Audiovisual Didactic Experience for Latinx Patient Treatment Adherence and Non-English Speaker Trial Enrollment (ADELANTE) Study in Radiation Oncology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 194
- 试验地点
- 2
- 主要终点
- Radiation Therapy (RT) Knowledge Questionnaire
研究概览
简要总结
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.
详细描述
Research suggests that utilization of audiovisual educational interventions may help to address health literacy and language barriers as well as suboptimal outcomes and trial enrollment in minority and/or non-English speaking patients. However, this has yet to be demonstrated in the radiation oncology setting, in which educational material is limited to written brochures for non-English speaking patients. Herein, the investigators propose to develop and implement a targeted linguistically and culturally appropriate audiovisual intervention (AVI) for Latinx/Spanish-speaking (SS) patients undergoing curative radiotherapy (RT). Our overall objective is to demonstrate benefit of AVI on RT knowledge, adherence, satisfaction and cancer trial perceptivity and enrollment in Latinx/SS patients. The investigators also aim to identify patient-specific and modifiable system-level factors predictive of quality RT delivery and clinical trial accrual to instruct future demographic-segmentation strategies focused on reducing outcomes disparities within radiation oncology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pilot Phase Inclusion Criteria:
- •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
- •Currently undergoing treatment for breast or prostate cancer, or recently been treated
- •Pilot Phase
排除标准
- •Patient with bilateral deafness and/or blindness
- •Patient with psychosis and/or dementia
- •Main Study Inclusion Criteria:
- •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
- •Patients with non-metastatic prostate or breast cancer
- •Histopathologically proven diagnosis of prostate or breast cancer
- •History and physical examination within 28 days prior to enrollment
- •Karnofsky performance status 70 or greater
- •For women of childbearing potential, pregnancy testing to be performed in accordance to institutional guidelines
- •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.
- •Consultation visit must be performed with a certified interpreter
- •Main Study Exclusion Criteria:
- •Patient with bilateral deafness and/or blindness
- •Patient with psychosis and/or dementia
- •Clinical or radiological evidence of metastatic disease
- •Prior participation in cancer patient education trial
- •RT for sites other than breast or prostate
研究组 & 干预措施
Audiovisual Intervention- Radiation Therapy Education
Audiovisual video will be provided to the subjects as educational material.
干预措施: Audiovisual Intervention- Radiation Therapy Education (Other)
Written Brochure- Radiation Therapy Education
Written brochures will be provided to the subjects as educational material.
干预措施: ASTRO Radiation Therapy for Breast or Prostate Cancer Brochure (Other)
Audiovisual Intervention- Cancer Clinical Trials
Audiovisual video will be provided to the subjects as educational material.
干预措施: Audiovisual Intervention- Cancer Clinical Trials Education (Other)
Written Brochure- Cancer Clinical Trials
Written brochures will be provided to the subjects as educational material.
干预措施: NCI Taking Part in Cancer Research Studies Brochure (Other)
结局指标
主要结局
Radiation Therapy (RT) Knowledge Questionnaire
时间窗: : 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)
Subjects will complete the "RT Knowledge Questionnaire" to measure the change in the subjects' understanding of radiation therapy. This will be administered twice- once prior the subject receiving either the AVI or written brochure on RT knowledge and before CT simulation, and again on the same day after CT simulation.
Radiation Therapy (RT) Adherence Score
时间窗: up to 6 weeks after completion of Radiation Therapy
Reflects the frequency of unplanned treatment and clinic absence as well as subject compliance of provider recommendations
Radiation Therapy (RT) Satisfaction Questionnaire
时间窗: 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)
Adapted for radiation oncology setting from the CAHPS Cancer Center and EORTC Cancer Patient Satisfaction Surveys
次要结局
- Clinical trial enrollment(following completion of RT (4-6 weeks from enrollment for breast cancer, 4-9 weeks for prostate cancer), for up to 5 years)
- Clinical Trials Perceptivity Questionnaire(Prior to second randomization during the last week of radiation therapy (4-6 weeks after enrollment for breast cancer, 4-9 weeks for prostate cancer) and again during the first follow-up visit after completing radiation therapy (8-12 weeks from e)
研究者
Lisa A. Kachnic
Professor and Chair, Department of Radiation Oncology
Columbia University