← Back to Search

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 below
Select...
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.
Select...
I can take care of myself and am up and about more than half of my waking hours.

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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline assessment repeated at four months, and completion of first chemotherapy regimen for newly diagnosed ovarian, peritoneal, or fallopian tube cancer patients. for reporting.

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 • NCT02008565
38%
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.

Find a Location

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

Usual Care Clinical Trial Eligibility Overview. Trial Name: NCT00515372 — Phase 1
Ovarian Cancer Research Study Groups: Intervention Group, Usual Care Group
Ovarian Cancer Clinical Trial 2023: Usual Care Highlights & Side Effects. Trial Name: NCT00515372 — Phase 1
Usual Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT00515372 — Phase 1

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
~61 spots leftby Dec 2027