Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Selvledelsesstøtte til lungekræftpatienter med kakeksi

11. maj 2026 opdateret af: Chang Li Chun, Changhua Christian Hospital

Effekten af ​​selvledelsesstøtte på ernæringsstatus hos lungekræftpatienter med kræftkakeksisyndrom: et randomiseret klinisk spor

Målet med dette randomiserede kliniske forsøg er at teste effektiviteten af ​​støttebaseret træning, der kombinerer ernæringsintervention hos lungekræftpatienter med cancerkakeksi anoreksi syndrom. Hovedspørgsmålet det sigter mod at besvare er:

• Ville træning kombineret med ernæringsintervention forbedre lungekræftpatienters ernæringsstatus? Deltagerne vil lave en skræddersyet træningsplan og spise nok proteinmad efter støtte baseret på selvledelse.

Og der er en sammenligningsgruppe: Forskere vil sammenligne sammenligningsgruppen for at se ernæringsstatus, der modtager rutinemæssig sundhedsundervisning.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

104

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Taiwan
    • Changhua
      • Changhua, Changhua, Taiwan, 51052
        • Changhua Christian Hospital
    • Taipei
      • Taipei, Taipei, Taiwan, 11219
        • Taipei Veterans General Hospital

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

20 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  1. Diagnosticeret lungekræft (ICD-10 kode: C33-C34)
  2. Kropsvægttab: kropsvægttab 2% før rekruttering 2 måneder eller kropsvægttab 5% før rekruttering 6 måneder.
  3. Bedømt læge kan lave hjemmetræning uden supervisor.
  4. Har smartphone og accepterer at bruge træningsassocieret applikation.
  5. Accepter at bære Xioami smart band så længe som muligt.
  6. Bevidst klar og kommunikation.
  7. Eastern Cooperative Oncology Group (ECOG) 0-1.

Ekskluderingskriterier:

  1. Deltagere med hjerte-kar-sygdomme kan ikke træne uden supervisor.
  2. Diabetes mellitus med dårlig blodsukkerkontrol.
  3. Kronisk obstruktiv lungesygdom med dyspnø ved anstrengelse.
  4. Blodplader < 50000 mm3 på grund af sygdom eller behandling.
  5. Hæmoglobin <10mg/dl.
  6. For nylig snuble, svær smerte, kognitiv og adfærdsændring.
  7. Mistænkt eller diagnosticeret hjernemetastase.
  8. Mistænkt eller diagnosticeret knoglemetastase.
  9. Modtag nasogastrisk sondeernæring eller parenteral ernæring.
  10. Lægen vurderet, kan ikke træne hjemme.

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: Combined Exercise and Nutrition Self-management Support Program
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.
Adfærdsmæssigt: Self-management support nutrition and exercise intervention
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.
Ingen indgriben: Routine health education group
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline Mini Nutrition Assessment(MNA)
Tidsramme: baseline, Week 8, Week 12.
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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility of the self-management support program
Tidsramme: Week 12
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)
Tidsramme: Baseline, Week 8, Week 12
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
Tidsramme: Baseline, Week 8, Week 12
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
Tidsramme: Baseline, Week 8, Week 12
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)
Tidsramme: Baseline, Week 8, Week 12
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)
Tidsramme: Baseline, Week 8, Week 12
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)
Tidsramme: Baseline, Week 8, Week 12
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)
Tidsramme: Baseline, Week 12
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)
Tidsramme: Baseline, Week 12
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)
Tidsramme: Baseline, Week 8, Week12
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
Tidsramme: Baseline to Week 8, and Week 8 to Week 12
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

Samarbejdspartnere og efterforskere

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

Sponsor

Changhua Christian Hospital

Samarbejdspartnere

National Taipei University of Nursing and Health Sciences
Taipei Veterans General Hospital, Taiwan

Efterforskere

  • Ledende efterforsker: Li Chun Chang, Master, Changhua Christian Hospital
  • Studieleder: Tsae Jyy Wang, PhD, National Taipei University of Nursing and Health Sciences

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)

20. januar 2023

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

23. januar 2023

Først indsendt, der opfyldte QC-kriterier

15. februar 2023

Først opslået (Faktiske)

16. februar 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 220582

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

På grund af etiske begrænsninger og betingelserne i det informerede samtykkeskema vil individuelle deltagerdata ikke blive delt med tredjeparter.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Lungeneoplasma ondartet

Kliniske forsøg med Self-management support nutrition and exercise intervention

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Cote d'Ivoire

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner