Cancer, BreastNCT05289258
Unified Barlow Protocol (UP) in Cancer Survivors for Cognitive Impairments
A study testing Neuropsychological treatment, Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (PU). and Waitlist group in people with Cancer, Breast, run by Universidad de Córdoba at 2 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cancer, Breast
- What is being tested?
- Neuropsychological treatment, Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (PU). and Waitlist group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 2 sitesSpain
- Study dates
- 25 Jan 2021to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
- Diagnosis of mental disorder (including substance abuse) prior to cancer diagnosis.
- Relapse in disease after chemotherapy treatment is completed.
- Neurodevelopmental Disorder Diagnosis.
- Diagnosis of diseases that affect cognitive performance such as: hypertension, cardiac diseases, epilepsy, dementias, multiple sclerosis, functional disorders (fibromyalgia, chronic fatigue syndrome, irritable bowel syndrome, post-concussion syndrome, whiplash syndrome), CNS infections (HIV, encephalitis), metabolic disorders (diabetes, B12 deficiency), obstructive sleep apnea, brain damage (stroke, TBI, CNS cancer) and use of medications / substances that interfere with cognitive function such as pregabalin, gabapentin, topiramate, antidepressants tricyclics, sodium valproate, anticholinergics, methylphenidate, typical antipsychotics.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Not yet recruiting
Hospital Universitario Reina Sofía
Córdoba, 14005
Enrique Aranda, PhD, 957 011 638, earandaa@seom.org
- Recruiting
Reina Sofía University Hospital
Córdoba
Francisco Garcia Torres, PhD, +3495721 ext. 8847, z12gatof@uco.es
Francisco García-Torres, PhD
About this study
Official title: Effectiveness of Cognitive Rehabilitation and the Unified Barlow Protocol (UP) in Cancer Survivors for Cognitive Impairments: a Randomized Controlled 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.
- Conditions
- Cancer, Breast
- Being tested
- Neuropsychological treatment, Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (PU)., Waitlist group
- Keywords
- Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP), cognitive impairments, quality of life, anxiety and depression.
- Medical subject headings
- Breast Neoplasms, Cognitive Dysfunction, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological treatmentBehavioural
combination of the programs tested by (Von Ah et al. 2012). These programs are, on the one hand, a cognitive training adapted from the Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE) (Jobe et al., 2001) and, on the other, a processing speed training using the Insight program (from Posit Science) (Mahncke et al., 2006). The first consists of teaching patients memorization techniques, and the second consists of a series of exercises on information processing of varying difficulty. These exercises automatically adjust your difficulty to maintain an 85% rate of return. Treatment is carried out in groups of 10 cancer survivors. It consists of 10 weekly sessions of 2 hours each (the first hour for memory training and the second for processing speed exercises). In order to improve the adherence to treatment of the participants, emails and telephone text messages will be sent with reminders of appointments and tasks to be performed.
Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (PU).Behavioural
This intervention focuses on a deficit in emotional regulation common in all emotional disorders (ED). Therefore, it focuses on the adaptive value of emotions and promotes tolerance to intense emotions as well as the identification and modification of dysfunctional emotional regulation strategies. Patients receive 10 group therapy sessions (3-5 cancer survivors per group) with all PU modules (Barlow et al., 2011). The Spanish version of the therapist's guide and the patient's workbook are used (Barlow et al., 2015). All patients receive the workbook to help them read the contents of each session, do the recommended exercises between sessions, and to help them once the treatment is finished. The treatment lasts 10 weeks (one session a week). As in the previous intervention group, emails and telephone text messages will be used with reminders of appointments and tasks to be carried out.
Waitlist groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Neuropsychological treatment | Active comparator | Combination of different neuropsychological rehabilitation programs Receives: Behavioral: Neuropsychological treatment |
| Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (PU). | Experimental | This intervention focuses on a deficit in emotional regulation common in all emotional disorders (ED). Receives: Behavioral: Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (PU). |
| Waitlist group | Other | 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. Receives: Behavioral: Waitlist group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional assessment of Cancer Therapy-Cognitive Function, version 3. (FACT-Cog).
This is an instrument developed to assess chemotherapy-induced cognitive problems in cancer patients. It includes four different subscales: Perceived Cognitive Impairments (score range from 0-72), Impact of Perceived Cognitive Impairments on QoL (score range from 0-16), Comments from Others (score range from 0-16), and Perceived Cognitive Abilities (scores range from 0-28) that are scored using a Likert scale of five points from 0 (never) to 4 (several times a day). The higher the score, the better the cognitive function
Measured: Change of mean scores from baseline to immediately after intervention
Memory Failures Everyday (MFE-30).
