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

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ClinicalTrials.gov Identifier: NCT02609880
Recruitment Status : Recruiting
First Posted : November 20, 2015
Last Update Posted : January 7, 2020
Sponsor:
Collaborators:
University of Miami
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Florida

Brief 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.

Condition or disease Intervention/treatment Phase
Genital Neoplasms, Female Insomnia Pain Adaptation, Psychological Behavioral: Cognitive Behavioral Therapy Behavioral: Psychoeducation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Effects on Sleep, Pain, and Cytokines in Gynecologic Cancer
Actual Study Start Date : July 2009
Estimated Primary Completion Date : April 18, 2020
Estimated Study Completion Date : April 18, 2020

Arm Intervention/treatment
Experimental: Cognitive Behavioral Therapy
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.
Behavioral: Cognitive Behavioral Therapy
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.

Placebo Comparator: Psychoeducation
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.
Behavioral: Psychoeducation
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.




Primary Outcome Measures :
  1. Subjective Sleep Efficiency [ Time Frame: Pre-surgery (T0, which is baseline), 6-8 weeks (T1, which is post-surgery and pre-intervention), 12-16 weeks (T2, which is post-intervention), and 18-24 weeks (T3, which is follow-up) ]

    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.


  2. Subjective Sleep Quality [ Time Frame: Pre-surgery (T0, which is baseline), 6-8 weeks (T1, which is post-surgery and pre-intervention), 12-16 weeks (T2, which is post-intervention), and 18-24 weeks (T3, which is follow-up) ]

    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.


  3. Pain Quality and Intensity [ Time Frame: Pre-surgery (T0, which is baseline), 6-8 weeks (T1, which is post-surgery and pre-intervention), 12-16 weeks (T2, which is post-intervention), and 18-24 weeks (T3, which is follow-up) ]

    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.


  4. Pain Severity [ Time Frame: Pre-surgery (T0, which is baseline), 6-8 weeks (T1, which is post-surgery and pre-intervention), 12-16 weeks (T2, which is post-intervention), and 18-24 weeks (T3, which is follow-up) ]

    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.


  5. Pain Interference [ Time Frame: Pre-surgery (T0, which is baseline), 6-8 weeks (T1, which is post-surgery and pre-intervention), 12-16 weeks (T2, which is post-intervention), and 18-24 weeks (T3, which is follow-up) ]

    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.


  6. Serum Cortisol Concentrations [ Time Frame: Pre-surgery (T0, which is baseline), 6-8 weeks (T1, which is post-surgery and pre-intervention), 12-16 weeks (T2, which is post-intervention), and 18-24 weeks (T3, which is follow-up) ]

    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.


  7. Diurnal Salivary Cortisol Rhythm [ Time Frame: Pre-surgery (T0, which is baseline), 6-8 weeks (T1, which is post-surgery and pre-intervention), 12-16 weeks (T2, which is post-intervention), and 18-24 weeks (T3, which is follow-up) ]

    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.


  8. Serum Cytokine Concentrations [ Time Frame: Pre-surgery (T0, which is baseline), 6-8 weeks (T1, which is post-surgery and pre-intervention), 12-16 weeks (T2, which is post-intervention), and 18-24 weeks (T3, which is follow-up) ]

    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.



Secondary Outcome Measures :
  1. Depressed Mood [ Time Frame: Pre-surgery (T0, which is baseline), 6-8 weeks (T1, which is post-surgery and pre-intervention), 12-16 weeks (T2, which is post-intervention), and 18-24 weeks (T3, which is follow-up) ]

    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.


  2. Anxious Mood [ Time Frame: Pre-surgery (T0, which is baseline), 6-8 weeks (T1, which is post-surgery and pre-intervention), 12-16 weeks (T2, which is post-intervention), and 18-24 weeks (T3, which is follow-up) ]

    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.


  3. A-Delta Nerve Fiber (First Pain) Response [ Time Frame: Pre-surgery (T0, which is baseline), 6-8 weeks (T1, which is post-surgery and pre-intervention), 12-16 weeks (T2, which is post-intervention), and 18-24 weeks (T3, which is follow-up) ]

    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.


  4. C Nerve Fiber (Second Pain) Response [ Time Frame: Pre-surgery (T0, which is baseline), 6-8 weeks (T1, which is post-surgery and pre-intervention), 12-16 weeks (T2, which is post-intervention), and 18-24 weeks (T3, which is follow-up) ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Women 18 and older scheduled and/ or have recently had a surgical resection, debulking, or cytoreduction for gynecologic malignancies for which adjuvant treatment or chemotherapy is the standard of care. Most of these cases are expected to be: (i) epithelial ovarian cancer, any stage, any grade, (ii) epithelial endometrial cancer, clear cell, papillary serous, or carcinosarcoma morphologies; any stage; any grade, (iii) epithelial endometrial cancer, endometrioid morphology; any stage any grade, (iv) fallopian tube cancer, any stage, any grade, (v) peritoneal cancer, any stage, any grade, or (vi) squamous cell carcinomas of the female genital tract (uterus, cervix, vulva, and vagina), any stage, any grade, in situ, or (vii) borderline ovarian tumors.
  • Endorsement of any of the following sleep related complaints in the month prior to enrollment (at pre- or post-surgery): difficulty initiating sleep, difficulty maintaining sleep, waking up too early, or sleep that is chronically nonrestorative or poor in quality.
  • During the two weeks of sleep evaluation at the post-surgical timepoint: sleep diary/clinical interview confirmed insomnia (e.g., sleep onset or awake time during the night > 30 minutes) at least 3 nights per week; or, sleep diary/clinical interview confirmed insomnia on 1 to 5 nights across the two weeks of evaluation plus Sleep Efficiency on Pittsburgh Sleep Quality Index at post-surgery < 85%.
  • Presence of daytime dysfunction due to insomnia (mood, cognitive, social, or occupational impairment) at post-surgery.
  • Able to read and understand English.
  • Willing to undergo randomization.

Exclusion Criteria:

  • Unable to provide informed consent.
  • Current, severe, uncontrolled psychopathology that would make randomization to conditions unethical.
  • Past or current diagnosis of Bipolar Disorder or seizure disorder that would prevent the safe implementation of sleep restriction techniques.
  • Participation in Cognitive Behavioral Therapy or any nonpharmacological treatment for sleep outside of the current study.
  • Sleep apnea or periodic limb movement disorder (PLMD).
  • Physician estimated survival less than 6 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609880


Contacts
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Contact: Deidre B. Pereira, PhD 3522736039 dpereira@phhp.ufl.edu

Locations
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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Contact: Deidre B. Pereira, PhD    352-273-6039    dpereira@phhp.ufl.edu   
Principal Investigator: Deidre B. Pereira, PhD         
Sub-Investigator: Michael E. Robinson, PhD         
Sub-Investigator: Gregory Schultz, PhD         
Sub-Investigator: Richard B. Berry, MD         
Sub-Investigator: Christina S. McCrae, PhD         
Sponsors and Collaborators
University of Florida
University of Miami
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Deidre B. Pereira, PhD University of Florida

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02609880    
Other Study ID Numbers: IRB201600679-N
R01CA138808 ( U.S. NIH Grant/Contract )
287-2009 ( Other Identifier: Univeristy of Florida )
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
Psycho-Oncology
Psychoneuroimmunology
Cognitive Behavioral Therapy
Gynecologic Cancer
Insomnia
Pain
Distress
Cortisol
Cytokines
Additional relevant MeSH terms:
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Genital Neoplasms, Female
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Urogenital Neoplasms
Neoplasms by Site
Neoplasms