Breast CancerNCT00830635
Multimedia Educational Program for Patients With Early-Stage Prostate Cancer or Breast Cancer
A study testing educational intervention, informational intervention and internet-based intervention in people with Breast Cancer and Depression, run by University of Colorado, Denver at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer, Depression, Long-term Effects of Cancer Treatment
- What is being tested?
- educational intervention, informational intervention and internet-based intervention
- Type of treatment
- Surgery or procedure
- How many people
- 1,800 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2008to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, 33136
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
About this study
Official title: Cancer Information Service Research Consortium: Years 2006-2011 Program Narrative and Overview
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.
Read the 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.
- Conditions
- Breast Cancer, Depression, Long-term Effects of Cancer Treatment, Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment
- Being tested
- educational intervention, informational intervention, internet-based intervention, questionnaire administration, study of socioeconomic and demographic variables
- 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
- Medical subject headings
- Breast Neoplasms, Depression, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational interventionOther
informational interventionOther
internet-based interventionOther
questionnaire administrationOther
study of socioeconomic and demographic variablesOther
survey administrationOther
psychosocial assessment and careProcedure or surgery
quality-of-life assessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer-specific distress
Emotional quality of life
Physical functioning
Interpersonal functioning
Benefit-finding
Decisional conflict (projects 1 and 2)
Regret (projects 1 and 2)
Fear of recurrence (project 3)
Practical concerns (project 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2009 (estimated)
- Study startSep 2008
- Primary completionApr 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Alfred Marcus, PhD, Principal investigator, AMC Cancer Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00830635
- Sponsor's protocol ID
- 08-0498
- Other IDs
- AMCCRC-08-0498
- Status last verified
- Jun 2015
- First submitted
- 27 Jan 2009
- Last updated
- 16 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Information Service Research Consortium: Years 2006-2011 Program Narrative and Overview
- ClinicalTrials.gov ID
- NCT00830635
- Acronym / sponsor ID
- 08-0498
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2008
- Primary completion
- Apr 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 28 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educational intervention | Other | – |
| informational intervention | Other | – |
| internet-based intervention | Other | – |
| questionnaire administration | Other | – |
| study of socioeconomic and demographic variables | Other | – |
| survey administration | Other | – |
| psychosocial assessment and care | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Cancer-specific distress
Emotional quality of life
Physical functioning
Interpersonal functioning
Benefit-finding
Decisional conflict (projects 1 and 2)
Regret (projects 1 and 2)
Fear of recurrence (project 3)
Practical concerns (project 3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfred Marcus, PhD principal investigator
AMC Cancer Research Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational intervention, informational intervention and internet-based intervention in people with Breast Cancer and Depression, run by University of Colorado, Denver at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer-specific distress. The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2015; AzTrials last refreshed its copy on 27 Oct 2026.