Change of Fatigue and Physical Fitness in Hospitalized Hematology Patients

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01603290
First received: May 18, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
  Purpose

The purposes of this study are to (1) explore the severity of symptom of leukemia patients experienced before and after chemotherapy in hospital, (2) investigate the trajectories of the fatigue and physical fitness, and their related factors, and (3) the correlation between fatigue and physical fitness


Condition
Acute Leukemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Change of Fatigue and Physical Fitness and Their Related Factors in Hospitalized Hematology Patients

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 130
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hospitalized Leukemia Patients
leukemia patients with chemotherapy during hospitalization

Detailed Description:

Cancer-Related Fatigue (CRF) is one of the common distressed symptoms that leukemia patients experienced during the period of chemotherapy. Exercise is the most effective non-pharmacologic treatment but inpatients refuse to do exercise in clinical settings in Taiwan. Decreased physical activity may increase the intensity of fatigue and degenerate the physical fitness; however, there is no study to explore the trajectories of fatigue and physical fitness for leukemia patient during hospitalization. Therefore, the purposes of this study are to (1) explore the severity of symptom of leukemia patients experienced before and after chemotherapy in hospital, (2) investigate the trajectories of the fatigue and physical fitness, and their related factors, and (3) the correlation between fatigue and physical fitness. A longitudinal designed study will be conducted to recruit the leukemia patients in a medical center in Taipei. Eligible patients are those will be going to receive chemotherapy and in hospital at least one week. Time periods for data collection will be in the first 48 hours after hospitalization (T0) and the 48 hours before the patient discharged (T1). A set of structured questionnaire will be used to collected data including the Background information form, the Fatigue Symptom Inventory, the Cancer Fatigue Scale, the Symptom Severity Scale, and the Hospital Anxiety and Depression Scale. Patients will be received physical fitness test including the 6-Minute Walking Test, grip strength, and 30-second chair stand test. The descriptive statistics will be used to analyze the severity of symptom distress, fatigue, and the change of physical fitness, and the inferential statistics was used to analyze the correlation of the symptom, fatigue, and physical fitness. Besides, generalized estimating equations (GEE) will be used to analysis the average of population change of fatigue and physical fitness.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Acute leukemia inpatients

Criteria

Inclusion Criteria:

  • Acute leukemia patients with first complete remission status
  • Aged above 20
  • Be going to receive chemotherapy and in hospital at least one week.
  • Those Who willing to participate in the research

Exclusion Criteria:

  • Physician consider the patient was not suitable
  • Patients' limbs can not move
  • Patients' conscious was unclear during hospitalization
  • Patient with pain of joint and can't do 30-second chair stand test and 6-Minute Walking Test
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01603290

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital, Institutional Review Board
ClinicalTrials.gov Identifier: NCT01603290     History of Changes
Other Study ID Numbers: 201111066RIC
Study First Received: May 18, 2012
Last Updated: May 18, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by National Taiwan University Hospital:
Acute leukemia,
Chemotherapy,
Cancer-Related Fatigue,
Physical Fitness

Additional relevant MeSH terms:
Fatigue
Leukemia
Signs and Symptoms
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on September 16, 2014