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Genital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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Hydrocortisone

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This group will receive Cognitive Behavioral Therapy to optimize sleep, pain, and mood in women with gynecologic cancers. The therapy will be provided on a one-on-one basis, for 2 hours once a week for six weeks by a trained therapist with a master's degree in Clinical Psychology.

This group will receive Psychoeducation which is aimed at providing information, resources, and non-specific support related to adapting well to cancer. The education will be provided on a one-on-one basis, for 2 hours once a week for six weeks by a trained therapist with a master's degree in Clinical Psychology.

Cognitive Behavioral Therapy is used to optimize sleep, pain, and mood in women with gynecologic cancers and will be provided 2 hours once a week for six weeks.

Cognitive Behavioral Therapy

Psychoeducation is used to provide information, resources, and non-specific support related to adapting well to cancer. Sessions will be provided 2 hours once a week for 6 weeks.

Psychoeducation

Deidre B. Pereira, PhD

Gynecologic cancers cause substantial morbidity and mortality among women. Developing, implementing, and disseminating interventions that reduce morbidity and mortality secondary to gynecologic cancers are a public health priority. In spite of this, there is a paucity of research examining the effects of psychosocial interventions on patient-centered and physiological outcomes in this population. To the extent that psychological factors may influence quality of life and tumor biology among women with gynecologic cancers, psychological interventions may represent an important adjunct to standard clinical care in this population. As such, this study will examine the effects of a psychosocial intervention on sleep, pain, mood, cortisol, and cytokines in women with gynecologic cancers.

Gynecologic cancers cause substantial morbidity and mortality among women. Developing, implementing, and disseminating interventions that reduce morbidity and mortality secondary to gynecologic cancers are a public health priority. To the extent that psychological factors may influence quality of life and tumor biology among women with gynecologic cancers, psychological interventions may represent an important adjunct to standard clinical care in this population. Among individuals with cancer, there is emerging evidence that stressors and psychological responses to stressors activate central and peripheral stress systems, resulting in downstream effects on the tumor microenvironment, e.g. hypothalamic-pituitary-adrenal (HPA) axis dysregulation, inflammatory/growth factor upregulation that may favor tumorigenesis. Little is known about whether psychological interventions may modulate biobehavioral factors that may promote tumorigenesis among women with gynecologic cancer. This is a significant gap in the literature. Sleep quality, pain, and mood are three patient-centered outcomes that may represent important intervention targets for women with gynecologic cancers, as insomnia, pain, and negative mood states are (1) prevalent and (2) have been associated with HPA dysregulation and inflammatory/growth factor upregulation in this population in empirical research. This study will examine cognitive behavioral therapy (CBT) intervention effects on patient centered and physiological outcomes among women with gynecologic cancers undergoing adjuvant chemotherapy. Grounded within the Central Arousal Theory of Stress (CATS) and a biobehavioral model of tumor biology, the central hypothesis is that a CBT intervention targeting insomnia and pain will (a) improve nighttime sleep patterns, pain, and negative mood states, and (b) reduce cortisol levels, normalize daytime cortisol rhythm, and reduce proinflammatory/proangiogenic cytokine levels in women with gynecologic cancers. The multidisciplinary team will have research/clinical experience in psycho-oncology, psychoneuroimmunology (PNI), behavioral sleep medicine, pain, reproductive immunology, and gynecologic oncology. The research study is innovative in that it will (1) combine empirically-supported CBT techniques for insomnia and pain into a multicomponent intervention tailored for women with gynecologic cancers, and (2) examine CBT effects on central sensitization of pain among individuals with cancer using quantitative sensory testing (QST). The results of this research will be significant to public health initiatives, because although gynecologic cancers are among the leading causes of cancer-related death among women, there is a paucity of research examining the effects of psychosocial interventions on patient-centered and physiological outcomes in this population.

Cognitive Behavioral Effects on Sleep, Pain, and Cytokines in Gynecologic Cancer

Subjective Sleep Efficiency is assessed using daily Sleep Diaries.

Analyses will examine intervention effects on changes in Sleep Efficiency from T1 to T2 and T1 to T3.

Subjective Sleep Quality is assessed using daily Sleep Diaries.

Analyses will examine intervention effects on changes in Sleep Quality from T1 to T2 and T1 to T3.

Pain quality and intensity are assessed with the McGill Pain Questionnaire (MPQ) Total Score.

Analyses will examine intervention effects on changes in pain severity from T1 to T2 and T1 to T3 while controlling for T0.

Pain Severity is assessed using daily sleep Diaries.

Analyses will examine intervention effects on changes in Pain Severity from T1 to T2 and T1 to T3.

Pain Interference is assessed with the Pain Disability Index (PDI).

