A Mobile SMART Exercise Support Program to Improve Fatigue in Lung Cancer Patients - A RCT
sunnuntai 29. toukokuuta 2022 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Rekrytointi
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Odotettu)
120
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: Agnes Lai, PhD
- Puhelinnumero: 852-3917-6328
- Sähköposti: agneslai@hku.hk
Tutki yhteystietojen varmuuskopiointi
- Nimi: George Cheung, MPhil
- Puhelinnumero: 852-3917-6563
- Sähköposti: ocgeorge@hku.hk
Opiskelupaikat
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Hong Kong, Hong Kong
- Rekrytointi
- Queen Mary Hospital
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Ottaa yhteyttä:
- Agnes Lai, PhD
- Puhelinnumero: 852-3917-6283
- Sähköposti: agneslai@hku.hk
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Ottaa yhteyttä:
- David Lam, PhD
- Puhelinnumero: 852-2255-4455
- Sähköposti: slnga@hku.hk
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Päätutkija:
- Agnes YK Lai, PhD
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta - 100 vuotta (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Tukevaa hoitoa
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 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.
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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.
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Placebo Comparator: General Hygiene Information (GHI)
Patients will receive an individual session, instant messages and telephone coaching regarding general hygiene information.
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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.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Change in fatigue level
Aikaikkuna: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Change in fatigue level
Aikaikkuna: Baseline and 6 months
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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.
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Baseline and 6 months
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Change in anxiety symptoms
Aikaikkuna: Baseline, 6 weeks, 6 months
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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.
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Baseline, 6 weeks, 6 months
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Change in depression symptoms
Aikaikkuna: Baseline, 6 weeks, 6 months
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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.
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Baseline, 6 weeks, 6 months
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Change in physical activity level
Aikaikkuna: Baseline, 6 weeks, 6 months
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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.
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Baseline, 6 weeks, 6 months
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Change in sleep quality
Aikaikkuna: Baseline, 6 weeks, 6 months
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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.
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Baseline, 6 weeks, 6 months
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Change in health-related quality of life
Aikaikkuna: Baseline, 6 weeks, 6 months
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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.
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Baseline, 6 weeks, 6 months
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Change in happiness level
Aikaikkuna: Baseline, 6 weeks, 6 months
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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.
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Baseline, 6 weeks, 6 months
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Change in cancer-related symptoms
Aikaikkuna: Baseline, 6 weeks and 6 months
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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.
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Baseline, 6 weeks and 6 months
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Change in acceptance of illness
Aikaikkuna: Baseline, 6 weeks and 6 months
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Measured by a 5-item subscale of Peace, Equanimity, and Acceptance in the Cancer Experience questionnaire
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Baseline, 6 weeks and 6 months
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Change in exercise self-efficacy
Aikaikkuna: Baseline, 6 weeks and 6 months
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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.
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Baseline, 6 weeks and 6 months
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Change in social and family support
Aikaikkuna: Baseline, 6 weeks and 6 months
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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.
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Baseline, 6 weeks and 6 months
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Change in grip strength
Aikaikkuna: Baseline, 6 weeks and 6 months
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Measured by a dynamometer
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Baseline, 6 weeks and 6 months
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Change in lower limb strength
Aikaikkuna: Baseline, 6 weeks, and 6 months
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Measured by 30-second chair stand test.
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Baseline, 6 weeks, and 6 months
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Change in balance
Aikaikkuna: Baseline, 6 weeks and 6 months
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Measured by single-leg-stance test
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Baseline, 6 weeks and 6 months
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Change in flexibility
Aikaikkuna: Baseline, 6 weeks, and 6 months
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Measured by chair sit and reach test
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Baseline, 6 weeks, and 6 months
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Change in objective physical activity levels, including duration, frequency and intensity
Aikaikkuna: Baseline, 6 weeks, and 6 months
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Measured by a waist-worn accelerometer
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Baseline, 6 weeks, and 6 months
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Change in sleep and wake intervals
Aikaikkuna: Baseline, 6 weeks , and 6 months
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Measured by watch-like activity monitor
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Baseline, 6 weeks , and 6 months
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Change in exercise capacity
Aikaikkuna: Baseline, 6 weeks and 6 months
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Measured by a 6-min walk test
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Baseline, 6 weeks and 6 months
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Päätutkija: Agnes YK Lai, PhD, School of Nursing, The University of Hong Kong
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Yleiset julkaisut
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- Bonomi AG, Westerterp KR. Advances in physical activity monitoring and lifestyle interventions in obesity: a review. Int J Obes (Lond). 2012 Feb;36(2):167-77. doi: 10.1038/ijo.2011.99. Epub 2011 May 17. Review.
- Kushida CA, Chang A, Gadkary C, Guilleminault C, Carrillo O, Dement WC. Comparison of actigraphic, polysomnographic, and subjective assessment of sleep parameters in sleep-disordered patients. Sleep Med. 2001 Sep;2(5):389-96.
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