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

29. maj 2022 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

120

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

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

Undersøgelse Kontakt Backup

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

Studiesteder

  • Hong Kong
      • Hong Kong, Hong Kong
        • Rekruttering
        • Queen Mary Hospital
        • Kontakt:
        • Kontakt:
          • David Lam, PhD
          • Telefonnummer: 852-2255-4455
          • E-mail: slnga@hku.hk
        • Ledende efterforsker:
          • Agnes YK Lai, PhD

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

18 år til 100 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in fatigue level
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in fatigue level
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline, 6 weeks and 6 months
Measured by a dynamometer
Baseline, 6 weeks and 6 months
Change in lower limb strength
Tidsramme: Baseline, 6 weeks, and 6 months
Measured by 30-second chair stand test.
Baseline, 6 weeks, and 6 months
Change in balance
Tidsramme: Baseline, 6 weeks and 6 months
Measured by single-leg-stance test
Baseline, 6 weeks and 6 months
Change in flexibility
Tidsramme: 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
Tidsramme: Baseline, 6 weeks, and 6 months
Measured by a waist-worn accelerometer
Baseline, 6 weeks, and 6 months
Change in sleep and wake intervals
Tidsramme: Baseline, 6 weeks , and 6 months
Measured by watch-like activity monitor
Baseline, 6 weeks , and 6 months
Change in exercise capacity
Tidsramme: Baseline, 6 weeks and 6 months
Measured by a 6-min walk test
Baseline, 6 weeks and 6 months

Samarbejdspartnere og efterforskere

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

Sponsor

The University of Hong Kong

Efterforskere

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

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)

1. maj 2022

Primær færdiggørelse (Forventet)

30. juni 2023

Studieafslutning (Forventet)

30. september 2024

Datoer for studieregistrering

Først indsendt

11. april 2022

Først indsendt, der opfyldte QC-kriterier

11. april 2022

Først opslået (Faktiske)

15. april 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juni 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. maj 2022

Sidst verificeret

1. maj 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • UW21-148

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