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Educational Media Interventions for Cancer (ADELANTE Trial)
N/A
Recruiting
Led By Lisa Kachnic, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with non-metastatic prostate or breast cancer
Karnofsky performance status 70 or greater
Must not have
RT for sites other than breast or prostate
Prior RT
Timeline
Screening 3 weeks
Treatment Varies
Follow Up following completion of rt (4-6 weeks from enrollment for breast cancer, 4-9 weeks for prostate cancer), for up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying how well educational media interventions work in preparing Latinx Spanish-speaking patients for radiation therapy for breast or prostate cancer and in fostering receptivity to and informed decision-making around cancer clinical trial participation.
Who is the study for?
This trial is for Latinx Spanish-speaking individuals with a confirmed diagnosis of non-metastatic breast or prostate cancer. They must have a Karnofsky performance status of 70 or above, indicating they are able to care for themselves. Women who can bear children need pregnancy tests as per guidelines. Participants should be planning to receive or currently undergoing curative radiation therapy and must consult using a certified interpreter.
What is being tested?
The study is testing educational media interventions designed to help Latinx patients understand radiation therapy for breast or prostate cancer and encourage informed participation in clinical trials. It includes an audiovisual education program on radiation therapy and brochures from ASTRO and NCI about cancer treatments and research studies.
What are the potential side effects?
Since this trial focuses on educational materials rather than medical treatments, there are no direct side effects related to drugs or therapies being tested. However, participants may experience emotional responses to the information provided.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has not spread beyond my prostate or breast.
Select...
I am able to care for myself but cannot do normal activities without help.
Select...
I have been diagnosed with prostate or breast cancer through a tissue examination.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have received radiation therapy for areas other than my breast or prostate.
Select...
I have previously undergone radiation therapy.
Select...
My cancer has spread to other parts of my body.
Select...
I am deaf and/or blind in both ears/eyes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ following completion of rt (4-6 weeks from enrollment for breast cancer, 4-9 weeks for prostate cancer), for up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~following completion of rt (4-6 weeks from enrollment for breast cancer, 4-9 weeks for prostate cancer), for up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Radiation Therapy (RT) Adherence Score
Radiation Therapy (RT) Knowledge Questionnaire
Radiation Therapy (RT) Satisfaction Questionnaire
Secondary study objectives
Clinical Trials Perceptivity Questionnaire
Clinical trial enrollment
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Audiovisual Intervention- Radiation Therapy EducationExperimental Treatment1 Intervention
Audiovisual video will be provided to the subjects as educational material.
Group II: Audiovisual Intervention- Cancer Clinical TrialsExperimental Treatment1 Intervention
Audiovisual video will be provided to the subjects as educational material.
Group III: Written Brochure- Radiation Therapy EducationActive Control1 Intervention
Written brochures will be provided to the subjects as educational material.
Group IV: Written Brochure- Cancer Clinical TrialsActive Control1 Intervention
Written brochures will be provided to the subjects as educational material.
Find a Location
Who is running the clinical trial?
VarianUNKNOWN
4 Previous Clinical Trials
186 Total Patients Enrolled
Columbia UniversityLead Sponsor
1,486 Previous Clinical Trials
2,655,073 Total Patients Enrolled
30 Trials studying Breast Cancer
23,654 Patients Enrolled for Breast Cancer
Varian Medical SystemsIndustry Sponsor
61 Previous Clinical Trials
3,439 Total Patients Enrolled
3 Trials studying Breast Cancer
362 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has not spread beyond my prostate or breast.I am currently being treated for breast or prostate cancer, or was recently.You have a mental illness such as psychosis or dementia.I have undergone a pregnancy test as per the guidelines.I have had a physical exam in the last 28 days.I have received radiation therapy for areas other than my breast or prostate.I have previously undergone radiation therapy.I am able to care for myself but cannot do normal activities without help.My cancer has spread to other parts of my body.I had a consultation with a certified interpreter present.People who speak Spanish and have ancestry from Mexico, Puerto Rico, Cuba, Dominican Republic, or Central or South America.I have been diagnosed with prostate or breast cancer through a tissue examination.I am scheduled for radiation aimed at curing my cancer.I am deaf and/or blind in both ears/eyes.You have previously been enrolled in a cancer education study.
Research Study Groups:
This trial has the following groups:- Group 1: Written Brochure- Radiation Therapy Education
- Group 2: Audiovisual Intervention- Cancer Clinical Trials
- Group 3: Written Brochure- Cancer Clinical Trials
- Group 4: Audiovisual Intervention- Radiation Therapy Education
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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