A Telehealth-Based Cognitive-Adaptive Training (e-OTCAT) to Prevent Cancer and Chemotherapy-Related Cognitive Impairment in Women with Breast Cancer: Protocol for a Randomized Controlled Trial

Overview

Journal Int J Environ Res Public Health

Publisher MDPI

Specialties Environmental Health
Public Health

Date 2022 Jun 24

PMID 35742400

Authors

Angela Gonzalez-Santos

Maria Lopez-Garzon

Carmen Sanchez-Salado

Paula Postigo-Martin

Mario Lozano-Lozano

Noelia Galiano-Castillo

Carolina Fernandez-Lao

Eduardo Castro-Martin

Tania Gallart-Aragon

Marta Legeren-Alvarez

Rocio Gil-Gutierrez

Lydia Martin-Martin

Affiliations

Soon will be listed here.

Abstract

Background: Many women with breast cancer experience a great number of side effects, such as cognitive impairment, during and after chemotherapy that reduces their quality of life. Currently, research focusing on the use of non-pharmacological, and specifically telehealth interventions to prevent or mitigate them has been insufficient.

Methods: This protocol describes a randomized controlled trial aimed at studying the preventive effects of a videoconferenced cognitive-adaptive training (e-OTCAT) program (ClinicalTrials.gov NCT04783402). A number of 98 eligible participants will be randomized to one of the following groups: (a) the experimental group receiving the e-OTCAT program during 12 consecutive weeks since the beginning of chemotherapy; and (b) the control group receiving and educational handbook and usual care. The primary outcome will be the cognitive function. Secondary measures will be psychological distress, fatigue, sleep disturbance, quality of life and occupational performance. The time-points for these measures will be placed at baseline, after 12 weeks and six months of post-randomization.

Conclusion: This trial may support the inclusion of multidimensional interventions through a telehealth approach in a worldwide growing population suffering from breast cancer, emphasizing the prevention of cognitive impairment as one of the side effects of cancer and its treatments.

Citing Articles

Nose-to-brain Drug Delivery System: An Emerging Approach to Chemotherapy-induced Cognitive Impairment.

Jannapu Reddy S, Mutalik S, Viswanatha G, Kumar G, John J, Chamallamudi M Pharm Nanotechnol. 2024; 13(1):212-238.

PMID: 38757164 DOI: 10.2174/0122117385291482240426101519.

Use of Telemedicine to Improve Cognitive Functions and Psychological Well-Being in Patients with Breast Cancer: A Systematic Review of the Current Literature.

Giustiniani A, Danesin L, Pezzetta R, Masina F, Oliva G, Arcara G Cancers (Basel). 2023; 15(4).

PMID: 36831693 PMC: 9954456. DOI: 10.3390/cancers15041353.

References

Buysse D, Reynolds 3rd C, Monk T, BERMAN S, Kupfer D . The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989; 28(2):193-213. DOI: 10.1016/0165-1781(89)90047-4. View

Piper B, Dibble S, Dodd M, Weiss M, Slaughter R, Paul S . The revised Piper Fatigue Scale: psychometric evaluation in women with breast cancer. Oncol Nurs Forum. 1998; 25(4):677-84. View

Vardy J, Bray V, Dhillon H . Cancer-induced cognitive impairment: practical solutions to reduce and manage the challenge. Future Oncol. 2017; 13(9):767-771. DOI: 10.2217/fon-2017-0027. View

Villoria E, Lara L . Assessment of the Hospital Anxiety and Depression Scale for cancer patients. Rev Med Chil. 2018; 146(3):300-307. DOI: 10.4067/s0034-98872018000300300. View

Cheung Y, Lim S, Shwe M, Tan Y, Chan A . Psychometric properties and measurement equivalence of the English and Chinese versions of the functional assessment of cancer therapy-cognitive in Asian patients with breast cancer. Value Health. 2013; 16(6):1001-13. DOI: 10.1016/j.jval.2013.06.017. View

