Breast cancer is the most common cancer in women in Singapore. Breast cancer survivors usually experience side effects/symptoms after surgery and/or adjuvant chemotherapy and/or radiotherapy such as fatigue, lymphedema, problems with sleeping, peripheral neuropathy, and anxiety/depression. Currently, there is no study to include both symptom management and mindfulness training components for breast cancer survivors. And given breast cancer survivors have infrequent clinical follow-up, we aim to develop an e-Home based symptom management and mindfulness training programme for breast cancer survivors and to determine its effects on quality of life, symptom distress, psychosocial adjustment, psychological morbidity, and unplanned outpatient attendance or hospitalisation in breast cancer survivors. We employ a randomised clinical trial with four study arms (with 47 subjects in each arm) together with a process evaluation; group 1 (usual care), group 2 (experimental group: five weekly sessions of online symptom management + mindfulness training programme and usual care), group 3 (comparison group 1: five weekly sessions of online symptom management programme and usual care), and group 4 (comparison group 2: five weekly sessions of online mindfulness training programme and usual care). Subjects will complete questionnaires measures of 6-item Social Support Questionnaire, Breast Cancer Survivor Self-Efficacy Scale, the Quality of Life-Cancer Survivor Scale, Memorial Symptom Assessment Scale, Psychosocial Adjustment to Illness Scale, short version of the Fear of Recurrence Scale, Hospital and anxiety Depression Scale and Five Facet Mindfulness Questionnaire at baseline (printed questionnaires), at 8 weeks from baseline, at 12 weeks from baseline and at 24 weeks from baseline by an online system or printed questionnaires. Individualised semi-structured interview (15-25 mins) for experimental and comparison groups will be conducted at 24 weeks from baseline to understand the subjects' experiences of the study programme. Data will be analysed using SPSS version 24. Baseline demographic and clinical information of subjects in the experimental, comparison and control groups will be summarised using descriptive statistics, and will be compared using chi square tests and ANOVA/ANCOVA tests. Intention-to-treat approach will be used. Repeated measures analysis of variance will be used to examine the differences on outcome measures among the experimental, comparison and control groups across study time points. In addition, differences in changes in outcome measures among experimental, comparison groups and usual care groups will be tested using multilevel modelling techniques. A p-value smaller than 5% will be considered as statistically significant. Content analysis will be conducted to analyse the interviews data.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
172
5 weekly sessions of online self-administered mindfulness training programme in which they will receive audio-recorded and video-recorded instructions, pictorial or text-based instructions for various mindfulness exercises such as body scan meditation, mindful breathing and walking meditation.
5 weekly online education module in which they will receive video-recorded, audio-recorded, pictorial or text-based instructions for various self-management strategies. Topics include fatigue, pain, numbness/tingling, lymphedema, anxiety/depression, and problems with sleeping.
National Cancer Centre Singapore
Singapore, Singapore
National University Hospital
Singapore, Singapore
Change from baseline quality of life score at 8 weeks
Time frame: Change between baseline and at 8 weeks
Change from baseline quality of life score at 12 weeks
Time frame: Change between baseline and at 12 weeks
Change from baseline quality of life score at 24 weeks
Time frame: Change between baseline and at 24 weeks
Change from baseline social support score at 8 weeks
Time frame: Change between baseline and at 8 weeks
Change from baseline social support score at 12 weeks
Time frame: Change between baseline and at 12 weeks
Change from baseline social support score at 24 weeks
Time frame: Change between baseline and at 24 weeks
Change from baseline self-efficacy score at 8 weeks
Time frame: Change between baseline and at 8 weeks
Change from baseline self-efficacy score at 12 weeks
Time frame: Change between baseline and at 12 weeks
Change from baseline self-efficacy score at 24 weeks
Time frame: Change between baseline and at 24 weeks
Change from baseline symptom score at 8 weeks
Time frame: Change between baseline and at 8 weeks
Change from baseline symptom score at 12 weeks
Time frame: Change between baseline and at 12 weeks
Change from baseline symptom score at 24 weeks
Time frame: Change between baseline and at 24 weeks
Change from baseline psychosocial adjustment to illness score at 8 weeks
Time frame: Change between baseline and at 8 weeks
Change from baseline psychosocial adjustment to illness score at 12 weeks
Time frame: Change between baseline and at 12 weeks
Change from baseline psychosocial adjustment to illness score at 24 weeks
Time frame: Change between baseline and at 24 weeks
Change from baseline fear of recurrence score at 8 weeks
Time frame: Change between baseline and at 8 weeks
Change from baseline fear of recurrence score at 12 weeks
Time frame: Change between baseline and at 12 weeks
Change from baseline fear of recurrence score at 24 weeks
Time frame: Change between baseline and at 24 weeks
Change from baseline anxiety and depression score at 8 weeks
Time frame: Change between baseline and at 8 weeks
Change from baseline anxiety and depression score at 12 weeks
Time frame: Change between baseline and at 12 weeks
Change from baseline anxiety and depression score at 24 weeks
Time frame: Change between baseline and at 24 weeks
Change from baseline mindfulness score at 8 weeks
Time frame: Change between baseline and at 8 weeks
Change from baseline mindfulness score at 12 weeks
Time frame: Change between baseline and at 12 weeks
Change from baseline mindfulness score at 24 weeks
Time frame: Change between baseline and at 24 weeks
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