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Effectiveness of Exercise Program in Improving Quality of Life in Patients With Gastric Cancer Undergoing Gastrectomy

19 dicembre 2021 aggiornato da: Taipei Veterans General Hospital, Taiwan

The Effect of Home Based Walking Exercise on Fatigue, Anxiety, Depression, Sleep Quality, Circadian Rhythms and Quality of Life in Patients With Gastric Cancer Undergoing Gastrectomy

This study will investigate the effectiveness of a rehabilitation program in improving fatigue, negative emotions , sleep quality, circadian rhythms and quality of life in patients with gastric cancer undergoing gastrectomy in Taiwan.

Hypothesis:

The fatigue in exercise group is significant improving than usual-care group at 1st, 2nd, 3rd, 6th, 12th, 24th and 36th month.
The negative emotions in exercise group is significant improving than usual-care group at 1st, 2nd, 3rd, 6th, 12th, 24th and 36th month.
The sleep quality in exercise group is significant improving than usual-care group at 1st, 2nd, 3rd, 6th, 12th, 24th and 36th month.
The quality of life in exercise group is significant improving than usual-care group at 1st, 2nd,3rd, 6th, 12th, 24th and 36th month.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Tumore gastrico

Intervento / Trattamento

Comportamentale: exercise group

Descrizione dettagliata

Tipo di studio

Interventistico

Iscrizione (Anticipato)

160

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: HUI-MEI CHEN, PhD
Numero di telefono: 886-939654302
Email: alice@ntunhs.edu.tw

Backup dei contatti dello studio

Nome: Pei-Shan Ho, BSN
Numero di telefono: 886-933937197
Email: psho@vghtpe.gov.tw

Luoghi di studio

Taiwan
- - Taipei county, Taiwan, 112
    - Reclutamento
    - Taipei Veterans General Hospital
    - Contatto:
      
      Taipei Veterans General Hospital
      
      Numero di telefono: +886-2-2875-7808

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 20 anni a 90 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

After undergoing surgery and clinically diagnosed as gastric cancer.
Adults over 20 years old.
Hemoglobin (above 10 g/dL).
Clear consciousness and could communicate in either Mandarin or Taiwanese, and were not cognitively impaired were included.
No lower limb disability and able to walk on their own.

Exclusion Criteria:

Suspected or confirmed bone metastasis.
Poorly controlled cardiovascular disease such as heart failure, arrhythmia, angina, myocardial infarction, chest pain during activities or rest in the past three months, and valvular heart disease using anticoagulants.
Poorly diabetes controlled, glycosylated hemoglobin (HbA1C)>9%, blood sugar higher than 250mg/dl or lower than 80mg/dl.
Those with poor blood pressure control, systolic blood pressure greater than 160mmHg or diastolic blood pressure than 100mmHg when quiet, and heart rate is greater than 100bpm when quiet.
Diagnosed as recurrent depression.
Regular exercise above moderate intensity, such as 150 minutes per week in the past three months.

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

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm	Intervento / Trattamento
Sperimentale: exercise group A 12-week regimen of home-based walking exercises, comprising walking at a moderate intensity for 40 min, three times a Week.	Comportamentale: exercise group exercise education: A 12-week regimen of homebased walking exercises, include moderate intensity for 40 min, three times a week. We explained the participants how to perform the exercises, according to an instruction manual for the exercise regimen. Participants were instructed that the exercises would be effective only if they reached 40%-60% of the heart rate reserve, as determined by the Karvonen method, or 13-14 on the RPE. Exercise education: Weekly telephone or mobile application "LINE" consultations concerning exercise.we discussed whether participants' exercise fulfilled the prescribed intensity, duration, frequency and whether the participants experienced any adverse effects.
Nessun intervento: usual-care group These participants follows the standard post-surgery follow-up consisting of counseling by dietitians, nurses and doctors.

Gruppo di partecipanti / Arm

Intervento / Trattamento

Sperimentale: exercise group

A 12-week regimen of home-based walking exercises, comprising walking at a moderate intensity for 40 min, three times a Week.

