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

NCT02609880 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2023-06-15

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • University of Miami

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Florida

    lead OTHER

Principal Investigators

  • Deidre B. Pereira, PhD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2019-04-18
Completion
2023-05-02

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02609880 on ClinicalTrials.gov