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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Esophageal Cancer
• Intervention / Treatment: Other: exercise and dietary education; Other: weekly telephone consultations concerning exercise and diet.

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.

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • National Taipei University of Nursing and Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: exercise group; The rehabilitation program was composed of two parts: an exercise program and a diet-teaching program. The exercise program was a 12-week home-based program that comprised moderate-intensity brisk walking for 40 min per session, with 3 sessions per week; in addition, weekly exercise counseling was provided through telephone. The diet teaching program was provided to the patients by using a diet booklet at baseline (same timing as the exercise program), and its contents were used to instruct the patients regarding dietary principles to be followed.	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).; Other: 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.
No Intervention: usual-care group; The control group (CG) received usual care, whereas a nurse, the manager for esophageal cancer treatment, provided routine care, conducted follow-ups, and offered information on esophageal cancer to the experimental group (EG).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life (EORTC QLQ-C30 )	using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.	baseline
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
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
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
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
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective sleep quality	using Pittsburgh Sleep Quality Index	baseline
Subjective sleep quality	using Pittsburgh Sleep Quality Index	3rd month after recruited
Subjective sleep quality	using Pittsburgh Sleep Quality Index	6th month after recruited
Subjective sleep quality	using Pittsburgh Sleep Quality Index	12th month after recruited
Subjective sleep quality	using Pittsburgh Sleep Quality Index	24th month after recruited
Subjective sleep quality	using Pittsburgh Sleep Quality Index	36th month after recruited
Objective sleep quality	using Actigraph for measure Objective sleep quality	baseline
Objective sleep quality	using Actigraph for measure Objective sleep quality	3rd month after recruited
Objective sleep quality	using Actigraph for measure Objective sleep quality	6th month after recruited
Objective sleep quality	using Actigraph for measure Objective sleep quality	12th month after recruited
Objective sleep quality	using Actigraph for measure Objective sleep quality	24th month after recruited
Objective sleep quality	using Actigraph for measure Objective sleep quality	36th month after recruited
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
Circadian rhythms	Circadian rhythms including 24-h autocorrelation coefficient (r24) and in bed less than out of bed dichotomy index (I<O) collection from actigraphy.	baseline, 3rd month, 6th month, 12th month, 24th month, and 36th month after recruited

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence status	Recurrence status was assessed through chart review.	Third month (T2), sixth month (T3), twelfth month (T4), twenty-fourth month (T5), and thirty-sixth month (T6).
Nutritional status	Nutritional status, including body weight, Body Mass Index (BMI), and serum albumin level, was assessed through chart review. However, patients will not be required to return to the hospital for blood tests; only existing blood test reports available in the medical records will be retrieved.	Baseline (T1), third month (T2), sixth month (T3), twelfth month (T4), twenty-fourth month (T5), and thirty-sixth month (T6)
Survival status	Survival status was assessed through chart review.	Third month (T2), sixth month (T3), twelfth month (T4), twenty-fourth month (T5), and thirty-sixth month (T6).

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Investigators: Principal Investigator: Hui-Mei Chen, PhD, National Taipei University of Nursing and Health Sciences; Principal Investigator: YU-CHUNG WU, M.D., Taipei Veterans General Hospital, Taiwan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2017
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: May 17, 2017
• First Submitted That Met QC Criteria: May 18, 2017
• First Posted (Actual): May 22, 2017

Study Record Updates

• Last Update Posted (Actual): July 28, 2025
• Last Update Submitted That Met QC Criteria: July 23, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: 2017-04-001A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No