Comportamentale: exercise group

exercise education: A 12-week regimen of homebased walking exercises, include moderate intensity for 40 min, three times a week.

We explained the participants how to perform the exercises, according to an instruction manual for the exercise regimen. Participants were instructed that the exercises would be effective only if they reached 40%-60% of the heart rate reserve, as determined by the Karvonen method, or 13-14 on the RPE.

Exercise education:

Weekly telephone or mobile application "LINE" consultations concerning exercise.we discussed whether participants' exercise fulfilled the prescribed intensity, duration, frequency and whether the participants experienced any adverse effects.

Nessun intervento: usual-care group

These participants follows the standard post-surgery follow-up consisting of counseling by dietitians, nurses and doctors.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Quality of Life (EORTC QLQ-C30 ) Lasso di tempo: baseline (one week after recruited)	The EORTC QLQ-C30 :This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-C30 consists of three subscales with 30 questions. The EORTC QLQ-C30 have three subscales in the scale include functioning scales (15 questions), symptom scales (13 questions), and global health status (2 questions). The reliability and validity of Cronbach'α was 0.81-0.94. The functional scale and the global health status , the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.	baseline (one week after recruited)
Quality of Life (EORTC QLQ-C30 ) Lasso di tempo: 1st month after recruited	The EORTC QLQ-C30 :This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-C30 consists of three subscales with 30 questions. The EORTC QLQ-C30 have three subscales in the scale include functioning scales (15 questions), symptom scales (13 questions), and global health status (2 questions). The reliability and validity of Cronbach'α was 0.81-0.94. The functional scale and the global health status , the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.	1st month after recruited
Quality of Life (EORTC QLQ-C30) Lasso di tempo: 2nd month after recruited	The EORTC QLQ-C30 :This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-C30 consists of three subscales with 30 questions. The EORTC QLQ-C30 have three subscales in the scale include functioning scales (15 questions), symptom scales (13 questions), and global health status (2 questions). The reliability and validity of Cronbach'α was 0.81-0.94. The functional scale and the global health status , the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.	2nd month after recruited
Quality of Life (EORTC QLQ-C30) Lasso di tempo: 3rd month after recruited	The EORTC QLQ-C30 :This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-C30 consists of three subscales with 30 questions. The EORTC QLQ-C30 have three subscales in the scale include functioning scales (15 questions), symptom scales (13 questions), and global health status (2 questions). The reliability and validity of Cronbach'α was 0.81-0.94. The functional scale and the global health status , the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.	3rd month after recruited
Quality of Life (EORTC QLQ-C30) Lasso di tempo: 6th month after recruited	The EORTC QLQ-C30 :This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-C30 consists of three subscales with 30 questions. The EORTC QLQ-C30 have three subscales in the scale include functioning scales (15 questions), symptom scales (13 questions), and global health status (2 questions). The reliability and validity of Cronbach'α was 0.81-0.94. The functional scale and the global health status , the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.	6th month after recruited
Quality of Life (EORTC QLQ-C30) Lasso di tempo: 12th month after recruited	The EORTC QLQ-C30 :This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-C30 consists of three subscales with 30 questions. The EORTC QLQ-C30 have three subscales in the scale include functioning scales (15 questions), symptom scales (13 questions), and global health status (2 questions). The reliability and validity of Cronbach'α was 0.81-0.94. The functional scale and the global health status , the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.	12th month after recruited
Quality of Life (EORTC QLQ-C30) Lasso di tempo: 24th month after recruited	The EORTC QLQ-C30 :This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-C30 consists of three subscales with 30 questions. The EORTC QLQ-C30 have three subscales in the scale include functioning scales (15 questions), symptom scales (13 questions), and global health status (2 questions). The reliability and validity of Cronbach'α was 0.81-0.94. The functional scale and the global health status , the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.	24th month after recruited
Quality of Life (EORTC QLQ-C30) Lasso di tempo: 36th month after recruited	The EORTC QLQ-C30 :This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-C30 consists of three subscales with 30 questions. The EORTC QLQ-C30 have three subscales in the scale include functioning scales (15 questions), symptom scales (13 questions), and global health status (2 questions). The reliability and validity of Cronbach'α was 0.81-0.94. The functional scale and the global health status , the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.	36th month after recruited
Quality of Life (EORTC QLQ-STO22) Lasso di tempo: baseline (one week after recruited)	The EORTC QLQ-STO22:This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-STO22 consists of one subscale with 22 questions.The EORTC QLQ-STO22 scale include symptom scales (22 questions) The Cronbach'α was 0.70-0.94.The lower the score in the symptom scale, the better the quality of life.	baseline (one week after recruited)
Quality of Life (EORTC QLQ-STO22) Lasso di tempo: 1st month after recruited	The EORTC QLQ-STO22:This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-STO22 consists of one subscale with 22 questions.The EORTC QLQ-STO22 scale include symptom scales (22 questions) The Cronbach'α was 0.70-0.94.The lower the score in the symptom scale, the better the quality of life.	1st month after recruited
Quality of Life (EORTC QLQ-STO22) Lasso di tempo: 2nd month after recruited	The EORTC QLQ-STO22:This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-STO22 consists of one subscale with 22 questions.The EORTC QLQ-STO22 scale include symptom scales (22 questions) The Cronbach'α was 0.70-0.94.The lower the score in the symptom scale, the better the quality of life.	2nd month after recruited
Quality of Life (EORTC QLQ-STO22) Lasso di tempo: 3rd month after recruited	The EORTC QLQ-STO22:This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-STO22 consists of one subscale with 22 questions.The EORTC QLQ-STO22 scale include symptom scales (22 questions) The Cronbach'α was 0.70-0.94.The lower the score in the symptom scale, the better the quality of life.	3rd month after recruited
Quality of Life (EORTC QLQ-STO22) Lasso di tempo: 6th month after recruited	The EORTC QLQ-STO22:This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-STO22 consists of one subscale with 22 questions.The EORTC QLQ-STO22 scale include symptom scales (22 questions) The Cronbach'α was 0.70-0.94.The lower the score in the symptom scale, the better the quality of life.	6th month after recruited
Quality of Life (EORTC QLQ-STO22) Lasso di tempo: 12th month after recruited	The EORTC QLQ-STO22:This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-STO22 consists of one subscale with 22 questions.The EORTC QLQ-STO22 scale include symptom scales (22 questions) The Cronbach'α was 0.70-0.94.The lower the score in the symptom scale, the better the quality of life.	12th month after recruited
Quality of Life (EORTC QLQ-STO22) Lasso di tempo: 24th month after recruited	The EORTC QLQ-STO22:This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-STO22 consists of one subscale with 22 questions.The EORTC QLQ-STO22 scale include symptom scales (22 questions) The Cronbach'α was 0.70-0.94.The lower the score in the symptom scale, the better the quality of life.	24th month after recruited
Quality of Life (EORTC QLQ-STO22) Lasso di tempo: 36th month after recruited	The EORTC QLQ-STO22:This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-STO22 consists of one subscale with 22 questions.The EORTC QLQ-STO22 scale include symptom scales (22 questions) The Cronbach'α was 0.70-0.94.The lower the score in the symptom scale, the better the quality of life.	36th month after recruited

