Clinical trial NCT00830635: Multimedia Educational Program for Patients With Early-Stage Prostate Cancer or Breast Cancer
Official title: Cancer Information Service Research Consortium: Years 2006-2011 Program Narrative and Overview
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Depression
Long-term Effects of Cancer Treatment
Prostate Cancer
Psychosocial Effects of Cancer and Its Treatment
Keywords: 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
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-01-28
Enrollment: 1800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.

Eligibility 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

Primary outcomes:
measure: Cancer-specific distress
measure: Emotional quality of life
measure: Physical functioning
measure: Interpersonal functioning
measure: Benefit-finding
measure: Decisional conflict (projects 1 and 2)
measure: Regret (projects 1 and 2)
measure: Fear of recurrence (project 3)
measure: Practical concerns (project 3)
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Sylvester Comprehensive Cancer Center - Miami
state: Florida
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: AMC Cancer Research Center
name: Alfred Marcus, PhD
role: PRINCIPAL_INVESTIGATOR
References: