Localized Prostate Carcinoma, Oligometastatic Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
Conditions
Brief summary
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.
Detailed description
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. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I (INTERVENTION): Patients receive standard SCP during a provider visit and a tailored SCP with a low literacy educational supplement during a structured interview over 30-60 minutes. GROUP II (CONTROL): Patients receive standard SCP using the prostate cancer ASCO template during a provider visit and undergo a structured interview over 30-60 minutes.
Interventions
OTHEREducational Intervention
Receive a low literacy educational supplement
OTHERInterview
Undergo a structured interview
OTHERQuestionnaire Administration
Ancillary studies
OTHERSupportive Care
Receive standard SCP
Sponsors
National Cancer Institute (NCI)
United States Department of Defense
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comprehension of survivorship care recommendations and prostate specific antigen surveillance | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in decisional conflict | At baseline and up to 3 month phone call | The two-sample t-test will be used to evaluate the change in the average decisional conflict score between patients in the control arm (standard SCP) and patients in the intervention arm (standard SCP + tailoring + educational supplement). |
| Access to survivorship care for late and long-term side effects | At baseline and up to 3 month phone call | Will be assessed using the Patients Access Score (PAS). Descriptive statistics will be used to characterize patient access to survivorship care. The difference in mean PAS will be compared between the two arms using a 2 sample t-test. Results will be compared to previous studies, published work, and other historical cohorts. The concordance of urologists' assessment of patients' outcomes with outcomes obtained from patients will be analyzed as the percent of concordant responses, and with unweighted and weighted kappa coefficients. Linear regression models will be used to identify predictors of access to survivorship care. Parsimonious models will be favored due to the relatively small sample size. |
| Patient self-efficacy | At baseline and up to 3 month phone call | Descriptive statistics will be used to characterize patient self-efficacy. Results will be compared to previous studies, published work, and other historical cohorts. The concordance of urologists' assessment of patients' outcomes with outcomes obtained from patients will be analyzed as the percent of concordant responses, and with unweighted and weighted kappa coefficients. Parsimonious models will be favored due to the relatively small sample size. |
| Preparedness for survivorship | At baseline and up to 3 month phone call | Descriptive statistics will be used to characterize preparedness for survivorship. Results will be compared to previous studies, published work, and other historical cohorts. The concordance of urologists' assessment of patients' outcomes with outcomes obtained from patients will be analyzed as the percent of concordant responses, and with unweighted and weighted kappa coefficients. Parsimonious models will be favored due to the relatively small sample size. |
| Decision regret | At baseline and up to 3 month phone call | Descriptive statistics will be used to characterize decision regret. Results will be compared to previous studies, published work, and other historical cohorts. The concordance of urologists' assessment of patients' outcomes with outcomes obtained from patients will be analyzed as the percent of concordant responses, and with unweighted and weighted kappa coefficients. Parsimonious models will be favored due to the relatively small sample size. |
Countries
United States
Contacts
Primary ContactKerry L. Kilbridge, MD, MSc
Outcome results
None listed