CanCOG®: Pilot Trial of Cognitive Rehabilitation for Cancer Survivors

NCT07755839 | Not Yet Recruiting

• 2 other identifiers: 2023.03752.BDhttps://doi.org/10.54499/2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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; cancer-related cognitive impairment

Outcome Measures

Primary Outcomes (10)

• Feasibility - Screening rate

  Screening rate will be assessed as the proportion of potentially eligible cancer survivors who undergo eligibility screening.

  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.

  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.

  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.

  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.

  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.

  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.

  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).

  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.

  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.

  Baseline (2 weeks before intervention) and post-intervention (2 weeks after).

Secondary Outcomes (11)

• Perceived cognitive functioning

  Baseline (2 weeks before intervention), post-intervention (2weeks after), 3-month and 6-month follow-ups.

• Objective cognitive functioning (Global cognition)

  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)

  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)

  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)

  Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-up.

Study Arms (2)

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.

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.

Interventions

CanCOG® - Cogntive Rehabilitation in Cancer BEHAVIORAL

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.

Cognitive rehabilitation intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aveiro University: lead
• Foundation for Science and Technology, Portugal: collaborator

Study Sites (1)

University of Aveiro

Aveiro, 3810-193, Portugal

Location

Related Publications (35)

• 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.

  PMID: 39260437 BACKGROUND

• 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.

  PMID: 31959511 BACKGROUND

• 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.

  PMID: 22918524 BACKGROUND

• 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.

  PMID: 36241767 BACKGROUND

• 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.

  PMID: 34812790 BACKGROUND

• 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.

  PMID: 34830829 BACKGROUND

• 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.

  PMID: 25908249 BACKGROUND

• 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.

  PMID: 36240847 BACKGROUND

• 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.

  PMID: 36891148 BACKGROUND

• 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.

  PMID: 20957426 BACKGROUND

• 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.

  PMID: 38582840 BACKGROUND

• 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.

  PMID: 37677800 BACKGROUND

• 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.

  PMID: 36611601 BACKGROUND

• 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.

  PMID: 36517827 BACKGROUND

• 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.

  PMID: 40954944 BACKGROUND

• Monteiro, S., Bártolo, A., Torres, A., Pereira, A., & Albuquerque, E. (2019). Examining the construct validity of the Portuguese version of the Patient Health Questionnaire-9 among college students. PSICOLOGIA, 33(2), 1-8. https://doi.org/10.17575/rpsicol.v33i2.1421

  BACKGROUND

• Mackenzie L, Marshall K. Effective non-pharmacological interventions for cancer related cognitive impairment in adults (excluding central nervous system or head and neck cancer): systematic review and meta-analysis. Eur J Phys Rehabil Med. 2022 Apr;58(2):258-270. doi: 10.23736/S1973-9087.21.06898-2. Epub 2021 Sep 9.

  PMID: 34498828 BACKGROUND

• Lange 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 BACKGROUND

• Hopewell S, Chan AW, Collins GS, Hrobjartsson A, Moher D, Schulz KF, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne D, Farmer A, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson D, Vohra S, White IR, Boutron I. CONSORT 2025 statement: updated guideline for reporting randomised trials. BMJ. 2025 Apr 14;389:e081123. doi: 10.1136/bmj-2024-081123.

  PMID: 40228833 BACKGROUND

• Haywood D, Dauer E, Baughman FD, Lawrence BJ, Rossell SL, Hart NH, O'Connor M. "Is My Brain Ever Going to Work Fully Again?": Challenges and Needs of Cancer Survivors with Persistent Cancer-Related Cognitive Impairment. Cancers (Basel). 2023 Nov 8;15(22):5331. doi: 10.3390/cancers15225331.

  PMID: 38001592 BACKGROUND

• Freitas S, Simoes MR, Alves L, Santana I. Montreal Cognitive Assessment (MoCA): normative study for the Portuguese population. J Clin Exp Neuropsychol. 2011 Nov;33(9):989-96. doi: 10.1080/13803395.2011.589374. Epub 2011 Jul 4.

  PMID: 22082082 BACKGROUND

• Fernandes HA, Richard NM, Edelstein K. Cognitive rehabilitation for cancer-related cognitive dysfunction: a systematic review. Support Care Cancer. 2019 Sep;27(9):3253-3279. doi: 10.1007/s00520-019-04866-2. Epub 2019 May 30.

  PMID: 31147780 BACKGROUND

• Ercoli LM, Petersen L, Hunter AM, Castellon SA, Kwan L, Kahn-Mills BA, Embree LM, Cernin PA, Leuchter AF, Ganz PA. Cognitive rehabilitation group intervention for breast cancer survivors: results of a randomized clinical trial. Psychooncology. 2015 Nov;24(11):1360-7. doi: 10.1002/pon.3769. Epub 2015 Mar 10.

