Esophageal Cancer
Conditions
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.
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.
Interventions
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).
OTHERweekly 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.
Sponsors
Taipei Veterans General Hospital, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (EORTC QLQ-C30 ) | baseline | using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life. |
| Quality of life (EORTC QLQ-OES 18 ) | baseline | using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective sleep quality | baseline | using Actigraph for measure Objective sleep quality |
| Subjective sleep quality | baseline | using Pittsburgh Sleep Quality Index |
| Emotional distress | 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. |
| Circadian rhythms | 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
| Measure | Time frame | Description |
|---|---|---|
| Nutritional status | 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. |
| Recurrence status | 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. |
| Survival status | 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. |
Countries
Taiwan
Outcome results
None listed