Behaviors and Mental Disorders

All Conditions

Quality of Life

Tai Chi Chuan

This study will compare the effectiveness of Tai Chi (a sequence of slow, graceful body movements) and a cardiovascular exercise fitness program in improving physical fitness and endurance, reducing stress and improving well-being in adult survivors of cancer. Tai Chi, described by some as a moving form of yoga and meditation combined, evolved from martial arts and breathing exercises in China hundreds of years ago. This study uses the 24-posture standardized Tai Chi. The movements are continuous, smooth, and natural, with the upper and lower parts of the body following each other. The entire body is always in motion, with the movements performed gently and at a uniform speed. The exercise training program uses an exercise machine. The training regimen is adjusted to maintain the individual's average training heart rate at 70 to 80 percent heart rate reserve; i.e., 220 minus the person's age.

Cancer survivors of solid tumor cancers who are between 18 and 65 years of age, whose treatment included chemotherapy, biologic agents or vaccines, who have had no cancer treatment for at least 24 months, and who have had no evaluable disease within 3 months of screening for this study may be eligible to participate.

Participants are randomly assigned to one of three study groups: Tai Chi, exercise training, or a waiting list. Individuals in the Tai Chi and exercise training groups participate in a supervised program for 1 hour 3 times a week for 12 weeks in the NIH Clinical Center's Rehabilitation Medicine department. Individuals assigned to the waiting list are followed for 12 weeks during the waiting period and are then assigned to either the Tai Chi or exercise program for another 12 weeks as described above.

At three time points during the study-before starting the program and after 6 weeks and 12 weeks of practicing the study intervention or being on the waiting list-participants undergo the following procedures:

Complete questionnaires regarding their quality of life and stress

Rehabilitation medicine evaluation, including the following:

* Questions about managing their daily activities, whether their skills have changed over time, what they may or may not have been able to do, or what they may have had to overcome as a result of their previous illness and the study program they have been practicing
* Measurements of strength and mobility
* Evaluation of overall physical fitness and endurance
* Blood tests to measure blood cell counts and cholesterol, lipid, hormone and mineral levels

Diagnosis and treatment for cancer represent a major life-time stressor for any patient. While the diagnosis of a life-threatening illness is stressful, undergoing treatment for cancer including surgery, radiotherapy and chemotherapy result in stress to the patient. In addition, cancer treatment frequently is associated with fatigue, physical de-conditioning and metabolic abnormalities characteristic of the metabolic syndrome, leading to speculations that cancer therapy may render survivors more prone to developing metabolic syndrome and its sequelae, cardiovascular disease. In a recently conducted study we detected a high incidence of hyperlipidemia and increased body fat content, decreased aerobic performance and musculoskeletal functioning and a high frequency of parameters of psychological distress in long-term survivors of pediatric sarcoma. Based on these data and findings, it appears desirable to devise a program that would help cancer survivors not only to improve musculoskeletal functioning and aerobic performance, as a physical exercise program would offer, but in addition relieve psychological stress and enhance the well-being of cancer survivors after completion of treatment with multimodality therapy. Tai Chi Chuan (TCC) has been used in Asian culture for centuries to improve wellness, reduce stress, and to promote healing by improving the flow of Qi. While a number of studies have provided scientific support for these claims in different populations, a beneficial role for TCC in the management of cancer survivors has not been established.

This study aims to compare in a randomized, wait-list controlled design, the efficacy of TCC to an exercise program in improving aerobic exercise capacity and endurance, reducing stress and improving Quality of Life in adult survivors of malignant solid tumors.

Effect of Tai Chi Vs. Structured Exercise on Physical Fitness and Stress in Cancer Survivors

A Randomized Study of the Effect of Tai Chi Chuan Compared to a Structured Exercise Program on Parameters of Physical Fitness and Stress in Adult Cancer Survivors

National Center for Complementary and Integrative Health (NCCIH)

Symptoms and General Pathology

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nervous System Diseases

Pain

Genital Neoplasms, Female

Sleep Initiation and Maintenance Disorders

Parasomnias

Sleep Disorders, Intrinsic

Dyssomnias

Sleep Wake Disorders

Mental Disorders

Psychotic Disorders

Urogenital Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Anti-Inflammatory Agents

All Drugs and Chemicals

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Tai Chi Vs. Structured Exercise on Physical Fitness and Stress in Cancer Survivors	NCT00246818	Cancer Cancer Survivor	Tai Chi Chuan	18 Years - 65 Years	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
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

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