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A Mobile SMART Exercise Support Program to Improve Fatigue in Lung Cancer Patients - A RCT

29. Mai 2022 aktualisiert von: Dr. Agnes Yuen-Kwan Lai, The University of Hong Kong

A Brief Mobile SMART Exercise Support Program to Improve Fatigue in Patients With Advanced Lung Cancer - A Pragmatic Randomized Controlled Trial With Outcome and Process Evaluation

Lung cancer (LC) is a common cancer in the world. Among all symptoms, Fatigue is considered as the most distressing medical condition of LC. Prior studies revealed that physical activity effectively relieve fatigue and related problems. The current study attempt to explore the effectiveness of SMART Exercise Support Program (SES) with the use of mobile instant messaging application, on reducing symptoms such as fatigue, and improving physical activity level, physical fitness performance, sleep quality and habits, and quality of life in advanced lung cancer (ALC) patients.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Lung cancer (LC) is the most and second most common cancer globally and locally, respectively. Nearly half of LC patients are diagnosed in the advanced stage. Fatigue is perceived to be the most distressing symptom. Physical activity has been proposed as an alternative treatment to relieve fatigue and related problems.

Mobile instant messaging applications (e.g. WhatsApp/WeChat) are popular and inexpensive for interactive messaging. A systematic review showed a majority of messaging interventions were effective in diabetes self-management, weight loss, physical activity (PA), smoking cessation, and medication adherence.

The proposed randomized controlled trial (RCT) aims to examine the effectiveness of SES on relieving fatigue, pain, dyspnea, happiness, anxiety and depression symptoms, physical activity level, physical fitness performance, sleep quality and habits, and quality of life in ALC patients (SES group), compared to the General Hygiene Information (GHI, control) group.

Questionnaires and simple fitness tests will be used at baseline, 6-week, and 24-week assessments. Qualitative feedback will be obtained at the completion of the trial.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

120

Phase

  • Unzutreffend

Kontakte und Standorte

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

Studienkontakt

  • Name: Agnes Lai, PhD
  • Telefonnummer: 852-3917-6328
  • E-Mail: agneslai@hku.hk

Studieren Sie die Kontaktsicherung

  • Name: George Cheung, MPhil
  • Telefonnummer: 852-3917-6563
  • E-Mail: ocgeorge@hku.hk

Studienorte

  • Hongkong
      • Hong Kong, Hongkong
        • Rekrutierung
        • Queen Mary Hospital
        • Kontakt:
        • Kontakt:
          • David Lam, PhD
          • Telefonnummer: 852-2255-4455
          • E-Mail: slnga@hku.hk
        • Hauptermittler:
          • Agnes YK Lai, PhD

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

18 Jahre bis 100 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Aged 18 years and above;
  • Diagnosis of Stage III or IV non-small cell lung cancer;
  • Edmonton Symptom Assessment System Scale fatigue symptom score ≥4 out of 10
  • Self-reported engagement of <150 minutes of moderate intensity PA each week,
  • Ambulatory and capable of all self-care activities (European Co-operative Oncology Group (ECOG) Performance Status of ≤2)
  • Either undergoing or finished oncology therapy, biological agents and/or support care;
  • Mentally, cognitively and physically fit to join the trial as determined by the doctor in-charge and responsible clinical investigators;
  • Able to speak and read Chinese;
  • Willing to complete the patient-reported outcome questionnaire;
  • Completion of the Physical Activity Readiness Questionnaire; and
  • Possession of a smartphone with instant messaging functions such as WhatsApp or WeChat.

Exclusion Criteria:

  • Those preparing for lung operation;
  • Skeletal fragility;
  • Serious active infection;
  • Inability to walk;
  • Previously untreated symptomatic brain metastases;
  • Severe respiratory insufficiency;
  • Uncontrolled pain; or
  • Diagnosed psychiatric illness with or without medication such as major depressive disorder.