Analyses will examine intervention effects on changes in Pain Disability from T1 to T2 and T1 to T3 while controlling for T0.

Serum Cortisol Concentrations are assessed with peripheral venous blood draw.

Analyses will examine intervention effects on changes in Serum Cortisol Concentrations from T1 to T2 and T1 to T3 controlling for T0.

Diurnal Salivary Cortisol Rhythm is assessed with saliva sampling.

Analyses will examine intervention effects on changes in Diurnal Salivary Cortisol Rhythm from T1 to T2 and T2 to T3 controlling for T0.

Cytokines are assessed by measuring serum concentrations of Interleukin (IL)-1, IL-6, IL-8, Tumor Necrosis Factor (TNF)-alpha, and Vascular Endothelial Growth Factor (VEGF).

Analyses will examine intervention effects on changes in Cytokine Concentrations from T1 to T2 and T1 to T3 controlling for T0.

Depressed Mood is assessed using the GRID-Hamilton Rating Scale for Depression (GRID-HAMD).

Analyses will examine intervention effects on changes on GRID-HAMD scores from T1 to T2 and T1 to T3 controlling for T0.

Anxious mood is assessed via the State-Trait Anxiety Inventory (STAI).

Analyses will examine intervention effects on changes on STAI State Anxiety scores from T1 to T2 and T1 to T3 controlling for T0.

This is assessed by measuring pain severity ratings in response to Graded Thermal Stimulation or RAMP and HOLD using Quantitative Sensory Testing.

Analyses will examine intervention effects on changes in pain severity ratings from T1 to T2 and T1 to T3.

This is assessed by measuring pain severity ratings in response to a Thermal Protocol for Temporal Summation or Wind-Up using Quantitative Sensory Testing

Analyses will examine intervention effects on changes in pain severity ratings from T1 to T2 and T1 to T3.

University of Miami

National Cancer Institute (NCI)

University of Florida

This study will look at how people cope with an upcoming bone marrow transplant and how personality characteristics influence coping styles in stressful medical situations. Personality traits, such as extraversion, optimism and self-esteem have been related to active, problem-focused coping styles, whereas neuroticism has been related to increased psychological distress and denial as a way of coping. Coping styles, in turn, have been related to disease outcome. For example, a fighting spirit and avoidance have been correlated with longer survival, whereas fatalism, anxious preoccupation and feelings of helplessness and hopelessness were related to a poor disease outcome. A better understanding of the relationship between coping styles and personality may help improve supportive care for people undergoing bone marrow transplants. This study will:

* Explore the relationship between personality traits, coping styles and psychological stress in patients awaiting bone marrow transplantation
* Identify what coping styles people use to prepare for bone marrow transplantation
* Identify what personality traits are related to particular coping styles in patients awaiting bone marrow transplantation
* Identify the relationship between personality factors and level of psychological distress in patients awaiting bone marrow transplantation

Cancer patients 18 years of age and older who are scheduled for bone marrow transplant are eligible for this study.

Participants will fill out pencil-and-paper questionnaires providing demographic information (such as age, gender, marital status, ethnicity, and so forth) and answering questions about their opinions and preferences. The information will be used to assess the participants' personality characteristics, coping styles, and psychological distress. The questionnaires take about 45 to 50 minutes to complete.

Over the last decade, more and more focus has been placed upon the psychological adjustment of patients who have undergone bone marrow transplants (BMT). There have been studies that focused on the coping styles and levels of psychological distress in patients immediately after transplantation. Studies have been done based on a specific point during the process or at multiple points throughout the course of the procedure and still other studies have focused on assessment points several months post transplant. However, very little attention has been focused on patients' psychological functioning prior to transplantation. The purpose of the present study is to examine the relationship between personality traits and coping styles among patients awaiting BMT.

Relationship Between Personality and Coping Styles in Bone Marrow Transplant Candidates

Exploring the Relationship Between Personality and Coping Styles in Bone Marrow Transplant Candidates

National Institutes of Health Clinical Center (CC)

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

Cola

Inclusion criteria:

Patients with first-diagnosed colon cancer. Age 18-60 y.o.

Exclusion criteria:

Metastatic colon cancer. Former psychiatric history. Substance use. Previous serious medical conditions.

Diomidis Antoniadis, Phd Student

The purpose of the study is to investigate whether there are prognostic factors regarding the mental and functional adjustment of colon cancer patients following curative surgery. Patients will be selected using specific inclusion criteria. Prognostic factors investigated include personality characteristics, initial distress, medical, social and economic factors. The utmost purpose of the study is to assist clinicians with the timely identification of vulnerable patients in order to ensure their proper management and their optimal adjustment.

Moreover this is the first study using the Distress Thermometer in Greek patients with cancer.

