CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 64 enrolled
Drug / intervention
Cognitive Behavioral Therapy +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02609880
NCT02609880N/ACompleted

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

University of Florida·interventional·Posted Nov 20, 2015·Updated Jun 15, 2023

In Brief

A clinical study evaluating Cognitive Behavioral Therapy and Psychoeducation for Genital Neoplasms, Female and 3 related conditions. Completed, enrolled 64 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 20, 2015
Enrollment StartJul 1, 2009
Primary CompletionApr 18, 2019
Study CompletionMay 2, 2023
TodayJul 2, 2026
Enrollment to primary: 9.8 yearsPosted 10.6 years ago

Interventions

Cognitive Behavioral Therapybehavioral

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.

Psychoeducationbehavioral

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.