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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00830635
First received: January 27, 2009
Last updated: January 5, 2011
Last verified: February 2009
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Official Title: Cancer Information Service Research Consortium: Years 2006-2011 Program Narrative and Overview

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Cancer-specific distress [ Designated as safety issue: No ]
  • Emotional quality of life [ Designated as safety issue: No ]
  • Physical functioning [ Designated as safety issue: No ]
  • Interpersonal functioning [ Designated as safety issue: No ]
  • Benefit-finding [ Designated as safety issue: No ]
  • Decisional conflict (projects 1 and 2) [ Designated as safety issue: No ]
  • Regret (projects 1 and 2) [ Designated as safety issue: No ]
  • Fear of recurrence (project 3) [ Designated as safety issue: No ]
  • Practical concerns (project 3) [ Designated as safety issue: No ]

Estimated Enrollment: 1800
Study Start Date: September 2008
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00830635

Locations
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center - Miami Recruiting
Miami, Florida, United States, 33136
Contact: CIS Contact Center    1-800-4-CANCER      
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: CIS Contact Center    1-800-4-CANCER      
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109-1024
Contact: CIS Contact Center    1-800-4-CANCER      
Sponsors and Collaborators
AMC Cancer Research Center
Investigators
Principal Investigator: Alfred Marcus, PhD AMC Cancer Research Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00830635     History of Changes
Other Study ID Numbers: CDR0000617990, AMCCRC-08-0498
Study First Received: January 27, 2009
Last Updated: January 5, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
long-term effects of cancer treatment
psychosocial effects of cancer and its treatment
depression
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage I prostate cancer
stage II prostate cancer

Additional relevant MeSH terms:
Breast Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Depression
Depressive Disorder
Behavioral Symptoms
Breast Diseases
Genital Diseases, Male
Mental Disorders
Mood Disorders
Prostatic Diseases
Skin Diseases

ClinicalTrials.gov processed this record on November 23, 2014