Development and Validation of Perceived Fatigue Meaning Scale on Walking Program

NCT ID: NCT01178775

Last Updated: 2010-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1

control design

Group Type NO_INTERVENTION

No interventions assigned to this group

2

education only group

Group Type NO_INTERVENTION

No interventions assigned to this group

3

education and education and walking program design

Group Type EXPERIMENTAL

walking

Intervention Type BEHAVIORAL

use a pedometer for records steps.

Interventions

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walking

use a pedometer for records steps.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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National Taiwan University

Principal Investigators

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Shiow-Ching Shun, Ph.D

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Shiow-Ching Shun, Ph.D

Role: CONTACT

886-2-2312-3456 ext. 88439

Facility Contacts

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Shiow-Ching Shun, Ph.D

Role: primary

886-2-2312-3456 ext. 88439

Other Identifiers

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200807050R

Identifier Type: -

Identifier Source: org_study_id

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