Genital Neoplasms, FemaleNCT02609880
Cognitive Behavioral Effects on Sleep, Pain, and Cytokines in Gynecologic Cancer
A study testing Cognitive Behavioral Therapy and Psychoeducation in people with Genital Neoplasms, Female and Insomnia, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Genital Neoplasms, Female, Insomnia, Pain
- What is being tested?
- Cognitive Behavioral Therapy and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to 2 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Genital Neoplasms, Female, Insomnia, Pain, Adaptation, Psychological
- Being tested
- Cognitive Behavioral Therapy, Psychoeducation
- Keywords
- Psycho-Oncology, Psychoneuroimmunology, Cognitive Behavioral Therapy, Gynecologic Cancer, Insomnia, Pain, Distress, Cortisol, Cytokines
- Medical subject headings
- Genital Neoplasms, Female, Sleep Initiation and Maintenance Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
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.
PsychoeducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startJul 2009
- Primary completion18 Apr 2019
- Study completion2 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Genital Neoplasms, FemaleStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Deidre B. Pereira, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609880
- Sponsor's protocol ID
- IRB201600679-N
- Other IDs
- R01CA138808, 287-2009
- Status last verified
- Jun 2023
- First submitted
- 9 Nov 2015
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34124972Hanvey 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.
PubMed 35651964Cai 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.
PubMed 41170811Kacel 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.
PubMed 31368718Kirsch 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.
PubMed 30481329
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Effects on Sleep, Pain, and Cytokines in Gynecologic Cancer
- ClinicalTrials.gov ID
- NCT02609880
- Acronym / sponsor ID
- IRB201600679-N
- Conditions
- Genital Neoplasms, Female, Insomnia, Pain, Adaptation, Psychological
- Keywords
- Psycho-Oncology, Psychoneuroimmunology, Cognitive Behavioral Therapy, Gynecologic Cancer, Insomnia, Pain, Distress, Cortisol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- University of Miami, National Cancer Institute (NCI)
- Study start
- Jul 2009 (actual)
- Primary completion
- 18 Apr 2019 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Behavioral: Cognitive Behavioral TherapyThis 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. |
| Psychoeducation | Placebo comparator | Behavioral: PsychoeducationThis 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyCognitive 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. | Behavioural | Cognitive Behavioral Therapy |
| PsychoeducationPsychoeducation 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. | Behavioural | Psychoeducation |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
4 secondary outcomes
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Results publication: PubMed 34124972Padron 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.
- Results publication: PubMed 35651964Hanvey 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.
- Derived from this study: PubMed 41170811Cai 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.
- Derived from this study: PubMed 31368718Kacel 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.
- Derived from this study: PubMed 30481329Kirsch 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deidre B. Pereira, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy and Psychoeducation in people with Genital Neoplasms, Female and Insomnia, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02609880, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.