An observational study in Breast Cancer, Cervical Cancer and Prostate Cancer, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-29.
Sponsored by M.D. Anderson Cancer Center · Observational
The goal of this behavioral research study is to improve the use of cancer prevention services, increase early detection, and treatment of cancer. A secondary outcome of this demonstration project proposes that a structured patient navigator (PN) will reduce the cost of Medicare services.
Screening Questionnaire:
Before you can start on this study, you will answer a 20 minute Triage questionnaire. The questionnaire will ask you if you have had cancer, what type of cancer, and when you were last treated.
Cancer-Screening Groups and Treatment Groups:
Once you answer the Triage questionnaire and if you are found to be eligible to take part in this study, you will be placed in the Cancer Screening Group or the Treatment Group based on your answers to the Triage questionnaire.
If you have not been treated for cancer in the past or if it has been more than 5 years since you were last treated, you will be in the Cancer Screening Group and you will complete the screening Cancer Screening Assessment (CSA). The CSA will ask you about cancer screenings, lifestyle, and other health related items. The questionnaire should take about a total of 45-60 minutes to complete.
If you have been treated for cancer in the past 5 years, you will be in the Treatment Group. The CSA will ask you about cancer screenings, cancer treatment, and other health related items. The questionnaire should take about a total of 45-60 minutes to complete.
After completion of the Cancer Screening Assessment (CSA) for either the Cancer Screening Group or the Treatment Group, you will complete a CSA addendum questionnaire. This CSA addendum questionnaire will ask you about barriers and factors that may influence your health related decisions. The questionnaire should take 15-20 minutes to complete.
Intervention and Comparison Groups:
Participants in either the cancer-screening group or the treatment group will be randomly assigned (as in the flip of a coin) to one of 2 additional groups, the "Intervention group" or the "Comparison" group. You will have an equal chance of being in either group.
If you are in the Intervention Group, you will work with a staff member, called a patient navigator (PN), who will assist with medical care and/or screenings (intervention group). For example, the staff member may help schedule screening appointments, medical care appointments, or any other necessary assistance to meet health care needs. The PN will be responsible for recording information about your care and any cancer treatment, should that be necessary.
You will complete a CSA questionnaire 1 time a year for up to 4 years. A staff member will contact you by phone to set up an appointment to give you the CSA questionnaires. All questionnaires will be completed at a time and place that you and the study staff agree upon. For example, the study staff may meet you at a community center, independent-living center, or another agreed upon location. The questionnaire should take about 45-60 minutes to complete.
If you are in the Comparison Group, you will not work with a staff member and you will not complete any additional questionnaires during the 4 years on study.
Both the intervention group and the comparison group will receive educational materials.
Exit Questionnaire:
About 4 years after you join the study, you will be contacted by a staff member and you will set up an exit questionnaire meeting. This questionnaire will be completed at a time and place that you and the staff member agree upon. This questionnaire will contain similar questions to those you have been answering since your participation in the study. The questionnaire will take about 45-60 minutes to complete.
Length of Study:
You will be considered off-study after 4 years.
This is an investigational study. Up to 11,964 participants will take part in this study. A total of 2,812 will be enrolled at M. D. Anderson.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 2,472 is above the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Hispanic American 40 Years + treated for cancer and Medicare eligible.
Exclusion Criteria:
Patient Navigator (PN) + Educational Materials + Annual Questionnaires
Behavioral: Questionnaire · Behavioral: Patient Navigator (PN)
Educational Materials + Exit Questionnaire
Behavioral: Questionnaire
Intervention Group: Cancer Screening Assessment (CSA) questionnaire 45-60 minutes annually for 4 years + Exit Questionnaire at end of study. Comparison Group: Exit Questionnaire only.
Also known as: Survey
Staff member, called patient navigator (PN), who assist with medical care and/or screenings, questionnaires.
Screening Rates
Time frame: 4 Years
Compliance Rate Across 5 Cancer Types
Time frame: 4 Years
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center