Cancer-related cognitive impairment (CRCI) affects a large proportion of non-central nervous system cancer survivors and can negatively impact cognitive functioning and daily life. Cognitive rehabilitation has shown promising results in addressing these difficulties. The goal of this pilot randomized controlled trial is to evaluate the feasibility, acceptability, and preliminary efficacy of the CanCOG®- Cognitive Rehabilitation in Cancer program in Portuguese adult cancer survivors with CRCI.
Adult non-central nervous system cancer survivors (n=60) will be randomly assigned to receive either the CanCOG® intervention or treatment as usual.
CanCOG® is a structured cognitive rehabilitation program designed to help cancer survivors manage cognitive difficulties through cognitive training exercises, psychoeducation, and compensatory strategy training. The program consists of six weekly sessions of 1 hour and 30 minutes each, delivered over six consecutive weeks. Sessions are administered in person in small groups (3-9 participants) and are led by a trained professional.
The main focus of the study is to assess feasibility outcomes, including recruitment, retention, adherence to the intervention, and completion of study assessments, as well as acceptability and participant satisfaction.
The study will also explore preliminary effects of the intervention on cognitive functioning (both perceived and objective), symptoms of anxiety and depression, and quality of life. Participants will complete assessments at baseline (2 weeks after the intervention), 2 weeks after the intervention, and at 3- and 6-month follow-ups. Some participants (10-15) will also take part in interviews to provide feedback on their experience with the program.
Adults aged 18 to 65 years whose native language is European Portuguese;
Diagnosis of cancer not involving the central nervous system (non-CNS cancer);
Disease stage I to III;
Completion of primary cancer treatment at least 6 months and no more than 5 years prior to enrollment (with the exception of ongoing hormone therapy and immunotherapy);
Diagnosis of current severe psychiatric disorders (e.g., schizophrenia, psychosis, bipolar disorder, major depressive disorder, or attention-deficit/hyperactivity disorder);
Diagnosis of communication disorders;
Diagnosis of neurodevelopmental disorders or other severe medical conditions (e.g., history of stroke, encephalitis, dementia or neurodegenerative disease, epilepsy, or traumatic brain injury);
Presence of metastases or other tumors;
Parallel
CanCOG® - Cogntive Rehabilitation in Cancer
BehavioralCanCOG® is a structured cognitive rehabilitation program designed for cancer survivors experiencing cancer-related cognitive impairment (CRCI). The intervention is delivered in person in small groups of 3 to 9 participants by a trained professional and consists of six weekly sessions of 90 minutes each over six consecutive weeks. The program combines psychoeducation about CRCI, cognitive training exercises targeting domains such as attention, memory, and executive functioning, and compensatory strategy training to support everyday cognitive functioning and self-management of cognitive difficulties.
Feasibility - Screening rate
Screening rate will be assessed as the proportion of potentially eligible cancer survivors who undergo eligibility screening.
Feasibility - Eligibility rate
The eligibility rate will be assessed as the proportion of screened individuals who meet the eligibility criteria. Reasons for ineligibility will be documented whenever available.
Feasibility - Consent rate
Consent rate will be assessed as the proportion of eligible individuals who provide informed consent. Reasons for refusal to participate will be documented whenever available.
Feasibility - Retention rate
Retention rate will be assessed as the proportion of participants who remain enrolled until study completion. Reasons for withdrawal will be documented whenever available.
Perceived cognitive functioning
Perceived cognitive functioning will be assessed with the Functional Assessment of Cancer Therapy-Cognitive Function version 3 (FACT-Cog v3). It consists of a 37-item self-report questionnaire composed of four subscales: Perceived Cognitive Impairments (CogPCI), Perceived Cognitive Abilities (CogPCA), Comments from Others (CogOth), and Impact on Quality of Life (CogQoL). The higher the score, the better the perceived functioning.
Objective cognitive functioning (Global cognition)
Global cognition will be assessed using the Montreal Cognitive Assessment (MoCA). The instrument's scores range from 0 to 30, with lower scores indicating poorer cognitive performance.
Objective cognitive functioning (Verbal learning and memory)
The test includes immediate recall across five learning trials, delayed recall after 30 minutes, and a recognition trial, allowing the assessment of acquisition, retention, and recognition processes. Lower scores indicate poorer performance.
Objective cognitive functioning (Attention and processing speed)
Attention and processing speed will be assessed with the Trail Making Test Part A (TMT-A) and D2 Test of Attention. TMT- A: Performance is based on completion time and errors. Higher adjusted scores correspond to better performance. D2 Test of Attention: The scoring of this test provides the following results: Total Characters Processed, Total Correct Responses, Total Efficiency and Concentration Index. Higher scores suggest better performance.
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Aveiro University
Lead sponsor
Foundation for Science and Technology, Portugal
Collaborator
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