It is a unifactorial questionnaire that measures a single construct: "cognitive complaints". It is made up of 30 items that are answered on a 5-point Likert scale from 1 (never) to 4 (always or almost always) with higher scores indicate poorer memory function. Scores are from 1 to with higher scores indicating higher memory impairments
Measured: Change of mean scores from baseline to immediately after intervention
Hopkins Verbal Learning Test-Revised (HVLT-R).
This test measures primary and secondary memory, the rate of verbal learning throughout three trials, as well as three forms of mnesic organization: serial ordering, semantic grouping, and subjective organization. The test consists of a list of 12 words that are presented orally at a speed of one word for every two seconds. a higher number of words is interpreted as better recall and recognition
Measured: Change of mean scores from baseline to immediately after intervention
Trail Making Test (TMT).
The TMT consists of two parts: Part A measures attention, processing speed, visual search, and working memory; on the other hand, part B is used to measure attention, executive function (cognitive flexibility, ability to change tasks, coordination of categories), working memory, visual-motor skills and processing speed. A greater time to complete the tasks is interpreted as a greater deterioration
Measured: Change of mean scores from baseline to immediately after intervention
Controlled Oral Word Association Test (COWAT).
The COWAT is a test that measures verbal fluency and is a recognized and sensitive indicator of cognitive functioning. the participant has to say as many words as possible in one minute, and a greater number of words is associated with greater verbal fluency.
Measured: Change of mean scores from baseline to immediately after intervention
Secondary outcomes (2)
Hospital Anxiety and Depression Scale (HADS)
This scale is used to assess anxiety and depression in a hospital settings. It is made up of 14 items (7 for anxiety and 7 for depression), which are answered on a scale from 0 to 3, with maximum values of 21 in each of the subscales. Higher scores indicates the presence of anxiety and depression.
Measured: Change of mean scores from baseline to immediately after intervention]
Quality of Life scores using EORTC QLQ C-30.
EORTC QLQ C-30 (version 3), this is an instrument developed to assess the quality of life in cancer patients using 30 questions that refer to the quality of life experienced by the patient during the last week. The first twenty-eight items include questions about different symptoms and are answered on a scale that ranges from 1 (not at all) to 4 (a lot), while the last two ask patients about the perception of their global health and quality of life in a scale from 1 (terrible) to 7 (excellent). The different items are grouped into functional scales (physical / role / emotional / cognitive / social and global) and symptom scale (fatigue / nausea and vomiting / dyspnea / sleep problems / loss of appetite / constipation / diarrhea and financial impact ). Higher scores indicates a better function.
Measured: Change of mean scores from baseline to immediately after intervention]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start25 Jan 2021
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer, BreastStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a three-arm randomized clinical trial, with a pre-post-follow-up repeated measures intergroup design.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 123 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Garcia Torres, Universidad de Córdoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289258
- Sponsor's protocol ID
- 1380800-R
- Status last verified
- Apr 2026
- First submitted
- 28 Dec 2021
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not applicable for this trial
Publications
Garcia-Torres F, Tejero-Perea A, Gomez-Solis A, Castillo-Mayen R, Jaen-Moreno MJ, Luque B, Galvez-Lara M, Sanchez-Raya A, Jablonski M, Rodriguez-Alonso B, Aranda E. Effectiveness of the Unified Barlow Protocol (UP) and neuropsychological treatment in cancer survivors for cognitive impairments: study protocol for a randomized controlled trial. Trials. 2022 Sep 30;23(1):819. doi: 10.1186/s13063-022-06731-w.
PubMed 36175973
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Cognitive Rehabilitation and the Unified Barlow Protocol (UP) in Cancer Survivors for Cognitive Impairments: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05289258
- Acronym / sponsor ID
- 1380800-R
- Conditions
- Cancer, Breast
- Keywords
- Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP), cognitive impairments, quality of life, anxiety and depression.
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 123 participants (estimated)
- Lead sponsor
- Universidad de CórdobaUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- This study is a three-arm randomized clinical trial, with a pre-post-follow-up repeated measures intergroup design.
