Quality-of-Life Assessment for Fallopian Tube Cancer
Palo Alto Medical Foundation-Gynecologic Oncology, Mountain View, CA
Targeting 4 different conditionsQuality-of-Life Assessment +5 moreN/AWaitlist AvailableLed by Heidi DonovanResearch Sponsored by Gynecologic Oncology GroupEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Constipation
Anorexia
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow upsbaseline and at 4, 8, and 12 weeks
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Fallopian Tube Cancer
- Psychological Impact of Cancer
- Primary Peritoneal Carcinoma
- Recurrent Ovarian Cancer
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You experience difficulty or infrequent bowel movements.
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You have a loss of appetite or trouble eating.
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You experience frequent and extreme changes in your mood.
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You have sores in your mouth.
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You are experiencing pain.
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Your sexual orientation or preferences are not relevant for this study.
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You have trouble sleeping.
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You have difficulty breathing.
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You have a skin rash or a condition called palmar-plantar erythrodysesthesia (which causes redness and discomfort on the palms and soles of your feet).
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You have problems with your bladder or urination.
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You have anxiety.
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You experience frequent episodes of feeling dizzy.
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You feel very sleepy or are often tired.
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You have a condition called dry mouth.
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You experience hair loss.
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You experience frequent and intense episodes of feeling very hot.
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You are currently experiencing depression.
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You have been diagnosed with ovarian, fallopian tube, or primary peritoneal cancer that has come back or continued after the initial treatment.
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You have frequent or severe headaches.
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You must have at least three symptoms related to ovarian cancer or its treatment. These symptoms can include, but are not limited to, the following:
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You experience bloating or cramping in your stomach area.
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You experience frequent feelings of sickness in your stomach, throwing up, or having loose bowel movements.
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You experience extreme tiredness or lack of energy.
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You have problems with your memory.
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You have nerve problems in your hands or feet.
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You have experienced significant changes in your weight, either gaining a lot of weight or losing a lot of weight.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow ups ~ baseline and at 4, 8, and 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow ups ~ baseline and at 4, 8, and 12 weeks
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%
Constipation
22%
Mucositis oral
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%
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%
Flushing
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%
Palpitations
2%
Acute kidney injury
2%
Leukocytosis
2%
Myocardial infarction
2%
Vertigo
2%
Hypothyroidism
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%
Hemorrhoids
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%
Urticaria
2%
Unintended pregnancy
2%
Flu like symptoms
2%
Nail infection
2%
Pancreatitis
2%
Blood and lymphatic system disorders - Other, specify
2%
Blurred vision
2%
Oral pain
2%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Sorafenib Tosylate)
Arm II (Placebo)
Crossover Group
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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 site
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,368 Previous Clinical Trials
41,215,582 Total Patients Enrolled
Gynecologic Oncology GroupLead Sponsor
250 Previous Clinical Trials
70,438 Total Patients Enrolled
Heidi DonovanPrincipal Investigator
Gynecologic Oncology GroupMedia Library
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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