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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 uppdaterad 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.

Studieöversikt

Studietyp

Interventionell

Inskrivning (Faktisk)

172

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

21 år till 100 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: Usual care group
Usual care is meant the routine medical and health care services at the hospital.
Experimentell: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Change from baseline quality of life score at 8 weeks
Tidsram: Change between baseline and at 8 weeks
Change between baseline and at 8 weeks
Change from baseline quality of life score at 12 weeks
Tidsram: Change between baseline and at 12 weeks
Change between baseline and at 12 weeks
Change from baseline quality of life score at 24 weeks
Tidsram: Change between baseline and at 24 weeks
Change between baseline and at 24 weeks

Sekundära resultatmått

Resultatmått
Tidsram
Change from baseline social support score at 8 weeks
Tidsram: Change between baseline and at 8 weeks
Change between baseline and at 8 weeks
Change from baseline social support score at 12 weeks
Tidsram: Change between baseline and at 12 weeks
Change between baseline and at 12 weeks
Change from baseline social support score at 24 weeks
Tidsram: Change between baseline and at 24 weeks
Change between baseline and at 24 weeks
Change from baseline self-efficacy score at 8 weeks
Tidsram: Change between baseline and at 8 weeks
Change between baseline and at 8 weeks
Change from baseline self-efficacy score at 12 weeks
Tidsram: Change between baseline and at 12 weeks
Change between baseline and at 12 weeks
Change from baseline self-efficacy score at 24 weeks
Tidsram: Change between baseline and at 24 weeks
Change between baseline and at 24 weeks
Change from baseline symptom score at 8 weeks
Tidsram: Change between baseline and at 8 weeks
Change between baseline and at 8 weeks
Change from baseline symptom score at 12 weeks
Tidsram: Change between baseline and at 12 weeks
Change between baseline and at 12 weeks
Change from baseline symptom score at 24 weeks
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Change between baseline and at 24 weeks
Change between baseline and at 24 weeks
Change from baseline fear of recurrence score at 8 weeks
Tidsram: Change between baseline and at 8 weeks
Change between baseline and at 8 weeks
Change from baseline fear of recurrence score at 12 weeks
Tidsram: Change between baseline and at 12 weeks
Change between baseline and at 12 weeks
Change from baseline fear of recurrence score at 24 weeks
Tidsram: Change between baseline and at 24 weeks
Change between baseline and at 24 weeks
Change from baseline anxiety and depression score at 8 weeks
Tidsram: Change between baseline and at 8 weeks
Change between baseline and at 8 weeks
Change from baseline anxiety and depression score at 12 weeks
Tidsram: Change between baseline and at 12 weeks
Change between baseline and at 12 weeks
Change from baseline anxiety and depression score at 24 weeks
Tidsram: Change between baseline and at 24 weeks
Change between baseline and at 24 weeks
Change from baseline mindfulness score at 8 weeks
Tidsram: Change between baseline and at 8 weeks
Change between baseline and at 8 weeks
Change from baseline mindfulness score at 12 weeks
Tidsram: Change between baseline and at 12 weeks
Change between baseline and at 12 weeks
Change from baseline mindfulness score at 24 weeks
Tidsram: Change between baseline and at 24 weeks
Change between baseline and at 24 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Karis Cheng, National University of Singapore

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

6 december 2016

Primärt slutförande (Faktisk)

14 mars 2020

Avslutad studie (Faktisk)

14 mars 2020

Studieregistreringsdatum

Först inskickad

10 oktober 2016

Först inskickad som uppfyllde QC-kriterierna

11 oktober 2016

Första postat (Uppskatta)

13 oktober 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

23 september 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 september 2020

Senast verifierad

1 september 2020

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • R-545-000-073-592

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

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