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

Trial Information

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

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.