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Exercise and Quality of Life in Leukemia Patients (EQUAL)

Primary Purpose

Acute Leukemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
UNC Lineberger Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Leukemia focused on measuring Health related quality of life

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of North Carolina Lineberger Comprehenisive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Control Group

Exercise

Arm Description

The control group will receive standard of care which includes recreational therapy and standard encouragement.

Participants in this arm will receive standard of care plus exercise for the duration of their inpatient stay for induction chemotherapy.

Outcomes

Primary Outcome Measures

Compare symptoms of fatigue in newly diagnosed acute leukemia patients
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

Evaluate health-related quality of life changes over time
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
Compare symptoms of anxiety between groups
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.
Compare symptoms of depression between groups
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.
Compare sleep quality between groups
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.
Changes in cardiovascular function
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.
Changes in muscle strength
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.
Changes in body composition
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.
Changes in functional mobility
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.
Changes in muscle size
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.

Full Information

First Posted
March 27, 2014
Last Updated
November 22, 2016
Sponsor
UNC Lineberger Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02246907
Brief Title
Exercise and Quality of Life in Leukemia Patients
Acronym
EQUAL
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 Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Leukemia
Keywords
Health related quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group will receive standard of care which includes recreational therapy and standard encouragement.
Arm Title
Exercise
Arm Type
Other
Arm Description
Participants in this arm will receive standard of care plus exercise for the duration of their inpatient stay for induction chemotherapy.
Intervention Type
Other
Intervention Name(s)
Exercise
Other Intervention Name(s)
Exercise and Quality of Life in Acute Leukemia Patients
Intervention Description
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.
Primary Outcome Measure Information:
Title
Compare symptoms of fatigue in newly diagnosed acute leukemia patients
Description
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.
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Secondary Outcome Measure Information:
Title
Evaluate health-related quality of life changes over time
Description
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
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Title
Compare symptoms of anxiety between groups
Description
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.
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Title
Compare symptoms of depression between groups
Description
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.
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Title
Compare sleep quality between groups
Description
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.
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Title
Changes in cardiovascular function
Description
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.
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Title
Changes in muscle strength
Description
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.
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Title
Changes in body composition
Description
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.
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Title
Changes in functional mobility
Description
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.
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Title
Changes in muscle size
Description
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.
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashley Bryant, PhD, RN
Organizational Affiliation
UNC- Chapel Hill
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Claudio Battaglini, PhD
Organizational Affiliation
UNC- Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina Lineberger Comprehenisive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

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Exercise and Quality of Life in Leukemia Patients

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