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T) Lasso di tempo: baseline (one week after recruited)	The scale is measured by the respondent self-assessed the frequency of various problems with activities of daily living in 24 hours. BFI-T has 9 questions in total； it is a self-reported 11-Point Likert Scale. Retest reliability was 0.89-0.97.	baseline (one week after recruited)
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T) Lasso di tempo: 1st month after recruited	The scale is measured by the respondent self-assessed the frequency of various problems with activities of daily living in 24 hours. BFI-T has 9 questions in total；it is a self-reported 11-Point Likert Scale. Retest reliability was 0.89-0.97.	1st month after recruited
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T) Lasso di tempo: 2nd month after recruited	The scale is measured by the respondent self-assessed the frequency of various problems with activities of daily living in 24 hours. BFI-T has 9 questions in total；it is a self-reported 11-Point Likert Scale. Retest reliability was 0.89-0.97.	2nd month after recruited
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T) Lasso di tempo: 3rd month after recruited	The scale is measured by the respondent self-assessed the frequency of various problems with activities of daily living in 24 hours. BFI-T has 9 questions in total； it is a self-reported 11-Point Likert Scale. Retest reliability was 0.89-0.97.	3rd month after recruited
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T) Lasso di tempo: 6th month after recruited	The scale is measured by the respondent self-assessed the frequency of various problems with activities of daily living in 24 hours. BFI-T has 9 questions in total； it is a self-reported 11-Point Likert Scale. Retest reliability was 0.89-0.97.	6th month after recruited
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T) Lasso di tempo: 12th month after recruited	The scale is measured by the respondent self-assessed the frequency of various problems with activities of daily living in 24 hours. BFI-T has 9 questions in total； it is a self-reported 11-Point Likert Scale. Retest reliability was 0.89-0.97.	12th month after recruited
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T) Lasso di tempo: 24th month after recruited	The scale is measured by the respondent self-assessed the frequency of various problems with activities of daily living in 24 hours. BFI-T has 9 questions in total； it is a self-reported 11-Point Likert Scale. Retest reliability was 0.89-0.97.	24th month after recruited
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T) Lasso di tempo: 36th month after recruited	The scale is measured by the respondent self-assessed the frequency of various problems with activities of daily living in 24 hours. BFI-T has 9 questions in total； it is a self-reported 11-Point Likert Scale. Retest reliability was 0.89-0.97.	36th month after recruited
Emotional distress( Hospital Anxiety and Depression Scale, HADS) Lasso di tempo: baseline (one week after recruited)	Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.	baseline (one week after recruited)
Emotional distress( Hospital Anxiety and Depression Scale, HADS) Lasso di tempo: 1st month after recruited	Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.	1st month after recruited
Emotional distress( Hospital Anxiety and Depression Scale, HADS) Lasso di tempo: 2nd month after recruited	Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.	2nd month after recruited
Emotional distress( Hospital Anxiety and Depression Scale, HADS) Lasso di tempo: 3rd month after recruited	Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.	3rd month after recruited
Emotional distress( Hospital Anxiety and Depression Scale, HADS) Lasso di tempo: 6th month after recruited	Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.	6th month after recruited
Emotional distress( Hospital Anxiety and Depression Scale, HADS) Lasso di tempo: 12th month after recruited	Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.	12th month after recruited
Emotional distress( Hospital Anxiety and Depression Scale, HADS) Lasso di tempo: 24th month after recruited	Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.	24th month after recruited
Emotional distress( Hospital Anxiety and Depression Scale, HADS) Lasso di tempo: 36th month after recruited	Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.	36th month after recruited
