Cancer-related Cognitive ImpairmentCanCOG®NCT07755839

CanCOG®: Pilot Trial of Cognitive Rehabilitation for Cancer Survivors

A study testing CanCOG® - Cogntive Rehabilitation in Cancer in people with Cancer-related Cognitive Impairment and Cancer-related Cognitive Dysfunction, run by Aveiro University at 1 site in Portugal.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Cancer-related Cognitive Impairment, Cancer-related Cognitive Dysfunction, Cancer-related Cognitive Difficulties
What is being tested?: CanCOG® - Cogntive Rehabilitation in Cancer
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 sitePortugal
Study dates: Sep 2026to May 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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sofia A Marques-Fernandes, M.Sc. contact

965252831 ext. 00351

sofiafernandes6@ua.pt

Portugal1 site

University of Aveiro
Aveiro, 3810-193
Sofia A Marques-Fernandes, M.Sc., 00351965252831, sofiafernandes6@ua.pt
Sofia A Marques-Fernandes, M.Sc.

Other trials in Portugal

About this study

Official title: CanCOG® - Cognitive Rehabilitation in Cancer: A Protocol for a Multicenter Pilot Randomized Controlled Trial With Non-central Nervous System Cancer Survivors

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.

Read the 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).

Conditions: Cancer-related Cognitive Impairment, Cancer-related Cognitive Dysfunction, Cancer-related Cognitive Difficulties, Depression and Anxiety Symptoms, Quality of Life
Being tested: CanCOG® - Cogntive Rehabilitation in Cancer
Keywords: cancer, cancer survivors, cognitive rehabilitation, cognition, non-pharmacological interventions, RCT, Pilot study, crci, cancer-related cognitive impairment
Medical subject headings: Depression, Anxiety Disorders, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CanCOG® - Cogntive Rehabilitation in CancerBehavioural
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.

Study groups in NCT07755839
Study group	Role	What they receive
Cognitive rehabilitation intervention	Experimental	Participants allocated to this arm will receive the CanCOG® cognitive rehabilitation intervention in addition to usual care. Following baseline assessment (2 weeks before the intervention), participants will attend the intervention over a 6-week period and complete study assessments 2 weeks after the intervention and at 3- and 6-month follow-up time points. Participants will be asked to complete neuropsychological and psychosocial assessments at each evaluation point. A subset of participants (10-15) may also be invited to participate in a semi-structured interview to explore the acceptability of the intervention, perceived benefits, barriers to participation, and overall satisfaction with the program and study procedures. Receives: Behavioral: CanCOG® - Cogntive Rehabilitation in Cancer
Treatment-as-usual	No intervention	Participants allocated to this arm will continue to receive the usual care and support available through their healthcare providers and will not receive the CanCOG® intervention during the study period. Participants will complete the same schedule of neuropsychological and psychosocial assessments as the intervention group at baseline, post-intervention, and at 3- and 6-month follow-up time points.

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility - Screening rate
Screening rate will be assessed as the proportion of potentially eligible cancer survivors who undergo eligibility screening.
Measured: Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-ups.
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.
Measured: Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-ups
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.
Measured: Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-ups.
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.
Measured: Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-ups
Feasibility - Assesment completion rate
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.
Measured: Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-ups
Feasibility - Intervention adherence
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.
Measured: Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-ups
Feasibility - Intervention fidelity
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.
Measured: Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-ups
Acceptability - Participant retention and intervention adherence
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).
Measured: Baseline ( 2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-up.
Acceptability - Qualitative feedback
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.
Measured: Post-intervention (2 weeks after)
Acceptability - ACRIS-CS
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.
Measured: Baseline (2 weeks before intervention) and post-intervention (2 weeks after).

Secondary outcomes (11)

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.
Measured: Baseline (2 weeks before intervention), post-intervention (2weeks after), 3-month and 6-month follow-ups.
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.
Measured: Baseline (2 weeks before intervention), Post-intervention (2 weeks after), and 3-month and 6-month follow-up.
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.
Measured: Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-up.
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.
Measured: Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-up.
Objective cognitive functioning (Executive functioning and cognitive flexibility)
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.
Measured: Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-up.
Objective cognitive functioning (Working memory)
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.
Measured: Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-up.
Objective cognitive functioning (Verbal fluency)
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.
Measured: Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-up.
Objective cognitive functioning (Inhibitory control)
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.
Measured: Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-up.
Anxiety Symptoms
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.
Measured: Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-ups.
Depressive Symptoms
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.
Measured: Baseline (2 weeks before intervention) , post-intervention (2 weeks after), and 3-month and 6-month follow-up.
Health-related quality of life
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.
Measured: Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2026May 2028

