Clinical trial NCT05409248: Cognitive Stimulation and Chemobrain. An Innovative Intervention for Cancer Survivors
Official title: Cognitive Stimulation Intervention Program for Cancer Survivors and Its Benefit on Cognitive Performance and Quality of Life
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Cognitive Decline
Keywords: Breast cancer
Cancer survivors
Chemobrain
Cognitive stimulation
Online intervention
Lead sponsor: Universidad Antonio de Nebrija
Sponsor class: OTHER
Collaborators: name: Hospital de la Ribera
First posted: 2022-06-08
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A home-based intervention will be set through the CogniFit® online platform. Participants will access remotely from home using a personal computer or smart device. The cognitive stimulation program will be held for 5 consecutive days (Monday to Friday) for 8 weeks, completing a total of 40 training sessions. Researchers will supervise the participant's performance daily and will periodically contact participants via telephone.
Primary purpose: TREATMENT

Brief summary: The present study aims to establish a non-pharmacological alternative in alleviating cognitive deterioration derived from undergoing chemotherapy treatment. Thus, the effectiveness of a personalized and computerized cognitive stimulation program in breast cancer survivors is assessed.

Detailed description: A phase I/II/III clinical trial is proposed in which the first two phases will serve to evaluate the safety of the intervention and the maximum tolerated time of computerized cognitive training per session in the absence of adverse effects. The third phase will consist of a double-blind randomized controlled trial where the effectiveness of the personalized and self-administered computerized cognitive stimulation program will be evaluated.

Phase I. Based on a dose-escalation 3+3 design, experienced fatigue or adverse effects will be measured after succeeding 15 minutes cognitive stimulation training blocks. The training dose will be set to a block before extreme fatigue or notable adverse effect has been reported by two or more participants. A trained psychologist will supervise the process.

Phase II. To evaluate the effectiveness of the intervention, 20 participants will undertake an interspersed training day and evaluation day through 15 consecutive days. In this way, a total of 8 evaluation sessions (day 1, 3, 5, 7, 9, 11, 13, and 15) and 7 cognitive stimulation sessions (day 2, 4, 6, 8, 10, 12, and 14) will be carried out. A trained psychologist will supervise every step of the process.

Phase III. An 8-week personalized and computerized cognitive stimulation program will be established, where the training time per session will be as determined on phase I. 120 participants will be randomized 1:1 ratio to an intervention or active control group. All participants will undertake a pre and post-test, with a total of 40 training sessions (Monday to Friday) during 8 weeks. Although this phase is set to be an online home-based stage, the responsible psychologist will be monitoring participants' performance and will periodically contact participants via telephone.

Eligibility criteria: Inclusion Criteria:

* Have been diagnosed with breast cancer.
* Having undergone chemotherapy.
* Report objective or subjective complaints of cognitive impairment.

Exclusion Criteria:

* Metastases or brain tumors.
* Existence of a relevant medical, psychiatric, or neurological disorder.
* Significant visual or motor impairments.
* History of alcohol or drug abuse or dependence.
* Be receiving another cognitive stimulation intervention.

Primary outcomes:
measure: Change from Baseline in mini-Mental Adjustment to Cancer Scale (mini-MAC) at Week 8
timeFrame: Baseline and Week 8
measure: Change from Baseline in Cognitive Assessment for Chemo Fog Research (CAB-CF) at Week 8
timeFrame: Baseline and Week 8
measure: Change from Baseline in the Functionality Assessment Instrument in Cancer Treatment - Cognitive Function (FACT-COG) at Week 8
timeFrame: Baseline and Week 8
Secondary outcomes:
measure: Change from Baseline in the State-Trait Anxiety Inventory (STAI) at Week 8
timeFrame: Baseline and Week 8
measure: Change from Baseline in the Beck Depression Inventory (BDI-II) at Week 8
timeFrame: Baseline and Week 8
measure: Change from Baseline in the Brief Fatigue Inventory (BFI) at Week 8
timeFrame: Baseline and Week 8
measure: Change from Baseline in the Measuring Quality of Life | The World Health Organization - abridged version (WHOQOL-BREF) at Week 8
timeFrame: Baseline and Week 8
measure: Change from Baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS) at Week 8
timeFrame: Baseline and Week 8
Other outcomes:
Locations:
city: Alzira
country: Spain
facility: Hospital la Ribera
state: Valencia
Study officials:
affiliation: Universidad Nebrija
name: Jon A Duñabeitia
role: STUDY_DIRECTOR
affiliation: Univerisdad Nebrija
name: Jose L Tapia
role: PRINCIPAL_INVESTIGATOR
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