Psychological Well-being Outcomes in Disease-free Survivors of Colorectal Cancer Following Curative Surgery

Aristotle University Of Thessaloniki

Phd student

Caregiver Burden

Stress, Psychological

Behavioral Symptoms

Quality of Life

4 week psycho-educational support group focusing on topics specific to psychosocial and emotional aspects of the cancer caregiving role

Weekly sessions lasting 60 minutes. Topics addressed each week:

Week 1: Coping with the diagnosis of loved one and dealing with uncertainty

Week 2: Caring for the carer 1: Feeding your body (self-care, stress management, mindfulness concepts)

Week 3: Caring for the carer 2: Feeding your mind (challenging negative thinking habits)

Week 4: The emotions of caregiving (handling emotional reactivity)

Psycho-educational support group therapy

Joyce Tan

Rathi Mahendran

This is a study to determine the effectiveness of a Group Therapy that provides psycho-education and support for caregivers of cancer patients. Caregivers must be between 21 and 64 years of age and be willing to attend a one-hour a week program for four weeks. The sessions will be in English, and a set of questionnaires (demographic data, some information about your family member with cancer, and scales: Caregiver Quality of Life-Cancer Scale (CQOLC), Perceived Stress Scale and the Hospital Anxiety Depression Scale (HADS)) will be completed at the start, at 4 weeks, at 8 weeks and at 12 weeks. Some participants placed on a wait-list to start the Group Therapy 4 weeks later will also complete the set of questionnaires at this point. A Feedback and Satisfaction Questionnaire will be completed at the end of the 4 week program. In addition, at the end of the 4 week program, some participants will go through a 15-minute interview.

Participants Study participants are caregivers, recruited from the Medical Oncology Clinic (under NCIS) at NUH.

Intervention and Evaluation of the Psycho-educational Support Group Therapy This is a pre and post-intervention study with a control group design. The strength of this design is its experimental nature but without randomization, thereby avoiding the problems related to randomization. Instead, a wait-list is used as the control group.

Consecutive family caregivers who agree to participate will be placed in the first group (Group 1a) till a group size of ten is reached. The next ten will be put on a wait-list and form the control group (Group 1b), who will still be able to benefit from the program at a later time. In this manner subsequent treatment and control groups will be recruited.

The Intervention consists of weekly Psycho-educational Support Groups focusing on topics specific to psychosocial and emotional aspects of the cancer caregiving role. The Intervention is over a short duration of 4 weeks so as to appeal to caregivers and reduce the attrition rate. The proposed intervention is exploratory in nature but is hypothesized to be beneficial in helping to recognize and handle the difficult and often tumultuous journey of cancer caregiving. The planned Intervention was developed in discussions and consensus views using the Delphi method and adapted the brief integrative psychological therapy developed by Kua et al and psycho-educational programs at overseas centres. The CQOLC, the Perceived Stress Scale, and the HADS will be administered to participants at 4 time points: T1 (week 0), T2 (end of week 4), T3 (end of week 8) and T4 (end of week 12). The fourth time point is to evaluate whether the effects of the intervention are sustained. A Satisfaction and Feedback Questionnaire will be administered to participants at T2, immediately upon completion of the intervention. Some participants who have gone through the program will be invited to take part in a 15 minute interview. The purpose of the interview is to obtain feedback on the ways in which the program has been beneficial. The participants in the control group will complete a set of the same questionnaires when they are entered into the wait list; they will complete the questionnaires 5 times.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cognitive Behavioral Effects on Sleep, Pain, and Cytokines in Gynecologic Cancer	NCT02609880	Genital Neoplas... Insomnia Pain Adaptation, Psy...	Cognitive Behav... Psychoeducation	18 Years - 90 Years	University of Florida
Relationship Between Personality and Coping Styles in Bone Marrow Transplant Candidates	NCT00048256	Adaptation, Psy... Bone Marrow Tra...		-	National Institutes of Health Clinical Center (CC)
Cognitive Behavioral Effects on Sleep, Pain, and Cytokines in Gynecologic Cancer	NCT02609880	Genital Neoplas... Insomnia Pain Adaptation, Psy...	Cognitive Behav... Psychoeducation	18 Years - 90 Years	University of Florida
Psychological Well-being Outcomes in Disease-free Survivors of Colorectal Cancer Following Curative Surgery	NCT01675505	Adaptation, Psy... Functional Insu...		18 Years - 60 Years	Aristotle University Of Thessaloniki
Investigating the Effects of a Psycho-educational Support Group Therapy on Cancer Caregivers' Burden and Quality of Life	NCT02120183	The Effect of a...	Psycho-educatio...	21 Years - 64 Years	National University Hospital, Singapore

Spots Global Cancer Trial Database for adaptation, psychological