NCT00863200

Brief Summary

The goal of this research study is to learn how well a telephone system works for improving the management of emotional distress, sadness, and/or depression in patients who are being treated for cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2009

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2019

Completed
Last Updated

May 28, 2019

Status Verified

May 1, 2019

Enrollment Period

10 years

First QC Date

March 16, 2009

Last Update Submit

May 23, 2019

Conditions

Keywords

DepressionCancerAfrican AmericansLatinosHispanicsInteractive voice responseIVRBehavioral Intervention

Outcome Measures

Primary Outcomes (1)

  • Learn how well a telephone system works for improving the management of emotional distress, sadness, and/or depression in patients who are being treated for cancer.

    3 Years

Study Arms (2)

Telephone Intervention Group

Behavioral: Telephone InterventionBehavioral: Questionnaires & Interviews

Standard Care Group

Behavioral: Questionnaires & Interviews

Interventions

Symptom information will be collected using an automated telephone system, approximately 5 minutes per week.

Also known as: Interactive voice response, IVR
Telephone Intervention Group

3 questionnaires and one-on-one interviews during 3 regularly scheduled clinic visits.

Also known as: Survey
Standard Care GroupTelephone Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

African American or Hispanics over 18 years of age being treated for cancer at LBJ General Hospital in Houston.

You may qualify if:

  • Diagnosis of cancer
  • Self-identified as African American or Latino
  • English or Spanish speaking
  • years of age or older
  • Receiving treatment in the medical oncology, genitourinary oncology, or gynecologic oncology clinics at LBJ General Hospital
  • Reports a level of "4" or greater on the MDASI "sadness" and/or "distress" items.

You may not qualify if:

  • \) Not willing to use a telephone to report symptoms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LBJ General Hospital

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

NeoplasmsDepression

Interventions

Surveys and QuestionnairesInterviews as Topic

Condition Hierarchy (Ancestors)

Behavioral 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

  • Tito Mendoza, BS,MED,MS,PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2009

First Posted

March 17, 2009

Study Start

March 1, 2009

Primary Completion

February 12, 2019

Study Completion

February 12, 2019

Last Updated

May 28, 2019

Record last verified: 2019-05

Locations