Clinical Trial

Effect of Two Cognitive-Behavioral Interventions on Cervical Cancer Patients

Enrolling by Invitation
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Record status
This record was last updated May 28, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
Cancer represents the second cause of death in general population worldwide and according to statistics, it is expected to increase in the next 20 years. Cervical cancer is the fourth cause of morbidity and mortality among women around the world. Late diagnosis and treatment indices several emotional reactions in patients leading to psychological disorders with an impact in quality of life. Anxiety and depression are the most frequent emotional reactions in cancer patients, which may vary depending on psychosocial factors such as coping and family support, mostly provided by the primary caregiver. Despite the high psychological morbidity in cancer patients, it is estimated that, among those patients needing psychological support, only 10% receive such interventions. A growing interest on psychological interventions in oncology has increased in the last 40 years, however, scarce investigations have been performed, especially in cervical cancer patients. The Cognitive-Behavioral Therapy has proven to be beneficial in general cancer population decreasing the psychological symptoms and improving the quality of life. Thus, the aim of this study is to evaluate the effect of two Cognitive-Behavioral psychological interventions on anxiety, depression, coping, therapeutic adherence, sexual satisfaction and quality of life of cervical cancer patients with locally-advanced and advanced disease attended at the National Cancer Institute from Mexico. Psychological intervention will be provided during ten weekly sessions including psychoeducation, relaxation, cognitive restructuring and problem solving with a pretest, posttest performed one week after intervention, and finally a follow up after three months after finishing the psychological intervention.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2019-11-13; most recent amendment 2025-05-22.
Status change: Recruiting → Enrolling by Invitation 2023-10-27
Status change: Not Yet Recruiting → Recruiting 2020-05-25
Trial Details
NCT Number NCT04165460
Lead Sponsor National Institute of Cancerología
Conditions Cervical Cancer, Psychological Distress, Coping Skills
Enrollment 92 participants
Start Date 2020-03-02
Primary Completion 2025-12-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-05-28