sleep quality(Pittsburgh Sleep Quality Index and using Actigraph) Lasso di tempo: baseline (one week after recruited)	The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Actigraph is the gold standard for evaluating sleep disorders. As the name suggests, it is an electrophysiological recording of multiple parameters, including total sleep time(TST), sleep efficiency(SE), and sleep onset latency(SOL) which help to score various sleep stages.	baseline (one week after recruited)
sleep quality(Pittsburgh Sleep Quality Index and using Actigraph) Lasso di tempo: 3rd month after recruited	The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Actigraph is the gold standard for evaluating sleep disorders. As the name suggests, it is an electrophysiological recording of multiple parameters, including total sleep time(TST), sleep efficiency(SE), and sleep onset latency(SOL) which help to score various sleep stages.	3rd month after recruited
sleep quality(Pittsburgh Sleep Quality Index and using Actigraph) Lasso di tempo: 6th month after recruited	The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Actigraph is the gold standard for evaluating sleep disorders. As the name suggests, it is an electrophysiological recording of multiple parameters, including total sleep time(TST), sleep efficiency(SE), and sleep onset latency(SOL) which help to score various sleep stages.	6th month after recruited
sleep quality(Pittsburgh Sleep Quality Index and using Actigraph) Lasso di tempo: 12th month after recruited	The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Actigraph is the gold standard for evaluating sleep disorders. As the name suggests, it is an electrophysiological recording of multiple parameters, including total sleep time(TST), sleep efficiency(SE), and sleep onset latency(SOL) which help to score various sleep stages.	12th month after recruited
sleep quality(Pittsburgh Sleep Quality Index and using Actigraph) Lasso di tempo: 24th month after recruited	The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Actigraph is the gold standard for evaluating sleep disorders. As the name suggests, it is an electrophysiological recording of multiple parameters, including total sleep time(TST), sleep efficiency(SE), and sleep onset latency(SOL) which help to score various sleep stages.	24th month after recruited
sleep quality(Pittsburgh Sleep Quality Index and using Actigraph) Lasso di tempo: 36th month after recruited	The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Actigraph is the gold standard for evaluating sleep disorders. As the name suggests, it is an electrophysiological recording of multiple parameters, including total sleep time(TST), sleep efficiency(SE), and sleep onset latency(SOL) which help to score various sleep stages.	36th month after recruited
Circadian rhythms(using Actigraph) Lasso di tempo: baseline (one week after recruited)	Circadian rhythms including 24-h autocorrelation coefficient (r24) and in bed less than out of bed dichotomy index (I<O) collection from actigraphy.	baseline (one week after recruited)
Circadian rhythms(using Actigraph) Lasso di tempo: 3rd month after recruited	Circadian rhythms including 24-h autocorrelation coefficient (r24) and in bed less than out of bed dichotomy index (I<O) collection from actigraphy.	3rd month after recruited
Circadian rhythms(using Actigraph) Lasso di tempo: 6th month after recruited	Circadian rhythms including 24-h autocorrelation coefficient (r24) and in bed less than out of bed dichotomy index (I<O) collection from actigraphy.	6th month after recruited
Circadian rhythms(using Actigraph) Lasso di tempo: 12th month after recruited	Circadian rhythms including 24-h autocorrelation coefficient (r24) and in bed less than out of bed dichotomy index (I<O) collection from actigraphy.	12th month after recruited
Circadian rhythms(using Actigraph) Lasso di tempo: 24th month after recruited	Circadian rhythms including 24-h autocorrelation coefficient (r24) and in bed less than out of bed dichotomy index (I<O) collection from actigraphy.	24th month after recruited
Circadian rhythms(using Actigraph) Lasso di tempo: 36th month after recruited	Circadian rhythms including 24-h autocorrelation coefficient (r24) and in bed less than out of bed dichotomy index (I<O) collection from actigraphy.	36th month after recruited

