NCT00515372

Brief Summary

The goal of this behavioral research study is to find a quick and effective way to identify depression in patients with ovarian, peritoneal, or fallopian tube cancer. Another goal of this study is to compare an intervention program with "enhanced" standard care to see which may be more effective in improving quality of life for these patients.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
409

participants targeted

Target at P75+ for phase_1 ovarian-cancer

Timeline
20mo left

Started Dec 2002

Longer than P75 for phase_1 ovarian-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Dec 2002Dec 2027

Study Start

First participant enrolled

December 20, 2002

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 13, 2007

Completed
20.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

25 years

First QC Date

August 10, 2007

Last Update Submit

March 5, 2026

Conditions

Keywords

Ovarian CancerPeritoneal CancerFallopian Tube CancerDepressionTelephone CounselingQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Patient Responses to Questionnaire Assessment of Depression Measures

    Baseline assessment repeated at four months, and completion of first chemotherapy regimen for newly diagnosed ovarian, peritoneal, or fallopian tube cancer patients.

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

Weekly phone calls lasting about 30 minutes. Lists of professional resources and referral recommendations will be provided.

Other: Telephone Counseling

Usual Care Group

OTHER

Lists of professional resources and referral recommendations will be provided.

Other: Usual Care

Interventions

Weekly phone calls lasting about 30 minutes.

Also known as: Survey
Intervention Group

Lists of professional resources and referral recommendations will be provided.

Usual Care Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women are eligible if they a) are on active treatment, but not at the end of a treatment regimen) for newly diagnosed, recurrent, or persistent ovarian cancer or peritoneal cancer or fallopian tube cancer (any stage) c) are at least 18 years of age; d) speak and read English at a 7th grade level; e) are oriented to time, person, and place; g) have a Zubrod performance status (49) of 0-2; and h) provide informed consent.
  • They are eligible for the pilot intervention phase of the study if they have a diagnosis of major depressive disorder, dysthymic disorder, adjustment disorder with depressed mood, minor depression, major depression in partial remission, or recurrent brief depressive disorder.

You may not qualify if:

  • \) They will be excluded from this phase of the study if they are diagnosed as having a bipolar disorder or psychosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Ovarian NeoplasmsFallopian Tube NeoplasmsDepression

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Eileen H. Shinn, PhD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2007

First Posted

August 13, 2007

Study Start

December 20, 2002

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 9, 2026

Record last verified: 2026-03

Locations