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

NCT05331391 | Unknown DMC

• 1 other identifier: UW21-148
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Change in fatigue level

  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

Secondary Outcomes (18)

• Change in fatigue level

  Baseline and 6 months

• Change in anxiety symptoms

  Baseline, 6 weeks, 6 months

• Change in depression symptoms

  Baseline, 6 weeks, 6 months

• Change in physical activity level

  Baseline, 6 weeks, 6 months

• Change in sleep quality

  Baseline, 6 weeks, 6 months

Study Arms (2)

Brief mobile SMART Exercise Support Program

EXPERIMENTAL

Patients will receive a brief SMART Exercise individual session with instant messages and telephone coaching for exercise habit formation and maintenance.

Behavioral: Brief mobile SMART Exercise Support Program

General Hygiene Information (GHI)

PLACEBO COMPARATOR

Patients will receive an individual session, instant messages and telephone coaching regarding general hygiene information.

Behavioral: Brief mobile SMART Exercise Support Program

Interventions

Brief mobile SMART Exercise Support Program BEHAVIORAL

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.

Brief mobile SMART Exercise Support Program; General Hygiene Information (GHI)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (12)

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MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Agnes YK Lai, PhD

  School of Nursing, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnes Lai, PhD

CONTACT

852-3917-6328; agneslai@hku.hk

George Cheung, MPhil

CONTACT

852-3917-6563; ocgeorge@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor did not aware of which groups the patients belongs to.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: The Experimental group will receive a brief SMART Exercise individual face-to-face session, and a package of information on lifestyle-integrated exercise and physical activity delivered through instant messaging and telephone calls. The Control group will receive a face-to-face individual session on general hygiene (GH) information, and a package of information on GH delivered through instant messaging and telephone calls.

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 15, 2022
• Study Start: May 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: September 30, 2024
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)