Ahles T, Root J . Cognitive Effects of Cancer and Cancer Treatments. Annu Rev Clin Psychol. 2018; 14:425-451. PMC: 9118140. DOI: 10.1146/annurev-clinpsy-050817-084903. View

Galiano-Castillo N, Arroyo-Morales M, Lozano-Lozano M, Fernandez-Lao C, Martin-Martin L, Del-Moral-Avila R . Effect of an Internet-based telehealth system on functional capacity and cognition in breast cancer survivors: a secondary analysis of a randomized controlled trial. Support Care Cancer. 2017; 25(11):3551-3559. DOI: 10.1007/s00520-017-3782-9. View

Jia M, Zhang X, Wei L, Gao J . Measurement, outcomes and interventions of cognitive function after breast cancer treatment: A narrative review. Asia Pac J Clin Oncol. 2020; 17(4):321-329. DOI: 10.1111/ajco.13484. View

. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. J Am Coll Dent. 2015; 81(3):14-8. View

10.

Cup E, Scholte Op Reimer W, Thijssen M, van Kuyk-Minis M . Reliability and validity of the Canadian Occupational Performance Measure in stroke patients. Clin Rehabil. 2003; 17(4):402-9. DOI: 10.1191/0269215503cr635oa. View

11.

Liou K, Ahles T, Garland S, Li Q, Bao T, Li Y . The Relationship Between Insomnia and Cognitive Impairment in Breast Cancer Survivors. JNCI Cancer Spectr. 2019; 3(3):pkz041. PMC: 6640530. DOI: 10.1093/jncics/pkz041. View

12.

Damholdt M, Mehlsen M, OToole M, Andreasen R, Pedersen A, Zachariae R . Web-based cognitive training for breast cancer survivors with cognitive complaints-a randomized controlled trial. Psychooncology. 2016; 25(11):1293-1300. PMC: 5111748. DOI: 10.1002/pon.4058. View

13.

da Costa R, Passos G, Quintao N, Fernandes E, Maia J, Campos M . Taxane-induced neurotoxicity: Pathophysiology and therapeutic perspectives. Br J Pharmacol. 2020; 177(14):3127-3146. PMC: 7312267. DOI: 10.1111/bph.15086. View

14.

Hurria A, Lachs M . Is cognitive dysfunction a complication of adjuvant chemotherapy in the older patient with breast cancer?. Breast Cancer Res Treat. 2007; 103(3):259-68. DOI: 10.1007/s10549-006-9383-9. View

15.

McCue M, Fairman A, Pramuka M . Enhancing quality of life through telerehabilitation. Phys Med Rehabil Clin N Am. 2009; 21(1):195-205. DOI: 10.1016/j.pmr.2009.07.005. View

16.

Gutenkunst S, Vardy J, Dhillon H, Bell M . Correlates of cognitive impairment in adult cancer survivors who have received chemotherapy and report cognitive problems. Support Care Cancer. 2020; 29(3):1377-1386. PMC: 10109511. DOI: 10.1007/s00520-020-05616-5. View

17.

Herrero M, Blanch J, Peri J, de Pablo J, Pintor L, Bulbena A . A validation study of the hospital anxiety and depression scale (HADS) in a Spanish population. Gen Hosp Psychiatry. 2003; 25(4):277-83. DOI: 10.1016/s0163-8343(03)00043-4. View

18.

Lyons K, Erickson K, Hegel M . Problem-solving strategies of women undergoing chemotherapy for breast cancer. Can J Occup Ther. 2012; 79(1):33-40. PMC: 3660993. DOI: 10.2182/cjot.2012.79.1.5. View

19.

Hita-Contreras F, Martinez-Lopez E, Latorre-Roman P, Garrido F, Santos M, Martinez-Amat A . Reliability and validity of the Spanish version of the Pittsburgh Sleep Quality Index (PSQI) in patients with fibromyalgia. Rheumatol Int. 2014; 34(7):929-36. DOI: 10.1007/s00296-014-2960-z. View

20.

Aaronson N, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez N . The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993; 85(5):365-76. DOI: 10.1093/jnci/85.5.365. View