Electroacupuncture for Cognitive Toxicity in Cancer Survivors: Assessing Implementation, Cost, and Effectiveness for Integration (EAST-ALIGN)
6 mei 2026 bijgewerkt door: National Cancer Centre, Singapore
ElectroAcupuncture to Manage Symptoms of Cognitive Toxicity in Cancer Survivors: Assessing impLementation, Cost, and effectIveness for inteGratioN (EAST-ALIGN)
The goal of this clinical trial is to evaluate the clinical effectiveness and understand the biological mechanisms of electroacupuncture (EA) in reducing cognitive toxicity among cancer survivors. The study aims are:
- To evaluate the clinical effectiveness of a 10-week EA regimen targeting neuropsychiatric-related acupoints in reducing cognitive toxicity among cancer survivors in Singapore.
- To explore the biological mechanisms underlying EA's effects on cognitive function.
- To assess the early implementation of EA for managing cognitive toxicity in cancer survivors.
Researchers will compare results from the true EA arm, sham EA arm and waitlist control arm, to see if electroacupuncture can help improve cognitive issues related to cancer and its treatment, how it may work, and what factors may affect how it is delivered in cancer care.
Participants will:
- Be assigned to either of the 3 arms (true EA, sham EA, waitlist control)
- Received 10 EA sessions (if assigned to true or sham EA arm)
- Complete 3 study assessment visits at baseline, Week 13, and Week 17
- Be invited to a one-time interview to share their study experience (optional, if selected)
Studie Overzicht
Toestand
Nog niet aan het werven
Interventie / Behandeling
Gedetailleerde beschrijving
Electroacupuncture (EA) is a promising, emerging intervention to manage cognitive toxicity among patients with cancer.
The primary goal of the EAST-ALIGN study is to evaluate the clinical effectiveness and understand the biological mechanisms of EA in reducing cognitive toxicity among cancer survivors through a randomized, blinded sham and waitlist controlled, clinical trial.
Simultaneously, the investigators will collect implementation data on engaging community Traditional Chinese Medicine (TCM) practitioners to deliver EA.
This approach facilitates the early identification and resolution of implementation barriers, accelerating EA adoption into clinical practice if proven effective.
Studietype
Ingrijpend
Inschrijving (Geschat)
168
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Yu KE, PhD
- Telefoonnummer: +65 66836174
- E-mail: ke.yu@nccs.com.sg
Studie Contact Back-up
- Naam: Benton PT TAM, MSc
- E-mail: benton.tam.p.t@nccs.com.sg
Studie Locaties
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Singapore, Singapore, 168583
- National Cancer Center Singapore
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Contact:
- Yu KE, PhD
- Telefoonnummer: 66836174
- E-mail: ke.yu@nccs.com.sg
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
Survivor participants
- Aged 21-85 years
- Documented cancer diagnosis in electronic health records
- Perceived by the survivor or oncology care provider that cognitive function has worsened since cancer diagnosis and/or beginning of cancer treatment
- Able to understand English or Mandarin
- Able to provide informed consent
Stakeholder participants
- Aged ≥21 years
- Identified as having a relevant role, experience, or perspective relating to the delivery, referral, coordination, or implementation of EA or supportive cancer care in the study context
- Able to provide informed consent
Exclusion Criteria:
Survivor participants
- Presence of brain metastases
- Severe needle phobia
- Known bleeding disorder (e.g. hemophilia, von Willebrand disease, thrombocytopenia).
- Current use of antiplatelet or anticoagulant therapy (e.g. aspirin, clopidogrel, warfarin, enoxaparin, rivaroxaban, dabigatran)
- Known blood-borne communicable disease (e.g. hepatitis B, hepatitis C, human immunodeficiency virus)
- Presence of a pacemaker or other electronic implant, or a history of epilepsy
- Current acupuncture treatment or acupuncture received within the past 3 months
- Current pregnancy, planned pregnancy over the next 5 months, or breastfeeding.
- Incapable of providing informed consent
- Unable to complete study procedures
Stakeholder participants
- Incapable of providing informed consent
- Unable to complete study procedures
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: True electroacupuncture arm
Each participant will receive 10 electroacupuncture treatment sessions over the course of 10-12 weeks.