Collaboratori e investigatori

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

Sponsor

Taipei Veterans General Hospital, Taiwan

Investigatori

Cattedra di studio: Hui-Mei Chen, PhD, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan

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)

10 novembre 2020

Completamento primario (Anticipato)

31 ottobre 2024

Completamento dello studio (Anticipato)

31 ottobre 2025

Date di iscrizione allo studio

Primo inviato

21 settembre 2020

Primo inviato che soddisfa i criteri di controllo qualità

13 ottobre 2020

Primo Inserito (Effettivo)

19 ottobre 2020

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

21 dicembre 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 dicembre 2021

Ultimo verificato

1 dicembre 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

2020-10-006A

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Descrizione del piano IPD

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Periodo di condivisione IPD

Beginning 12 months following article publication

Criteri di accesso alla condivisione IPD

Researchers who provide a methodologically sound proposal and receive the authors consent.

Tipo di informazioni di supporto alla condivisione IPD

STUDIO_PROTOCOLLO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

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Prove cliniche su Tumore gastrico

Second Affiliated Hospital, School of Medicine,...

Attivo, non reclutante

Elettroacopuntura combinata con il paclitaxel legato alle proteine e l'anticorpo PD-1 per il trattamento di seconda linea di HER2 negativo, PMMR/MSS Advanced Gastric Cancer: un studio clinico prospettico, a etichetta aperta, a braccio singolo, fase ⅱ (EAPPA)

Elettroacopuntura combinata con paclitaxel legato alla proteina e anticorpo PD-1 per il trattamento di seconda linea di HER2 negativo, PMMR/MSS Advanced Gastric Cancer

Cina
Zeba Ahmad, Ph.D.
American Cancer Society, Inc.

