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NCT Number: NCT02931864

Effects of an e-Home Based Symptom Management and Mindfulness Training Programme on QoL in Breast Cancer Survivors

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.

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Key information

Conditions

Breast Cancer Survivors Mindfulness Based Cognitive Therapy Neoplasms Oncology Quality of Life Symptom Management

Age range

21 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Centre Singapore, Singapore

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • they are illiterate
  • have serious psychiatric disorders (e.g. schizophrenia, dementia, and intellectual disabilities)
  • with ECOG Performance Status score of 2 or above

Treatment and study plan

Online mindfulness training

Other

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.

Online symptom management

Other

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.

Primary outcomes

  1. Change from baseline quality of life score at 8 weeks

    Time frame: Change between baseline and at 8 weeks

  2. Change from baseline quality of life score at 12 weeks

    Time frame: Change between baseline and at 12 weeks

  3. Change from baseline quality of life score at 24 weeks

    Time frame: Change between baseline and at 24 weeks

Secondary outcomes

  1. Change from baseline social support score at 8 weeks

    Time frame: Change between baseline and at 8 weeks

  2. Change from baseline social support score at 12 weeks

    Time frame: Change between baseline and at 12 weeks

  3. Change from baseline social support score at 24 weeks

    Time frame: Change between baseline and at 24 weeks

  4. Change from baseline self-efficacy score at 8 weeks

    Time frame: Change between baseline and at 8 weeks

  5. Change from baseline self-efficacy score at 12 weeks

    Time frame: Change between baseline and at 12 weeks

  6. Change from baseline self-efficacy score at 24 weeks

    Time frame: Change between baseline and at 24 weeks

  7. Change from baseline symptom score at 8 weeks

    Time frame: Change between baseline and at 8 weeks

  8. Change from baseline symptom score at 12 weeks

    Time frame: Change between baseline and at 12 weeks

  9. Change from baseline symptom score at 24 weeks

    Time frame: Change between baseline and at 24 weeks

  10. Change from baseline psychosocial adjustment to illness score at 8 weeks

    Time frame: Change between baseline and at 8 weeks

  11. Change from baseline psychosocial adjustment to illness score at 12 weeks

    Time frame: Change between baseline and at 12 weeks

  12. Change from baseline psychosocial adjustment to illness score at 24 weeks

    Time frame: Change between baseline and at 24 weeks

  13. Change from baseline fear of recurrence score at 8 weeks

    Time frame: Change between baseline and at 8 weeks

  14. Change from baseline fear of recurrence score at 12 weeks

    Time frame: Change between baseline and at 12 weeks

  15. Change from baseline fear of recurrence score at 24 weeks

    Time frame: Change between baseline and at 24 weeks

  16. Change from baseline anxiety and depression score at 8 weeks

    Time frame: Change between baseline and at 8 weeks

  17. Change from baseline anxiety and depression score at 12 weeks

    Time frame: Change between baseline and at 12 weeks

  18. Change from baseline anxiety and depression score at 24 weeks

    Time frame: Change between baseline and at 24 weeks

  19. Change from baseline mindfulness score at 8 weeks

    Time frame: Change between baseline and at 8 weeks

  20. Change from baseline mindfulness score at 12 weeks

    Time frame: Change between baseline and at 12 weeks

  21. Change from baseline mindfulness score at 24 weeks

    Time frame: Change between baseline and at 24 weeks

Sponsors and collaborators

Lead sponsor

National University of Singapore

Other

Collaborators

  • National Cancer Centre, Singapore
  • National University Hospital, Singapore

Registry information

Official study title

Effects of an e-Home Based Symptom Management and Mindfulness Training Programme on Quality of Life in Breast Cancer Survivors

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Oct 13, 2016
Registry last updated
Sep 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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