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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02609880
• Other study ID #: IRB201600679-N
• Secondary ID: R01CA138808287-2
• Status: Completed
• Phase: N/A
• Start date: July 2009
• Est. completion date: May 2, 2023

Study information

• Verified date: June 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Adaptation, Psychological
• Genital Neoplasms, Female
• Insomnia
• Pain
• Sleep Initiation and Maintenance Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Florida	National Cancer Institute (NCI), University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

Outcome

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)