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Electroacupuncture is administered at 13 predefined acupoints: Shenting (GV24), Baihui (DU20), Sishencong (EX-HN1), Zhongwan (CV12), Guanyuan (CV4), Neiguan (PC6, bilateral), Shenmen (HT7, bilateral), Zusanli (ST36, bilateral), Sanyinjiao (SP6, bilateral), Taixi (KI3, bilateral), Zhaohai (KI6, bilateral), Hegu (LI4, bilateral), and Taichong (LIV3, bilateral.
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Sham-vergelijker: Sham electroacupuncture arm
Each participant will receive 10 sham electroacupuncture sessions designed to mimic treatment without therapeutic stimulation over the course of 10-12 weeks.
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Electroacupuncture is administered at predefined non-disease related acupoints: Pianli (LI6) bilateral, Wenliu (LI7) bilateral, Futu (ST32) bilateral, Xiajuxu (ST39) bilateral, Daheng (SP15) bilateral, and Jiaosun (TE20) bilateral.
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Geen tussenkomst: Waitlist control arm
Each participant will continue to receive usual care, but will not receive electroacupuncture or other acupuncture treatments.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Objective cognitive function - multitasking
Tijdsspanne: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB®) Multitasking Test, a computerized cognitive testing software.
Score ranges from 0-160, with a lower score reflecting better performance.
Clinically significant improvement is defined as a Reliable Change Index (RCI) exceeding 1.96 from baseline in at least one out of five tests (including this Multitasking Test).
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Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Objective cognitive function - learning and memory
Tijdsspanne: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB®) Paired Associates Learning Test, a computerized cognitive testing software.
Score ranges from 0-70, with a lower score reflecting better performance.
Clinically significant improvement is defined as a Reliable Change Index (RCI) exceeding 1.96 from baseline in at least one out of five tests (including this Paired Associates Learning Test).
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Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Objective cognitive function - sustained attention
Tijdsspanne: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB®) Rapid Visual Information Processing Test, a computerized cognitive testing software.
Score ranges from 0-1, with a higher score reflecting better performance.
Clinically significant improvement is defined as a Reliable Change Index (RCI) exceeding 1.96 from baseline in at least one out of five tests (including this Rapid Visual Information Processing Test).
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Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Objective cognitive function - response speed
Tijdsspanne: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB®) Reaction Time Test, a computerized cognitive testing software.
Score ranges from 100-5100 ms, with a lower score reflecting faster reaction time.
Clinically significant improvement is defined as a Reliable Change Index (RCI) exceeding 1.96 from baseline in at least one out of five tests (including this Reaction Time Test).
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Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Objective cognitive function - working memory
Tijdsspanne: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB®) Spatial Working Memory Test, a computerized cognitive testing software.
Score ranges from 0-153, with a lower score reflecting better performance.
Clinically significant improvement is defined as a Reliable Change Index (RCI) exceeding 1.96 from baseline in at least one out of five tests (including this Spatial Working Memory Test).
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Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Subjective cognitive function
Tijdsspanne: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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The Functional Assessment of Cancer Therapy-Cognition (FACT-Cog) version 3 is a validated 37-item questionnaire assessing self-perceived subjective cognitive function.
The total FACT-Cog score is summed from all items (range: 0-148), with higher scores indicating better subjective cognitive functioning.
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Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Fatigue
Tijdsspanne: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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The Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) is a validated questionnaire that comprises 30 items and contains 5 subscales, each with 6 items: general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor.
The total MFSI-SF score is obtained by subtracting the vigor subscale from the sum of all items (range: 24-96), with a higher score indicating higher fatigue level.
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Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Symptom burden
Tijdsspanne: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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The Rotterdam Symptom Checklist (RSCL) is a validated self-report measure of quality of life in patients with cancer.
It includes 30 symptom items, 8 activity items, and 1 overall quality-of-life item.
The symptom distress score combines the physical symptom distress scale (23 items, range 23-92) and, psychological distress scale (7 items, range 7-28), for a total range of 30-120.
Higher scores indicate greater symptom burden, distress, or quality of life.
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Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Work productivity
Tijdsspanne: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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The Work Productivity and Activity Impairment (WPAI) questionnaire is a patient-reported outcome measure that assesses the impact of health problems on work productivity and regular activities, including absenteeism, presenteeism, overall work impairment, and activity impairment.
Scores in each of these four areas are expressed as a percentage from 0% to 100%, with higher scores indicating greater impairment and worse productivity.
