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Exercise and Quality of Life in Leukemia Patients (EQUAL)

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ClinicalTrials.gov Identifier: NCT02246907
Recruitment Status : Completed
First Posted : September 23, 2014
Last Update Posted : November 23, 2016
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Brief Summary:
The purpose of this study is to evaluate the impact of an exercise intervention on patient-reported anxiety, depression, fatigue, and sleep disturbances among acute leukemia patients. The investigators hypothesize that exercise will reduce fatigue in acute leukemia patients.

Condition or disease Intervention/treatment Phase
Acute Leukemia Other: Exercise Not Applicable

Detailed Description:
The purpose of this randomized, prospective, longitudinal study is to evaluate the impact of an exercise intervention on patient-reported anxiety, depression, fatigue, and sleep disturbances outcomes among acute leukemia patients. The study will include 2 groups for a total sample size of 30: n=15 control group and n=15 intervention group. Each patient enrolled in the intervention arm will participate in an exercise program for the duration of their hospitalization, 4-6 weeks on average during the first treatment (induction chemotherapy).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Exercise on Patient Reported Outcomes in Newly Diagnosed Adults With Acute Leukemia During Induction Treatment: Exercise and Quality of Life in Leukemia Patients (EQUAL)
Study Start Date : January 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control Group
The control group will receive standard of care which includes recreational therapy and standard encouragement.
Exercise
Participants in this arm will receive standard of care plus exercise for the duration of their inpatient stay for induction chemotherapy.
Other: Exercise
All intervention patients will participate in an individualized prescriptive exercise intervention 2 to 4 times per week for a period of the induction chemotherapy/in-hospital recovery. The exercise intervention will begin on week 1 of the study, the day after the first batteries of initial assessments are concluded. Each exercise session will be divided into two parts. One part will be administered in the morning and the second one late in the afternoon. There will be a period of rest of at least 36 hours between each exercise session.
Other Name: Exercise and Quality of Life in Acute Leukemia Patients




Primary Outcome Measures :
  1. Compare symptoms of fatigue in newly diagnosed acute leukemia patients [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks ]
    Symptoms will be assessed by patient reported survey at baseline, weekly through patient hospitalization, and then again at patient's first appointment after hospital discharge. We are interested in how the symptom changes over time.


Secondary Outcome Measures :
  1. Evaluate health-related quality of life changes over time [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks ]
    Health related quality of life will be assessed by patient reported survey at baseline, and at the week 4 timepoint. We are interested in change over time between groups

  2. Compare symptoms of anxiety between groups [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks ]
    Symptoms will be assessed by patient reported survey at baseline, weekly during hospitalization, and at first clinic visit after discharge from hospital. We are interested in change over time between groups.

  3. Compare symptoms of depression between groups [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks ]
    Symptoms will be assessed by patient reported survey at baseline, weekly during hospitalization, and at first clinic visit after discharge from hospital. We are interested in change over time between groups.

  4. Compare sleep quality between groups [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks ]
    Symptoms will be assessed by patient reported survey at baseline, weekly during hospitalization, and at first clinic visit after discharge from hospital. We are interested in change over time between groups.

  5. Changes in cardiovascular function [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks ]
    Exercise testing which will assess the outcome measures will be performed at baseline, and after 4 weeks of training (for the intervention group), or at the week 4 time point (for the control group). We are interested in change over time between groups.

  6. Changes in muscle strength [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks ]
    Exercise testing which will assess the outcome measures will be performed at baseline, and after 4 weeks of training (for the intervention group), or at the week 4 time point (for the control group). We are interested in change over time between groups.

  7. Changes in body composition [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks ]
    Exercise testing which will assess the outcome measures will be performed at baseline, and after 4 weeks of training (for the intervention group), or at the week 4 time point (for the control group). We are interested in change over time between groups.

  8. Changes in functional mobility [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks ]
    Exercise testing which will assess the outcome measures will be performed at baseline, and after 4 weeks of training (for the intervention group), or at the week 4 time point (for the control group). We are interested in change over time between groups.

  9. Changes in muscle size [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks ]
    Exercise testing which will assess the outcome measures will be performed at baseline, and after 4 weeks of training (for the intervention group), or at the week 4 time point (for the control group). We are interested in change over time between groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed with acute leukemia by pathology report
  • Admitted for induction chemotherapy within in the previous 96 hours or +/- 3 days from initiation of induction chemotherapy
  • An expected hospital stay of 3-4 weeks or longer
  • Participation in the study must be approved by the physician directly responsible for the patient's care while at University of North Carolina -Hospitals
  • Age >21 years of age
  • Willing and able to provide, signed informed consent
  • Willing and able to use a computer to complete study questionnaires
  • Ability to understand and speak English

Exclusion Criteria:

The criteria below will be determined by the patient's physician and a review of the patient's medical history. If any of the exclusion criteria are observed, the patients will be informed and excluded from participating in the study.

Participation in this study will involve the same risks as any exercise regimen. Given the potential risks involved, patients will be screened for exclusion based upon the following criteria:

  • Cardiovascular disease (unless the disease would not compromise the patient's ability to participate in the exercise rehabilitation program)
  • Acute or chronic respiratory disease that would compromise the patient's ability to participate in the exercise rehabilitation program
  • Acute or chronic bone, joint, or muscular abnormalities that would compromise the patient's ability to participate in the exercise rehabilitation program
  • Inability to understand and speak English
  • Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
  • Another active malignancy
  • Patients will also be excluded if they have active bleeding, acute thrombosis, ischemia, hemodynamically unstable, and uncontrolled pain.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246907


Locations
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United States, North Carolina
University of North Carolina Lineberger Comprehenisive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
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Principal Investigator: Ashley Bryant, PhD, RN UNC- Chapel Hill
Principal Investigator: Claudio Battaglini, PhD UNC- Chapel Hill

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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02246907     History of Changes
Other Study ID Numbers: LCCC1234
First Posted: September 23, 2014    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: November 2016
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
Health related quality of life
Additional relevant MeSH terms:
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Leukemia
Neoplasms by Histologic Type
Neoplasms