Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Behaviors and Mental Disorders

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Quality of Life

Coping Skills Training teaches skills for managing physical, emotional, and social challenges of symptoms commonly experienced by men who have undergone treatment for early stage prostate cancer. Coping skills include activity pacing, managing negative mood, communication enhancement, and applied relaxation.

Coping Skills Training

Prostate Cancer Education provides information on the following topics: common treatment side-effects, medical options for symptom management, nutrition to support recovery, and guidelines for communicating with your healthcare team.

Prostate Cancer Education

Francis J Keefe, Ph.D.

Lisa C Campbell, Ph.D.

This study will test the effectiveness of an 8-week group intervention for African American men who have been treated for prostate cancer. The group intervention is based on 1) the cognitive-behavioral theoretical approach to improving adjustment to cancer and 2) masculinity theory as it relates to coping strengths and preferences in men. We will test the effectiveness of this coping skills intervention for improving survivors' quality of life in 4 areas: 1) distress related to sexual, urinary, and bowel symptoms; 2) self-confidence for managing symptoms; 3) overall emotional functioning; and 4) overall physical functioning. The effect of the coping skills group intervention in these 4 areas will be compared to a comparison intervention in which African American men will receive basic education about prostate cancer, but will not participate in coping skills training.

African American men have higher diagnosis and death rates from prostate cancer than any other ethnic group. After treatment for prostate cancer, African American men also report slower recovery, including physical symptoms (e.g., sexual dysfunction, urinary incontinence) that can persist well beyond the immediate post-treatment period. Despite the evidence that African American men have poorer outcomes following prostate cancer treatment, very little is known about how to improve quality of life and enhance recovery in this group of survivors.

This study will test the effectiveness of an 8-week group intervention for African American men who have been treated for prostate cancer. The group intervention is based on 1) the cognitive-behavioral theoretical approach to improving adjustment to cancer and 2) masculinity theory as it relates to coping strengths and preferences in men. In this group intervention African American prostate cancer survivors will be taught a variety of coping skills for managing both the physical and emotional challenges of living with prostate cancer. The coping skills training groups will consist of 6-8 survivors and will be conducted in both medical center clinic settings and community settings (e.g., churches). Each group session will be co-led by an African American psychologist and an African American male lay person. We will test the effectiveness of this coping skills intervention for improving survivors' quality of life in 4 areas: 1) distress related to sexual, urinary, and bowel symptoms; 2) self-confidence for managing symptoms; 3) overall emotional functioning; and 4) overall physical functioning. The effect of the coping skills group intervention in these 4 areas will be compared to a comparison intervention in which African American men will receive basic education about prostate cancer, but will not participate in coping skills training. The recruitment goal for this project is 154 African American men treated for early stage prostate cancer.

Due to the comprehensive nature of the coping skills training intervention (i.e., a variety of coping skills targeting both physical and emotional challenges of prostate cancer), we expect coping skills training to be significantly more effective than cancer education. Ultimately, findings from this study could fill a significant gap that exists in the research literature regarding our understanding of how to help African American men achieve the fullest possible recovery following prostate cancer treatment.

Coping in African American Prostate Cancer Survivors

Coping Skills Training Groups to Enhance Recovery From Prostate Cancer in African American Men

United States Department of Defense

Duke University

All participants recruited to the trial will receive the decision aid. This a one-group study with a quasi-experiemental pre/post evaluation design.

All patients recruited to the study will receive the PCSPrep decision aid. There is only 'study arm.' The Clinical Research Coordinator (CRC) will provide the patient with an iPad to complete the pre-test, PCSPrep and post-test. Individuals will see the survey questions on screen and will hear accompanying audio through headsets. Participants will: (1) be introduced to PCSPrep and the menu of activities/topics; (2) enter information about themselves for personal tailoring (e.g., risk factors); (3) participate in a values-clarification exercise to rate the personal importance of varied courses of action (i.e., pros/cons of PCS); (4) receive a printout with an individualized plan for discussing PCS with their primary care provider.

