None listed
Conditions
Brief summary
This study will evaluate a novel intervention designed to help people with a brain tumour better manage their fatigue. Who is it for? You may be eligible for this study if you are an adult with a confirmed diagnosis of a malignant primary brain tumour. Study details Participants will be randomly assigned to either an online program addressing cancer-related fatigue, or an online relaxation program. Both programs will consist of six 30-minutes sessions designed to be completed over 12 weeks. Participants will be asked to complete questionnaires and interviews focused on fatigue self-management and quality of life. It is hoped that findings from this study will contribute towards designing evidence-based interventions to address cancer-related fatigue for people living with a primary brain tumour.
Interventions
An online intervention targeting self-efficacy to self-manage cancer-related fatigue (CRF). The online intervention consists of six sessions that will be completed across a 12 week period. Each session takes approximately 30 minutes to complete. The content of each session is summarised below: Session 1 (About Fatigue) provides education about CRF, including how it is commonly experienced by people with a primary brain tumour and what the possible causes and impacts are. It includes video animations of patient narratives about their experiences of CRF. Participants are asked to identify areas of their life affected by fatigue that they would like to focus on throughout the intervention. An optional quiz on CRF is provided for those who would like to assess their own knowledge. Session 2 (Making Plans) introduces the concept of self-monitoring and setting plans to address fatigue using SMART goals (i.e. specific, measurable, attainable, relevant, and time bound). Possible barriers to following plans are discussed and video animations of patient narratives describing the usefulness of setting plans to manage fatigue are included. External links to useful resources are also provided. Session 3 (Home and Lifestyle) describes how CRF may impact on aspects of everyday life including home life, and how setting effective plans can help to manage this interference. Impacts of CRF on exercise, housework, laundry, childcare, diet, grocery shopping, sleep and meal preparation are discussed, along with strategies for managing these impacts. External links to useful information and resources are provided. Session 4 (Work) focuses on how CRF can impact on work and provides strategies for managing these impacts including by setting effective plans. External links are provided to useful information and resources. Session 5 (Thoughts & Feelings) focuses on how thoughts and feelings can impact CRF and how this can be managed using CBT principles, as well as by setting effective management plans. It discusses self-esteem, uncertainty, stress, worry and anxiety, and negative thoughts and feelings generally, and provides strategies for helping to manage them. External links to additional information and resources are provided. Session 6 (Talking to Others) describes the difficulties of talking to others about CRF and introduces strategies to help manage this, including through setting effective plans. It includes strategies for talking to employers, friends and family, health professionals, and choosing not to talk. External links to useful resources are provided. Activities are available throughout each session. These include an online fatigue diary participants can use to monitor their fatigue from day-to-day, in addition to single-item assessments of fatigue at the beginning of each session. Stories (video animations) from people with primary brain tumour are included throughout to provide examples of how people with a brain tumour are affected by CRF and strategies they have used to help them manage. Automated tailored feedback based on goal-related progress and change in fatigue levels from the previous session are included throughout and links are provided to additional information and useful resources relevant to each session. Participants can pause completion and return to a particular session either later that same day or on a different day if necessary. During the trial, patients will receive automated emails encouraging them to complete their session or begin the next session if they have not done so within 14 days. Similar emails will be sent to prompt completion of outcome measures. If participants choose not to complete a particular session they will be asked to provide a reason. Adherence to the intervention will be captured using website analytics.
Sponsors
Study design
Eligibility
Inclusion criteria
Eligible patients: • Will have a histologically confirmed diagnosis of a malignant primary brain tumour • Will have a life expectancy of at least 24 weeks • Will have a score in the clinical range (4 or more) on the unidimensional 11-point numeric single item rating scale for fatigue included in the Edmonton Symptom Assessment Scale (ESAS). • Will be 18 years or older • Are able to provide informed consent in the opinion of a member of their healthcare team • Will be English-speaking • Will have or are willing to create an email account and have access to the internet
Exclusion criteria
Exclusion criteria are: • Less than 6-8 weeks post-surgery or radiation treatment • ECOG Performance status of 3 or more • Diagnosis of a benign primary brain tumour • Unable to engage in the intervention and/or study assessments determined by a member of their clinical team