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

22. september 2020 oppdatert av: 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.

Studieoversikt

Studietype

Intervensjonell

Registrering (Faktiske)

172

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

21 år til 100 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Usual care group
Usual care is meant the routine medical and health care services at the hospital.
Eksperimentell: Experimental group
Five weekly sessions of online symptom management + mindfulness training programme + usual care
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.
Aktiv komparator: Comparison group 1
Five weekly sessions of online symptom management programme + usual care
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.
Aktiv komparator: Comparison group 2
Five weekly sessions of online mindfulness training programme and usual care
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Change from baseline quality of life score at 8 weeks
Tidsramme: Change between baseline and at 8 weeks
Change between baseline and at 8 weeks
Change from baseline quality of life score at 12 weeks
Tidsramme: Change between baseline and at 12 weeks
Change between baseline and at 12 weeks
Change from baseline quality of life score at 24 weeks
Tidsramme: Change between baseline and at 24 weeks
Change between baseline and at 24 weeks

Sekundære resultatmål

Resultatmål
Tidsramme
Change from baseline social support score at 8 weeks
Tidsramme: Change between baseline and at 8 weeks
Change between baseline and at 8 weeks
Change from baseline social support score at 12 weeks
Tidsramme: Change between baseline and at 12 weeks
Change between baseline and at 12 weeks
Change from baseline social support score at 24 weeks
Tidsramme: Change between baseline and at 24 weeks
Change between baseline and at 24 weeks
Change from baseline self-efficacy score at 8 weeks
Tidsramme: Change between baseline and at 8 weeks
Change between baseline and at 8 weeks
Change from baseline self-efficacy score at 12 weeks
Tidsramme: Change between baseline and at 12 weeks
Change between baseline and at 12 weeks
Change from baseline self-efficacy score at 24 weeks
Tidsramme: Change between baseline and at 24 weeks
Change between baseline and at 24 weeks
Change from baseline symptom score at 8 weeks
Tidsramme: Change between baseline and at 8 weeks
Change between baseline and at 8 weeks
Change from baseline symptom score at 12 weeks
Tidsramme: Change between baseline and at 12 weeks
Change between baseline and at 12 weeks
Change from baseline symptom score at 24 weeks
Tidsramme: Change between baseline and at 24 weeks
Change between baseline and at 24 weeks
Change from baseline psychosocial adjustment to illness score at 8 weeks
Tidsramme: Change between baseline and at 8 weeks
Change between baseline and at 8 weeks
Change from baseline psychosocial adjustment to illness score at 12 weeks
Tidsramme: Change between baseline and at 12 weeks
Change between baseline and at 12 weeks
Change from baseline psychosocial adjustment to illness score at 24 weeks
Tidsramme: Change between baseline and at 24 weeks
Change between baseline and at 24 weeks
Change from baseline fear of recurrence score at 8 weeks
Tidsramme: Change between baseline and at 8 weeks
Change between baseline and at 8 weeks
Change from baseline fear of recurrence score at 12 weeks
Tidsramme: Change between baseline and at 12 weeks
Change between baseline and at 12 weeks
Change from baseline fear of recurrence score at 24 weeks
Tidsramme: Change between baseline and at 24 weeks
Change between baseline and at 24 weeks
Change from baseline anxiety and depression score at 8 weeks
Tidsramme: Change between baseline and at 8 weeks
Change between baseline and at 8 weeks
Change from baseline anxiety and depression score at 12 weeks
Tidsramme: Change between baseline and at 12 weeks
Change between baseline and at 12 weeks
Change from baseline anxiety and depression score at 24 weeks
Tidsramme: Change between baseline and at 24 weeks
Change between baseline and at 24 weeks
Change from baseline mindfulness score at 8 weeks
Tidsramme: Change between baseline and at 8 weeks
Change between baseline and at 8 weeks
Change from baseline mindfulness score at 12 weeks
Tidsramme: Change between baseline and at 12 weeks
Change between baseline and at 12 weeks
Change from baseline mindfulness score at 24 weeks
Tidsramme: Change between baseline and at 24 weeks
Change between baseline and at 24 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Karis Cheng, National University of Singapore

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

6. desember 2016

Primær fullføring (Faktiske)

14. mars 2020

Studiet fullført (Faktiske)

14. mars 2020

Datoer for studieregistrering

Først innsendt

10. oktober 2016

Først innsendt som oppfylte QC-kriteriene

11. oktober 2016

Først lagt ut (Anslag)

13. oktober 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. september 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. september 2020

Sist bekreftet

1. september 2020

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • R-545-000-073-592

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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