Development and Validation of Perceived Fatigue Meaning Scale on Walking Program (PFMS)

National Taiwan University

Status: Unknown

Conditions: Gastric Cancer

Treatments: Behavioral: walking

Study type: Interventional

Funder types: Other

Identifiers

NCT01178775

200807050R

Details and patient eligibility

About

The aims of this three-year study are to:

1. develop and validate a perceived meaning of fatigue scale
2. examine the effect of individualized patient education and walking programs on alleviating fatigue in patients with gastric or colorectal cancer,and further explore the relationship between the perceived meaning of fatigue and intervention outcome.

Full description

In the first year, patients will be recruited from oncology inpatient wards and outpatient clinics in two medical center hospitals in Taipei. Purposive sampling will be used to recruit outpatients or inpatients receiving chemotherapy. Data will be analyzed by descriptive analysis, independent t-test, Pearson correlation, one-way analysis of variance, and exploratory factor analysis.

In the second and third years, an experimental design consisting of three groups including a control group, an education only group, and an education and walking program group will be used. Data will be collected at treatment weeks 1, 4,8,12,16 including three cycles of chemotherapy. Data will be analyzed by descriptive analysis, independent t-test, Pearson correlation, and generalized estimating equations. At least 230 subjects will be interviewed in the first year.

At least 105 of patients with gastric cancer or colorectal will be classified into the three groups in the second and third year. We expect the results of this study to explore the meaning of fatigue and to help develop a common strategy to manage fatigue in Taiwan. The results can help clinicians and researchers to tailor interventions for cancer patients with severe fatigue.

Enrollment: 105 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• The patients with gastric cancer during receiving chemotherapy
• Those who are willing to participate in the research
• Aged above 18

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 3 patient groups

1

No Intervention group

Description:

control design

2

No Intervention group

Description:

education only group

3

Experimental group

Description:

education and education and walking program design

Treatment:

Behavioral: walking