Reclutamento

Adattare l'intervento di resilienza psicosociale per i genitori di adolescenti e giovani adulti con cancro (RAISE)

Caregiving for Cancer

Stati Uniti
Institut Cancerologie de l'Ouest
Amgen Ltd., United Kingdom

Ritirato

Studio di fase 2 multicentrico non randomizzato in aperto emergente che valuta la combinazione di chemioterapia di bemarituzumab + flot in ambito perioperatorio per lo stadio resecabile CT2-T4A o N + Gastric e GEJ adenocarcinoma che sovraesprimono FGFR2B (BEMAFLOT)

Junction gastric e gastro-esofageo (GEJ) adenocarcinomi | Sovraespressione FGFR2B

Francia
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Completato

Bevacizumab, capecitabina e oxaliplatino nel trattamento dell'intestino tenue avanzato o dell'ampolla dell'adenocarcinoma di Vater

Adenocarcinoma dell'intestino tenue | Adenocarcinoma dell'intestino tenue in stadio III AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIA AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIB AJCC v8 | Adenocarcinoma dell'intestino tenue stadio IV AJCC v8 | Ampolla di Vater... e altre condizioni

Stati Uniti
Georgetown University
National Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...

Completato

Donne cinesi e screening mammografico

Studio delle donne cinesi che non hanno aderito alle linee guida per lo screening mammografico dell'American Cancer Society

Stati Uniti
Institut Cancerologie de l'Ouest

Attivo, non reclutante

Valutazione dell'efficienza del massaggio touch sulla qualità della vita al lavoro del personale infermieristico che lavora in un centro per il cancro. (Pausa "Massage toucher (TM)") (PauseTM)

Qualità della vita al lavoro | Professionisti paramedici | Toccare Massaggio | Cancer Center

Francia
Emory University
National Cancer Institute (NCI)

Ritirato

Radiochirurgia stereotassica con Abemaciclib, Ribociclib o Palbociclib nel trattamento di pazienti con carcinoma mammario positivo ai recettori ormonali con metastasi cerebrali

Cancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nel cervello | Carcinoma mammario metastatico | Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8
Yonsei University

Non ancora reclutamento

Uno studio di fase II multicentrico a braccio aperto, singolo per valutare l'efficacia di amivantamab in combinazione con FOLFIRI come trattamento di seconda linea in pazienti con carcinoma del colon-retto avanzato di tipo selvaggio RAS/BRAF che progredisce su un precedente trattamento anti-EGFR.

RAS/BRAF Wild-Type Advanced Cancer Mathement

Corea, Repubblica di
NRG Oncology
National Cancer Institute (NCI)

Completato

Testare se il trattamento delle metastasi del cancro al seno con la chirurgia o le radiazioni ad alte dosi migliora la sopravvivenza

Cancro al seno in stadio anatomico IV AJCC v8 | Cancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nell'osso | Neoplasia maligna metastatica nei linfonodi | Neoplasia maligna metastatica nel fegato | Carcinoma mammario metastatico | Neoplasia maligna metastatica nel... e altre condizioni

Stati Uniti, Canada, Arabia Saudita, Corea del Sud
Jonsson Comprehensive Cancer Center

Reclutamento

Terapia Focale con Radiazioni (HDR-Brachyterapia) per il Trattamento del Cancro alla Prostata

Adenocarcinoma prostatico | Cancro alla prostata in stadio II AJCC v8 | Fase I Cancro alla prostata American Joint Committee on Cancer (AJCC) v8

Stati Uniti

Prove cliniche su exercise group

Universidad Central de Venezuela

Completato

Terapia Vitale della Polpa vs. Trattamento Canalare in Denti Maturi con Pulpite Irreversibile

Pulpite | Terapia canalare | Pulpite - Irreversibile | Pulpotomia

Venezuela
Bursa City Hospital

Reclutamento

Blocco piane intercostale e sottocostato romboide e blocco piano Spinae erector in chirurgia toracoscopica assistita video.

