Recruiting

Observational Study

Sponsor:

Columbia University

Code:

NCT05351424

Conditions

Breast Cancer Invasive

Prostate Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Audiovisual Intervention- Radiation Therapy Education

ASTRO Radiation Therapy for Breast or Prostate Cancer Brochure

Audiovisual Intervention- Cancer Clinical Trials Education

NCI Taking Part in Cancer Research Studies Brochure

Study Details

Brief summary:

The study aims to develop educational media interventions to prepare Latinx Spanish-speaking radiation oncology patients for a course of breast or prostate cancer radiation therapy and to foster receptivity and informed decision-making around cancer clinical trial participation.

Conditions

Breast Cancer Invasive

Prostate Cancer

Study ID

NCT05351424

Start date

May 3, 2022

Status verified date

Feb, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Pilot Phase Inclusion Criteria:

1. Spanish speakers of Latinx background as defined by the U.S. Census Bureau as anyone from Mexican, Puerto Rican, Cuban, Dominican, Central or South American ancestry
2. Currently undergoing treatment for breast or prostate cancer, or recently been treated

Pilot Phase Exclusion Criteria:

1. Patient with bilateral deafness and/or blindness
2. Patient with psychosis and/or dementia

Main Study Inclusion Criteria:

1. Spanish speakers of Latinx background as defined by the U.S. Census Bureau as anyone from Mexican, Puerto Rican, Cuban, Dominican, Central or South American ancestry
2. Patients with non-metastatic prostate or breast cancer
3. Histopathologically proven diagnosis of prostate or breast cancer
4. History and physical examination within 28 days prior to enrollment
5. Karnofsky performance status 70 or greater
6. For women of childbearing potential, pregnancy testing to be performed in accordance to institutional guidelines
7. Plan to receive definitive, curative radiation. Patients planning to receive curative RT after upcoming adjuvant chemotherapy or induction hormonal therapy may enroll at reconsult "follow-up" visit.
8. Consultation visit must be performed with a certified interpreter

Main Study Exclusion Criteria:

1. Patient with bilateral deafness and/or blindness
2. Patient with psychosis and/or dementia
3. Clinical or radiological evidence of metastatic disease
4. Prior participation in cancer patient education trial
5. Prior RT
6. RT for sites other than breast or prostate

Study Design

Enrollment

194 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Audiovisual Intervention- Radiation Therapy Education

Audiovisual video will be provided to the subjects as educational material.

active comparator: Written Brochure- Radiation Therapy Education

Written brochures will be provided to the subjects as educational material.

experimental: Audiovisual Intervention- Cancer Clinical Trials

Audiovisual video will be provided to the subjects as educational material.

active comparator: Written Brochure- Cancer Clinical Trials

Written brochures will be provided to the subjects as educational material.

Interventions

Audiovisual Intervention- Radiation Therapy Education

A video with educational information will be shown regarding radiation therapy.

ASTRO Radiation Therapy for Breast or Prostate Cancer Brochure

Brochure with written information will be given to the subject regarding radiation therapy.

Audiovisual Intervention- Cancer Clinical Trials Education

A video with educational information will be shown regarding cancer clinical trials.

NCI Taking Part in Cancer Research Studies Brochure

Brochure with written information will be given to the subject regarding cancer clinical trials.

Primary outcome measure

  • Radiation Therapy (RT) Knowledge Questionnaire [ Time Frame: : baseline prior to first randomization (within 1 week of enrollment for both breast and prostate cancer) and before CT simulation visit, and again during CT simulation visit (1-4 weeks from enrollment for both breast and prostate cancer) ]
  • Radiation Therapy (RT) Adherence Score [ Time Frame: up to 6 weeks after completion of Radiation Therapy ]
  • Radiation Therapy (RT) Satisfaction Questionnaire [ Time Frame: during or immediately prior to the end-of-treatment visit (4-6 weeks from enrollment for breast cancer, 4-9 weeks from enrollment for prostate cancer) ]

Central Contacts and Locations

Central contacts

Locations

Mount Sinai Medical Center

Recruiting

Miami Beach, Florida, United States, 33140

Contacts

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

More Information

Sponsor

Columbia University

Last update posted

Feb 12, 2026

Last verified

Feb, 2026

Keywords

  • breast cancer
  • prostate cancer
  • audiovisual intervention
  • Spanish-speaking
  • focus group
  • treatment experience
  • patient education
  • radiotherapy adherence
  • cancer trial participation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Columbia University on 2026-02-12.