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| Name | Class |
|---|---|
| Taipei Veterans General Hospital, Taiwan | OTHER_GOV |
| National Taipei University of Nursing and Health Sciences | OTHER |
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The goal of this randomized clinical trial is to evaluate the efficacy of a self-management support program combining exercise and nutrition intervention for lung cancer patients with cancer cachexia anorexia syndrome.
This study is conducted in two stages. In the first stage (Pilot Phase), the researchers aim to assess the feasibility of the intervention and its potential impact on nutritional status in 20 participants. Based on these preliminary results, the intervention protocol or supervision model may be refined for the subsequent full-scale trial.
The main questions it aims to answer are:
Is the combined exercise and nutrition self-management support program feasible for lung cancer patients with cachexia?
Can this integrated intervention improve the nutritional status of these patients compared to routine care?
Participants in the intervention group will receive self-management support-based education to develop personalized exercise plans and ensure adequate protein intake. The researchers will compare this group to a control group receiving routine health education to evaluate differences in nutritional outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined Exercise and Nutrition Self-management Support Program | Experimental | Participants receive a 12-week multimodal intervention. This includes personalized exercise prescriptions (aerobic, resistance, and flexibility training) guided by wearable technology and structured nutritional counseling focused on adequate protein intake (e.g., 1.2 g/kg/day). All activities are supported by a self-management behavioral framework to enhance adherence. In addition, both arms receive baseline cancer care from hospital case managers to ensure ethical standards of care are met. |
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| Routine health education group | No Intervention | Participants will receive standard of care provided by cancer case managers, including education on medication adherence, symptom/side-effect management, and nutritional supplement trials as needed. To maintain study blinding, participants in this group will also wear Xiaomi smart bands and undergo the same assessment schedule (Baseline, Week 8, Week 12) without the additional self-management support program. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-management support nutrition and exercise intervention | Behavioral | A structured 12-week multimodal support program. (1) Exercise: Personalized home-based aerobic, resistance, and flexibility training (at least 3 times/week, 30 min/session) monitored via Xiaomi smart bands. (2) Nutrition: Goal-oriented counseling focused on achieving a high-protein intake (e.g., 1.2-1.5 g/kg/day). (3) Self-management: Continuous support using a self-monitoring manual, wearable device feedback, and a dedicated Line@ social media platform for real-time interaction with researchers, providing counseling and symptom management support to enhance patient adherence. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Mini Nutrition Assessment(MNA) | The MNA consists of 18 self-reported questions covering ingestion, weight loss, mobility, acute illness/stress, neuropsychological problems, BMI, living arrangements, polypharmacy, skin ulcers, meal frequency, food/fluid intake, and mode of feeding. The maximal score is 30. A score >23.5 means well-nourished, 17-23.5 means risk of malnutrition, and <17 means malnutrition. Higher scores indicate better nutritional status. | baseline, Week 8, Week 12. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the self-management support program | Assessed by recruitment rate (percentage of eligible patients enrolled), retention rate (percentage of participants completing the 12-week study), and adherence to the wearable device and Line@ interaction. | Week 12 |
| Change from balseline in Body Mass Index(BMI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li Chun Chang, Master | Changhua Christian Hospital | Principal Investigator |
| Tsae Jyy Wang, PhD | National Taipei University of Nursing and Health Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhua Christian Hospital | Changhua | Changhua | 51052 | Taiwan | ||
| Taipei Veterans General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21296615 | Background | Fearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4. | |
| 28138933 |
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Due to ethical restrictions and the terms of the informed consent form, individual participant data will not be shared with third parties.
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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This is a two-stage, randomized supportive care trial. Stage 1 (Pilot Phase, n=20) focuses on evaluating the feasibility of the self-management support program (exercise and nutrition) in lung cancer patients with cachexia. Based on Stage 1 results, the intervention protocol may be refined to optimize adherence. Stage 2 (Main Trial) will follow to evaluate clinical efficacy. To maintain participant masking, all subjects undergo identical assessment procedures and wear smart bands, with health education delivered as a personalized service based on individual test results.
