Clinical trial · Interventional
Effect of Two Cognitive-Behavioral Interventions on Cervical Cancer Patients
Effect of Two Cognitive-Behavioral Interventions on Psychosocial Factors and Quality of Life of Cervical Cancer Patients With Locally-advanced and Advanced Disease
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Coping Skills | — | UNRESOLVED | — |
| Psychological Distress | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive Restructuring | Other | — | UNRESOLVED |
| Psychoeducation | Other | — | UNRESOLVED |
| Relaxation | Other | — | UNRESOLVED |
| Solving Problems | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- "A" Intervention
- description
- Psychoeducation, Relaxation, Cognitive Reestructuring and Problem Solving
- interventionNames
- Other: Psychoeducation
- Other: Relaxation
- Other: Cognitive Restructuring
- Other: Solving Problems
- type
- ACTIVE_COMPARATOR
- label
- "B" Intervention
- description
- Psychoeducation, Relaxation
- interventionNames
- Other: Psychoeducation
- Other: Relaxation
Primary outcomes (6)
- measure
- Change in Anxiety and Depression
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * PATIENTS: * Affiliated to the MICAELA (Modelo Integral para el Cáncer Cervicouterino Localmente Avanzado y Avanzado) program * Ability to understand the study and to provide signed informed consent * Diagnosed with locally advanced and advanced cervical cancer * Patients newly diagnosed or with recurrence about to start treatment * Patients with moderate or severe anxiety, and/or depression symptoms or maladaptive coping * PRIMARY CAREGIVERS: * Relatives, acquaintance or friends reported to be the principal caregiver of the patient * Relatives, acquaintance or friends who do not perceived economic remuneration for taking care of the patient Exclusion Criteria: * PATIENTS: * Patients with psychological or psychiatric treatment or who received previous mental-health treatment. * Patients with any alteration of the Central Nervous System * Patients with moderated or severe cognitive impairment * Patients under palliative care or in terminal phase * PRIMARY CAREGIVERS * Caregivers with severe hearing and/or visual problems * Caregivers with a professional or technical training in patient care Elimination criteria Patients referred to palliative care
References
Publications (27)
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