First posted10 Aug 2026
Study startSep 2026 (estimated)
Primary completionJun 2027 (estimated)
Study completionMay 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (35)Papers the sponsor has linked to this study.
Other trials for Cancer-related Cognitive ImpairmentStudies 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
Masking: None (open label)
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07755839
Sponsor's protocol ID: 2023.03752.BD
Other IDs: 2023.03752.BD, https://doi.org/10.54499/2023, 2023
Acronym: CanCOG®
Status last verified: Aug 2026
First submitted: 29 Jul 2026
Last updated: 10 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Yang Y, Von Ah D. Cancer-related cognitive impairment: updates to treatment, the need for more evidence, and impact on quality of life-a narrative review. Ann Palliat Med. 2024 Sep;13(5):1265-1280. doi: 10.21037/apm-24-70. Epub 2024 Sep 9.
PubMed 39260437
Von Ah D, Crouch A. Cognitive Rehabilitation for Cognitive Dysfunction after Cancer and Cancer Treatment: Implications for Nursing Practice. Semin Oncol Nurs. 2020 Feb;36(1):150977. doi: 10.1016/j.soncn.2019.150977. Epub 2020 Jan 17.
PubMed 31959511
Von Ah D, Carpenter JS, Saykin A, Monahan P, Wu J, Yu M, Rebok G, Ball K, Schneider B, Weaver M, Tallman E, Unverzagt F. Advanced cognitive training for breast cancer survivors: a randomized controlled trial. Breast Cancer Res Treat. 2012 Oct;135(3):799-809. doi: 10.1007/s10549-012-2210-6. Epub 2012 Aug 24.
PubMed 22918524
Vardy JL, Pond GR, Bell ML, Renton C, Dixon A, Dhillon HM. A randomised controlled trial evaluating two cognitive rehabilitation approaches for cancer survivors with perceived cognitive impairment. J Cancer Surviv. 2023 Dec;17(6):1583-1595. doi: 10.1007/s11764-022-01261-5. Epub 2022 Oct 15.
PubMed 36241767
Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility Pilot Studies. Med Care. 2022 Jan 1;60(1):95-103. doi: 10.1097/MLR.0000000000001664.
PubMed 34812790
Stelwagen J, Meuleman AT, Lubberts S, Steursma G, Kruyt LM, Donkerbroek JW, Meijer C, Walenkamp AME, Lefrandt JD, Rakers SE, Huitema RB, de Jong MAA, Wiegman EM, van den Bergh ACM, de Jong IJ, van Rentergem JAA, Schagen SB, Nuver J, Gietema JA. Cognitive Impairment in Long-Term Survivors of Testicular Cancer More Than 20 Years after Treatment. Cancers (Basel). 2021 Nov 12;13(22):5675. doi: 10.3390/cancers13225675.
PubMed 34830829
Sousa TV, Viveiros V, Chai MV, Vicente FL, Jesus G, Carnot MJ, Gordo AC, Ferreira PL. Reliability and validity of the Portuguese version of the Generalized Anxiety Disorder (GAD-7) scale. Health Qual Life Outcomes. 2015 Apr 25;13:50. doi: 10.1186/s12955-015-0244-2.
PubMed 25908249
Sanft T, Day A, Peterson L, Rodriguez MA, Ansbaugh S, Armenian S, Baker KS, Ballinger T, Broderick G, Demark-Wahnefried W, Dickinson K, Fairman NP, Friedman DL, Goldman M, Henry NL, Hill-Kayser C, Hudson M, Khakpour N, Koura D, McDonough AL, Melisko M, Mooney K, Moore HCF, Moryl N, Neuman H, O'Connor T, Overholser L, Paskett ED, Patel C, Pirl W, Porpiglia A, Ruddy KJ, Schapira L, Shockney L, Smith S, Syrjala KL, Tevaarwerk A, Yang EH, Zee P, McMillian NR, Freedman-Cass DA. NCCN Guidelines(R) Insights: Survivorship, Version 1.2022. J Natl Compr Canc Netw. 2022 Oct;20(10):1080-1090. doi: 10.6004/jnccn.2022.0052.
PubMed 36240847
Saita K, Amano S, Kaneko F, Okamura H. A scoping review of cognitive assessment tools and domains for chemotherapy-induced cognitive impairments in cancer survivors. Front Hum Neurosci. 2023 Feb 20;17:1063674. doi: 10.3389/fnhum.2023.1063674. eCollection 2023.
PubMed 36891148
Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.
PubMed 20957426
Pfledderer CD, von Klinggraeff L, Burkart S, da Silva Bandeira A, Lubans DR, Jago R, Okely AD, van Sluijs EMF, Ioannidis JPA, Thrasher JF, Li X, Beets MW. Consolidated guidance for behavioral intervention pilot and feasibility studies. Pilot Feasibility Stud. 2024 Apr 6;10(1):57. doi: 10.1186/s40814-024-01485-5.
PubMed 38582840
Oppegaard KR, Mayo SJ, Armstrong TS, Anguera JA, Kober KM, Miaskowski C. The Multifactorial Model of Cancer-Related Cognitive Impairment. Oncol Nurs Forum. 2023 Feb 17;50(2):135-147. doi: 10.1188/23.ONF.135-147.
PubMed 37677800
Oliveira AF, Sosa-Napolskij M, Torres A, Queiroz DF, Bartolo A, Sousa H, Monteiro S, Van Dyk K, Ercoli LM, Santos IM. CanCOG(R): Cultural Adaptation of the Evidence-Based UCLA Cognitive Rehabilitation Intervention Program for Cancer Survivors in Portugal. Healthcare (Basel). 2023 Jan 2;11(1):141. doi: 10.3390/healthcare11010141.
PubMed 36611601
Oliveira AF, Santos IM, Fernandes S, Bem-Haja P, Torres A. Validation study of the Functional Assessment of Cancer Therapy-Cognitive Function-Version 3 for the Portuguese population. BMC Psychol. 2022 Dec 14;10(1):305. doi: 10.1186/s40359-022-01018-w.
PubMed 36517827
Oliveira AF, Marques-Fernandes SA, Bartolo A, Bem-Haja P, Torres A, Santos IM. Establishing Diagnostic Cut-Off Scores for the Perceived Cognitive Impairment Subscale of the Functional Assessment of Cancer Therapy-Cognitive Function-Version 3 in Portuguese Cancer Survivors. Psychooncology. 2025 Sep;34(9):e70278. doi: 10.1002/pon.70278.
PubMed 40954944

