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

29 maggio 2022 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

120

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Agnes Lai, PhD
  • Numero di telefono: 852-3917-6328
  • Email: agneslai@hku.hk

Backup dei contatti dello studio

  • Nome: George Cheung, MPhil
  • Numero di telefono: 852-3917-6563
  • Email: ocgeorge@hku.hk

Luoghi di studio

  • Hong Kong
      • Hong Kong, Hong Kong
        • Reclutamento
        • Queen Mary Hospital
        • Contatto:
        • Contatto:
          • David Lam, PhD
          • Numero di telefono: 852-2255-4455
          • Email: slnga@hku.hk
        • Investigatore principale:
          • Agnes YK Lai, PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 100 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Comparatore placebo: General Hygiene Information (GHI)
Patients will receive an individual session, instant messages and telephone coaching regarding general hygiene information.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in fatigue level
Lasso di tempo: 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

Misure di risultato secondarie

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

The University of Hong Kong

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 maggio 2022

Completamento primario (Anticipato)

30 giugno 2023

Completamento dello studio (Anticipato)

30 settembre 2024

Date di iscrizione allo studio

Primo inviato

11 aprile 2022

Primo inviato che soddisfa i criteri di controllo qualità

11 aprile 2022

Primo Inserito (Effettivo)

15 aprile 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 giugno 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 maggio 2022

Ultimo verificato

1 maggio 2022

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • UW21-148

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

No

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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