Pain Clinical Trial
Official title:
Cognitive Behavioral Effects on Sleep, Pain, and Cytokines in Gynecologic Cancer
Verified date | June 2023 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | May 2, 2023 |
Est. primary completion date | April 18, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 90 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Florida | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida | National Cancer Institute (NCI), University of Miami |
United States,
Hanvey GA, Padron A, Kacel EL, Cartagena G, Bacharz KC, McCrae CS, Robinson ME, Waxenberg LB, Antoni MH, Berry RB, Schultz GS, Castagno J, Pereira DB. Accrual and retention of diverse patients in psychosocial cancer clinical trials. J Clin Transl Sci. 202 — View Citation
Padron A, McCrae CS, Robinson ME, Waxenberg LB, Antoni MH, Berry RB, Castagno J, Schultz G, Kacel EL, Ulfig C, Garey S, Patidar S, Sannes T, Trinastic L, Wong S, Pereira DB. Impacts of Cognitive Behavioral Therapy for Insomnia and Pain on Sleep in Women w — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Subjective Sleep Efficiency | 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. |
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) | |
Primary | Subjective Sleep Quality | 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. |
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) | |
Primary | Pain Quality and Intensity | 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. |
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) | |
Primary | Pain Severity | 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. |
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) | |
Primary | Pain Interference | 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. |
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) | |
Primary | Serum Cortisol Concentrations | 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. |
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) | |
Primary | Diurnal Salivary Cortisol Rhythm | 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. |
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) | |
Primary | Serum Cytokine Concentrations | 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. |
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) | |
Secondary | Depressed Mood | 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. |
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) | |
Secondary | Anxious Mood | 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. |
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) | |
Secondary | A-Delta Nerve Fiber (First Pain) Response | 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. |
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) | |
Secondary | C Nerve Fiber (Second Pain) Response | 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. |
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) |
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