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Clinical Trials/NCT00830635
NCT00830635
Completed
Not Applicable

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

University of Colorado, Denver3 sites in 1 country1,800 target enrollmentSeptember 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
University of Colorado, Denver
Enrollment
1800
Locations
3
Primary Endpoint
Physical functioning
Status
Completed
Last Updated
10 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 2008
End Date
December 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Physical functioning

Benefit-finding

Decisional conflict (projects 1 and 2)

Interpersonal functioning

Cancer-specific distress

Emotional quality of life

Regret (projects 1 and 2)

Fear of recurrence (project 3)

Practical concerns (project 3)

Study Sites (3)

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