Effects of an e-Home Based Symptom Management and Mindfulness Training Programme on QoL in Breast Cancer Survivors
Condition: Breast Cancer Survivors; Symptom Management; Mindfulness Based Cognitive Therapy; Quality of Life; Oncology
MeSH terms: Breast Neoplasms
Study type: Interventional

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.
    


Intervention name(s): Online mindfulness training; Online symptom management
Intervention type(s): Other; Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care