| Arm | Type | Receives |
|---|---|---|
| Neuropsychological treatment | Active comparator | Behavioral: Neuropsychological treatmentCombination of different neuropsychological rehabilitation programs |
| Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (PU). | Experimental | Behavioral: 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). |
| Waitlist group | Other | Behavioral: Waitlist groupThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
- Diagnosis of mental disorder (including substance abuse) prior to cancer diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological treatmentcombination of the programs tested by (Von Ah et al. 2012). These programs are, on the one hand, a cognitive training adapted from the Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE) (Jobe et al., 2001) and, on the other, a processing speed training using the Insight program (from Posit Science) (Mahncke et al., 2006). The first consists of teaching patients memorization techniques, and the second consists of a series of exercises on information processing of varying difficulty. These exercises automatically adjust your difficulty to maintain an 85% rate of return. Treatment is carried out in groups of 10 cancer survivors. It consists of 10 weekly sessions of 2 hours each (the first hour for memory training and the second for processing speed exercises). In order to improve the adherence to treatment of the participants, emails and telephone text messages will be sent with reminders of appointments and tasks to be performed. | Behavioural | Neuropsychological treatment |
| 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). Therefore, it focuses on the adaptive value of emotions and promotes tolerance to intense emotions as well as the identification and modification of dysfunctional emotional regulation strategies. Patients receive 10 group therapy sessions (3-5 cancer survivors per group) with all PU modules (Barlow et al., 2011). The Spanish version of the therapist's guide and the patient's workbook are used (Barlow et al., 2015). All patients receive the workbook to help them read the contents of each session, do the recommended exercises between sessions, and to help them once the treatment is finished. The treatment lasts 10 weeks (one session a week). As in the previous intervention group, emails and telephone text messages will be used with reminders of appointments and tasks to be carried out. | Behavioural | Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (PU). |
| Waitlist groupThe 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. | Behavioural | Waitlist group |
Primary outcome
Functional assessment of Cancer Therapy-Cognitive Function, version 3. (FACT-Cog).
Time frame: Change of mean scores from baseline to immediately after intervention
This is an instrument developed to assess chemotherapy-induced cognitive problems in cancer patients. It includes four different subscales: Perceived Cognitive Impairments (score range from 0-72), Impact of Perceived Cognitive Impairments on QoL (score range from 0-16), Comments from Others (score range from 0-16), and Perceived Cognitive Abilities (scores range from 0-28) that are scored using a Likert scale of five points from 0 (never) to 4 (several times a day). The higher the score, the better the cognitive function
Memory Failures Everyday (MFE-30).
Time frame: Change of mean scores from baseline to immediately after intervention
It is a unifactorial questionnaire that measures a single construct: "cognitive complaints". It is made up of 30 items that are answered on a 5-point Likert scale from 1 (never) to 4 (always or almost always) with higher scores indicate poorer memory function. Scores are from 1 to with higher scores indicating higher memory impairments
Hopkins Verbal Learning Test-Revised (HVLT-R).
Time frame: Change of mean scores from baseline to immediately after intervention
This test measures primary and secondary memory, the rate of verbal learning throughout three trials, as well as three forms of mnesic organization: serial ordering, semantic grouping, and subjective organization. The test consists of a list of 12 words that are presented orally at a speed of one word for every two seconds. a higher number of words is interpreted as better recall and recognition
Trail Making Test (TMT).
Time frame: Change of mean scores from baseline to immediately after intervention
The TMT consists of two parts: Part A measures attention, processing speed, visual search, and working memory; on the other hand, part B is used to measure attention, executive function (cognitive flexibility, ability to change tasks, coordination of categories), working memory, visual-motor skills and processing speed. A greater time to complete the tasks is interpreted as a greater deterioration
Controlled Oral Word Association Test (COWAT).
Time frame: Change of mean scores from baseline to immediately after intervention
The COWAT is a test that measures verbal fluency and is a recognized and sensitive indicator of cognitive functioning. the participant has to say as many words as possible in one minute, and a greater number of words is associated with greater verbal fluency.
2 secondary outcomes
Hospital Anxiety and Depression Scale (HADS)
Time frame: Change of mean scores from baseline to immediately after intervention]
Quality of Life scores using EORTC QLQ C-30.
Time frame: Change of mean scores from baseline to immediately after intervention]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Derived from this study: PubMed 36175973Garcia-Torres F, Tejero-Perea A, Gomez-Solis A, Castillo-Mayen R, Jaen-Moreno MJ, Luque B, Galvez-Lara M, Sanchez-Raya A, Jablonski M, Rodriguez-Alonso B, Aranda E. Effectiveness of the Unified Barlow Protocol (UP) and neuropsychological treatment in cancer survivors for cognitive impairments: study protocol for a randomized controlled trial. Trials. 2022 Sep 30;23(1):819. doi: 10.1186/s13063-022-06731-w.
- Individual participant dataSharing planned: No. not applicable for this trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological treatment, Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (PU). and Waitlist group in people with Cancer, Breast, run by Universidad de Córdoba at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional assessment of Cancer Therapy-Cognitive Function, version 3. (FACT-Cog). (time frame: Change of mean scores from baseline to immediately after intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05289258, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.