Multimedia Educational Program for Patients With Early-Stage Prostate Cancer or Breast Cancer

June 12, 2015 updated by: University of Colorado, Denver

Cancer Information Service Research Consortium: Years 2006-2011 Program Narrative and Overview

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Determine whether an innovative multimedia educational program will help newly diagnosed prostate (project 1) and breast (project 2) cancer patients prepare for their journey as cancer patients, promote informed treatment decision-making and reduce cancer-specific distress, and among breast cancer patients at re-entry, facilitate an informed re-entry transition to cancer survivorship and reduce cancer-specific distress (project 3).
  • Determine whether having Cancer Information Service (CIS) Information Specialists make a scheduled telephone callback to callers in project 3 will augment and support use of the CIS Research Consortium (CISRC) multimedia educational programs and further enhance the study outcomes examined in this program of research.
  • Determine whether the hypothesized mediational variables account for significant intervention effects in each of the three component projects.
  • Examine potential moderator variables to assess potential differences in intervention efficacy by selected subgroups (e.g., age, education) within each component project.
  • Conduct an in-depth tracking study of utilization patterns for a detailed description of different patterns of use, as well as elucidating those components or modules within the program that had differential utilization by participants.
  • Assist the CIS and other similar cancer information systems in disseminating one or more of the CISRC interventions should they prove effective in this program of research.

Secondary

  • Conduct secondary analyses across projects (i.e., perceived need for and benefit from the CISRC interventions and intervention efficacy across three high priority cancer patient populations) that will be made possible by the use of a common theoretical framework, the same or similar intervention and research design across projects, and a common set of endpoints.

OUTLINE: This is a multicenter study.

Patients are assessed by demographic questions and a baseline interview conducted by Cancer Information Service (CIS) Information Specialists.

Patients are randomized to 1 of 3 intervention groups:

  • Group 1: Patients receive a mailing containing standard CIS print materials. In project 1, patients receive " Treatment Choices for Men with Early-Stage Prostate Cancer" and "What You Need to Know About Prostate Cancer". In project 2, patients receive "What You Need to Know About Breast Cancer" and "Surgery Choices for Women with Early-Stage Breast Cancer". In project 3, patients receive "Facing Forward: Life After Cancer Treatment" and "What You Need to Know About Breast Cancer".
  • Group 2: Patients receive mailings appropriate to their project as in group 1. Patients also receive the multimedia program via the Internet or CD-ROM.
  • Group 3: In project 3 only, patients receive mailings appropriate to their project as in group 1 and the multimedia program as in group 2. Patients also receive a CIS callback intervention at 10-14 days from trained Information Specialists from the CIS.

After completion of study therapy, patients are followed at 2 and 9 months.

Study Type

Interventional

Enrollment (Actual)

1800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Sylvester Comprehensive Cancer Center - Miami
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center
    • Washington
      • Seattle, Washington, United States, 98109-1024
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Physical functioning
Cancer-specific distress
Emotional quality of life
Interpersonal functioning
Benefit-finding
Decisional conflict (projects 1 and 2)
Regret (projects 1 and 2)
Fear of recurrence (project 3)
Practical concerns (project 3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Alfred Marcus, PhD, AMC Cancer Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

January 27, 2009

First Submitted That Met QC Criteria

January 27, 2009

First Posted (Estimate)

January 28, 2009

Study Record Updates

Last Update Posted (Estimate)

June 16, 2015

Last Update Submitted That Met QC Criteria

June 12, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-0498
  • AMCCRC-08-0498

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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