Effectiveness of a Rehabilitation Program in Improving Quality of Life in Patients With Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

Effectiveness of a Rehabilitation Program in Improving Sleep Quality, Emotional Distress, Circadian Rhythms, and Quality of Life in Patients With Esophageal Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03161535
• Other study ID #: 2017-04-001A
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 19, 2017
• Est. completion date: July 2024

Study information

• Verified date: May 2023
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will investigate the effectiveness of a rehabilitation program in improving sleep quality, emotional distress, circadian rhythms, and quality of life in patients with esophageal cancer in Taiwan.

Hypothesis:

1. The quality of life in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, 24th, and 36th month.

2. The quality of sleep in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, 24th, and 36th month.

3. The emotional distress in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, 24th, and 36th month.

4. The circadian rhythms in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, 24th, and 36th month.

Description:

This study will investigate the effectiveness of a rehabilitation program in improving sleep quality, emotional distress, circadian rhythms, and quality of life in patients with esophageal cancer in Taiwan.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 85
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients with esophageal cancer who were aged =20 years, could communicate in either Mandarin or Taiwanese, and were not cognitively impaired were included.

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Other:
• exercise and dietary education
A 12-week regimen of home-based walking exercises, comprising walking at a moderate intensity for 40 min, three times a week, was administered along with weekly exercise counseling. After collecting pretrial measurements, we explained the participants how to perform the exercises, according to an instruction manual for the exercise regimen. The detailed instructions, provided at the hospital clinics, included the determination of activity intensity, demonstration of pulse measurement, criteria for scores of 6-20 on the Borg's rating of perceived exertion (RPE), prevention of exercise-related injuries, and conditions necessitating termination of an exercise session. Participants were instructed that the exercises would be effective only if they reached 60%-80% of the target heart rate, as determined by the Karvonen method, and 13-15 on the RPE. Diet-teaching program (using dietary education booklet).
• weekly telephone consultations concerning exercise and diet.
For each participant, we discussed exercise regimen-related issues and diet weekly through the telephone. For instance, we discussed whether participants' exercise fulfilled the prescribed intensity, duration, or frequency and whether the participants experienced any adverse effects.

Locations

Country	Name	City	State
Taiwan	National Taipei University of Nursing and Health Sciences	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life (EORTC QLQ-C30 )	using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.	baseline
Primary	Quality of life (EORTC QLQ-C30 )	using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.	3rd month after recruited
Primary	Quality of life (EORTC QLQ-C30 )	using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.	6th month after recruited
Primary	Quality of life (EORTC QLQ-C30 )	using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.	12th month after recruited
Primary	Quality of life (EORTC QLQ-C30 )	using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.	24th month after recruited
Primary	Quality of life (EORTC QLQ-C30 )	using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.	36th month after recruited
Primary	Quality of life (EORTC QLQ-OES 18 )	using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.	baseline
Primary	Quality of life (EORTC QLQ-OES 18 )	using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.	3rd month after recruited
Primary	Quality of life (EORTC QLQ-OES 18 )	using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.	6th month after recruited
Primary	Quality of life (EORTC QLQ-OES 18 )	using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.	12th month after recruited
Primary	Quality of life (EORTC QLQ-OES 18 )	using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.	24th month after recruited
Primary	Quality of life (EORTC QLQ-OES 18 )	using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.	36th month after recruited
Secondary	Subjective sleep quality	using Pittsburgh Sleep Quality Index	baseline
Secondary	Subjective sleep quality	using Pittsburgh Sleep Quality Index	3rd month after recruited
Secondary	Subjective sleep quality	using Pittsburgh Sleep Quality Index	6th month after recruited
Secondary	Subjective sleep quality	using Pittsburgh Sleep Quality Index	12th month after recruited
Secondary	Subjective sleep quality	using Pittsburgh Sleep Quality Index	24th month after recruited
Secondary	Subjective sleep quality	using Pittsburgh Sleep Quality Index	36th month after recruited
Secondary	Objective sleep quality	using Actigraph for measure Objective sleep quality	baseline
Secondary	Objective sleep quality	using Actigraph for measure Objective sleep quality	3rd month after recruited
Secondary	Objective sleep quality	using Actigraph for measure Objective sleep quality	6th month after recruited
Secondary	Objective sleep quality	using Actigraph for measure Objective sleep quality	12th month after recruited
Secondary	Objective sleep quality	using Actigraph for measure Objective sleep quality	24th month after recruited
Secondary	Objective sleep quality	using Actigraph for measure Objective sleep quality	36th month after recruited
Secondary	Emotional distress	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, 3rd month, 6th month, 12th month, 24th month, and 36th month after recruited
Secondary	Circadian rhythms	Circadian rhythms including 24-h autocorrelation coefficient (r24) and in bed less than out of bed dichotomy index (I	baseline, 3rd month, 6th month, 12th month, 24th month, and 36th month after recruited