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Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Health utility
Tijdsspanne: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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EuroQOL Group 5-Dimension (EQ-5D-5L) contains a 5-item descriptive system measuring 5 dimensions: mobility, self-care, usual activities, pain/ discomfort, anxiety/ depression; a visual analogue scale (VAS) measuring overall health status.
EQ-5D Index Value (Utility Score) ranges from 0 to 1.0 with higher value indicating better health-related quality of life.
The VAS ranges from 0 to 100, with higher scores reflecting better self-rated health.
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Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Biomarkers - plasma BDNF
Tijdsspanne: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Plasma brain-derived neurotropic factor levels at each time point will be analyzed from blood samples collected.
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Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Biomarkers - plasma cytokines (IL-1β, IL-4, IL-6, IL-8, IL-10, TNF-alpha)
Tijdsspanne: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Plasma concentrations of interleukin-1 beta (IL-1β), interleukin-4 (IL-4), interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10), and tumor necrosis factor-alpha (TNF-alpha) will be measured from blood samples.
Each cytokine will be reported in picograms per milliliter (pg/mL).
Higher values indicate higher plasma cytokine concentrations.
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Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Biomarkers - epigenetic ageing
Tijdsspanne: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Epigenetic ageing will be assessed using DNA methylation-based biological age metrics derived from blood samples.
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Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Safety assessment
Tijdsspanne: 13 weeks after baseline and 17 weeks after baseline.
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Participants will be monitored for adverse events and the severity will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE).
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13 weeks after baseline and 17 weeks after baseline.
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Implementation - acceptability of electroacupuncture treatment
Tijdsspanne: 13 weeks after baseline.
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Participants in the true and sham EA arms will complete a questionnaire evaluating their perceptions towards the true/sham EA treatment.
Participants will be asked if they are satisfied and benefited from the treatment, and whether they would consider undergoing treatment again outside of a trial setting.
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13 weeks after baseline.
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Implementation - adoption of EA
Tijdsspanne: From commencement of study recruitment till the end of recruitment, assessed up to 3 years.
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Adoption will be evaluated by tracking study enrollment logs, including the number of eligible individuals approached, the number recruited, and documented reasons for non-participation when available.
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From commencement of study recruitment till the end of recruitment, assessed up to 3 years.
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Implementation - treatment fidelity
Tijdsspanne: 13 weeks after baseline.
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Treatment fidelity will be assessed from standardized treatment logs for each true/sham EA session by the TCM practitioners.
For blinding assessment, participants in the true and sham EA arms will be asked to guess their treatment arm allocation (True EA/ Sham EA/ Don't know).
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13 weeks after baseline.
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Implementation - feasibility
Tijdsspanne: 17 weeks after baseline, through study completion, estimated as up to 3 years.
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Semi-structured interviews conducted using an interview guide developed based on the Consolidated Framework for Implementation Research (CFIR).
Semi-structured interviews with key stakeholders (TCM practitioners, tertiary healthcare providers, clinical operations staff) to identify barriers and facilitators to integrating EA into routine oncology care.
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17 weeks after baseline, through study completion, estimated as up to 3 years.
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Implementation - implementation cost
Tijdsspanne: From commencement of study recruitment, through study completion, estimated as up to 3 years.
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Implementation cost will be assessed using a time-driven activity-based costing approach.
A structured activity log will be maintained by study personnel to document the time and resources required for each implementation activity, including personnel effort and fixed consumable resources.
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From commencement of study recruitment, through study completion, estimated as up to 3 years.
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Studie stoel: Yu KE, PhD, National Cancer Centre, Singapore
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
- Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993 Nov;4(5):353-65. doi: 10.2165/00019053-199304050-00006.
- Cidav Z, Mandell D, Pyne J, Beidas R, Curran G, Marcus S. A pragmatic method for costing implementation strategies using time-driven activity-based costing. Implement Sci. 2020 May 5;15(1):28. doi: 10.1186/s13012-020-00993-1.
- Wefel JS, Vardy J, Ahles T, Schagen SB. International Cognition and Cancer Task Force recommendations to harmonise studies of cognitive function in patients with cancer. Lancet Oncol. 2011 Jul;12(7):703-8. doi: 10.1016/S1470-2045(10)70294-1. Epub 2011 Feb 25.
