Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02246907
Other study ID # LCCC1234
Secondary ID
Status Completed
Phase N/A
First received March 27, 2014
Last updated November 22, 2016
Start date January 2014
Est. completion date December 2015

Study information

Verified date November 2016
Source UNC Lineberger Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Data and Safety Monitoring BoardUnited States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date December 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of North Carolina Lineberger Comprehenisive Cancer Center Chapel Hill North Carolina

Sponsors (1)

Lead Sponsor Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. participants will be followed for the duration of hospital stay, an expected average of 6 weeks No
Secondary 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 participants will be followed for the duration of hospital stay, an expected average of 6 weeks No
Secondary 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. participants will be followed for the duration of hospital stay, an expected average of 6 weeks No
Secondary 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. participants will be followed for the duration of hospital stay, an expected average of 6 weeks No
Secondary 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. participants will be followed for the duration of hospital stay, an expected average of 6 weeks No
Secondary 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. participants will be followed for the duration of hospital stay, an expected average of 6 weeks No
Secondary 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. participants will be followed for the duration of hospital stay, an expected average of 6 weeks No
Secondary 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. participants will be followed for the duration of hospital stay, an expected average of 6 weeks No
Secondary 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. participants will be followed for the duration of hospital stay, an expected average of 6 weeks No
Secondary 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. participants will be followed for the duration of hospital stay, an expected average of 6 weeks No
See also
  Status Clinical Trial Phase
Recruiting NCT05088356 - Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft Phase 1
Recruiting NCT04904588 - HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide Phase 2
Recruiting NCT04969601 - Anti-Covid-19 Vaccine in Children With Acute Leukemia and Their Siblings Phase 1/Phase 2
Recruiting NCT02356159 - Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation Phase 1/Phase 2
Withdrawn NCT05170828 - Cryopreserved MMUD BM With PTCy for Hematologic Malignancies Phase 1
Terminated NCT02877082 - Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients Phase 2
Active, not recruiting NCT01956630 - Clinical Study of DC Plus CIK for Patients With Relapse Acute Leukemia After Allo-HSCT Phase 1/Phase 2
Completed NCT00988013 - Intensity Modulated Total Marrow Irradiation (IM-TMI) for Advanced Hematologic Malignancies N/A
Enrolling by invitation NCT01728402 - Pathogenesis of Hematologic Malignancies
Active, not recruiting NCT03595800 - Extension of a Study of Allogeneic Hematopoietic Stem Cell Transplantation From One Haplotype Mismatch Related Donor or From an Unrelated Donor to Younger Patients Eligible for Reduced-intensity Conditioning Regimen Phase 3
Completed NCT02440178 - Micafungin Prophylaxis During 1st Induction Chemotherapy for De Novo Acute Leukemia Phase 2
Recruiting NCT05071482 - Flumatinib Versus Imatinib Combined With Chemotherapy for de Novo Ph+ ALL Phase 4
Withdrawn NCT03138395 - iCare3: Monitoring Circulating Cancer DNA After Chemotherapy in MDS and AML N/A
Completed NCT03042676 - Electronic Database for the Follow up of the ATG_FamilyStudy
Completed NCT04597086 - Bright White Light Therapy for the Improvement of Sleep, Fatigue, Distress, Depression, and Anxiety in Hospitalized Leukemia Patients N/A
Terminated NCT03588936 - Nivolumab and Tocilizumab for Relapsed Hematological Malignancy Post-allogeneic Transplant Phase 1
Recruiting NCT05521204 - Olverembatinib for FGFR1-rearranged Neoplasms Phase 2
Not yet recruiting NCT04084327 - Immunophenotyping of Acute b Cell Lymphoblstic Leukemia
Terminated NCT00852709 - Phase I Dose-Escalation Trial of Clofarabine Followed by Escalating Doses of Fractionated Cyclophosphamide in Children With Relapsed or Refractory Acute Leukemias Phase 1
Not yet recruiting NCT06026839 - Longitudinal Study on the QoL of Pediatric Patients After HSCT and Its Influencing Factors