Clinical trial · Interventional
Combined Model of Online Remote Interventions for Cancer-Related Cognitive Impairment
- 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 survival rates have increased dramatically in recent years. However, many survivors report cognitive decline following treatment, which significantly impairs their quality of life. Online cognitive training programs have shown promise in improving cognitive functions in cancer survivors, but most studies report limited impact of training on everyday function. A complementary treatment approach is functional treatment delivered by occupational therapists, which directly targets daily function. Combining the two approaches has the potential to overcome the limitations of both approaches, enabling improved cognitive functions and transfer to daily function. Remotely-administrated interventions further make treatment accessible and cost-effective. The current study is aimed at testing the efficacy of a novel, combined, remotely-delivered treatment approach: Cognitive Retraining and Functional Treatment(CRAFT), using a Randomized Controlled Trial (RCT) design. 90 cancer survivors will be randomly assigned to receive 15 weeks of either the combined treatment, computerized training only, or treatment-as-usual. Outcomes will be assessed at completion, and following 3 months of no contact, to test immediate and enduring effects of treatment. Baseline predictors for treatment response will be further assessed. Positive results in the proposed study could potentially change the therapeutic landscape for rehabilitation of cancer-related cognitive decline, which currently impair the lives of millions worldwide.
Conditions
Conditions (2)
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 | Malignant Neoplasm | ALIAS | 0.90 |
| Cognitive Decline | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive orientation to daily occupational performance (CO-OP) | Behavioral | — | UNRESOLVED |
| Computerized Cognitive Training (BrainHQ, posit science) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- CRAFT (Cognitive Training and Functional Treatment)
- description
- Over 12 weeks this group will be instructed to complete 3 weekly sessions of Computerized Cognitive Training, in addition to a weekly 1 hour remote CO- OP (Meta cognitive strategy training) session. Each participant will set three occupational goals that will be the focus of the CO -OP treatment
- interventionNames
- Behavioral: Cognitive orientation to daily occupational performance (CO-OP)
- Behavioral: Computerized Cognitive Training (BrainHQ, posit science)
- type
- ACTIVE_COMPARATOR
- label
- Computerized Cognitive Training
- description
- This group will be instructed to complete 3 weekly sessions of Computerized Cognitive Training
- interventionNames
- Behavioral: Computerized Cognitive Training (BrainHQ, posit science)
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. age ≥ 18; 2. Subjective concern about declines in cognitive functioning related to a diagnosis of cancer and/or cancer related treatment. This will be obtained by asking participants the question "do you have concerns about your memory or other thinking abilities following cancer treatment?". Participants are required to answer yes to this question. 3. interested in treatment and state they have 2 weekly hours available for the intervention. 4. Completion of active treatment for non-Central Nervous System (CNS) cancer (e.g., chemotherapy,radiation therapy and surgery) 6 months or more in the past. 5. Cognitive decline with no dementia: 21\<Mini-Mental State Examination \<27 (Folstein, Folstein, \& McHugh, 1975) and/or 19\< Montreal Cognitive Assessment \<26 (Nasreddine et al., 2005); 6. Daily access to a computer and Internet facilities; 7. Able to sign an informed consent; 8. Stable psychiatric condition (according to participants self- report and medical file). Exclusion Criteria: 1. no prior experience using computers; 2. pregnancy; 3. History of a central nervous system tumor.
References
Publications (8)
- 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
- BACKGROUNDCicerone KD, Goldin Y, Ganci K, Rosenbaum A, Wethe JV, Langenbahn DM, Malec JF, Bergquist TF, Kingsley K, Nagele D, Trexler L, Fraas M, Bogdanova Y, Harley JP. Evidence-Based Cognitive Rehabilitation: Systematic Review of the Literature From 2009 Through 2014. Arch Phys Med Rehabil. 2019 Aug;100(8):1515-1533. doi: 10.1016/j.apmr.2019.02.011. Epub 2019 Mar 26. PMID 30926291
- BACKGROUNDLange M, Joly F, Vardy J, Ahles T, Dubois M, Tron L, Winocur G, De Ruiter MB, Castel H. Cancer-related cognitive impairment: an update on state of the art, detection, and management strategies in cancer survivors. Ann Oncol. 2019 Dec 1;30(12):1925-1940. doi: 10.1093/annonc/mdz410. PMID 31617564
- BACKGROUNDMerzenich MM, Van Vleet TM, Nahum M. Brain plasticity-based therapeutics. Front Hum Neurosci. 2014 Jun 27;8:385. doi: 10.3389/fnhum.2014.00385. eCollection 2014. PMID 25018719
- BACKGROUNDNg EM, Polatajko HJ, Marziali E, Hunt A, Dawson DR. Telerehabilitation for addressing executive dysfunction after traumatic brain injury. Brain Inj. 2013;27(5):548-64. doi: 10.3109/02699052.2013.766927. Epub 2013 Mar 8. PMID 23472964
- BACKGROUNDMissiuna C, Mandich AD, Polatajko HJ, Malloy-Miller T. Cognitive orientation to daily occupational performance (CO-OP): part I--theoretical foundations. Phys Occup Ther Pediatr. 2001;20(2-3):69-81. PMID 11345513
- BACKGROUNDWolf TJ, Doherty M, Kallogjeri D, Coalson RS, Nicklaus J, Ma CX, Schlaggar BL, Piccirillo J. The Feasibility of Using Metacognitive Strategy Training to Improve Cognitive Performance and Neural Connectivity in Women with Chemotherapy-Induced Cognitive Impairment. Oncology. 2016;91(3):143-52. doi: 10.1159/000447744. Epub 2016 Jul 23.