Study Protocol for NeuroCARE: a Randomised Controlled Trial of a Psychological Intervention for Caregivers of Patients with Primary Malignant Brain Tumours

Overview

Journal BMJ Open

Specialty General Medicine

Date 2023 Sep 7

PMID 37678946

Authors

Deborah Anne Forst

John Y Rhee

Michelle Marie Mesa

Alyx F Podgurski

Sumita Madhok Strander

Shibani Datta

Emilia Kaslow-Zieve

Nora K Horick

Joseph A Greer

Areej El-Jawahri

Timothy S Sannes

Jennifer S Temel

Jamie Jacobs

Affiliations

Soon will be listed here.

Abstract

Introduction: Caregivers of patients with primary malignant brain tumours experience substantial psychological distress while caring for someone with a progressive, life-limiting neurological illness. However, there are few interventions aimed at addressing the psychosocial needs of this population. We developed and are testing a population-specific, evidence-based, telehealth intervention (NeuroCARE) to reduce anxiety symptoms and improve psychosocial functioning in this caregiver population.

Methods And Analysis: This study is a non-blinded, randomised controlled trial of a psychological intervention for caregivers of patients with primary malignant brain tumours receiving care at the Massachusetts General Hospital Cancer Center or Dana-Farber Cancer Institute. We will enrol 120 caregivers who screen positive for heightened anxiety. Participants will be randomised 1:1 to the NeuroCARE intervention or a usual care control condition. Caregivers assigned to NeuroCARE will complete six individual telehealth sessions with a trained behavioural health specialist over 12 weeks. Caregivers randomised to the control condition will receive usual care, including possible referral to social work or other appropriate resources. Participants will complete self-report questionnaires at baseline and 11 weeks and 16 weeks postrandomisation. The primary outcome is anxiety symptoms at 11 weeks among NeuroCARE participants, compared with usual care. Secondary outcomes include caregiver-reported depressive symptoms, quality of life, caregiver burden, caregiving self-efficacy, perceived coping skills and post-traumatic stress disorder symptoms. We also will explore potential mediators of the NeuroCARE effect on caregiver anxiety symptoms.

Ethics And Dissemination: The study is funded by a Career Development Award from Conquer Cancer, the American Society of Clinical Oncology Foundation (award number 2019CDA-7743456038) and approved by the Dana-Farber/Harvard Cancer Center Institutional Review Board (Protocol #19-250 V.10.1). The study will be reported in accordance with the Consolidated Standards of Reporting Trials statement for non-pharmacological trials. Results will be presented at scientific meetings and in peer-reviewed journals.

Trial Registration Number: NCT04109209.

References

Freedland K, Mohr D, Davidson K, Schwartz J . Usual and unusual care: existing practice control groups in randomized controlled trials of behavioral interventions. Psychosom Med. 2011; 73(4):323-35. PMC: 3091006. DOI: 10.1097/PSY.0b013e318218e1fb. View

Aoun S, Deas K, Howting D, Lee G . Exploring the Support Needs of Family Caregivers of Patients with Brain Cancer Using the CSNAT: A Comparative Study with Other Cancer Groups. PLoS One. 2015; 10(12):e0145106. PMC: 4682982. DOI: 10.1371/journal.pone.0145106. View

Sherwood P, Cwiklik M, Donovan H . Neuro-oncology family caregiving: review and directions for future research. CNS Oncol. 2015; 5(1):41-8. PMC: 6078154. DOI: 10.2217/cns.15.43. View

Boele F, Heimans J, Aaronson N, Taphoorn M, Postma T, Reijneveld J . Health-related quality of life of significant others of patients with malignant CNS versus non-CNS tumors: a comparative study. J Neurooncol. 2013; 115(1):87-94. DOI: 10.1007/s11060-013-1198-z. View

Minaya P, Baumstarck K, Berbis J, Goncalves A, Barlesi F, Michel G . The CareGiver Oncology Quality of Life questionnaire (CarGOQoL): development and validation of an instrument to measure the quality of life of the caregivers of patients with cancer. Eur J Cancer. 2011; 48(6):904-11. DOI: 10.1016/j.ejca.2011.09.010. View

