Clinical trial NCT03161535: Effectiveness of a Rehabilitation Program in Improving Quality of Life in Patients With Esophageal Cancer
Official title: Effectiveness of a Rehabilitation Program in Improving Sleep Quality, Emotional Distress, Circadian Rhythms, and Quality of Life in Patients With Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Cancer
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2017-05-22
Enrollment: 85
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Quality of life (EORTC QLQ-C30 )
timeFrame: baseline
measure: Quality of life (EORTC QLQ-C30 )
timeFrame: 3rd month after recruited
measure: Quality of life (EORTC QLQ-C30 )
timeFrame: 6th month after recruited
measure: Quality of life (EORTC QLQ-C30 )
timeFrame: 12th month after recruited
measure: Quality of life (EORTC QLQ-C30 )
timeFrame: 24th month after recruited
measure: Quality of life (EORTC QLQ-C30 )
timeFrame: 36th month after recruited
measure: Quality of life (EORTC QLQ-OES 18 )
timeFrame: baseline
measure: Quality of life (EORTC QLQ-OES 18 )
timeFrame: 3rd month after recruited
measure: Quality of life (EORTC QLQ-OES 18 )
timeFrame: 6th month after recruited
measure: Quality of life (EORTC QLQ-OES 18 )
timeFrame: 12th month after recruited
measure: Quality of life (EORTC QLQ-OES 18 )
timeFrame: 24th month after recruited
measure: Quality of life (EORTC QLQ-OES 18 )
timeFrame: 36th month after recruited
Secondary outcomes:
measure: Subjective sleep quality
timeFrame: baseline
measure: Subjective sleep quality
timeFrame: 3rd month after recruited
measure: Subjective sleep quality
timeFrame: 6th month after recruited
measure: Subjective sleep quality
timeFrame: 12th month after recruited
measure: Subjective sleep quality
timeFrame: 24th month after recruited
measure: Subjective sleep quality
timeFrame: 36th month after recruited
measure: Objective sleep quality
timeFrame: baseline
measure: Objective sleep quality
timeFrame: 3rd month after recruited
measure: Objective sleep quality
timeFrame: 6th month after recruited
measure: Objective sleep quality
timeFrame: 12th month after recruited
measure: Objective sleep quality
timeFrame: 24th month after recruited
measure: Objective sleep quality
timeFrame: 36th month after recruited
measure: Emotional distress
timeFrame: baseline, 3rd month, 6th month, 12th month, 24th month, and 36th month after recruited
measure: Circadian rhythms
timeFrame: baseline, 3rd month, 6th month, 12th month, 24th month, and 36th month after recruited
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taipei University of Nursing and Health Sciences
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: Hui-Mei Chen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Taipei Veterans General Hospital, Taiwan
name: YU-CHUNG WU, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen HM, Lin YY, Wu YC, Huang CS, Hsu PK, Chien LI, Lin YJ, Huang HL. Effects of Rehabilitation Program on Quality of Life, Sleep, Rest-Activity Rhythms, Anxiety, and Depression of Patients With Esophageal Cancer: A Pilot Randomized Controlled Trial. Cancer Nurs. 2022 Mar-Apr 01;45(2):E582-E593. doi: 10.1097/NCC.0000000000000953.