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

NCT03161535 | Active Not Recruiting

• 1 other identifier: 2017-04-001A
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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. 1.The quality of life in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, 24th, and 36th month.
2. 2.The quality of sleep in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, 24th, and 36th month.
3. 3.The emotional distress in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, 24th, and 36th month.
4. 4.The circadian rhythms in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, 24th, and 36th month.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (14)

• Subjective sleep quality

  baseline

• Subjective sleep quality

  3rd month after recruited

• Subjective sleep quality

  6th month after recruited

• Subjective sleep quality

  12th month after recruited

• Subjective sleep quality

  24th month after recruited

Other Outcomes (3)

• Recurrence status

  Third month (T2), sixth month (T3), twelfth month (T4), twenty-fourth month (T5), and thirty-sixth month (T6).

• Nutritional status

  Baseline (T1), third month (T2), sixth month (T3), twelfth month (T4), twenty-fourth month (T5), and thirty-sixth month (T6)

• Survival status

  Third month (T2), sixth month (T3), twelfth month (T4), twenty-fourth month (T5), and thirty-sixth month (T6).

Study Arms (2)

exercise group

EXPERIMENTAL

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; Other: weekly telephone consultations concerning exercise and diet.

usual-care group

NO INTERVENTION

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).

Interventions

exercise and dietary education OTHER

1. 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. 2. Diet-teaching program (using dietary education booklet).

exercise group

weekly telephone consultations concerning exercise and diet. OTHER

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.

exercise group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

National Taipei University of Nursing and Health Sciences

Taipei, 112, Taiwan

Location

Related Publications (2)

• Chen HM, Huang CS, Wu YC, Chien LI, Hsu PK. The effects of a 3-month walking and dietary education program on the quality of life of patients with esophageal cancer: a 1-year follow-up randomized controlled trial. Support Care Cancer. 2025 May 1;33(5):441. doi: 10.1007/s00520-025-09489-4.

  PMID: 40312569 DERIVED

• 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.

  PMID: 33813524 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Exercise; Nutrition Assessment; Diet

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Hui-Mei Chen, PhD

  National Taipei University of Nursing and Health Sciences

  PRINCIPAL INVESTIGATOR

• YU-CHUNG WU, M.D.

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 22, 2017
• Study Start: September 19, 2017
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07

Locations

TW (1)