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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-19

Study Completion Date

2026-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Esophageal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

exercise and dietary education

Intervention Type 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).

weekly telephone consultations concerning exercise and diet.

Intervention Type 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.

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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exercise and dietary education

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).

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.