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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00830635
Recruitment Status : Completed
First Posted : January 28, 2009
Last Update Posted : June 16, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Depression Long-term Effects of Cancer Treatment Prostate Cancer Psychosocial Effects of Cancer and Its Treatment Other: educational intervention Other: informational intervention Other: internet-based intervention Other: questionnaire administration Other: study of socioeconomic and demographic variables Other: survey administration Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Not Applicable

Detailed Description:



  • 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.


  • 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  (Clinical Trial)
Actual Enrollment : 1800 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Cancer Information Service Research Consortium: Years 2006-2011 Program Narrative and Overview
Study Start Date : September 2008
Actual Primary Completion Date : April 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Cancer-specific distress
  2. Emotional quality of life
  3. Physical functioning
  4. Interpersonal functioning
  5. Benefit-finding
  6. Decisional conflict (projects 1 and 2)
  7. Regret (projects 1 and 2)
  8. Fear of recurrence (project 3)
  9. Practical concerns (project 3)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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)


  • 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


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00830635

United States, Florida
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
University of Colorado, Denver
National Cancer Institute (NCI)
Principal Investigator: Alfred Marcus, PhD AMC Cancer Research Center

Responsible Party: University of Colorado, Denver Identifier: NCT00830635     History of Changes
Other Study ID Numbers: 08-0498
First Posted: January 28, 2009    Key Record Dates
Last Update Posted: June 16, 2015
Last Verified: June 2015

Keywords provided by University of Colorado, Denver:
long-term effects of cancer treatment
psychosocial effects of cancer and its treatment
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage I prostate cancer
stage II prostate cancer

Additional relevant MeSH terms:
Breast Neoplasms
Prostatic Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Behavioral Symptoms