Interested in taking part?

Sofia A Marques-Fernandes, M.Sc.

965252831 ext. 00351

sofiafernandes6@ua.pt

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Recruiting
Virtual Home-based Exercise Intervention (RISE) to Improve Cancer-Related Cognitive Impairment and Gut Microbiome in Adolescent and Young Adult Brain Tumor Survivors
Cancer-related Cognitive Dysfunction, Primary Brain Neoplasm
Active, not recruitingObservational study
Association of POCD With Circulating Biomarkers in Patients Undergoing TUR of Bladder Tumor
Cognitive Decline, Urinary Bladder Cancer
Not yet recruiting
Photobiomodulation for Cancer-Related Cognitive Impairment
Cancer-related Cognitive Impairment
Not yet recruiting
Transcranial Direct Current Stimulation for Chemotherapy-Related Chronic Pain in Cancer Survivors
Chronic Pain, Neuropathic Pain
RecruitingObservational study
Older Breast Cancer Patients: Risk for Cognitive Decline
Cancer, Breast, Age-related Cognitive Decline

Study at a glance

From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CanCOG® - Cognitive Rehabilitation in Cancer: A Protocol for a Multicenter Pilot Randomized Controlled Trial With Non-central Nervous System Cancer Survivors
ClinicalTrials.gov ID: NCT07755839
Acronym / sponsor ID: CanCOG® / 2023.03752.BD
Conditions: Cancer-related Cognitive Impairment, Cancer-related Cognitive Dysfunction, Cancer-related Cognitive Difficulties, Depression and Anxiety Symptoms, Quality of Life
Keywords: cancer, cancer survivors, cognitive rehabilitation, cognition, non-pharmacological interventions, RCT, Pilot study, crci
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 60 participants (estimated)
Lead sponsor: Aveiro UniversityUniversity, hospital or other
Collaborators: Foundation for Science and Technology, Portugal
Study start: Sep 2026 (estimated)
Primary completion: Jun 2027 (estimated)
Study completion: May 2028 (estimated)
First posted: 10 Aug 2026 (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.