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: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Brief mobile SMART Exercise Support Program
Patients will receive a brief SMART Exercise individual session with instant messages and telephone coaching for exercise habit formation and maintenance.
Verhalten: Brief mobile SMART Exercise Support Program
Patients will receive 1) a brief SMART Exercise individual face-to-face session; 2) a theory-based instant messaging (WhatsApp/WeChat) and telephone-delivered health coaching on a 2-stage tapering schedule. Stage 1 (week 1 to 6): daily messages and two biweekly phone calls for exercise habit formation. Stage 2 (week 7 to 12): messages twice a week and monthly phone calls for exercise habit maintenance.
Placebo-Komparator: General Hygiene Information (GHI)
Patients will receive an individual session, instant messages and telephone coaching regarding general hygiene information.
Verhalten: Brief mobile SMART Exercise Support Program
Patients will receive 1) a brief SMART Exercise individual face-to-face session; 2) a theory-based instant messaging (WhatsApp/WeChat) and telephone-delivered health coaching on a 2-stage tapering schedule. Stage 1 (week 1 to 6): daily messages and two biweekly phone calls for exercise habit formation. Stage 2 (week 7 to 12): messages twice a week and monthly phone calls for exercise habit maintenance.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in fatigue level
Zeitfenster: Baseline and 6 weeks
Measured by a 13-item Functional Assessment of Cancer Therapy - Fatigue subscale. The level of fatigue is measured on a five-point Likert scale. The scale range is 0 to 52, with 0 being the worst possible score and 52 being the best possible score indicating no fatigue.
Baseline and 6 weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in fatigue level
Zeitfenster: Baseline and 6 months
Measured by a 13-item Functional Assessment of Cancer Therapy - Fatigue subscale. The level of fatigue is measured on a five-point Likert scale. The scale range is 0 to 52, with 0 being the worst possible score and 52 being the best possible score indicating no fatigue.
Baseline and 6 months
Change in anxiety symptoms
Zeitfenster: Baseline, 6 weeks, 6 months
Measured by a 7-item Generalised Anxiety Disorder Assessment. Each item asks the individual to rate the severity of his or her symptoms with a 4-point Likert scale. The total score ranges from 0 to 21. The higher scores the greater severity of anxiety symptoms.
Baseline, 6 weeks, 6 months
Change in depression symptoms
Zeitfenster: Baseline, 6 weeks, 6 months
Measured by a 9-item Patient Health Questionaire. Each item asks the individual to rate the severity of his or her symptoms with a 4-point Likert scale. The total score ranges from 0 to 27. The higher scores the greater severity of depression symptoms.
Baseline, 6 weeks, 6 months
Change in physical activity level
Zeitfenster: Baseline, 6 weeks, 6 months
Measured the days and duration of physical activity level and sitting time in the past 7 days by the International Physical Activity Questionnaire (short version) with 4 questions.
Baseline, 6 weeks, 6 months
Change in sleep quality
Zeitfenster: Baseline, 6 weeks, 6 months
Measured by 7-item Severe Insomnia Index. Each item asks the individual to rate the severity of his or her symptoms with a 4-point Likert scale. The total score ranges from 0 to 28. The higher scores the greater severity of insomnia.
Baseline, 6 weeks, 6 months
Change in health-related quality of life
Zeitfenster: Baseline, 6 weeks, 6 months
Measured by a 30-item European Organization for Research and Treatment of Cancer and Lung Module. It contains five functioning scales (physical, social, role, cognitive, and emotional functioning), and eight symptom scales (fatigue, nausea/vomiting, pain, dyspnea, sleep disturbances, appetite loss, constipation, and diarrhoea), and financial impact, and overall quality of life. All scale scores are linearly converted to a range from 0 to 100. Higher scores indicate better functioning for the functioning scales and global QOL; for the symptom scales, higher scores indicate higher symptom burden.
Baseline, 6 weeks, 6 months
Change in happiness level
Zeitfenster: Baseline, 6 weeks, 6 months
Measured by 4-item Subjective Happiness Scale with a 7-point Likert scale. Total scores range from 4 to 28. The highest scores reflect greater happiness.
Baseline, 6 weeks, 6 months
Change in cancer-related symptoms
Zeitfenster: Baseline, 6 weeks and 6 months
Measured by 3 items of the Edmonton Symptom Assessment System Scale. The severity at the time of assessment of each symptom is rated from 0 to 10 on a numerical scale, 0 meaning that the symptom is absent and 10 that it is of the worst possible severity.
Baseline, 6 weeks and 6 months
Change in acceptance of illness
Zeitfenster: Baseline, 6 weeks and 6 months
Measured by a 5-item subscale of Peace, Equanimity, and Acceptance in the Cancer Experience questionnaire
Baseline, 6 weeks and 6 months
Change in exercise self-efficacy
Zeitfenster: Baseline, 6 weeks and 6 months
Measured by a question with a scale from 0 to 10; "0" indicates no exercise self-efficacy, while "10" indicates highest level of exercise self-efficacy.
Baseline, 6 weeks and 6 months
Change in social and family support
Zeitfenster: Baseline, 6 weeks and 6 months
Measured by 8-item family and friend subscales of multidimensional Scale of Perceived Social Support with a 7-point Likert scale. Each scale ranges from 4 to 28. A higher score equates with higher social support.
Baseline, 6 weeks and 6 months
Change in grip strength
Zeitfenster: Baseline, 6 weeks and 6 months
Measured by a dynamometer
Baseline, 6 weeks and 6 months
Change in lower limb strength
Zeitfenster: Baseline, 6 weeks, and 6 months
Measured by 30-second chair stand test.
Baseline, 6 weeks, and 6 months
Change in balance
Zeitfenster: Baseline, 6 weeks and 6 months
Measured by single-leg-stance test
Baseline, 6 weeks and 6 months
Change in flexibility
Zeitfenster: Baseline, 6 weeks, and 6 months
Measured by chair sit and reach test
Baseline, 6 weeks, and 6 months
Change in objective physical activity levels, including duration, frequency and intensity
Zeitfenster: Baseline, 6 weeks, and 6 months
Measured by a waist-worn accelerometer
Baseline, 6 weeks, and 6 months
Change in sleep and wake intervals
Zeitfenster: Baseline, 6 weeks , and 6 months
Measured by watch-like activity monitor
Baseline, 6 weeks , and 6 months
Change in exercise capacity
Zeitfenster: Baseline, 6 weeks and 6 months
Measured by a 6-min walk test
Baseline, 6 weeks and 6 months

Mitarbeiter und Ermittler

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

Sponsor

The University of Hong Kong

Ermittler

  • Hauptermittler: Agnes YK Lai, PhD, School of Nursing, The University of Hong Kong

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)

1. Mai 2022

Primärer Abschluss (Voraussichtlich)

30. Juni 2023

Studienabschluss (Voraussichtlich)

30. September 2024

Studienanmeldedaten

Zuerst eingereicht

11. April 2022

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. April 2022

Zuerst gepostet (Tatsächlich)

15. April 2022

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. Juni 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. Mai 2022

Zuletzt verifiziert

1. Mai 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • UW21-148

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

Beschreibung des IPD-Plans

For those who want the patient data, please contact PI directly by written email.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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