Addressing Health Literacy With a Tailored Survivorship Care Plan to Improve Access in Underserved African American Prostate Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 6
- 主要终点
- Comprehension of survivorship care recommendations and prostate specific antigen surveillance
研究概览
简要总结
This clinical trial compares the impact of a tailored survivorship care plan (SCP) to a standard SCP on the understanding of and access to survivorship care in black or African American patients with prostate cancer that has not spread to other parts of the body (localized) or that has spread from where it first started (primary site) to a limited number of places in the body (oligometastatic). SCPs summarize treatment history and recommendations for monitoring and maintaining health, and may also include potential long term effects of treatments received. The intention of a SCP is to help patients participate in their own health care. However, many patients have below basic levels of health literacy, meaning, they have a lower ability to obtain, communicate, process and understand basic health information and services to make health decisions. In fact, poor health literacy has been linked with worse quality of life in prostate cancer survivors. A tailored SCP includes the addition of an educational supplement based on lower reading and writing skills (low literacy) and may address health literacy barriers to understanding of treatment options and side effects. A standard SCP uses a template based on the American Society of Clinical Oncology (ASCO) guidelines for prostate cancer. A tailored SCP with low literacy educational supplements may be more effective compared to a standard SCP in improving understanding and access to survivorship care in black or African American patients with localized or oligometastatic prostate cancer.
详细描述
PRIMARY OBJECTIVES:
I. Compare outcomes after patients receive usual care from their providers with a standard SCP and after patients receive tailoring of the SCP with the low literacy educational supplement.
II. To quantify the potential benefit of tailoring the care plan and the educational supplement.
III. Compare providers' assessment of patients':
IIIa. Health literacy; IIIb. Comprehension of survivorship care recommendations; IIIc. Understanding of long term and late effects from treatment; IIId. To measures obtained from patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Black and African American men who are disease-free after completing primary surgery and/or radiation treatment for localized or oligometastatic prostate cancer between 1 to 4 years prior to enrollment. (Race/ethnicity per medical records and self report)
- •Patients who are still receiving adjuvant androgen deprivation therapy following primary radiation with non-palliative intent may be included
排除标准
- •Dementia or cognitive impairment per provider clinical assessment
- •Unable to give informed consent in the judgement of the patient's oncology provider
- •Recurrent prostate cancer after primary treatment
- •Less than 18 years of age at the time of informed consent
- •Diagnosis of active second malignancy requiring treatment
- •Individuals who are not able to clearly understand English since the outcome measures require understanding of English
结局指标
主要结局
Comprehension of survivorship care recommendations and prostate specific antigen surveillance
时间窗: At baseline and up to 3 month phone call
Comprehension will be scored as dichotomous variables, correct or incorrect. The proportion of patients who correctly understand after the standard survivorship care plan (SCP) compared to the proportion who correctly understand after the standard SCP + tailoring + educational support will be analyzed using a two-tailed Z-score test for equality of two proportions at a significance level of P \< 0.05.
Comprehension of treatment side effects and late effects
时间窗: At baseline and up to 3 month phone call
Comprehension will be scored as dichotomous variables, correct or incorrect. The proportion of patients who correctly understand after the standard SCP compared to the proportion who correctly understand after the standard SCP + tailoring + educational support will be analyzed using a two-tailed Z-score test for equality of two proportions at a significance level of P \< 0.05.
次要结局
- Access to survivorship care for late and long-term side effects(At baseline and up to 3 month phone call)
- Decision regret(At baseline and up to 3 month phone call)
- Change in decisional conflict(At baseline and up to 3 month phone call)
- Preparedness for survivorship(At baseline and up to 3 month phone call)
- Patient self-efficacy(At baseline and up to 3 month phone call)
研究者
Viraj Master
Principal Investigator
Emory University