Effects of an e-Home Based Symptom Management and Mindfulness Training Programme on QoL in Breast Cancer Survivors
22 september 2020 bijgewerkt door: Karis Cheng, National University of Singapore
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
172
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Singapore, Singapore
- National University Hospital
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Singapore, Singapore
- National Cancer Centre Singapore
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
21 jaar tot 100 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Geen tussenkomst: Usual care group
Usual care is meant the routine medical and health care services at the hospital.
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Experimenteel: Experimental group
Five weekly sessions of online symptom management + mindfulness training programme + usual care
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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.
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Actieve vergelijker: Comparison group 1
Five weekly sessions of online symptom management programme + usual care
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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.
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Actieve vergelijker: Comparison group 2
Five weekly sessions of online mindfulness training programme and usual care
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Change from baseline quality of life score at 8 weeks
Tijdsspanne: Change between baseline and at 8 weeks
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Change between baseline and at 8 weeks
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Change from baseline quality of life score at 12 weeks
Tijdsspanne: Change between baseline and at 12 weeks
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Change between baseline and at 12 weeks
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Change from baseline quality of life score at 24 weeks
Tijdsspanne: Change between baseline and at 24 weeks
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Change between baseline and at 24 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Change from baseline social support score at 8 weeks
Tijdsspanne: Change between baseline and at 8 weeks
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Change between baseline and at 8 weeks
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Change from baseline social support score at 12 weeks
Tijdsspanne: Change between baseline and at 12 weeks
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Change between baseline and at 12 weeks
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Change from baseline social support score at 24 weeks
Tijdsspanne: Change between baseline and at 24 weeks
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Change between baseline and at 24 weeks
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Change from baseline self-efficacy score at 8 weeks
Tijdsspanne: Change between baseline and at 8 weeks
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Change between baseline and at 8 weeks
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Change from baseline self-efficacy score at 12 weeks
Tijdsspanne: Change between baseline and at 12 weeks
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Change between baseline and at 12 weeks
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Change from baseline self-efficacy score at 24 weeks
Tijdsspanne: Change between baseline and at 24 weeks
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Change between baseline and at 24 weeks
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Change from baseline symptom score at 8 weeks
Tijdsspanne: Change between baseline and at 8 weeks
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Change between baseline and at 8 weeks
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Change from baseline symptom score at 12 weeks
Tijdsspanne: Change between baseline and at 12 weeks
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Change between baseline and at 12 weeks
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Change from baseline symptom score at 24 weeks
Tijdsspanne: Change between baseline and at 24 weeks
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Change between baseline and at 24 weeks
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Change from baseline psychosocial adjustment to illness score at 8 weeks
Tijdsspanne: Change between baseline and at 8 weeks
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Change between baseline and at 8 weeks
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Change from baseline psychosocial adjustment to illness score at 12 weeks
Tijdsspanne: Change between baseline and at 12 weeks
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Change between baseline and at 12 weeks
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Change from baseline psychosocial adjustment to illness score at 24 weeks
Tijdsspanne: Change between baseline and at 24 weeks
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Change between baseline and at 24 weeks
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Change from baseline fear of recurrence score at 8 weeks
Tijdsspanne: Change between baseline and at 8 weeks
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Change between baseline and at 8 weeks
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Change from baseline fear of recurrence score at 12 weeks
Tijdsspanne: Change between baseline and at 12 weeks
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Change between baseline and at 12 weeks
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Change from baseline fear of recurrence score at 24 weeks
Tijdsspanne: Change between baseline and at 24 weeks
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Change between baseline and at 24 weeks
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Change from baseline anxiety and depression score at 8 weeks
Tijdsspanne: Change between baseline and at 8 weeks
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Change between baseline and at 8 weeks
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Change from baseline anxiety and depression score at 12 weeks
Tijdsspanne: Change between baseline and at 12 weeks
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Change between baseline and at 12 weeks
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Change from baseline anxiety and depression score at 24 weeks
Tijdsspanne: Change between baseline and at 24 weeks
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Change between baseline and at 24 weeks
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Change from baseline mindfulness score at 8 weeks
Tijdsspanne: Change between baseline and at 8 weeks
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Change between baseline and at 8 weeks
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Change from baseline mindfulness score at 12 weeks
Tijdsspanne: Change between baseline and at 12 weeks
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Change between baseline and at 12 weeks
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Change from baseline mindfulness score at 24 weeks
Tijdsspanne: Change between baseline and at 24 weeks
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Change between baseline and at 24 weeks
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Karis Cheng, National University of Singapore
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- 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.
- 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.
- Bower 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.
- 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.
- Ferrell 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.
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
6 december 2016
Primaire voltooiing (Werkelijk)
14 maart 2020
Studie voltooiing (Werkelijk)
14 maart 2020
Studieregistratiedata
Eerst ingediend
10 oktober 2016
Eerst ingediend dat voldeed aan de QC-criteria
11 oktober 2016
Eerst geplaatst (Schatting)
13 oktober 2016
Updates van studierecords
Laatste update geplaatst (Werkelijk)
23 september 2020
Laatste update ingediend die voldeed aan QC-criteria
22 september 2020
Laatst geverifieerd
1 september 2020
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- R-545-000-073-592
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
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