Adult non-central nervous system cancer survivors (n=60) will be randomly assigned to receive either the CanCOG® intervention or treatment as usual.

Detailed description

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.

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).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cognitive rehabilitation intervention	Experimental	Behavioral: CanCOG® - Cogntive Rehabilitation in CancerParticipants allocated to this arm will receive the CanCOG® cognitive rehabilitation intervention in addition to usual care. Following baseline assessment (2 weeks before the intervention), participants will attend the intervention over a 6-week period and complete study assessments 2 weeks after the intervention and at 3- and 6-month follow-up time points. Participants will be asked to complete neuropsychological and psychosocial assessments at each evaluation point. A subset of participants (10-15) may also be invited to participate in a semi-structured interview to explore the acceptability of the intervention, perceived benefits, barriers to participation, and overall satisfaction with the program and study procedures.
Treatment-as-usual	No intervention	–Participants allocated to this arm will continue to receive the usual care and support available through their healthcare providers and will not receive the CanCOG® intervention during the study period. Participants will complete the same schedule of neuropsychological and psychosocial assessments as the intervention group at baseline, post-intervention, and at 3- and 6-month follow-up time points.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (6 listed)

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);

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
CanCOG® - Cogntive Rehabilitation in CancerCanCOG® 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.	Behavioural	Cognitive rehabilitation intervention

Primary outcome

Feasibility - Screening rate
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.

11 secondary outcomes

Perceived cognitive functioning
Time frame: Baseline (2 weeks before intervention), post-intervention (2weeks after), 3-month and 6-month follow-ups.
Objective cognitive functioning (Global cognition)
Time frame: Baseline (2 weeks before intervention), Post-intervention (2 weeks after), and 3-month and 6-month follow-up.
Objective cognitive functioning (Verbal learning and memory)
Time frame: Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-up.
Objective cognitive functioning (Attention and processing speed)
Time frame: Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-up.
Objective cognitive functioning (Executive functioning and cognitive flexibility)
Time frame: Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-up.
Objective cognitive functioning (Working memory)
Time frame: Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-up.
Objective cognitive functioning (Verbal fluency)
Time frame: Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-up.
Objective cognitive functioning (Inhibitory control)
Time frame: Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-up.
Anxiety Symptoms
Time frame: Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-ups.
Depressive Symptoms
Time frame: Baseline (2 weeks before intervention) , post-intervention (2 weeks after), and 3-month and 6-month follow-up.
Health-related quality of life
Time frame: Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-up.

