Clinical trial · Interventional
CanCOG®: Pilot Trial of Cognitive Rehabilitation for Cancer Survivors
CanCOG® - Cognitive Rehabilitation in Cancer: A Protocol for a Multicenter Pilot Randomized Controlled Trial With Non-central Nervous System Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer-related Cognitive Difficulties | — | UNRESOLVED | — |
| Cancer-related Cognitive Dysfunction | — | UNRESOLVED | — |
| Cancer-related Cognitive Impairment | — | UNRESOLVED | — |
| Depression and Anxiety Symptoms | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CanCOG® - Cogntive Rehabilitation in Cancer | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cognitive rehabilitation intervention
- description
- 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.
- interventionNames
- Behavioral: CanCOG® - Cogntive Rehabilitation in Cancer
- type
- NO_INTERVENTION
- label
- Treatment-as-usual
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (35)
- BACKGROUNDYang 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. PMID 39260437
- BACKGROUNDVon 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. PMID 31959511
- BACKGROUNDVon 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. PMID 22918524
- BACKGROUNDVardy 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. PMID 36241767
- BACKGROUNDTeresi 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. PMID 34812790
- BACKGROUNDStelwagen 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. PMID 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.