- Cheung YT, Ng T, Shwe M, Ho HK, Foo KM, Cham MT, Lee JA, Fan G, Tan YP, Yong WS, Madhukumar P, Loo SK, Ang SF, Wong M, Chay WY, Ooi WS, Dent RA, Yap YS, Ng R, Chan A. Association of proinflammatory cytokines and chemotherapy-associated cognitive impairment in breast cancer patients: a multi-centered, prospective, cohort study. Ann Oncol. 2015 Jul;26(7):1446-51. doi: 10.1093/annonc/mdv206. Epub 2015 Apr 28.
- Cheung YT, Shwe M, Tan YP, Fan G, Ng R, Chan A. Cognitive changes in multiethnic Asian breast cancer patients: a focus group study. Ann Oncol. 2012 Oct;23(10):2547-2552. doi: 10.1093/annonc/mds029. Epub 2012 Mar 6.
- Cheung YT, Lim SR, Ho HK, Chan A. Cytokines as mediators of chemotherapy-associated cognitive changes: current evidence, limitations and directions for future research. PLoS One. 2013 Dec 5;8(12):e81234. doi: 10.1371/journal.pone.0081234. eCollection 2013.
- Damschroder LJ, Reardon CM, Widerquist MAO, Lowery J. The updated Consolidated Framework for Implementation Research based on user feedback. Implement Sci. 2022 Oct 29;17(1):75. doi: 10.1186/s13012-022-01245-0.
- Janelsins MC, Kesler SR, Ahles TA, Morrow GR. Prevalence, mechanisms, and management of cancer-related cognitive impairment. Int Rev Psychiatry. 2014 Feb;26(1):102-13. doi: 10.3109/09540261.2013.864260.
- Wesevich A, Johnson K, Altomare I: Cancer-Related Cognitive Impairment, 2021, pp 139-152
- Cerulla Torrente N, Navarro Pastor JB, de la Osa Chaparro N. Systematic review of cognitive sequelae of non-central nervous system cancer and cancer therapy. J Cancer Surviv. 2020 Aug;14(4):464-482. doi: 10.1007/s11764-020-00870-2. Epub 2020 Mar 7.
- Moreno AM, Hamilton RA, Currier MB: Chapter 20 - Cancer-Related Cognitive Impairment: Diagnosis, Pathogenesis, and Management, in Cristian A (ed): Breast Cancer and Gynecologic Cancer Rehabilitation. St. Louis, Elsevier, 2021, pp 211-223
- Bolton G, Isaacs A. Women's experiences of cancer-related cognitive impairment, its impact on daily life and care received for it following treatment for breast cancer. Psychol Health Med. 2018 Dec;23(10):1261-1274. doi: 10.1080/13548506.2018.1500023. Epub 2018 Jul 26.
- 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.
- Dorland HF, Abma FI, Roelen CAM, Stewart RE, Amick BC, Ranchor AV, Bultmann U. Work functioning trajectories in cancer patients: Results from the longitudinal Work Life after Cancer (WOLICA) study. Int J Cancer. 2017 Nov 1;141(9):1751-1762. doi: 10.1002/ijc.30876. Epub 2017 Jul 19.
- Xie L, Ng DQ, Heshmatipour M, Acharya M, Coluzzi P, Guerrero N, Lee S, Malik S, Parajuli R, Stark C, Tain R, Zabokrtsky K, Torno L, Chan A. Electroacupuncture for the management of symptom clusters in cancer patients and survivors (EAST). BMC Complement Med Ther. 2023 Mar 27;23(1):92. doi: 10.1186/s12906-023-03926-9.
- Liu S, Wang ZF, Su YS, Ray RS, Jing XH, Wang YQ, Ma Q. Somatotopic Organization and Intensity Dependence in Driving Distinct NPY-Expressing Sympathetic Pathways by Electroacupuncture. Neuron. 2020 Nov 11;108(3):436-450.e7. doi: 10.1016/j.neuron.2020.07.015. Epub 2020 Aug 12.
- Hwang IK, Chung JY, Yoo DY, Yi SS, Youn HY, Seong JK, Yoon YS. Effects of electroacupuncture at Zusanli and Baihui on brain-derived neurotrophic factor and cyclic AMP response element-binding protein in the hippocampal dentate gyrus. J Vet Med Sci. 2010 Nov;72(11):1431-6. doi: 10.1292/jvms.09-0527. Epub 2010 Jul 7.