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 10 Aug 2026.
Background: PubMed 39260437Yang Y, Von Ah D. Cancer-related cognitive impairment: updates to treatment, the need for more evidence, and impact on quality of life-a narrative review. Ann Palliat Med. 2024 Sep;13(5):1265-1280. doi: 10.21037/apm-24-70. Epub 2024 Sep 9.
Background: PubMed 31959511Von Ah D, Crouch A. Cognitive Rehabilitation for Cognitive Dysfunction after Cancer and Cancer Treatment: Implications for Nursing Practice. Semin Oncol Nurs. 2020 Feb;36(1):150977. doi: 10.1016/j.soncn.2019.150977. Epub 2020 Jan 17.
Background: PubMed 22918524Von Ah D, Carpenter JS, Saykin A, Monahan P, Wu J, Yu M, Rebok G, Ball K, Schneider B, Weaver M, Tallman E, Unverzagt F. Advanced cognitive training for breast cancer survivors: a randomized controlled trial. Breast Cancer Res Treat. 2012 Oct;135(3):799-809. doi: 10.1007/s10549-012-2210-6. Epub 2012 Aug 24.
Background: PubMed 36241767Vardy JL, Pond GR, Bell ML, Renton C, Dixon A, Dhillon HM. A randomised controlled trial evaluating two cognitive rehabilitation approaches for cancer survivors with perceived cognitive impairment. J Cancer Surviv. 2023 Dec;17(6):1583-1595. doi: 10.1007/s11764-022-01261-5. Epub 2022 Oct 15.
Background: PubMed 34812790Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility Pilot Studies. Med Care. 2022 Jan 1;60(1):95-103. doi: 10.1097/MLR.0000000000001664.
Background: PubMed 34830829Stelwagen J, Meuleman AT, Lubberts S, Steursma G, Kruyt LM, Donkerbroek JW, Meijer C, Walenkamp AME, Lefrandt JD, Rakers SE, Huitema RB, de Jong MAA, Wiegman EM, van den Bergh ACM, de Jong IJ, van Rentergem JAA, Schagen SB, Nuver J, Gietema JA. Cognitive Impairment in Long-Term Survivors of Testicular Cancer More Than 20 Years after Treatment. Cancers (Basel). 2021 Nov 12;13(22):5675. doi: 10.3390/cancers13225675.
Background: PubMed 25908249Sousa TV, Viveiros V, Chai MV, Vicente FL, Jesus G, Carnot MJ, Gordo AC, Ferreira PL. Reliability and validity of the Portuguese version of the Generalized Anxiety Disorder (GAD-7) scale. Health Qual Life Outcomes. 2015 Apr 25;13:50. doi: 10.1186/s12955-015-0244-2.
Background: PubMed 36240847Sanft T, Day A, Peterson L, Rodriguez MA, Ansbaugh S, Armenian S, Baker KS, Ballinger T, Broderick G, Demark-Wahnefried W, Dickinson K, Fairman NP, Friedman DL, Goldman M, Henry NL, Hill-Kayser C, Hudson M, Khakpour N, Koura D, McDonough AL, Melisko M, Mooney K, Moore HCF, Moryl N, Neuman H, O'Connor T, Overholser L, Paskett ED, Patel C, Pirl W, Porpiglia A, Ruddy KJ, Schapira L, Shockney L, Smith S, Syrjala KL, Tevaarwerk A, Yang EH, Zee P, McMillian NR, Freedman-Cass DA. NCCN Guidelines(R) Insights: Survivorship, Version 1.2022. J Natl Compr Canc Netw. 2022 Oct;20(10):1080-1090. doi: 10.6004/jnccn.2022.0052.
Background: PubMed 36891148Saita K, Amano S, Kaneko F, Okamura H. A scoping review of cognitive assessment tools and domains for chemotherapy-induced cognitive impairments in cancer survivors. Front Hum Neurosci. 2023 Feb 20;17:1063674. doi: 10.3389/fnhum.2023.1063674. eCollection 2023.
Background: PubMed 20957426Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.
Background: PubMed 38582840Pfledderer CD, von Klinggraeff L, Burkart S, da Silva Bandeira A, Lubans DR, Jago R, Okely AD, van Sluijs EMF, Ioannidis JPA, Thrasher JF, Li X, Beets MW. Consolidated guidance for behavioral intervention pilot and feasibility studies. Pilot Feasibility Stud. 2024 Apr 6;10(1):57. doi: 10.1186/s40814-024-01485-5.
Background: PubMed 37677800Oppegaard KR, Mayo SJ, Armstrong TS, Anguera JA, Kober KM, Miaskowski C. The Multifactorial Model of Cancer-Related Cognitive Impairment. Oncol Nurs Forum. 2023 Feb 17;50(2):135-147. doi: 10.1188/23.ONF.135-147.
Individual participant dataSharing planned: No

Related trials for Cancer-related Cognitive Impairment

Recruiting
Virtual Home-based Exercise Intervention (RISE) to Improve Cancer-Related Cognitive Impairment and Gut Microbiome in Adolescent and Young Adult Brain Tumor Survivors
Cancer-related Cognitive Dysfunction, Primary Brain Neoplasm
Active, not recruitingObservational study
Association of POCD With Circulating Biomarkers in Patients Undergoing TUR of Bladder Tumor
Cognitive Decline, Urinary Bladder Cancer
Not yet recruiting
Photobiomodulation for Cancer-Related Cognitive Impairment
Cancer-related Cognitive Impairment
Not yet recruiting
Transcranial Direct Current Stimulation for Chemotherapy-Related Chronic Pain in Cancer Survivors
Chronic Pain, Neuropathic Pain
RecruitingObservational study
Older Breast Cancer Patients: Risk for Cognitive Decline
Cancer, Breast, Age-related Cognitive Decline

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.

Sofia A Marques-Fernandes, M.Sc. contact

965252831 ext. 00351

sofiafernandes6@ua.pt

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 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: opening soon, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. 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?

Contact Sofia A Marques-Fernandes, M.Sc. (965252831 ext. 00351, sofiafernandes6@ua.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility - Screening rate (time frame: Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-ups.). The study lists 10 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 NCT07755839, which also lists 35 linked publications.

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 10 Aug 2026.