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To maintain blinding, all participants are provided with wearable devices and undergo identical assessment protocols. They are informed that personalized health education will be delivered at varying intervals based on clinical results, which prevents them from distinguishing between the experimental and control intervention models．
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BMI is calculated as weight in kilograms divided by the square of height in meters (kg/m^2), measured using Bioelectrical Impedance Analysis (BIA) with the InBodyDial H20 device. Data are recorded and rounded to one decimal place. |
| Baseline, Week 8, Week 12 |
| Change from baseline in skeletal muscle mass | Measured using Bioelectrical Impedance Analysis (BIA) with the InBodyDial H20 device. Data are recorded in percentage (%) and rounded to one decimal place. | Baseline, Week 8, Week 12 |
| Change from basleline body fat mass at 12weeks | The body fat mass will be detected by InBodyDial H20. Data record with percentage and after the first decimal place. | Baseline, Week 8, Week 12 |
| Change from Baseline in Upper Body Muscle Endurance (30-Second Arm Curl Test) | Used to evaluate upper body muscle endurance. The participant sits on a chair with back supported and performs as many bicep curls as possible in 30 seconds using a dumbbell (5 lbs for females; 8 lbs for males). The total number of completed curls is recorded. Higher scores (more repetitions) indicate better upper body muscle endurance. | Baseline, Week 8, Week 12 |
| Change from Baseline in Lower Body Muscle Strength (30-Second Chair-Stand Test) | Used to evaluate lower body muscle strength. The participant sits in the middle of a chair with back straight and feet flat on the floor, then stands up completely and sits down repeatedly for 30 seconds. The total number of completed stands is recorded. Higher scores (more repetitions) indicate better lower body muscle strength. | Baseline, Week 8, Week 12 |
| Change from Baseline in cardiopulmonary function (6-Minute Walk Test) | Examine cardiopulmonary function in this study. Let the participant sit and rest 10 minutes before test. Check vital signs and oxygen situation for patient safety. Position the participant at the starting line, and walking back and forth along the mark on the floor. When the participant starts to walk, starts the times. Don't walk nor talk with him/ her, and count the laps attentively. Participant can walk longer distance means better cardiopulmonary function. | Baseline, Week 8, Week 12 |
| Change from basline in quality of life (FACT-L) | The Functional Assessment of Cancer Therapy-Lung (FACT-L) is used to determine quality of life in lung cancer patients. It contains 5 dimensions: physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and lung cancer subscale (9 items). Items are rated on a 5-point Likert scale with total scores ranging from 0 to 144. Higher scores indicate better quality of life." | Baseline, Week 12 |
| Change from Baseline in Cancer anorexia-cachexia syndrome nutrition knowledge (CACSNKQ) | The CACSNKQ is designed to assess patients' knowledge regarding cancer anorexia-cachexia syndrome. All items are multiple-choice with one correct answer. The total score ranges from 0 to 21, with higher scores indicating better nutritional knowledge and self-management ability against the syndrome. | Baseline, Week 12 |
| Change from baseline in dietary intake (24 hours dietary recall) | To assess participants' nutritional intake. A 24-hour dietary recall interview is conducted to record all food and beverage consumption (including dish names, portion sizes, and preparation methods). Data are converted into total calories (kcal) and macronutrients (protein, fat, and carbohydrates in grams) by a registered dietitian using nutritional analysis software. | Baseline, Week 8, Week12 |
| Change from Baseline in amount of exercise | Measured using the Xiaomi Smart Band and a self-management support manual. The Xiaomi Smart Band is worn daily by participants to record continuous physical activity data, including daily step count, exercise duration, walking distance, and heart rate. Additionally, participants use the self-management support manual to log the specific duration and frequency of resistance training and stretching exercises. | Baseline to Week 8, and Week 8 to Week 12 |
| Taipei |
| Taipei |
| 11219 |
| Taiwan |
| Background |
| Anderson LJ, Albrecht ED, Garcia JM. Update on Management of Cancer-Related Cachexia. Curr Oncol Rep. 2017 Jan;19(1):3. doi: 10.1007/s11912-017-0562-0. |
| 31827357 | Background | Ozaki H, Nakagata T, Yoshihara T, Kitada T, Natsume T, Ishihara Y, Deng P, Kobayashi H, Machida S, Naito H. Effects of Progressive Walking and Stair-Climbing Training Program on Muscle Size and Strength of the Lower Body in Untrained Older Adults. J Sports Sci Med. 2019 Nov 19;18(4):722-728. eCollection 2019 Dec. |
| 33946039 | Result | Muscaritoli M, Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Oldervoll L, Ravasco P, Solheim TS, Strasser F, de van der Schueren M, Preiser JC, Bischoff SC. ESPEN practical guideline: Clinical Nutrition in cancer. Clin Nutr. 2021 May;40(5):2898-2913. doi: 10.1016/j.clnu.2021.02.005. Epub 2021 Mar 15. |
| 31626055 | Result | Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS, Zucker DS, Matthews CE, Ligibel JA, Gerber LH, Morris GS, Patel AV, Hue TF, Perna FM, Schmitz KH. Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable. Med Sci Sports Exerc. 2019 Nov;51(11):2375-2390. doi: 10.1249/MSS.0000000000002116. |
| 30741408 | Result | Peddle-McIntyre CJ, Singh F, Thomas R, Newton RU, Galvao DA, Cavalheri V. Exercise training for advanced lung cancer. Cochrane Database Syst Rev. 2019 Feb 11;2(2):CD012685. doi: 10.1002/14651858.CD012685.pub2. |
| 27637832 | Result | Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Fearon K, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Muscaritoli M, Oldervoll L, Ravasco P, Solheim T, Strasser F, de van der Schueren M, Preiser JC. ESPEN guidelines on nutrition in cancer patients. Clin Nutr. 2017 Feb;36(1):11-48. doi: 10.1016/j.clnu.2016.07.015. Epub 2016 Aug 6. |
| 32119883 | Result | Schreiber M, Bucher T, Collins CE, Dohle S. The Multiple Food Test: Development and validation of a new tool to measure food choice and applied nutrition knowledge. Appetite. 2020 Jul 1;150:104647. doi: 10.1016/j.appet.2020.104647. Epub 2020 Feb 29. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001519 | Behavior |