Effectiveness of Cognitive Rehabilitation and the Unified Barlow Protocol (UP) in Cancer Survivors for Cognitive Impairments: a Randomized Controlled Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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).

• Ability to be fluent in Spanish.

• Not currently participating in another clinical trial.

• Not currently receiving other psychological treatment

Locations
Other Locations
Spain
Hospital Universitario Reina Sofía
NOT_YET_RECRUITING
Córdoba
Reina Sofía University Hospital
RECRUITING
Córdoba
Time Frame
Start Date: 2021-01-25
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 123
Treatments
Active_comparator: Neuropsychological treatment
Combination of different neuropsychological rehabilitation programs
Experimental: Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (PU).
This intervention focuses on a deficit in emotional regulation common in all emotional disorders (ED).
Other: Waitlist group
The control group will receive the Adapted Mnesic Cognitive Training (ACTIVE) (Jobe, et al., 2001), as well as the Insight (Posit Science) program (Mahncke et al., 2006) once the interventions in groups 1 and 2 have been completed.
Related Therapeutic Areas
Sponsors
Leads: Universidad de Córdoba

This content was sourced from clinicaltrials.gov