Blocco regionale per il controllo del dolore | Chirurgia toracoscopica videoassistita | Funzioni polmonari | Blocchi regionali

Tacchino
Sandra Bucci
University of Edinburgh; NHS Lothian; Manchester University NHS Foundation Trust; Greater Manchester Mental Health NHS Foundation Trust e altri collaboratori

Completato

i-Minds Professional Stakeholder Studio qualitativo

Abusi sessuali su minori, confermati, sequel

Regno Unito
Istituto Scientifico Italiano Colonna Vertebrale

Attivo, non reclutante

Validazione dei Sistemi di Supporto alle Decisioni Cliniche (CDSS) Sviluppati nel Progetto UE Horizon PREPARE per il Trattamento Riabilitativo della Scoliosi Idiopatica (PREPARE)

Scoliosi idiopatica adolescenziale (AIS)

Italia
M.D. Anderson Cancer Center

Completato

Cure palliative e gestione dei sintomi per il paziente oncologico pediatrico

Tumori pediatrici

Stati Uniti
Northwell Health
The Cleveland Clinic; University of Kansas Medical Center; Cedars-Sinai Medical... e altri collaboratori

Reclutamento

Approccio centrato sul paziente per le decisioni terapeutiche nel prolasso della valvola mitrale (PRIMARY SDM)

Prolasso della valvola mitrale

Stati Uniti
University of Lisbon
Associacao Protectora dos Diabeticos de Portugal

Completato

Confronto tra protocolli di allenamento a intervalli moderati e ad alta intensità sui biomarcatori nei pazienti con diabete di tipo 2 (D2FIT)

Diabete di tipo 2
Rush University Medical Center

Completato

Elimina il morbo di Parkinson

Morbo di Parkinson

Stati Uniti
Greater Manchester Mental Health NHS Foundation...
Manchester University NHS Foundation Trust; University of Manchester; Anna Freud... e altri collaboratori

Completato

Miglioramento dei riferimenti ai servizi di salute mentale per bambini e adolescenti: EnCAMHS (EnCAMHS)

Problema di salute mentale

Regno Unito
Sunnybrook Health Sciences Centre

Ritirato

Dental PROBE (Dental Practice survey of Office Blood Pressure mEasurement) (Dental-PROBE)

Il focus dello studio è sugli atteggiamenti del dentista nei confronti delle misurazioni della pressione arteriosa

Canada

Effectiveness of Exercise Program in Improving Quality of Life in Patients With Gastric Cancer Undergoing Gastrectomy

The Effect of Home Based Walking Exercise on Fatigue, Anxiety, Depression, Sleep Quality, Circadian Rhythms and Quality of Life in Patients With Gastric Cancer Undergoing Gastrectomy

Panoramica dello studio

Stato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Tipo di studio

Iscrizione (Anticipato)

Fase

Contatti e Sedi

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

Criteri di partecipazione

Criteri di ammissibilità

Età idonea allo studio

Accetta volontari sani

Sessi ammissibili allo studio

Descrizione

Piano di studio

Come è strutturato lo studio?

Dettagli di progettazione

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm

Intervento / Trattamento

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato

Misura Descrizione

Lasso di tempo

Misure di risultato secondarie

Misura del risultato

Misura Descrizione

Lasso di tempo

Collaboratori e investigatori

Sponsor

Investigatori

Studiare le date dei record

Studia le date principali

Inizio studio (Effettivo)

Completamento primario (Anticipato)

Completamento dello studio (Anticipato)

Date di iscrizione allo studio

Primo inviato

Primo inviato che soddisfa i criteri di controllo qualità

Primo Inserito (Effettivo)

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

Ultimo aggiornamento inviato che soddisfa i criteri QC

Ultimo verificato

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

Piano per i dati dei singoli partecipanti (IPD)

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

Descrizione del piano IPD

Periodo di condivisione IPD

Criteri di accesso alla condivisione IPD

Tipo di informazioni di supporto alla condivisione IPD

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Prove cliniche su Tumore gastrico

Prove cliniche su exercise group

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Liberia

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi