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

Symptoms and General Pathology

Digestive System Diseases

Cancer Pain

Pain

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

The CST condition will receive 5 sessions of a cognitive behavior theory-based protocol that teaches coping skills (e.g., relaxation, activity pacing/planning, cognitive restructuring) relevant to managing pain as well as psychological distress.

The standard care control condition will receive resources and referrals related to survivorship health. This information will be provided to the participant during their initial survivorship care consult.

Telephone-Based Coping Skills Training (CST)

Sarah A. Kelleher, PhD

Colorectal cancer survivors experience long-term negative physical and psychosocial consequences of their disease. There is a critical need to develop novel behavioral interventions for improving colorectal cancer survivor outcomes. The investigators have developed a pain management intervention for colorectal cancer survivors that focuses on addressing both pain and psychological distress. Colorectal cancer survivors who endorse pain and comorbid psychological distress as a concern during a clinic-based survivorship care consult will be recruited. Participants will be randomized into either: Telephone-Based Coping Skills Training (CST) for pain and comorbid psychological distress or standard care. The CST condition will receive 5 sessions of a cognitive behavior theory-based protocol that teaches coping skills (e.g., relaxation, activity pacing/planning, cognitive restructuring) relevant to managing pain and psychological distress. The standard care control condition will receive resources and referrals related to managing survivorship health.

Pain Coping Skills for Colorectal Cancer Survivors

Pain Coping Skills Training for Colorectal Cancer Survivors With Pain and Distress

Client Satisfaction Questionnaire 10-item version.

The Functional Assessment of Cancer Therapy - General (FACT-G), version 4.0

Self-efficacy for pain management subscale of the Chronic Pain Self-Efficacy Scale

American Cancer Society, Inc.

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Skin and Connective Tissue Diseases

Diabetes Mellitus

Breast Neoplasms

Metabolic Diseases

Glucose Metabolism Disorders

Endocrine System Diseases

Twelve sessions are delivered over 6 months using a faded contact model involving 6 weekly sessions, 3 biweekly sessions and 3 monthly sessions.

one 60 minute diabetes education session.

Diabetes Coping Skills Training (DCST) consist of twelve 50 minutes sessions delivered over 6 months using a faded contact model ( 6 weekly session, 3 biweekly sessions and 3 monthly sessions)

Diabetes Coping Skills Training (DCST)

Rebecca A Shelby, PhD

The proposed randomized clinical trial evaluates a diabetes coping skills training (DCST) intervention for improving breast cancer survivors' abilities to manage symptoms and adhere to recommended diabetes self-management. The telephone-based DCST protocol integrates three key strategies to reduce symptoms and improve diabetes self-management: coping skills training for managing symptoms, adherence skills training, and healthy lifestyle skills training. The investigator will test the effects of the DCST intervention by comparing it to diabetes education alone. Physical symptoms, psychological distress, diabetes self-management behaviors, and self-efficacy for managing symptoms and diabetes self-management will be assessed at baseline and 3, 6, and 12 months. Physical activity (i.e., daily steps and distance) will be assessed using wireless activity trackers and data will be obtained from home blood glucose monitoring devices. Glycosylated hemoglobin (HbA1c) will be assessed at baseline, 6, and 12 months.

Together, breast cancer and type 2 diabetes represent a public health crisis. Approximately 20% of the 3.1 million breast cancer survivors in the U.S. have type 2 diabetes, and this number is expected to grow. Breast cancer survivors who have type 2 diabetes are at high risk for cancer recurrence, serious health complications, and premature death. Breast cancer survivors with type 2 diabetes experience more severe, disabling symptoms and psychological distress relative to breast cancer survivors without diabetes. For breast cancer survivors with type 2 diabetes, maintaining glycemic control is critical for decreasing symptoms and preventing serious health problems. Important diabetes self-management strategies include physical activity, dietary modifications, medication, and blood glucose monitoring. Many breast cancer survivors with type 2 diabetes have difficulty maintaining these behaviors and achieving glycemic control. Physical symptoms and psychological distress are often barriers to engaging in diabetes self-management. The proposed study evaluates a novel diabetes coping skills training (DCST) intervention for improving breast cancer survivors' abilities to manage symptoms and adhere to recommended diabetes self-management. The telephone-based DCST protocol is based on our prior work and integrates three key theory-based strategies: coping skills training for managing symptoms, adherence skills training, and healthy lifestyle skills training. The proposed randomized clinical trial (N=230) will test the effects of the DCST intervention by comparing it to diabetes education alone. Physical symptoms, psychological distress, diabetes self-management behaviors, and self-efficacy will be assessed at baseline and 3, 6, and 12 months. Physical activity will be assessed using wireless activity trackers and data will be obtained from home blood glucose monitoring devices. Glycosylated hemoglobin (HbA1c) will be assessed at baseline, 6, and 12 months. The proposed study addresses a critical gap in the care of breast cancer survivors by evaluating a novel behavioral intervention that aims to improve the management of symptoms, adherence, and glycemic control in breast cancer survivors with type 2 diabetes. The findings of this study could lead to significant improvements in clinical care and beneficial outcomes for breast cancer survivors.

I HEAL for Breast Cancer Survivors With Diabetes

Improving Health Engagement and Lifestyle Management for Breast Cancer Survivors With Diabetes

The Checklist measures the severity of different symptoms (e.g., pain, fatigue, numbness and tingling) associated with illness and disease.

The eight-item Patient Reported Outcomes Information System (PROMIS).

Anxiety will be assessed using the seven-item GAD-7 Scale.

Participants who receive DCST will exhibit greater improvements in medication adherence compare to the education group.

Participants who receive DCST will exhibit greater improvements in physical activity, dietary patterns, medication adherence, and adherence to blood glucose monitoring compare to the education group.

Participants who receive DCST will exhibit greater improvements in adherence to blood glucose monitoring compare to the education group.

Participants who receive DCST will show greater improvements in HbA1c compared to the diabetes education alone.

This contains 5 items that inquire about patients' certainty about degree of pain control, pain during daily activities, controlling pain during sleep, and making pain reductions without extra medication.

Patient-reported physical activity will be assessed using the well-validated Community Healthy Activities Model Program for Seniors (CHAMPS).

Participants who receive DCST will show improved self efficacy for managing symptoms and diabetes self-management compared to the diabetes education alone.

Wireless activity tracking devices will be used to assess daily steps and distance.

Participants who receive DCST will show improved self efficacy for managing symptoms and diabetes self-management compared to the diabetes education alone.

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
Pain Coping Skills for Colorectal Cancer Survivors	NCT02706301	Colorectal Canc...	Telephone-Based...	21 Years - 80 Years	Duke University
Pain Coping Skills for Colorectal Cancer Survivors	NCT02706301	Colorectal Canc...	Telephone-Based...	21 Years - 80 Years	Duke University
I HEAL for Breast Cancer Survivors With Diabetes	NCT02970344	Diabetes	Diabetes Coping...	21 Years -	Duke University
Pain Coping Skills for Colorectal Cancer Survivors	NCT02706301	Colorectal Canc...	Telephone-Based...	21 Years - 80 Years	Duke University
I HEAL for Breast Cancer Survivors With Diabetes	NCT02970344	Diabetes	Diabetes Coping...	21 Years -	Duke University

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