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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00830635
• Other study ID #: 08-0498
• Secondary ID: AMCCRC-08-0498
• Status: Completed
• Phase: N/A
• First received: January 27, 2009
• Last updated: June 12, 2015
• Start date: September 2008
• Est. completion date: December 2013

Study information

• Verified date: June 2015
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1800
• Est. completion date: December 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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)

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

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Depression
• Long-term Effects of Cancer Treatment
• Prostate Cancer
• Prostatic Neoplasms
• Psychosocial Effects of Cancer and Its Treatment

Intervention

Other:
• educational intervention

• informational intervention

• internet-based intervention

• questionnaire administration

• study of socioeconomic and demographic variables

• survey administration

Procedure:
• psychosocial assessment and care

• quality-of-life assessment

Locations

Country	Name	City	State
United States	University of Miami Sylvester Comprehensive Cancer Center - Miami	Miami	Florida
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer-specific distress			No
Primary	Emotional quality of life			No
Primary	Physical functioning			No
Primary	Interpersonal functioning			No
Primary	Benefit-finding			No
Primary	Decisional conflict (projects 1 and 2)			No
Primary	Regret (projects 1 and 2)			No
Primary	Fear of recurrence (project 3)			No
Primary	Practical concerns (project 3)			No