  PMID: 25759235 BACKGROUND

• Ercoli LM, Castellon SA, Hunter AM, Kwan L, Kahn-Mills BA, Cernin PA, Leuchter AF, Ganz PA. Assessment of the feasibility of a rehabilitation intervention program for breast cancer survivors with cognitive complaints. Brain Imaging Behav. 2013 Dec;7(4):543-53. doi: 10.1007/s11682-013-9237-0.

  PMID: 23955490 BACKGROUND

• Eldridge SM, Lancaster GA, Campbell MJ, Thabane L, Hopewell S, Coleman CL, Bond CM. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework. PLoS One. 2016 Mar 15;11(3):e0150205. doi: 10.1371/journal.pone.0150205. eCollection 2016.

  PMID: 26978655 BACKGROUND

• Duivon M, Lange M, Binarelli G, Lefel J, Hardy-Leger I, Kiasuwa-Mbengi R, Meric JB, Charles C, Joly F. Improve the management of cancer-related cognitive impairment in clinical settings: a European Delphi study. J Cancer Surviv. 2024 Dec;18(6):1974-1997. doi: 10.1007/s11764-023-01436-8. Epub 2023 Nov 7.

  PMID: 37934312 BACKGROUND

• Dos Santos M, Hardy-Leger I, Rigal O, Licaj I, Dauchy S, Levy C, Noal S, Segura C, Delcambre C, Allouache D, Parzy A, Barriere J, Petit T, Lange M, Capel A, Clarisse B, Grellard JM, Lefel J, Joly F. Cognitive rehabilitation program to improve cognition of cancer patients treated with chemotherapy: A 3-arm randomized trial. Cancer. 2020 Dec 15;126(24):5328-5336. doi: 10.1002/cncr.33186. Epub 2020 Sep 30.

  PMID: 32996583 BACKGROUND

• Demos-Davies K, Lawrence J, Seelig D. Cancer related cognitive impairment: a downside of cancer treatment. Front Oncol. 2024 Apr 23;14:1387251. doi: 10.3389/fonc.2024.1387251. eCollection 2024.

  PMID: 38715789 BACKGROUND

• Cherrier MM, Anderson K, David D, Higano CS, Gray H, Church A, Willis SL. A randomized trial of cognitive rehabilitation in cancer survivors. Life Sci. 2013 Oct 17;93(17):617-22. doi: 10.1016/j.lfs.2013.08.011. Epub 2013 Sep 5.

  PMID: 24012579 BACKGROUND

• Chan AW, Boutron I, Hopewell S, Moher D, Schulz KF, Collins GS, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne DR, Farmer AJ, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson DJ, Vohra S, White IR, Hrobjartsson A. SPIRIT 2025 statement: updated guideline for protocols of randomized trials. Nat Med. 2025 Jun;31(6):1784-1792. doi: 10.1038/s41591-025-03668-w. Epub 2025 Apr 29.

  PMID: 40295741 BACKGROUND

• Cavaco, S., Pinto, C., Gonçalves, A., Gomes, F., Pereira, A., & Malaquias, C. (2008). Auditory Verbal Learning Test. Psychologica, 49. https://doi.org/10.14195/1647-8606_49_10

  BACKGROUND

• Cavaco S, Goncalves A, Pinto C, Almeida E, Gomes F, Moreira I, Fernandes J, Teixeira-Pinto A. Auditory Verbal Learning Test in a Large Nonclinical Portuguese Population. Appl Neuropsychol Adult. 2015;22(5):321-31. doi: 10.1080/23279095.2014.927767. Epub 2015 Jan 12.

  PMID: 25580839 BACKGROUND

• Cavaco S, Goncalves A, Pinto C, Almeida E, Gomes F, Moreira I, Fernandes J, Teixeira-Pinto A. Trail Making Test: regression-based norms for the Portuguese population. Arch Clin Neuropsychol. 2013 Mar;28(2):189-98. doi: 10.1093/arclin/acs115. Epub 2013 Jan 7.

  PMID: 23299183 BACKGROUND

• Bell ML, Whitehead AL, Julious SA. Guidance for using pilot studies to inform the design of intervention trials with continuous outcomes. Clin Epidemiol. 2018 Jan 18;10:153-157. doi: 10.2147/CLEP.S146397. eCollection 2018.

  PMID: 29403314 BACKGROUND

• Ahles TA, Root JC. Cognitive Effects of Cancer and Cancer Treatments. Annu Rev Clin Psychol. 2018 May 7;14:425-451. doi: 10.1146/annurev-clinpsy-050817-084903. Epub 2018 Jan 18.

  PMID: 29345974 BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders; Neoplasms

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Central Study Contacts

Sofia A Marques-Fernandes, M.Sc.

CONTACT

965252831; sofiafernandes6@ua.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)