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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
Women on active treatment for newly diagnosed, recurrent, or persistent ovarian cancer, peritoneal cancer, or fallopian tube cancer (any stage)
At least 18 years of age
Must not have
Diagnosed as having bipolar disorder or psychosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with bipolar disorder or psychosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2016 Phase 3 trial • 300 Patients • NCT02008565
51%
Constipation
9%
Urinary tract infection
6%
Diarrhoea
6%
Headache
5%
Fall
5%
Abdominal distension
5%
Abdominal pain
5%
Upper respiratory tract infection
3%
Nausea
2%
Haemorrhoids
1%
Breast cancer
1%
Hip fracture
1%
Syncope
1%
Medical device removal
1%
Back pain
1%
Animal bite
1%
Suture related complication
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo - Education Only
Loperamide - Exercise Plus Biofeedback
Loperamide - Education Only
Placebo - Exercise Plus Biofeedback

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
3,070 Previous Clinical Trials
1,802,399 Total Patients Enrolled
Lance Armstrong FoundationOTHER
9 Previous Clinical Trials
642 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,022,761 Total Patients Enrolled
Eileen H. Shinn, PhDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
185 Total Patients Enrolled

Media Library

Usual Care Clinical Trial Eligibility Overview. Trial Name: NCT00515372 — Phase 1
Peritoneal Neoplasm Research Study Groups: Usual Care Group, Intervention Group
Peritoneal Neoplasm 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
~49 spots leftby Dec 2027
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