NCT00002848

Brief Summary

RATIONALE: Developing coping strategies may help improve the quality of life of patients with prostate cancer. PURPOSE: This randomized clinical trial is comparing the effect of group therapy with written educational materials on the quality of life of men with stage I or stage II prostate cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
480

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Apr 1997

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

7 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

April 1, 1997

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
Last Updated

March 5, 2013

Status Verified

March 1, 2013

Enrollment Period

7.4 years

First QC Date

November 1, 1999

Last Update Submit

March 4, 2013

Conditions

Keywords

stage I prostate cancerstage IIB prostate cancerstage IIA prostate cancerpsychosocial effects of cancer and its treatment

Interventions

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Biopsy-proven prostate cancer diagnosed within 1 year prior to entry * Clinical stage I/II (T1b-c or T2, N0 or Nx, M0) disease * Pathologic local upstaging (e.g., to T3) allowed * No Nx disease if pathologic or partial pathologic (e.g., lymph node biopsy or dissection) staging performed * No major psychiatric illness requiring hospitalization or medication other than depression or anxiety for less than 1 year * No second malignancy within 10 years except nonmelanomatous skin cancer * Clinical follow-up by a urologist, medical oncologist, or radiation therapist required at least semi-annually PATIENT CHARACTERISTICS: Age * Not specified Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * See Disease Characteristics PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified

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

Sponsors & Collaborators

Study Sites (7)

CCOP - Western Regional, Arizona

Phoenix, Arizona, 85006-2726, United States

Location

Stanford Cancer Center at Stanford University Medical Center

Stanford, California, 94305-5718, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

CCOP - Columbus

Columbus, Ohio, 43206, United States

Location

CCOP - Northwest

Tacoma, Washington, 98405-0986, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

RehabilitationTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Gary R. Morrow, PhD, MS

    James P. Wilmot Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, URCC CCOP Research Base

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

April 1, 1997

Primary Completion

September 1, 2004

Study Completion

September 1, 2004

Last Updated

March 5, 2013

Record last verified: 2013-03

Locations