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.
Study Goal
The researchers aimed to explore the feasibility and effects of combining mindfulness and exercise interventions on fatigue, sleep, mood, and quality of life in gynaecology cancer patients.
Results Summary
The study found that mindfulness, both alone and combined with exercise, showed favorable responses in managing symptoms like fatigue, sleep, mood, and quality of life, though full results are pending trial completion.
Population
Gynaecology cancer patients
Effective Dosage
Not specified
Duration
8 weeks
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
exercise | increase | management of cancer related fatigue | gynaecology cancer patients | - | has the most positive outcome | #1 |
mindfulness | increase | management of symptoms | cancer patients | - | have begun to show a favourable response | #2 |
mindfulness and exercise | increase | fatigue and wellbeing | gynaecology cancer | - | will further improve outcomes | #3 |
mindfulness and exercise | decrease | fatigue and other symptoms of sleep, mood | women diagnosed with cancer | - | assist to manage | #4 |
mindfulness and exercise | increase | quality of life | women diagnosed with cancer | - | impact | #5 |
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.