Effects of an e-Home Based Symptom Management and Mindfulness Training Programme on QoL in Breast Cancer Survivors
- Conditions
- Breast Cancer SurvivorsMindfulness Based Cognitive TherapyQuality of LifeOncologySymptom Management
- Interventions
- Other: Online symptom managementOther: Online mindfulness training
- Registration Number
- NCT02931864
- Lead Sponsor
- National University of Singapore
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 172
- women aged 21 or above
- able to speak and read English
- diagnosed with breast cancer stage 0 to 3 for the first time
- have completed cancer treatment including breast surgery and/or adjuvant chemotherapy and/or radiotherapy between 6 months to 5 years previously
- with and without ongoing HER2 target therapy (e.g.: Herceptin) and/or hormonal therapy
- with ECOG Performance Status score of 0 to 1
- able to understand the study and give informed consent
- have access to the internet through a handheld device
- they are illiterate
- have serious psychiatric disorders (e.g. schizophrenia, dementia, and intellectual disabilities)
- with ECOG Performance Status score of 2 or above
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Comparison group 1 Online symptom management Five weekly sessions of online symptom management programme + usual care Experimental group Online symptom management Five weekly sessions of online symptom management + mindfulness training programme + usual care Experimental group Online mindfulness training Five weekly sessions of online symptom management + mindfulness training programme + usual care Comparison group 2 Online mindfulness training Five weekly sessions of online mindfulness training programme and usual care
- Primary Outcome Measures
Name Time Method Change from baseline quality of life score at 8 weeks Change between baseline and at 8 weeks Change from baseline quality of life score at 12 weeks Change between baseline and at 12 weeks Change from baseline quality of life score at 24 weeks Change between baseline and at 24 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline social support score at 24 weeks Change between baseline and at 24 weeks Change from baseline self-efficacy score at 8 weeks Change between baseline and at 8 weeks Change from baseline fear of recurrence score at 8 weeks Change between baseline and at 8 weeks Change from baseline fear of recurrence score at 12 weeks Change between baseline and at 12 weeks Change from baseline fear of recurrence score at 24 weeks Change between baseline and at 24 weeks Change from baseline anxiety and depression score at 8 weeks Change between baseline and at 8 weeks Change from baseline anxiety and depression score at 24 weeks Change between baseline and at 24 weeks Change from baseline mindfulness score at 8 weeks Change between baseline and at 8 weeks Change from baseline mindfulness score at 12 weeks Change between baseline and at 12 weeks Change from baseline mindfulness score at 24 weeks Change between baseline and at 24 weeks Change from baseline social support score at 8 weeks Change between baseline and at 8 weeks Change from baseline social support score at 12 weeks Change between baseline and at 12 weeks Change from baseline self-efficacy score at 12 weeks Change between baseline and at 12 weeks Change from baseline self-efficacy score at 24 weeks Change between baseline and at 24 weeks Change from baseline symptom score at 8 weeks Change between baseline and at 8 weeks Change from baseline symptom score at 12 weeks Change between baseline and at 12 weeks Change from baseline symptom score at 24 weeks Change between baseline and at 24 weeks Change from baseline psychosocial adjustment to illness score at 8 weeks Change between baseline and at 8 weeks Change from baseline psychosocial adjustment to illness score at 12 weeks Change between baseline and at 12 weeks Change from baseline psychosocial adjustment to illness score at 24 weeks Change between baseline and at 24 weeks Change from baseline anxiety and depression score at 12 weeks Change between baseline and at 12 weeks
Trial Locations
- Locations (2)
National Cancer Centre Singapore
🇸🇬Singapore, Singapore
National University Hospital
🇸🇬Singapore, Singapore