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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedEducational/Counseling/Training, Health services researchActiveNot specifiedNCI, OtherCDR0000617990
AMCCRC-08-0498, 08-0498, NCT00830635

Trial Description

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.

Further Study Information

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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

AMC Cancer Research Center

National Cancer Institute

Alfred MarcusPrincipal Investigator

Trial Sites

U.S.A.
Florida
  Miami
 University of Miami Sylvester Comprehensive Cancer Center - Miami
 CIS Contact Center Ph: 1-800-4-CANCER
New York
  New York
 Memorial Sloan-Kettering Cancer Center
 CIS Contact Center Ph: 1-800-4-CANCER
Washington
  Seattle
 Fred Hutchinson Cancer Research Center
 CIS Contact Center Ph: 1-800-4-CANCER

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00830635
ClinicalTrials.gov processed this data on October 17, 2013

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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