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Active, Not Recruiting

NCT Number: NCT03161535

Effectiveness of a Rehabilitation Program in Improving 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taipei University of Nursing and Health Sciences

Taipei, 112, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

exercise and dietary education

Other
  • 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.

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.

Primary outcomes

  1. Quality of life (EORTC QLQ-C30 )

    Time frame: baseline

    using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.

  2. Quality of life (EORTC QLQ-C30 )

    Time frame: 3rd month after recruited

    using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.

  3. Quality of life (EORTC QLQ-C30 )

    Time frame: 6th month after recruited

    using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.

  4. Quality of life (EORTC QLQ-C30 )

    Time frame: 12th month after recruited

    using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.

  5. Quality of life (EORTC QLQ-C30 )

    Time frame: 24th month after recruited

    using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.

  6. Quality of life (EORTC QLQ-C30 )

    Time frame: 36th month after recruited

    using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.

  7. Quality of life (EORTC QLQ-OES 18 )

    Time frame: baseline

    using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.

  8. Quality of life (EORTC QLQ-OES 18 )

    Time frame: 3rd month after recruited

    using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.

  9. Quality of life (EORTC QLQ-OES 18 )

    Time frame: 6th month after recruited

    using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.

  10. Quality of life (EORTC QLQ-OES 18 )

    Time frame: 12th month after recruited

    using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.

  11. Quality of life (EORTC QLQ-OES 18 )

    Time frame: 24th month after recruited

    using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.

  12. Quality of life (EORTC QLQ-OES 18 )

    Time frame: 36th month after recruited

    using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.

Secondary outcomes

  1. Subjective sleep quality

    Time frame: baseline

    using Pittsburgh Sleep Quality Index

  2. Subjective sleep quality

    Time frame: 3rd month after recruited

    using Pittsburgh Sleep Quality Index

  3. Subjective sleep quality

    Time frame: 6th month after recruited

    using Pittsburgh Sleep Quality Index

  4. Subjective sleep quality

    Time frame: 12th month after recruited

    using Pittsburgh Sleep Quality Index

  5. Subjective sleep quality

    Time frame: 24th month after recruited

    using Pittsburgh Sleep Quality Index

  6. Subjective sleep quality

    Time frame: 36th month after recruited

    using Pittsburgh Sleep Quality Index

  7. Objective sleep quality

    Time frame: baseline

    using Actigraph for measure Objective sleep quality

  8. Objective sleep quality

    Time frame: 3rd month after recruited

    using Actigraph for measure Objective sleep quality

  9. Objective sleep quality

    Time frame: 6th month after recruited

    using Actigraph for measure Objective sleep quality

  10. Objective sleep quality

    Time frame: 12th month after recruited

    using Actigraph for measure Objective sleep quality

  11. Objective sleep quality

    Time frame: 24th month after recruited

    using Actigraph for measure Objective sleep quality

  12. Objective sleep quality

    Time frame: 36th month after recruited

    using Actigraph for measure Objective sleep quality

  13. Emotional distress

    Time frame: baseline, 3rd month, 6th month, 12th month, 24th month, and 36th month after recruited

    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.

  14. Circadian rhythms

    Time frame: baseline, 3rd month, 6th month, 12th month, 24th month, and 36th month after recruited

    Circadian rhythms including 24-h autocorrelation coefficient (r24) and in bed less than out of bed dichotomy index (I<O) collection from actigraphy.

Other outcomes

  1. Recurrence status

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

    Recurrence status was assessed through chart review.

  2. Nutritional status

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

    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.

  3. Survival status

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

    Survival status was assessed through chart review.

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
May 22, 2017
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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