Prostate Cancer Screening Decision Aid

Jennifer D Allen, SCD

This is a multicenter study that involves research on screening for prostate cancer. This study pilot tests a culturally appropriate decision aid (DA) for African American (AA) men that will empower them to take part in decision-making regarding prostate cancer screening (PCS). The Prostate Cancer Screening Preparation (PCSPrep) tool was designed with intend to be delivered in primary care settings with attention to patient/provider interaction. Funding for this study comes from the National Institute of Health/National Cancer Institute (1R21CA178296).

STUDY AIMS AIM 1: Among AA men ages 45-70, estimate the impact of PCSPrep on primary outcomes: (a) knowledge; (b) confidence in ability to make informed decisions and communicate with provider; (c) consistency between values \& PCS preferences.

AIM 2: Among primary care providers, to assess secondary outcomes: (a) perceptions regarding patient engagement in SDM; and (b) concordance with patient's ratings of SDM.

AIM 3: Among patients, providers and clinic staff, document the feasibility and acceptability of integrating PCSPrep into primary care practices.

RECRUITMENT \& ENROLLMENT

Primary Care Providers Recruitment:

PCPs eligible to participate will be Emory Health Care practitioners who see at least 20 potentially eligible patients. These PCPs will be sent information from the Investigator Team and Clinic Director explaining the study We will use effective clinician recruitment procedures established in our prior work, including presentations at standing clinician meetings, meeting individually with providers, and being on site to answer questions. Ten PCPs who consent to participate will complete a brief survey following the visit from each of their enrolled patients, and allow these clinical encounters to be audio-recorded. See appendix B for post encounter survey for providers. As is standard in studies involving physicians, a financial incentive will be provided following completion of post-visit data collection for each patient when allowable and not in conflict with federal regulations. In the case of the VA hospital system, providers are not allowed to take financial incentives for research, so they will not receive this. Following the visit from each of their enrolled patients, providers will respond to a brief, online survey about the extent to which they involved the patient in the SDM process, and their perceptions regarding the quality of the communication about PCS. Total provider time in the study is estimated at 120 minutes (up to 15 enrolled patients x 10 minutes per post-encounter survey + 20 minutes of informed consent discussions).

Patient Recruitment and Enrollment:

The study will enroll AA men (age 45-70) who have not undergone prostate cancer screening (PCS) in the prior 3 years. Additional eligibility criteria will include: (1) self-reported AA race/ethnicity; (2) age 45-70; (3) English speaking. Exclusion criteria will include: personal history of prostate cancer (CaP), life expectancy of \<10 years as determined by the primary care provider (PCP); or serious psychiatric conditions or cognitive impairment. Identification and recruitment of patients will be conducted by the Clinical Research Associate (CRA) under supervision of the investigators and in partnership with PCP's who opt to participate. Electronic medical records (EMR) and scheduling systems may be used to identify potentially eligible men who are scheduled for a non-acute, routine medical visit with a participating PCP during the enrollment period (i.e., Dr. Filson will access his EMR account and supervise all viewing by the CRA). See appendix D for Patient recruitment letter. Two weeks prior to a scheduled visit, eligible men will be mailed study information and an opt-out card informing them that they will be contacted by phone. Men who do not opt out will be called by the CRA, screened for eligibility, and provided with information about the study procedures. See appendix E for telephone recruitment script. Men interested in participating will be asked to arrive at the clinic 90 min prior to their scheduled visit to review study information with the CRA, provide informed consent, complete pre- and post-test and post-clinical encounter surveys, and the PSCPrep. The day prior to their scheduled visit, the CRA will call to remind them of their appointment and the opportunity to participate in this study.

INTERVENTION ADMINISTRATION PCSPrep meets the International Patient Decision Aid Standards for high quality DAs, and adheres to best practices for culturally relevant interventions.Learning objectives for participants include to: (1) understand that there is a decision to be made; (2) identify their preferred role in decision-making; (3) obtain accurate, unbiased information about benefits, limitations and potential harms of screening; (4) understand personal risk of CaP; (5) clarify one's values as they relate to the potential screening outcomes; (6) seek input from significant others, if desired; (7) develop skills for communicating with provider; (8) elicit input from provider; and (9) develop a plan for action based on desired course of action.

