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

NCT02609880 | Completed

• 3 other identifiers: IRB201600679-NR01CA138808287-2009
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Genital Neoplasms, Female; Insomnia; Pain; Adaptation, Psychological

Keywords

Psycho-Oncology; Psychoneuroimmunology; Cognitive Behavioral Therapy; Gynecologic Cancer; Insomnia; Pain; Distress; Cortisol; Cytokines

Outcome Measures

Primary Outcomes (8)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (4)

• Depressed Mood

  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

  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)

• A-Delta Nerve Fiber (First Pain) Response

  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)

• C Nerve Fiber (Second Pain) Response

  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)

Study Arms (2)

Cognitive Behavioral Therapy

EXPERIMENTAL

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

Psychoeducation

PLACEBO COMPARATOR

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

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

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 BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• University of Miami: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

Related Publications (5)

• 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 with Gynecologic Malignancies: A Randomized Controlled Trial. Behav Sleep Med. 2022 Jul-Aug;20(4):460-476. doi: 10.1080/15402002.2021.1932500. Epub 2021 Jun 14.

  PMID: 34124972 RESULT

• 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. 2022 Apr 1;6(1):e45. doi: 10.1017/cts.2022.380. eCollection 2022.

  PMID: 35651964 RESULT

• Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.

  PMID: 41170811 DERIVED

• Kacel EL, Kirsch JL, Sannes TS, Patidar S, Postupack R, Jensen S, Wong S, Garey S, Dodd S, Ulfig CM, McCrae CS, Robinson ME, Castagno J, Schultz GS, Pereira DB. Interleukin-6 and body mass index, tobacco use, and sleep in gynecologic cancers. Health Psychol. 2019 Oct;38(10):866-877. doi: 10.1037/hea0000775. Epub 2019 Aug 1.

  PMID: 31368718 DERIVED

• Kirsch JL, Robinson ME, McCrae CS, Kacel EL, Wong SS, Patidar S, Sannes TS, Garey S, Castagno JC, Pereira DB. Associations Among Sleep Latency, Subjective Pain, and Thermal Pain Sensitivity in Gynecologic Cancer. Pain Med. 2020 Jan 1;21(1):5-12. doi: 10.1093/pm/pny236.

  PMID: 30481329 DERIVED

MeSH Terms

Conditions

Genital Neoplasms, Female; Sleep Initiation and Maintenance Disorders; Pain

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Deidre B. Pereira, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2015
• First Posted: November 20, 2015
• Study Start: July 1, 2009
• Primary Completion: April 18, 2019
• Study Completion: May 2, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

US (1)