Efficacy and safety of non-pharmacological interventions for cancer-related insomnia: a study protocol for a systematic review and network meta-analysis

Abstract

Introduction: Cancer-related insomnia (CRI), a significant concurrent symptom of cancer, profoundly impacts patients. Non-pharmacological interventions include cognitive behavioural therapy, mindfulness-based stress reduction programmes, bright light, acupuncture, exercise and music therapies and tai chi. These approaches, unlike pharmacological treatments, exhibit minimal adverse effects, without drug-drug interactions. They are a promising treatment strategy for CRI patients. However, a comprehensive comparative study evaluating the efficacy and safety of all non-pharmacological interventions for CRI is lacking. Accordingly, we aim to conduct a relatively comprehensive systematic review and network meta-analysis.

Methods and analysis: We will conduct an extensive search across various databases, including Pubmed, Web of Science, Cochrane Library, Embase, Google Scholar, China National Knowledge Infrastructure (CNKI), China Biomedical Literature Database (CBM), Wanfang and Vip databases (VIP). The search will focus on non-pharmacological therapeutic interventions related to CRI in randomised controlled trials published from the inception of these databases until 15 May 2024. The primary outcomes of this study will encompass the Pittsburgh Sleep Quality Index (PSQI) and the Insomnia Severity Index (ISI), while the secondary outcomes will evaluate sleep parameters, fatigue levels, anxiety-depressive mood, quality of life and any potential adverse effects. Paired meta-analyses and network meta-analyses will be conducted utilising ADDIS V.1.16.8, Stata V.14.2 and V.R4.1.2. Bias risk will be independently assessed using the Cochrane Risk of Bias tool (ROB V.2.0), and the evidence quality will be evaluated according to Grading of Recommendations Assessment, Development, and Evaluation (GRADE) standards.

Ethics and dissemination: There are no ethical issues as this study did not conduct any experiments, surveys, or human trials. We will ensure that the findings are shared through pertinent channels.

Prospero registration number: CRD42023427752.

Keywords: COMPLEMENTARY MEDICINE; Insomnia; Network Meta-Analysis; ONCOLOGY.

Figure 1. Flowchart of study selection. CNKI, China National Knowledge Infrastructure; CBM, China Biomedical Literature Database; CRI, cancer-related insomnia.