- O'Leary OF, Ogbonnaya ES, Felice D, Levone BR, C Conroy L, Fitzgerald P, Bravo JA, Forsythe P, Bienenstock J, Dinan TG, Cryan JF. The vagus nerve modulates BDNF expression and neurogenesis in the hippocampus. Eur Neuropsychopharmacol. 2018 Feb;28(2):307-316. doi: 10.1016/j.euroneuro.2017.12.004.
- Hou Z, Qiu R, Wei Q, Liu Y, Wang M, Mei T, Zhang Y, Song L, Shao X, Shang H, Chen J, Sun Z. Electroacupuncture Improves Cognitive Function in Senescence-Accelerated P8 (SAMP8) Mice via the NLRP3/Caspase-1 Pathway. Neural Plast. 2020 Nov 4;2020:8853720. doi: 10.1155/2020/8853720. eCollection 2020.
- Jiang J, Liu H, Wang Z, Tian H, Wang S, Yang J, Li Z. Effects of electroacupuncture on DNA methylation of the TREM2 gene in senescence-accelerated mouse prone 8 mice. Acupunct Med. 2022 Oct;40(5):463-469. doi: 10.1177/09645284221077103. Epub 2022 Mar 2.
- Hou Z, Yang X, Li Y, Chen J, Shang H. Electroacupuncture Enhances Neuroplasticity by Regulating the Orexin A-Mediated cAMP/PKA/CREB Signaling Pathway in Senescence-Accelerated Mouse Prone 8 (SAMP8) Mice. Oxid Med Cell Longev. 2022 Feb 4;2022:8694462. doi: 10.1155/2022/8694462. eCollection 2022.
- Cheng X: Chinese acupuncture and moxibustion. Beijing, China, Foreign Language Press, 1987
- Jianqiao F, Baixiao Z: Acupuncture and Moxibustion (ed 3rd). China, People's Medical Publishing House, 2021.
- Kim JH, Cho MR, Park GC, Lee JS. Effects of different acupuncture treatment methods on mild cognitive impairment: a study protocol for a randomized controlled trial. Trials. 2019 Sep 4;20(1):551. doi: 10.1186/s13063-019-3670-3.
- Lim S. WHO Standard Acupuncture Point Locations. Evid Based Complement Alternat Med. 2010 Jun;7(2):167-8. doi: 10.1093/ecam/nep006. Epub 2009 Feb 24.
- Cheung YT, Tan EH, Chan A. An evaluation on the neuropsychological tests used in the assessment of postchemotherapy cognitive changes in breast cancer survivors. Support Care Cancer. 2012 Jul;20(7):1361-75. doi: 10.1007/s00520-012-1445-4. Epub 2012 Apr 5.
- Vardy J, Wefel JS, Ahles T, Tannock IF, Schagen SB. Cancer and cancer-therapy related cognitive dysfunction: an international perspective from the Venice cognitive workshop. Ann Oncol. 2008 Apr;19(4):623-9. doi: 10.1093/annonc/mdm500. Epub 2007 Oct 31.
- Cheung YT, Foo YL, Shwe M, Tan YP, Fan G, Yong WS, Madhukumar P, Ooi WS, Chay WY, Dent RA, Ang SF, Lo SK, Yap YS, Ng R, Chan A. Minimal clinically important difference (MCID) for the functional assessment of cancer therapy: cognitive function (FACT-Cog) in breast cancer patients. J Clin Epidemiol. 2014 Jul;67(7):811-20. doi: 10.1016/j.jclinepi.2013.12.011. Epub 2014 Mar 18.
- Guest G, Bunce A, Johnson L: How Many Interviews Are Enough?: An Experiment with Data Saturation and Variability. Field Methods 18:59-82, 2006
- Sayer M, Ng DQ, Chan R, Kober K, Chan A. Current evidence supporting associations of DNA methylation measurements with survivorship burdens in cancer survivors: A scoping review. Cancer Med. 2024 Jul;13(13):e7470. doi: 10.1002/cam4.7470.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 juli 2026
Primaire voltooiing (Geschat)
31 oktober 2028
Studie voltooiing (Geschat)
13 januari 2029
Studieregistratiedata
Eerst ingediend
24 april 2026
Eerst ingediend dat voldeed aan de QC-criteria
6 mei 2026
Eerst geplaatst (Werkelijk)
13 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
13 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
6 mei 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2026-0516
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .