Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

22. september 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

172

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år til 100 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

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

Hvad måler undersøgelsen?

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National University of Singapore

Samarbejdspartnere

National University Hospital, Singapore
National Cancer Centre, Singapore

Efterforskere

  • Ledende efterforsker: Karis Cheng, National University of Singapore

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

6. december 2016

Primær færdiggørelse (Faktiske)

14. marts 2020

Studieafslutning (Faktiske)

14. marts 2020

Datoer for studieregistrering

Først indsendt

10. oktober 2016

Først indsendt, der opfyldte QC-kriterier

11. oktober 2016

Først opslået (Skøn)

13. oktober 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. september 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. september 2020

Sidst verificeret

1. september 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • R-545-000-073-592

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Livskvalitet

Kliniske forsøg med Online mindfulness training

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Taiwan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner