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

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ClinicalTrials.gov Identifier: NCT03161535
Recruitment Status : Recruiting
First Posted : May 22, 2017
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Other: exercise and dietary education Other: weekly telephone consultations concerning exercise and diet. Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effectiveness of a Rehabilitation Program in Improving Sleep Quality, Emotional Distress, Circadian Rhythms, and Quality of Life in Patients With Esophageal Cancer
Actual Study Start Date : September 19, 2017
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2023


Arm Intervention/treatment
Experimental: exercise group Other: 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).

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



Primary Outcome Measures :
  1. quality of life [ Time Frame: 3rd month after recruited ]
    using European Organization for Research and Treatment cancer QLQ-C30 (EORTC QLQ-C30) to measure quality of life.

  2. quality of life [ Time Frame: 6th month after recruited ]
    using European Organization for Research and Treatment cancer QLQ-C30

  3. quality of life [ Time Frame: 12th month after recruited ]
    using European Organization for Research and Treatment cancer QLQ-C30

  4. quality of life [ Time Frame: 24th month after recruited ]
    using European Organization for Research and Treatment cancer QLQ-C30

  5. quality of life [ Time Frame: 36th month after recruited ]
    using European Organization for Research and Treatment cancer QLQ-C30


Secondary Outcome Measures :
  1. subjective sleep quality [ Time Frame: 3rd month after recruited ]
    using Pittsburgh Sleep Quality Index

  2. subjective sleep quality [ Time Frame: 6th month after recruited ]
    using Pittsburgh Sleep Quality Index

  3. subjective sleep quality [ Time Frame: 12th month after recruited ]
    using Pittsburgh Sleep Quality Index

  4. subjective sleep quality [ Time Frame: 24th month after recruited ]
    using Pittsburgh Sleep Quality Index

  5. subjective sleep quality [ Time Frame: 36th month after recruited ]
    using Pittsburgh Sleep Quality Index

  6. objective sleep quality [ Time Frame: 3rd month after recruited ]
    using Actigraph

  7. objective sleep quality [ Time Frame: 6th month after recruited ]
    using Actigraph

  8. objective sleep quality [ Time Frame: 12th month after recruited ]
    using Actigraph

  9. objective sleep quality [ Time Frame: 24th month after recruited ]
    using Actigraph

  10. objective sleep quality [ Time Frame: 36th month after recruited ]
    using Actigraph

  11. Emotional distress [ Time Frame: 3rd month after recruited ]
    Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale).

  12. Emotional distress [ Time Frame: 6th month after recruited ]
    Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale).

  13. Emotional distress [ Time Frame: 12th month after recruited ]
    Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale).

  14. Emotional distress [ Time Frame: 24th month after recruited ]
    Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale).

  15. Emotional distress [ Time Frame: 36th month after recruited ]
    Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale).

  16. Circadian rhythms [ Time Frame: 3rd 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.

  17. Circadian rhythms [ Time Frame: 6th 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.

  18. Circadian rhythms [ Time Frame: 12th 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.

  19. Circadian rhythms [ Time Frame: 24th 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.

  20. Circadian rhythms [ Time Frame: 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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03161535


Contacts
Contact: Hui-Mei Chen, PhD 886-939654302 alice@ntunhs.edu.tw
Contact: YU-CHUNG WU, M.D. 886-2-28757546 wuyc@vghtpe.gov.tw

Locations
Taiwan
National Taipei University of Nursing and Health Sciences Recruiting
Taipei, Taiwan, 112
Contact: HUI-MEI CHEN, PhD    886-939654302    alice@ntunhs.edu.tw   
Sponsors and Collaborators
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

Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT03161535     History of Changes
Other Study ID Numbers: 2017-04-001A
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases