Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Educational/Counseling/Training	Active	Not specified	NCI	AMCCRC-08-0498 08-0498, NCT00830635

Special Category: NCI Web site featured trial

Objectives

Primary

1. 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).
2. 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.
3. Determine whether the hypothesized mediational variables account for significant intervention effects in each of the three component projects.
4. Examine potential moderator variables to assess potential differences in intervention efficacy by selected subgroups (e.g., age, education) within each component project.
5. 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.
6. 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

1. 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.

Entry 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)

Prior/Concurrent Therapy:

• See Disease Characteristics

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

Expected Enrollment

Outcomes

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

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.

Trial Contact Information

Trial Lead Organizations

AMC Cancer Research Center

Alfred Marcus, PhD, Principal investigator		Ph: 303-239-3397 Email: darla.shaffer@ucdenver.edu

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

Related Information

Featured trial article

Registry Information
Official Title		Cancer Information Service Research Consortium: Years 2006-2011 Program Narrative and Overview
Trial Start Date		2008-09-01
Trial Completion Date		2009-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00830635
Date Submitted to PDQ		2008-10-17
Information Last Verified		2009-02-16

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