Multimedia Educational Program for Patients With Early-Stage Prostate Cancer or Breast Cancer
|ClinicalTrials.gov Identifier: NCT00830635|
Recruitment Status : Completed
First Posted : January 28, 2009
Last Update Posted : June 16, 2015
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|
- 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|
- Cancer-specific distress
- Emotional quality of life
- Physical functioning
- Interpersonal functioning
- Decisional conflict (projects 1 and 2)
- Regret (projects 1 and 2)
- Fear of recurrence (project 3)
- Practical concerns (project 3)
Please refer to this study by its ClinicalTrials.gov 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|
|Principal Investigator:||Alfred Marcus, PhD||AMC Cancer Research Center|