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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2023-05-02

Brief Summary

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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.

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Detailed Description

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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

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Genital Neoplasms, Female Insomnia Pain Adaptation, Psychological

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Psychoeducation

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No