NCT00830635

Brief Summary

RATIONALE: A multimedia educational program may help patients with newly diagnosed prostate cancer and breast cancer reduce distress, make informed treatment decisions, and improve quality of life. PURPOSE: This randomized clinical trial is studying how well a multimedia educational program works in patients with early-stage prostate cancer or breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,800

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

3 active sites

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

September 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2009

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

June 16, 2015

Status Verified

June 1, 2015

Enrollment Period

4.6 years

First QC Date

January 27, 2009

Last Update Submit

June 12, 2015

Conditions

Breast CancerDepressionLong-term Effects of Cancer TreatmentProstate CancerPsychosocial Effects of Cancer and Its Treatment

Keywords

long-term effects of cancer treatmentpsychosocial effects of cancer and its treatmentdepressionstage IA breast cancerstage IB breast cancerstage II breast cancerstage I prostate cancerstage II prostate cancer

Outcome Measures

Primary Outcomes (9)

  • Cancer-specific distress

  • Emotional quality of life

  • Physical functioning

  • Interpersonal functioning

  • Benefit-finding

  • Decisional conflict (projects 1 and 2)

  • Regret (projects 1 and 2)

  • Fear of recurrence (project 3)

  • Practical concerns (project 3)

Interventions

educational interventionOTHER
informational interventionOTHER
internet-based interventionOTHER
questionnaire administrationOTHER
study of socioeconomic and demographic variablesOTHER
survey administrationOTHER
psychosocial assessment and carePROCEDURE
quality-of-life assessmentPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Patients are diagnosed with 1 of the following: * Diagnosis of prostate cancer (project 1) * Early-stage disease * Previously untreated disease or treatment status unknown * Diagnosis of breast cancer (projects 2-3) * Early-stage disease * No ductal carcinoma in situ or lobular carcinoma in situ * Inflammatory breast cancer allowed (project 2) * Previously untreated disease, receiving concurrent treatment, previously treated disease, or treatment status unknown * No more than 30 days since completion of treatment OR no more than 6 months post-treatment (project 3) PATIENT CHARACTERISTICS: * Has access to a computer * Willing to provide mailing address and telephone number * Must be active information-seekers who have already called the CIS * Understands English PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, 33136, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsDepressionProstatic Neoplasms

Interventions

Early Intervention, EducationalPsychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavioral SymptomsBehaviorGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesRehabilitationTherapeutics

Study Officials

  • Alfred Marcus, PhD

    AMC Cancer Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2009

First Posted

January 28, 2009

Study Start

September 1, 2008

Primary Completion

April 1, 2013

Study Completion

December 1, 2013

Last Updated

June 16, 2015

Record last verified: 2015-06

Locations

US(3)