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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 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

172

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

21 Jahre bis 100 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: Usual care group
Usual care is meant the routine medical and health care services at the hospital.
Experimental: Experimental group
Five weekly sessions of online symptom management + mindfulness training programme + usual care
Sonstiges: 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.
Sonstiges: 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.
Aktiver Komparator: Comparison group 1
Five weekly sessions of online symptom management programme + usual care
Sonstiges: 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.
Aktiver Komparator: Comparison group 2
Five weekly sessions of online mindfulness training programme and usual care
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Change from baseline quality of life score at 8 weeks
Zeitfenster: Change between baseline and at 8 weeks
Change between baseline and at 8 weeks
Change from baseline quality of life score at 12 weeks
Zeitfenster: Change between baseline and at 12 weeks
Change between baseline and at 12 weeks
Change from baseline quality of life score at 24 weeks
Zeitfenster: Change between baseline and at 24 weeks
Change between baseline and at 24 weeks

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

National University of Singapore

Mitarbeiter

National University Hospital, Singapore
National Cancer Centre, Singapore

Ermittler

  • Hauptermittler: Karis Cheng, National University of Singapore

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

6. Dezember 2016

Primärer Abschluss (Tatsächlich)

14. März 2020

Studienabschluss (Tatsächlich)

14. März 2020

Studienanmeldedaten

Zuerst eingereicht

10. Oktober 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. Oktober 2016

Zuerst gepostet (Schätzen)

13. Oktober 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

23. September 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

22. September 2020

Zuletzt verifiziert

1. September 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • R-545-000-073-592

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

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