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

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ClinicalTrials.gov Identifier: NCT02931864
Recruitment Status : Recruiting
First Posted : October 13, 2016
Last Update Posted : August 23, 2018
Sponsor:
Collaborators:
National University Hospital, Singapore
National Cancer Centre, Singapore
Information provided by (Responsible Party):
Karis Cheng, National University, 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Survivors Symptom Management Mindfulness Based Cognitive Therapy Quality of Life Oncology Other: Online mindfulness training Other: Online symptom management Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of an e-Home Based Symptom Management and Mindfulness Training Programme on Quality of Life in Breast Cancer Survivors
Study Start Date : November 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Usual care group
Usual care is meant the routine medical and health care services at the hospital.
Experimental: Experimental group
Five weekly sessions of online symptom management + mindfulness training programme + usual care
Other: Online mindfulness training
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.

Other: Online symptom management
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.

Active Comparator: Comparison group 1
Five weekly sessions of online symptom management programme + usual care
Other: Online symptom management
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.

Active Comparator: Comparison group 2
Five weekly sessions of online mindfulness training programme and usual care
Other: Online mindfulness training
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   21 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02931864


Contacts
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Contact: Karis Cheng 6516 3117 karis_cheng@nuhs.edu.sg

Locations
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Singapore
National Cancer Centre Singapore Recruiting
Singapore, Singapore
Contact: Elaine Lim, MBBChir,MRCP    64368088      
National University Hospital Recruiting
Singapore, Singapore
Contact: Wan Hua Wong    6772 8208    wan_hua_wong1@nuhs.edu.sg   
Sponsors and Collaborators
National University, Singapore
National University Hospital, Singapore
National Cancer Centre, Singapore
Investigators
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Principal Investigator: Karis Cheng National University, Singapore

Publications:
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Responsible Party: Karis Cheng, Professor, National University, Singapore
ClinicalTrials.gov Identifier: NCT02931864     History of Changes
Other Study ID Numbers: R-545-000-073-592
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases