Evaluating the effectiveness of mindfulness alone compared to exercise and mindfulness on fatigue in women with gynaecology cancer (GEMS): Protocol for a randomised feasibility trial.

BACKGROUND: In 2020 Globocan reported nearly 1.4 million new cases of gynaecology cancer worldwide. Cancer related fatigue has been identified as a symptom that can be present for gynaecology cancer patients many years after treatment. The current evidence around the management of this symptom suggests that exercise has the most positive outcome. However, some ambiguity remains around the evidence and whether it can address all areas of fatigue effectively. More recently, other interventions such as mindfulness have begun to show a favourable response to the management of symptoms for cancer patients. To date there has been little research that explores the feasibility of using both these interventions together in a gynaecology cancer population. This study aims to explore the feasibility of delivering an intervention that involves mindfulness and mindfulness and exercise and will explore the effect of this on fatigue, sleep, mood and quality of life. METHODS/DESIGN: This randomised control trial will assess the interventions outcomes using a pre and post design and will also include a qualitative process evaluation. Participants will be randomised into one of 2 groups. One group will undertake mindfulness only and the other group will complete exercise and mindfulness. Both groups will use a mobile application to complete these interventions over 8 weeks. The mobile app will be tailored to reflect the group the participants have drawn during randomisation. Self-reported questionnaire data will be assessed at baseline prior to commencing intervention and at post intervention. Feasibility will be assessed through recruitment, adherence, retention and attrition. Acceptability and participant perspective of participation (process evaluation), will be explored using focus groups. DISCUSSION: This trial will hope to evidence and demonstrate that combination of two interventions such as mindfulness and exercise will further improve outcomes of fatigue and wellbeing in gynaecology cancer. The results of this study will be used to assess (i) the feasibility to deliver this type of intervention to this population of cancer patients using a digital platform; (ii) assist this group of women diagnosed with cancer to manage fatigue and other symptoms of sleep, mood and impact their quality of life. TRIAL REGISTRATION: NCT05561413.

Effects of mindfulness-based interventions on fatigue and psychological wellbeing in women with cancer: A systematic review and meta-analysis of randomised control trials.

BACKGROUND: Cancer diagnosis and treatment can cause fatigue, stress and anxiety which can have a detrimental effect on patients, families and the wider community. Mindfulness-based interventions appear to have positive effects on managing these cancer-related symptoms. OBJECTIVE: To investigate the efficacy of mindfulness on cancer related fatigue (CRF) and psychological well-being in female cancer patients. METHODS: Five databases (CINHAL, Ovid Medline, Ovid Psych Info, Scopus, and Cochrane), and two trial registers (WHO and Clinicaltrials.gov) were searched for randomised control trials from inception to April 2021 and updated in August 2022. Meta-analysis was performed using Review Manager 5.4. The standardised mean difference (SMD) and 95% confidence intervals (CI) were used to determine the intervention effect. Subgroup analysis was performed for adaptation to types of mindfulness, length of intervention and types of comparator used. RESULTS: Twenty-one studies with a total of 2326 participants were identified. Mindfulness significantly improved CRF (SMD -0.81, 95% CI -1.17 to -0.44), depression (SMD-0.74, 95% CI -1.08 to -0.39) and anxiety (SMD -0.92, 95% CI -1.50 to -0.33). No effect was observed for quality of life (SMD 0.32, 95% CI -0.13-0.87) and sleep (SMD -0.65, 95% CI -1.34-0.04). Subgroup analysis revealed that there was little difference in SMD for adapted type of mindfulness (p = 0.42), wait list control compared to active comparator (p = 0.05) or length of intervention (p = 0.29). CONCLUSION: Mindfulness appears to be effective in reducing CRF and other cancer related symptoms in women. Adaptations to mindfulness delivery did not have negative impact on results which may aid delivery in the clinical settings.