Cognitive Behavioral Effects on Sleep, Pain, and Cytokines in Gynecologic Cancer
Condition: Genital Neoplasms, Female; Insomnia; Pain; Adaptation, Psychological
MeSH terms: Genital Neoplasms, Female; Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Cognitive Behavioral Therapy; Psychoeducation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psycho-Oncology; Psychoneuroimmunology; Cognitive Behavioral Therapy; Gynecologic Cancer; Insomnia; Pain; Distress; Cortisol; Cytokines