling of my palms or soles.I experience dizziness.I have issues with urination.I experience mood swings.My ovarian, fallopian tube, or peritoneal cancer has come back or didn't go away after initial treatment.You have trouble sleeping.I am experiencing constipation.I have mouth sores.You have anxiety.I have been diagnosed with depression.
Research Study Groups:
This trial has the following groups:- Group 1: Arm III (standard care from local provider)
- Group 2: Arm II (self-directed intervention module)
- Group 3: Arm I (nurse-assisted intervention module)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there opportunities for individuals to join this medical investigation?
"According to clinicaltrials.gov, patient recruitment for this trial has concluded; the study was posted on January 19th 2010 and last modified March 8th 2019. However, there are 3293 other trials that still remain open to enrollment at present time."
Answered by AI
How many health centers in the state are engaged with this research?
"This clinical trial is utilizing several locations across the United States, including Methodist West Hospital in West Des Moines, Iowa, Palo Alto Medical Foundation-Gynecologic Oncology in Mountain View, California and Kansas City NCI Community Oncology Research Program in Prairie Village, Kansas."
Answered by AI
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