Effect of Two Cognitive-Behavioral Interventions on Cervical Cancer Patients

NCT04165460 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2025-05-28

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Psychoeducation

Delivering systematic information about cancer, oncological treatment and efficient coping strategies.

OTHER

Relaxation

Teaching the patient in diaphragmatic breathing retraining and passive relaxation with guided imagination.

OTHER

Cognitive Restructuring

Teaching the patient to identify dysfunctional cognitions about cancer and oncological treatment that trigger maladaptive emotions and behavior. Then, focus in generating alternative thoughts through contrast with empirical reality based on the Beck Model.

OTHER

Solving Problems

To generate alternative solutions to practical problems based on the model described by Nezu.

Sponsors & Collaborators

  • National Institute of Cancerología

    lead OTHER_GOV

Principal Investigators

  • Jessica Salazar, MSc · National Cancer Institute from Mexico

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-02
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Mexico

Study Locations

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Entities

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 NCT04165460 on ClinicalTrials.gov