NCT00516256

Brief Summary

The aims include:

  • CHESS and Cancer Information Mentor will not differ initially (6 weeks) or late in treatment (6 months) in QOL
  • CHESS +Cancer Information Mentor will have the largest impact on QOL (initially and late in treatment) and will be significantly better than either CHESS or Cancer Information Mentor alone.
  • To measure potential intervening or mediating processes, so that we can determine how CHESS and the Cancer Information Mentor produce associated QOL benefits.
  • To conduct exploratory use analyses examining which types of CHESS content, sequential patterns of content use, or other characteristics of use behavior are associated with greater pretest-posttest improvements in QOL.
  • To conduct a secondary analysis exploring whether men whose partners have actively used CHESS do better than those whose partners did not use CHESS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
209

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Jul 2007

Longer than P75 for not_applicable prostate-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

July 3, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 15, 2007

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2018

Completed
Last Updated

October 24, 2018

Status Verified

October 1, 2018

Enrollment Period

10.9 years

First QC Date

August 14, 2007

Last Update Submit

October 23, 2018

Conditions

Keywords

Prostate CancerQuality of LifeCancer Information MentorCHESSthe Comprehensive Health Enhancement Support SystemSocial supportSkill-building tools

Outcome Measures

Primary Outcomes (1)

  • Effect of three study conditions on Quality of Life

    6 Months

Study Arms (3)

CHESS System

EXPERIMENTAL

CHESS System - Internet-based computer program for 6 months.

Behavioral: CHESS System

Cancer Information Mentor

EXPERIMENTAL

Cancer Information Mentor - Phone calls to the patient for 6 months.

Behavioral: Cancer Information Mentor

CHESS System + Cancer Information Mentor

EXPERIMENTAL

CHESS System + Cancer Information Mentor

Behavioral: CHESS SystemBehavioral: Cancer Information Mentor

Interventions

CHESS SystemBEHAVIORAL

Internet-based computer program for 6 months.

Also known as: Comprehensive Health Enhancement Support System
CHESS SystemCHESS System + Cancer Information Mentor

Phone calls to the patient for 6 months.

CHESS System + Cancer Information MentorCancer Information Mentor

Eligibility Criteria

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

You may qualify if:

  • Being within 9 weeks of a primary diagnosis of Stage 1 or Stage 2 prostate cancer
  • Being 18 years of age or older
  • Being able to read and write English at the 6th grade level (as shown by an ability to understand the informed consent)

You may not qualify if:

  • \. Being under 18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Cindy Carmack Taylor, PhD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2007

First Posted

August 15, 2007

Study Start

July 3, 2007

Primary Completion

May 11, 2018

Study Completion

May 11, 2018

Last Updated

October 24, 2018

Record last verified: 2018-10

Locations