PCSPrep uses an audiovisual and touch-screen format on an iPad to simplify use for individuals with limited literacy and/or computer skills. It is comprised of a series of modules on the web in which professional actors describe the decision-making process, communication with a provider, and discussion of PCS. Content is delivered by actors presented as physicians who answer call-in questions in a format modeled on a health-focused television show, based on focus group feedback. Questions and discussion are presented to normalize the idea that decisions are based on individual values and preferences.

Addressing Prostate Cancer Information Disparities With eHealth Technology

Data Sharing Plan agreement between Tufts University, Emory University, and Dana-Farber Cancer Institute

Confidence in ones ability to gather requisite information and to make an informed decision

Knowledge regarding the potential benefits, harms and limitations of prostate cancer screening

Consistency between decision about screening and stated values regarding the pros and cons of screening

Tufts University

Associate Professor

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Abiraterone Acetate

Prednisone

Enzyme Inhibitors

Hormones

Hormone Antagonists

Cytochrome P-450 Enzyme Inhibitors

Abiraterone acetate 1000mg orally daily until the time of disease progression, in the absence of prohibitive toxicities.

Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily

Matthew Galsky, MD

This is a pilot study of abiraterone acetate in African American/Black patients with castration-resistant prostate cancer. The primary objective is to determine the correlation between germline polymorphisms and antitumor activity (as defined by a decline in PSA of ≥ 30%) in African American patients with castration-resistant prostate cancer treated with abiraterone acetate. Patients will receive abiraterone acetate until the time of disease progression, in the absence of prohibitive toxicities. Patients will be followed for disease progression and survival.

Abiraterone Acetate Trial in African American Prostate Cancer Patients

A Pilot Study of Abiraterone Acetate in African American/Black Patients With Castration Resistant Prostate Cancer

The primary objective of this study is to determine a correlation between inherited genetic polymorphisms and antitumor activity (as defined by a decline in PSA of ≥ 30%) in AA patients with castration-resistant prostate cancer treated with Abiraterone. The primary endpoint is the percent change in PSA from baseline to 12 weeks. A decline of ≥ 30% will be correlated with germline SNPs.

Post-treatment changes in measurable disease by RECIST - Response Evaluation Criteria in Solid Tumors Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions

post-treatment changes in measurable disease by time to disease progression (as per PCWG2 guidelines)

post-treatment changes in bone scans (as per PCWG2 guidelines) ("no new lesions" versus "new lesions.")

To determine the safety of abiraterone Adverse events as defined by CTCAE v4. Number of participants with serious adverse events grade 4 or 5

Icahn School of Medicine at Mount Sinai

Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily

Age, Continuous

Sex: Female, Male

Number of prior systemic therapies

ECOG (Eastern Cooperative Oncology Group) Performance Status:

0= Fully active; 1=restricted in physically strenuous activity but ambulatory, light work; 2= ambulatory and capable of self care, but no any work activities; 3= capable of only limited self care; 4 = completely disabled, 5= dead

Performance Status: ECOG

Dr. Matthew David Galsky

Number of Participants With ≥ 30% Change in PSA

Response Assessment

Time to Progression

Bone Scan

Safety of Abiraterone

Testosterone

Abiraterone acetate 1000mg orally daily until the time of disease progression, in the absence of prohibitive toxicities.

Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Coping in African American Prostate Cancer Survivors	NCT00589966	Prostate Cancer	Coping Skills T... Prostate Cancer...	-	Duke University
Addressing Prostate Cancer Information Disparities With eHealth Technology	NCT02787434	Prostate Neopla...	Prostate Cancer...	45 Years - 70 Years	Tufts University
Abiraterone Acetate Trial in African American Prostate Cancer Patients	NCT01735396	Prostate Cancer	Abiraterone Ace...	18 Years -	Icahn School of Medicine at Mount Sinai
Abiraterone Acetate Trial in African American Prostate Cancer Patients	NCT01735396	Prostate Cancer	Abiraterone Ace...	18 Years -	Icahn School of Medicine at Mount Sinai
Addressing Prostate Cancer Information Disparities With eHealth Technology	NCT02787434	Prostate Neopla...	Prostate Cancer...	45 Years - 70 Years	Tufts University

Spots Global Cancer Trial Database for african american men