Clinical trial NCT02931864: Effects of an e-Home Based Symptom Management and Mindfulness Training Programme on QoL in Breast Cancer Survivors
Official title: Effects of an e-Home Based Symptom Management and Mindfulness Training Programme on Quality of Life in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Survivors
Symptom Management
Mindfulness Based Cognitive Therapy
Quality of Life
Oncology
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: National University Hospital, Singapore
name: National Cancer Centre, Singapore
First posted: 2016-10-13
Enrollment: 172
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Change from baseline quality of life score at 8 weeks
timeFrame: Change between baseline and at 8 weeks
measure: Change from baseline quality of life score at 12 weeks
timeFrame: Change between baseline and at 12 weeks
measure: Change from baseline quality of life score at 24 weeks
timeFrame: Change between baseline and at 24 weeks
Secondary outcomes:
measure: Change from baseline social support score at 8 weeks
timeFrame: Change between baseline and at 8 weeks
measure: Change from baseline social support score at 12 weeks
timeFrame: Change between baseline and at 12 weeks
measure: Change from baseline social support score at 24 weeks
timeFrame: Change between baseline and at 24 weeks
measure: Change from baseline self-efficacy score at 8 weeks
timeFrame: Change between baseline and at 8 weeks
measure: Change from baseline self-efficacy score at 12 weeks
timeFrame: Change between baseline and at 12 weeks
measure: Change from baseline self-efficacy score at 24 weeks
timeFrame: Change between baseline and at 24 weeks
measure: Change from baseline symptom score at 8 weeks
timeFrame: Change between baseline and at 8 weeks
measure: Change from baseline symptom score at 12 weeks
timeFrame: Change between baseline and at 12 weeks
measure: Change from baseline symptom score at 24 weeks
timeFrame: Change between baseline and at 24 weeks
measure: Change from baseline psychosocial adjustment to illness score at 8 weeks
timeFrame: Change between baseline and at 8 weeks
measure: Change from baseline psychosocial adjustment to illness score at 12 weeks
timeFrame: Change between baseline and at 12 weeks
measure: Change from baseline psychosocial adjustment to illness score at 24 weeks
timeFrame: Change between baseline and at 24 weeks
measure: Change from baseline fear of recurrence score at 8 weeks
timeFrame: Change between baseline and at 8 weeks
measure: Change from baseline fear of recurrence score at 12 weeks
timeFrame: Change between baseline and at 12 weeks
measure: Change from baseline fear of recurrence score at 24 weeks
timeFrame: Change between baseline and at 24 weeks
measure: Change from baseline anxiety and depression score at 8 weeks
timeFrame: Change between baseline and at 8 weeks
measure: Change from baseline anxiety and depression score at 12 weeks
timeFrame: Change between baseline and at 12 weeks
measure: Change from baseline anxiety and depression score at 24 weeks
timeFrame: Change between baseline and at 24 weeks
measure: Change from baseline mindfulness score at 8 weeks
timeFrame: Change between baseline and at 8 weeks
measure: Change from baseline mindfulness score at 12 weeks
timeFrame: Change between baseline and at 12 weeks
measure: Change from baseline mindfulness score at 24 weeks
timeFrame: Change between baseline and at 24 weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University of Singapore
name: Karis Cheng
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cheng KK, Darshini Devi R, Wong WH, Koh C. Perceived symptoms and the supportive care needs of breast cancer survivors six months to five years post-treatment period. Eur J Oncol Nurs. 2014 Feb;18(1):3-9. doi: 10.1016/j.ejon.2013.10.005. Epub 2013 Dec 5.
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citation: Portenoy RK, Thaler HT, Kornblith AB, Lepore JM, Friedlander-Klar H, Kiyasu E, Sobel K, Coyle N, Kemeny N, Norton L, et al. The Memorial Symptom Assessment Scale: an instrument for the evaluation of symptom prevalence, characteristics and distress. Eur J Cancer. 1994;30A(9):1326-36. doi: 10.1016/0959-8049(94)90182-1.
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citation: Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
citation: Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.
citation: Champion VL, Ziner KW, Monahan PO, Stump TE, Cella D, Smith LG, Bell CJ, Von Ah D, Sledge GW. Development and psychometric testing of a breast cancer survivor self-efficacy scale. Oncol Nurs Forum. 2013 Nov;40(6):E403-10. doi: 10.1188/13.ONF.E403-E410.