Applebaum A, Kryza-Lacombe M, Buthorn J, DeRosa A, Corner G, Diamond E . Existential distress among caregivers of patients with brain tumors: a review of the literature. Neurooncol Pract. 2019; 3(4):232-244. PMC: 6657396. DOI: 10.1093/nop/npv060. View

Boele F, Rooney A, Bulbeck H, Sherwood P . Interventions to help support caregivers of people with a brain or spinal cord tumour. Cochrane Database Syst Rev. 2019; 7:CD012582. PMC: 6604115. DOI: 10.1002/14651858.CD012582.pub2. View

El-Jawahri A, Jacobs J, Nelson A, Traeger L, Greer J, Nicholson S . Multimodal psychosocial intervention for family caregivers of patients undergoing hematopoietic stem cell transplantation: A randomized clinical trial. Cancer. 2020; 126(8):1758-1765. PMC: 7103553. DOI: 10.1002/cncr.32680. View

Zigmond A, SNAITH R . The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983; 67(6):361-70. DOI: 10.1111/j.1600-0447.1983.tb09716.x. View

10.

Collins A, Lethborg C, Brand C, Gold M, Moore G, Sundararajan V . The challenges and suffering of caring for people with primary malignant glioma: qualitative perspectives on improving current supportive and palliative care practices. BMJ Support Palliat Care. 2014; 4(1):68-76. DOI: 10.1136/bmjspcare-2012-000419. View

11.

Grov E, Dahl A, Moum T, Fossa S . Anxiety, depression, and quality of life in caregivers of patients with cancer in late palliative phase. Ann Oncol. 2005; 16(7):1185-91. DOI: 10.1093/annonc/mdi210. View

12.

Given C, Given B, Stommel M, Collins C, King S, Franklin S . The caregiver reaction assessment (CRA) for caregivers to persons with chronic physical and mental impairments. Res Nurs Health. 1992; 15(4):271-83. DOI: 10.1002/nur.4770150406. View

13.

Onken L, Carroll K, Shoham V, Cuthbert B, Riddle M . Reenvisioning Clinical Science: Unifying the Discipline to Improve the Public Health. Clin Psychol Sci. 2015; 2(1):22-34. PMC: 4374633. DOI: 10.1177/2167702613497932. View

14.

Harris P, Taylor R, Minor B, Elliott V, Fernandez M, ONeal L . The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019; 95:103208. PMC: 7254481. DOI: 10.1016/j.jbi.2019.103208. View

15.

Bender R, Lange S . Adjusting for multiple testing--when and how?. J Clin Epidemiol. 2001; 54(4):343-9. DOI: 10.1016/s0895-4356(00)00314-0. View

16.

Pace A, Dirven L, Koekkoek J, Golla H, Fleming J, Ruda R . European Association for Neuro-Oncology (EANO) guidelines for palliative care in adults with glioma. Lancet Oncol. 2017; 18(6):e330-e340. DOI: 10.1016/S1470-2045(17)30345-5. View

17.

Harris P, Taylor R, Thielke R, Payne J, Gonzalez N, Conde J . Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2008; 42(2):377-81. PMC: 2700030. DOI: 10.1016/j.jbi.2008.08.010. View

18.

Spitzer R, Kroenke K, Williams J, Lowe B . A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006; 166(10):1092-7. DOI: 10.1001/archinte.166.10.1092. View

19.

Zwinkels H, Dirven L, Vissers T, Habets E, Vos M, Reijneveld J . Prevalence of changes in personality and behavior in adult glioma patients: a systematic review. Neurooncol Pract. 2019; 3(4):222-231. PMC: 6657393. DOI: 10.1093/nop/npv040. View

20.

Jacobs J, Nelson A, Traeger L, Waldman L, Nicholson S, Jagielo A . Enhanced coping and self-efficacy in caregivers of stem cell transplant recipients: Identifying mechanisms of a multimodal psychosocial intervention. Cancer. 2020; 126(24):5337-5346. PMC: 7950641. DOI: 10.1002/cncr.33191. View