Breast Cancer SurvivorsNCT02931864
Effects of an e-Home Based Symptom Management and Mindfulness Training Programme on QoL in Breast Cancer Survivors
A study testing Online mindfulness training and Online symptom management in people with Breast Cancer Survivors and Symptom Management, run by National University of Singapore at 2 sites in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 100 years, women only
- Conditions the study is for
- Breast Cancer Survivors, Symptom Management, Mindfulness Based Cognitive Therapy
- What is being tested?
- Online mindfulness training and Online symptom management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 2 sitesSingapore
- Study dates
- 6 Dec 2016to 14 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- they are illiterate
- have serious psychiatric disorders (e.g. schizophrenia, dementia, and intellectual disabilities)
- with ECOG Performance Status score of 2 or above
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
National Cancer Centre Singapore
Singapore
National University Hospital
Singapore
About this study
Official title: Effects of an e-Home Based Symptom Management and Mindfulness Training Programme on Quality of Life 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.
- Conditions
- Breast Cancer Survivors, Symptom Management, Mindfulness Based Cognitive Therapy, Quality of Life, Oncology
- Being tested
- Online mindfulness training, Online symptom management
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online mindfulness trainingOther
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 managementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care group | No intervention | Usual care is meant the routine medical and health care services at the hospital. |
| Experimental group | Experimental | Five weekly sessions of online symptom management + mindfulness training programme + usual care Receives: Other: Online mindfulness training; Other: Online symptom management |
| Comparison group 1 | Active comparator | Five weekly sessions of online symptom management programme + usual care Receives: Other: Online symptom management |
| Comparison group 2 | Active comparator | Five weekly sessions of online mindfulness training programme and usual care Receives: Other: Online mindfulness training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline quality of life score at 8 weeks
Measured: Change between baseline and at 8 weeks
Change from baseline quality of life score at 12 weeks
Measured: Change between baseline and at 12 weeks
Change from baseline quality of life score at 24 weeks
Measured: Change between baseline and at 24 weeks
Secondary outcomes (21)
Change from baseline social support score at 8 weeks
Measured: Change between baseline and at 8 weeks
Change from baseline social support score at 12 weeks
Measured: Change between baseline and at 12 weeks
Change from baseline social support score at 24 weeks
Measured: Change between baseline and at 24 weeks
Change from baseline self-efficacy score at 8 weeks
Measured: Change between baseline and at 8 weeks
Change from baseline self-efficacy score at 12 weeks
Measured: Change between baseline and at 12 weeks
Change from baseline self-efficacy score at 24 weeks
Measured: Change between baseline and at 24 weeks
Change from baseline symptom score at 8 weeks
Measured: Change between baseline and at 8 weeks
Change from baseline symptom score at 12 weeks
Measured: Change between baseline and at 12 weeks
Change from baseline symptom score at 24 weeks
Measured: Change between baseline and at 24 weeks
Change from baseline psychosocial adjustment to illness score at 8 weeks
Measured: Change between baseline and at 8 weeks
Change from baseline psychosocial adjustment to illness score at 12 weeks
Measured: Change between baseline and at 12 weeks
Change from baseline psychosocial adjustment to illness score at 24 weeks
Measured: Change between baseline and at 24 weeks
Change from baseline fear of recurrence score at 8 weeks
Measured: Change between baseline and at 8 weeks
Change from baseline fear of recurrence score at 12 weeks
Measured: Change between baseline and at 12 weeks
Change from baseline fear of recurrence score at 24 weeks
Measured: Change between baseline and at 24 weeks
Change from baseline anxiety and depression score at 8 weeks
Measured: Change between baseline and at 8 weeks
Change from baseline anxiety and depression score at 12 weeks
Measured: Change between baseline and at 12 weeks
Change from baseline anxiety and depression score at 24 weeks
Measured: Change between baseline and at 24 weeks
Change from baseline mindfulness score at 8 weeks
Measured: Change between baseline and at 8 weeks
Change from baseline mindfulness score at 12 weeks
Measured: Change between baseline and at 12 weeks
Change from baseline mindfulness score at 24 weeks
Measured: Change between baseline and at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study start6 Dec 2016
- Primary completion14 Mar 2020
- Study completion14 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer SurvivorsStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University Hospital, Singapore, National Cancer Centre, Singapore
- Responsible party
- Principal investigator, Karis Cheng, National University of Singapore
- Investigators
- Karis Cheng, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931864
- Sponsor's protocol ID
- R-545-000-073-592
- Status last verified
- Sep 2020
- First submitted
- 10 Oct 2016
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 24315730Ferrell BR, Dow KH, Grant M. Measurement of the quality of life in cancer survivors. Qual Life Res. 1995 Dec;4(6):523-31. doi: 10.1007/BF00634747.
PubMed 8556012Portenoy 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.
PubMed 7999421Bower JE, Ganz PA, Desmond KA, Bernaards C, Rowland JH, Meyerowitz BE, Belin TR. Fatigue in long-term breast carcinoma survivors: a longitudinal investigation. Cancer. 2006 Feb 15;106(4):751-8. doi: 10.1002/cncr.21671.
