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Esophageal CancerNCT03161535

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

A study testing exercise and dietary education and weekly telephone consultations concerning exercise and diet. in people with Esophageal Cancer, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Esophageal Cancer
What is being tested?
exercise and dietary education and weekly telephone consultations concerning exercise and diet.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteTaiwan
Study dates
19 Sep 2017to May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Taipei University of Nursing and Health Sciences

    Taipei, 112

Other trials in Taiwan

About this study

Official title: 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.
Read the 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.

Being tested
exercise and dietary education, weekly telephone consultations concerning exercise and diet.
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • exercise and dietary educationOther

    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.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.

Study groups in NCT03161535
Study groupRoleWhat they receive
exercise groupExperimentalThe 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.
Receives: Other: exercise and dietary education; Other: weekly telephone consultations concerning exercise and diet.
usual-care groupNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of life (EORTC QLQ-C30 )

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

    Measured: baseline

  2. Quality of life (EORTC QLQ-C30 )

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

    Measured: 3rd month after recruited

  3. Quality of life (EORTC QLQ-C30 )

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

    Measured: 6th month after recruited

  4. Quality of life (EORTC QLQ-C30 )

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

    Measured: 12th month after recruited

  5. Quality of life (EORTC QLQ-C30 )

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

    Measured: 24th month after recruited

  6. Quality of life (EORTC QLQ-C30 )

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

    Measured: 36th month after recruited

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

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

    Measured: baseline

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

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

    Measured: 3rd month after recruited

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

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

    Measured: 6th month after recruited

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

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

    Measured: 12th month after recruited

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

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

    Measured: 24th month after recruited

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

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

    Measured: 36th month after recruited

Secondary outcomes (14)

  1. Subjective sleep quality

    using Pittsburgh Sleep Quality Index

    Measured: baseline

  2. Subjective sleep quality

    using Pittsburgh Sleep Quality Index

    Measured: 3rd month after recruited

  3. Subjective sleep quality

    using Pittsburgh Sleep Quality Index

    Measured: 6th month after recruited

  4. Subjective sleep quality

    using Pittsburgh Sleep Quality Index

    Measured: 12th month after recruited

  5. Subjective sleep quality

    using Pittsburgh Sleep Quality Index

    Measured: 24th month after recruited

  6. Subjective sleep quality

    using Pittsburgh Sleep Quality Index

    Measured: 36th month after recruited

  7. Objective sleep quality

    using Actigraph for measure Objective sleep quality

    Measured: baseline

  8. Objective sleep quality

    using Actigraph for measure Objective sleep quality

    Measured: 3rd month after recruited

  9. Objective sleep quality

    using Actigraph for measure Objective sleep quality

    Measured: 6th month after recruited

  10. Objective sleep quality

    using Actigraph for measure Objective sleep quality

    Measured: 12th month after recruited

  11. Objective sleep quality

    using Actigraph for measure Objective sleep quality

    Measured: 24th month after recruited

  12. Objective sleep quality

    using Actigraph for measure Objective sleep quality

    Measured: 36th month after recruited

  13. 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.

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

  14. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2017
  2. Study start19 Sep 2017
  3. Primary completionMay 2026 (estimated)
  4. Study completionMay 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03161535
Sponsor's protocol ID
2017-04-001A
Status last verified
Jul 2025
First submitted
17 May 2017
Last updated
28 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 40312569

  • 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.

    PubMed 33813524

Questions about this trial

What is this clinical trial studying?

A study testing exercise and dietary education and weekly telephone consultations concerning exercise and diet. in people with Esophageal Cancer, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of life (EORTC QLQ-C30 ) (time frame: baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03161535, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.

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