Effects of Bright-light Exposure Combined With Specific Exercise Training (BEST) Program in Patients With Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorTaipei Veterans General Hospital, Taiwan

About this trial

This study plans to investigate the effectiveness of six-week light exposure combined with an exercise training program on improving sleep-wake rhythm, physical and mental symptoms, quality of life, one-year recurrence rate, and one-year survival rate of patients with lung and esophageal cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with newly diagnosed primary lung cancer or esophageal cancer, from the first stage to the third stage.

At least 20 years of age.

Able to communicate in Mandarin Chinese or Taiwanese.

Literate and free from cognitive disabilities.

Disqualifiers

Congestive heart failure.

Orthopedic diseases of the lower extremities that limit one's walking ability.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Daylight exposure combine walking

    Behavioral

    1. Out-door of bright-light exposure in the morning (36 min/day, 7 times/week) for six weeks. 2. Tailored to the individual patient with moderate intensity of walking (3 sessions/week) for six weeks. Duration of each session depends on one-on-one exercise consultation via communication software (LINE App). The duration of walking in week 1 is 15 minutes, then increasing 5 minutes each week if the patient has tolerance. If the patient cannot tolerate the duration, the coach will instruct to keep the same duration for the following week. Basically, the goal of duration in week six is 40 minutes. 3. Weekly exercise consultation via communication software (LINE App). 4. Teaching strategy includes one-on one instruction (hard-copy of teaching manual), video, and webpage.

  • Stretching exercise

    Behavioral

    The stretching exercise includes two movements for the upper body and two movements for the lower body, 10 minutes each time, three times a week, for 6 weeks. The researcher will explain to the participants about how to perform the stretching exercise, according to an instruction manual (hardcopy) for the exercise regimen. A video is shown to the participants (the content same as hardcopy of education manual).

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Active control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Sleep-wake rhythm

Using Actigraph to measure sleep-wake rhythm. The parameter including 24-h correlation coefficient(r24), in bed less than out of bed dichotomy index (I \< O), midline estimating statistic of rhythm (MESOR), and amplitude…etc.

Time frame
Baseline
2

Sleep-wake rhythm

Using Actigraph to measure sleep-wake rhythm. The parameter including 24-h correlation coefficient(r24), in bed less than out of bed dichotomy index (I \< O), midline estimating statistic of rhythm (MESOR), and amplitude…etc.

Time frame
Change from baseline sleep-wake rhythm at 6th week
3

Sleep-wake rhythm

Using Actigraph to measure sleep-wake rhythm. The parameter including 24-h correlation coefficient(r24), in bed less than out of bed dichotomy index (I \< O), midline estimating statistic of rhythm (MESOR), and amplitude…etc.

Time frame
Change from baseline sleep-wake rhythm at 12th week
4

Sleep-wake rhythm

Using Actigraph to measure sleep-wake rhythm. The parameter including 24-h correlation coefficient(r24), in bed less than out of bed dichotomy index (I \< O), midline estimating statistic of rhythm (MESOR), and amplitude…etc.

Time frame
Change from baseline sleep-wake rhythm at 6th month

Secondary outcomes

1

Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)

The scale consists of 19 questions covering collective sleep quality, sleep latency, total sleep hours, sleep habits, sleep disturbance, use of sleeping drugs, and daytime functioning. The PSQI score is calculated from the above seven facets. The score of each facet was 0-3 points, and the total score was 0-21 points. A score greater than 5 indicates that the total quality of sleep is poor.

Time frame
Baseline
2

Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)

The scale consists of 19 questions covering collective sleep quality, sleep latency, total sleep hours, sleep habits, sleep disturbance, use of sleeping drugs, and daytime functioning. The PSQI score is calculated from the above seven facets. The score of each facet was 0-3 points, and the total score was 0-21 points. A score greater than 5 indicates that the total quality of sleep is poor.

Time frame
Change from baseline sleep-wake rhythm at 6th week
3

Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)

The scale consists of 19 questions covering collective sleep quality, sleep latency, total sleep hours, sleep habits, sleep disturbance, use of sleeping drugs, and daytime functioning. The PSQI score is calculated from the above seven facets. The score of each facet was 0-3 points, and the total score was 0-21 points. A score greater than 5 indicates that the total quality of sleep is poor.

Time frame
Change from baseline sleep-wake rhythm at 12th week
4

Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)

The scale consists of 19 questions covering collective sleep quality, sleep latency, total sleep hours, sleep habits, sleep disturbance, use of sleeping drugs, and daytime functioning. The PSQI score is calculated from the above seven facets. The score of each facet was 0-3 points, and the total score was 0-21 points. A score greater than 5 indicates that the total quality of sleep is poor.

Time frame
Change from baseline sleep-wake rhythm at 6th month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Taipei Veterans General Hospital, Taiwan

Lead sponsor

National Taipei University of Nursing and Health Sciences

Collaborator