PubMed 16400678Zigmond 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.
PubMed 6880820Baer 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.
PubMed 16443717Champion 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.
PubMed 24161644
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an e-Home Based Symptom Management and Mindfulness Training Programme on Quality of Life in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT02931864
- Acronym / sponsor ID
- R-545-000-073-592
- Conditions
- Breast Cancer Survivors, Symptom Management, Mindfulness Based Cognitive Therapy, Quality of Life, Oncology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- National University Hospital, Singapore, National Cancer Centre, Singapore
- Study start
- 6 Dec 2016 (actual)
- Primary completion
- 14 Mar 2020 (actual)
- Study completion
- 14 Mar 2020 (actual)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Usual care group | No intervention | –Usual care is meant the routine medical and health care services at the hospital. |
| Experimental group | Experimental | Other: Online mindfulness training, Other: Online symptom managementFive weekly sessions of online symptom management + mindfulness training programme + usual care |
| Comparison group 1 | Active comparator | Other: Online symptom managementFive weekly sessions of online symptom management programme + usual care |
| Comparison group 2 | Active comparator | Other: Online mindfulness trainingFive weekly sessions of online mindfulness training programme and usual care |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- they are illiterate
- have serious psychiatric disorders (e.g. schizophrenia, dementia, and intellectual disabilities)
- with ECOG Performance Status score of 2 or above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online mindfulness training5 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 | Comparison group 2, Experimental group |
| Online symptom management5 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. | Other | Comparison group 1, Experimental group |
Primary outcome
Change from baseline quality of life score at 8 weeks
Time frame: Change between baseline and at 8 weeks
Change from baseline quality of life score at 12 weeks
Time frame: Change between baseline and at 12 weeks
Change from baseline quality of life score at 24 weeks
Time frame: Change between baseline and at 24 weeks
21 secondary outcomes
Change from baseline social support score at 8 weeks
Time frame: Change between baseline and at 8 weeks
Change from baseline social support score at 12 weeks
Time frame: Change between baseline and at 12 weeks
Change from baseline social support score at 24 weeks
Time frame: Change between baseline and at 24 weeks
Change from baseline self-efficacy score at 8 weeks
Time frame: Change between baseline and at 8 weeks
Change from baseline self-efficacy score at 12 weeks
Time frame: Change between baseline and at 12 weeks
Change from baseline self-efficacy score at 24 weeks
Time frame: Change between baseline and at 24 weeks
Change from baseline symptom score at 8 weeks
Time frame: Change between baseline and at 8 weeks
Change from baseline symptom score at 12 weeks
Time frame: Change between baseline and at 12 weeks
Change from baseline symptom score at 24 weeks
Time frame: Change between baseline and at 24 weeks
Change from baseline psychosocial adjustment to illness score at 8 weeks
Time frame: Change between baseline and at 8 weeks
Change from baseline psychosocial adjustment to illness score at 12 weeks
Time frame: Change between baseline and at 12 weeks
Change from baseline psychosocial adjustment to illness score at 24 weeks
Time frame: Change between baseline and at 24 weeks
Change from baseline fear of recurrence score at 8 weeks
Time frame: Change between baseline and at 8 weeks
Change from baseline fear of recurrence score at 12 weeks
Time frame: Change between baseline and at 12 weeks
Change from baseline fear of recurrence score at 24 weeks
Time frame: Change between baseline and at 24 weeks
Change from baseline anxiety and depression score at 8 weeks
Time frame: Change between baseline and at 8 weeks
Change from baseline anxiety and depression score at 12 weeks
Time frame: Change between baseline and at 12 weeks
Change from baseline anxiety and depression score at 24 weeks
Time frame: Change between baseline and at 24 weeks
Change from baseline mindfulness score at 8 weeks
Time frame: Change between baseline and at 8 weeks
Change from baseline mindfulness score at 12 weeks
Time frame: Change between baseline and at 12 weeks
Change from baseline mindfulness score at 24 weeks
Time frame: Change between baseline and at 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- Background: PubMed 24315730Cheng 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.
- Background: PubMed 8556012Ferrell BR, Dow KH, Grant M. Measurement of the quality of life in cancer survivors. Qual Life Res. 1995 Dec;4(6):523-31. doi: 10.1007/BF00634747.
- Background: PubMed 7999421Portenoy 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.
- Background: PubMed 16400678Bower JE, Ganz PA, Desmond KA, Bernaards C, Rowland JH, Meyerowitz BE, Belin TR. Fatigue in long-term breast carcinoma survivors: a longitudinal investigation. Cancer. 2006 Feb 15;106(4):751-8. doi: 10.1002/cncr.21671.
- Background: PubMed 6880820Zigmond 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.
- Background: PubMed 16443717Baer 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.
- Background: PubMed 24161644Champion 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karis Cheng principal investigator
National University of Singapore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online mindfulness training and Online symptom management in people with Breast Cancer Survivors and Symptom Management, run by National University of Singapore at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline quality of life score at 8 weeks (time frame: Change between baseline and at 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02931864, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2020.