Cancer-related Cognitive Difficulties, Cancer-related Cognitive Dysfunction, Cancer-related Cognitive Impairment, Depression and Anxiety Symptoms, Quality of Life
Conditions
Keywords
cancer, cancer survivors, cognitive rehabilitation, cognition, non-pharmacological interventions, RCT, Pilot study, crci, cancer-related cognitive impairment
Brief summary
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.
Detailed description
Cancer-related cognitive impairment (CRCI) is a frequent consequence of cancer and its treatments in non-central nervous system survivors and has been associated with persistent difficulties in multiple cognitive domains, including attention, memory, and executive functioning. Cognitive rehabilitation approaches aim to improve cognitive functioning and promote the use of compensatory strategies to support daily functioning in individuals experiencing CRCI. The CanCOG® program is a structured group-based cognitive rehabilitation intervention delivered by trained professionals and incorporating cognitive training exercises, psychoeducation, and strategy training. This study is a pilot randomized controlled trial designed to inform the feasibility and acceptability of the intervention and study procedures, as well as to provide preliminary evidence regarding potential intervention effects. The intervention consists of six weekly in-person group sessions (1 hour and 30 minutes each), delivered over six consecutive weeks in small groups of 3 to 9 participants. Outcomes will be assessed using a comprehensive neuropsychological and psychosocial evaluation battery covering global cognition, memory, attention, executive functioning, psychological distress, and quality of life, using validated instruments. Assessments will be conducted at baseline, post-intervention, and at 3- and 6-month follow-up time points. Data will be collected in Portuguese healthcare units. The study has been submitted to and approved by the relevant Ethics Committee, and complies with the General Data Protection Regulation (GDPR).
Interventions
BEHAVIORALCanCOG® - Cogntive Rehabilitation in Cancer
CanCOG® 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.
Sponsors
Aveiro University
Foundation for Science and Technology, Portugal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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); * Score \< 51 on the Perceived Cognitive Abilities subscale of the FACT-Cog v3. Stable psychiatric and neurological medication regimen for at least 3 months prior to enrollment; * Educational level equal to or higher than the 3rd year of primary education; * Ability to read and write in Portuguese and provide informed consent to participate.
Exclusion criteria
* 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; * History of substance abuse (alcohol or drugs); * Current or prior participation in another cognitive rehabilitation intervention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Screening rate | Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-ups. | Screening rate will be assessed as the proportion of potentially eligible cancer survivors who undergo eligibility screening. |
| Feasibility - Eligibility rate | Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-ups | 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 | Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-ups. | 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 | Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-ups | Retention rate will be assessed as the proportion of participants who remain enrolled until study completion. Reasons for withdrawal will be documented whenever available. |
| Feasibility - Assesment completion rate | Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-ups | Assessment completion rate will be assessed as the proportion of participants completing assessments at each assessment time point. Reasons for missed assessments will be documented whenever available. |
| Feasibility - Intervention adherence | Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-ups | Intervention adherence will be assessed as the proportion of intervention sessions attended by participants allocated to the intervention group. Reasons for missed sessions will be documented whenever available. |
| Feasibility - Intervention fidelity | Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-ups | Intervention fidelity, the extent to which the intervention is delivered according to the intervention manual and session plans, will be assessed through facilitator-completed fidelity checklists. |
| Acceptability - Participant retention and intervention adherence | Baseline ( 2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-up. | Acceptability of the intervention will be assessed using participant retention (proportion of participants who remain enrolled until study completion) and intervention adherence (proportion of intervention sessions attended by participants allocated to the intervention group). |
| Acceptability - Qualitative feedback | Post-intervention (2 weeks after) | Acceptability will be assessed through semi-structured interviews conducted with 10-15 participants from the intervention group. Interviews will explore participants' perceptions of the intervention content, format, duration, group delivery, perceived usefulness, and barriers or facilitators to participation. |
| Acceptability - ACRIS-CS | Baseline (2 weeks before intervention) and post-intervention (2 weeks after). | Acceptability will also be assessed through the Acceptability of Cognitive Rehabilitation Interventions Survey-Cancer Survivors (ACRIS-CS). This 11-item instrument evaluates participants' perceptions of the intervention's acceptability, including its perceived usefulness, appropriateness, and overall satisfaction. Higher scores indicate greater acceptability of the cognitive rehabilitation intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived cognitive functioning | Baseline (2 weeks before intervention), post-intervention (2weeks after), 3-month and 6-month follow-ups. | 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) | Baseline (2 weeks before intervention), Post-intervention (2 weeks after), and 3-month and 6-month follow-up. | 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) | Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-up. | 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) | Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-up. | 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. |
| Objective cognitive functioning (Executive functioning and cognitive flexibility) | Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-up. | Executive functioning and cognitive flexibility will be assessed using the Trail Making Test Part B (TMT-B). Performance is based on completion time and errors. Higher adjusted scores correspond to better performance. |
| Objective cognitive functioning (Working memory) | Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-up. | Working memory will be assessed using the Wechsler Adult Intelligence Scale's (WAIS) - Digit Span subtest. It consists of three components: Digit Span forward, Digit Span Backward, and Digit Span sequencing. Higher scores indicate better performance. |
| Objective cognitive functioning (Verbal fluency) | Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-up. | Verbal fluency will be assessed with the Verbal Fluency Test (VFT). For the VFT, participants are required to remember, in one minute, the maximum number of words possible started by a specific letter or belonging to a specific category. A higher number of words recalled indicates better cognitive performance. |
| Objective cognitive functioning (Inhibitory control) | Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-up. | Inhibitory control will be assessed with the Stroop Color and Word Test. It consists of three tasks: reading words, naming colors, and identifying the color in which each word is written, regardless of the word's meaning. The performance is scored as the number of correct responses completed within the specified time for each condition. Higher scores indicate better performance. |
| Anxiety Symptoms | Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-ups. | Anxiety symptoms will be assessed using the Generalized Anxiety Disorder Scale (GAD-7). It consists of seven items evaluating the presence of anxiety-related symptoms. Scores range from zero to 21, with higher scores indicating greater anxiety severity. |
| Depressive Symptoms | Baseline (2 weeks before intervention) , post-intervention (2 weeks after), and 3-month and 6-month follow-up. | Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a 9-item self-report measure of depression severity based on DSM criteria. Total scores range from 0 to 27, with higher scores indicate more severe depressive symptoms. |
| Health-related quality of life | Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-up. | Health-related quality of life will be assessed using a validated cancer-specific quality of life questionnaire, the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, version 3 (EORTC QLQ-C30, version 3). The EORTC QLQ-C30, is a 30-item instrument including global health status/quality of life, functional, and symptom scales. Scores range from 0 to 100, with higher scores indicating better functioning/global quality of life and worse symptom burden on the symptom scales. |
Countries
Portugal
Contacts
CONTACTSofia A Marques-Fernandes, M.Sc.
Outcome results
None listed