NCT04165460Enrolling by invitation
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 · Last updated 28 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 92 (estimated)
- First submitted
- 7 Oct 2019
- Start date
- 2 Mar 2020
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- National Institute of Cancerología
- Diseases
- Cervical cancer
- NCT number
- NCT04165460
What you commit to
- Study type: Interventional
- Planned participants: 92
- From 2 Mar 2020 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Nacional de Cancerologia Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.