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Telephone Counseling for Depression in Ovarian Cancer Patients
Phase 1
Waitlist Available
Led By Eileen H. Shinn, PhD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Oriented to time, person, and place
Diagnosis of major depressive disorder, dysthymic disorder, adjustment disorder with depressed mood, minor depression, major depression in partial remission, or recurrent brief depressive disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline assessment repeated at four months, and completion of first chemotherapy regimen for newly diagnosed ovarian, peritoneal, or fallopian tube cancer patients.
Awards & highlights
Study Summary
This trial is testing a new way to identify and treat depression in women with ovarian cancer.
Who is the study for?
This trial is for women over 18 with ovarian, peritoneal, or fallopian tube cancer who are currently receiving treatment. They must speak English at a 7th grade level, be mentally oriented, have a certain level of physical functioning (Zubrod status of 0-2), and consent to participate. They should also be diagnosed with some form of depression but not bipolar disorder or psychosis.Check my eligibility
What is being tested?
The study aims to identify an effective method for detecting depression in patients with specific types of cancer. It compares the effectiveness of telephone counseling versus 'enhanced' usual care in improving life quality for these patients.See study design
What are the potential side effects?
Since this trial involves behavioral interventions like telephone counseling rather than medications, typical drug side effects are not expected. However, participants may experience emotional discomfort discussing personal issues during sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am aware of the current time, who I am, and where I am.
Select...
I have been diagnosed with a form of depression.
Select...
I am currently being treated for ovarian, peritoneal, or fallopian tube cancer.
Select...
I am 18 years old or older.
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I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline assessment repeated at four months, and completion of first chemotherapy regimen for newly diagnosed ovarian, peritoneal, or fallopian tube cancer patients.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline assessment repeated at four months, and completion of first chemotherapy regimen for newly diagnosed ovarian, peritoneal, or fallopian tube cancer patients.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient Responses to Questionnaire Assessment of Depression Measures
Side effects data
From 2016 Phase 3 trial • 300 Patients • NCT0200856538%
Constipation
10%
Urinary tract infection
8%
Abdominal pain
8%
Fall
7%
Abdominal distension
7%
Diarrhoea
6%
Nausea
6%
Headache
6%
Back pain
3%
Upper respiratory tract infection
2%
Osteoarthritis
1%
Pulmonary embolism
1%
Anaemia
1%
Haemorrhoids
1%
Ventricular tachycardia
1%
Ankle fracture
1%
Vascular pseudoaneurysm
1%
Hyperglycaemia
1%
Transient ischaemic attack
1%
Chronic obstructive pulmonary disease
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo - Education Only
Loperamide - Education Only
Loperamide - Exercise Plus Biofeedback
Placebo - Exercise Plus Biofeedback
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Usual Care GroupExperimental Treatment1 Intervention
Lists of professional resources and referral recommendations will be provided.
Group II: Intervention GroupActive Control1 Intervention
Weekly phone calls lasting about 30 minutes. Lists of professional resources and referral recommendations will be provided.
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,040 Total Patients Enrolled
46 Trials studying Ovarian Cancer
16,336 Patients Enrolled for Ovarian Cancer
Lance Armstrong FoundationOTHER
9 Previous Clinical Trials
642 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,237 Total Patients Enrolled
285 Trials studying Ovarian Cancer
73,299 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently being treated for ovarian, peritoneal, or fallopian tube cancer.I am 18 years old or older.I have been diagnosed with a form of depression.I am aware of the current time, who I am, and where I am.I have been diagnosed with bipolar disorder or psychosis.I can take care of myself and am up and about more than half of my waking hours.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Group
- Group 2: Usual Care Group
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 participants still being admitted to this experiment?
"As indicated by clinicaltrials.gov, this trial is not presently accepting patients for participation. Initially posted on December 20th 2002 and last updated September 22nd 2022, the study has ceased recruitment; however, 1828 other trials are currently available to join."
Answered by AI
What safety measures have been taken to ensure Intervention Group is suitable for human use?
"As this is an early-stage clinical trial, the safety rating of Intervention Group has been assessed at 1 due to the restricted data regarding its efficacy and security."
Answered by AI
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