Unified Barlow Protocol (UP) in Cancer Survivors for Cognitive Impairments

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversidad de Córdoba

About this trial

Background: Cognitive impairment appears frequently in cancer survivors, negatively affecting the quality of life and emotional well-being of patients. This study compares the effectiveness of a well-established treatment (cognitive rehabilitation) with the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) to alleviate these cognitive deficits and evaluate its effect on anxiety-depressive symptoms and the quality of life of survivors.

Methods: A three-arm randomized superiority clinical trial, with a pre-post and follow-up repeated measures and intergroup design with a 1:1:1 allocation ratio will be carried out. A hundred and twenty-three breast cancer survivors with mild to moderate cognitive impairment will be randomly assigned to one of the interventions of the study: cognitive rehabilitation intervention group, an intervention group with UP intervention, or a control group on the waiting list. The primary outcome is to observe a significant improvement in cognitive function and quality of life in both intervention groups and a significant decrease in emotional impairments in comparison with the waitlist group. These results will be maintained at six months of follow-up.

Discussion: The aim of this work is to test the efficacy of the Unified Barlow Protocol in reducing cognitive deficits in breast cancer survivors. The results of this trial may be useful in reducing the presence of cognitive problems in survivors and improving their emotional state and quality of life.

Eligibility criteria

Qualifiers

Cancer diagnosis, stages I-III.

Cancer type: Breast.

Have received the last chemotherapy session in the last 6 months and a maximum of 6 years of treatment completion.

Probable or mild to moderate cognitive impairment (score between 26 and 10 points according to the MMSE).

Disqualifiers

Men and women aged > 70 years.

Diagnosis of cancer, stage IV or other types of cancer.

Last chemotherapy session < 6 months or > 6 years.

No cognitive impairment (MMSE score between 30 and 27 points).

Trial design

Treatments tested in this trial

  • Neuropsychological treatment
  • Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (PU).
  • Waitlist group

Treatment groups

123 Participants
are divided into 3 treatment groups

Sponsors and collaborators