Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Prehabilitation in Oncology Via Exercise- Bone Marrow Transplant (IMPROVE-BMT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03886909
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : April 12, 2021
Sponsor:
Information provided by (Responsible Party):
Kathryn Schmitz, Milton S. Hershey Medical Center

Brief Summary:
The purpose of this study is to determine whether patients are able to participate in a prehabilitation program (prior to the beginning of treatment) which includes: (1) a home-based exercise program or (2) just a prehabilitation education session.

Condition or disease Intervention/treatment Phase
Hematopoietic Stem Cell Transplant Hematologic Diseases Physical Activity Prehabilitation Behavioral: Exercise Behavioral: Prehabilitation Education Not Applicable

Detailed Description:

Hematopoietic stem cell transplant may have the potential for severe side effects, including functional (reduced aerobic capacity, reduced muscle strength) and psychosocial (e.g. reduced quality of life, increased fatigue) detriments.

Evidence shows that exercise is considered to be an effective treatment approach in hematopoietic stem cell transplant patients during and after treatment with regard to the above mentioned side-effects. Also, prehabilitative exercise in colon and lung cancer patients was shown as feasible and effective. However, no experience exists with regard to prehabilitation exercise in hematopoietic stem cell transplant patients.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effects of a Prehabilitation Exercise Program in Adults Receiving a Hematopoietic Stem Cell Transplant
Actual Study Start Date : June 20, 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Home-Based Prehabilitation
Will be offered an individual one-on-one appointment for an exercise introduction session with an exercise and cancer specialist and periodical phone calls to support and adapt the exercise program. The exercises should be done home-based for 5 times a week until the time of transplant.
Behavioral: Exercise
The exercise intervention is at least 2 weeks lasting (till the day transplant is taking place) 5-times weekly resistance training intervention combined with aerobic exercise (mostly walking).

Active Comparator: Prehabilitation Education
Will be offered a prehabilitation and stem cell education class at the Penn State Hershey Cancer Institute.
Behavioral: Prehabilitation Education
Participant will receive a prehabilitation and stem cell education class which will be held at the Penn State Cancer Institute.




Primary Outcome Measures :
  1. Feasibility of the exercise intervention: 50% of included patients actually complete at least one third of the exercise sessions [ Time Frame: Through study completion, an average of 18 months ]
    The exercise intervention will be considered feasible if 50% of included patients actually complete at least one third of the exercise sessions prescribed for 2 weeks or more.

  2. Acceptability of the exercise intervention: more than 50% of the patients approached [ Time Frame: During recruitment ]
    The exercise intervention will be considered acceptable if more than 50% of the patients approached agree to receive at least the first exercise session.

  3. Safety of the exercise intervention: questionnaire [ Time Frame: Through the study completion, an average of 18 months ]
    Within the questionnaire we will assess whether musculoskeletal occur (yes/no; ongoing; location; severity (mild-life threatening); daily activities affected). The intervention will be considered as safe if less than 25% of included patients report mild musculoskeletal impairments and less than 5% experienced musculoskeletal injuries (defined as symptoms lasting a week or longer and or requiring the attention of a medical professional).


Secondary Outcome Measures :
  1. Health-related Quality of Life: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30, version 3.0) [ Time Frame: Through study completion, an average of 18 months ]

    QoL will be assessed with the validated 30-item self-assessment questionnaire of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30, version 3.0).

    The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.


  2. Bone Marrow Transplant-related Quality of Life: EORTC QLQ-HDC29 [ Time Frame: Through study completion, an average of 18 months ]

    Quality of Life will be assessed with the validated 29-item self-assessment questionnaire of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire- High Dose Chemotherapy- 29 Items (EORTC QLQ-HDC29).

    The QLQ HDC29 module includes 29 items, consisting of six multi-item scales and eight single-items. For the multi-item scales and single-item scales a high score is equivalent to worse or more symptoms/problems.


  3. Fatigue [ Time Frame: Through study completion, an average of 18 months ]

    Fatigue will be assessed with the Multidimensional Fatigue Inventory (MFI) which is a 20-item, multidimensional self-assessment questionnaire.

    Respondents use a scale ranging from 1 to 7 to indicate how aptly certain statements regarding fatigue represent their experiences. Higher total scores correspond with more acute levels of fatigue.


  4. Sleep [ Time Frame: Through study completion, an average of 18 months ]

    Sleep quality and sleep problems will be assessed with the validated and frequently used Pittsburgh Sleep Quality Index (PSQI).

    In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.


  5. Depression [ Time Frame: Through study completion, an average of 18 months ]

    Depressive symptoms will be assessed with the 20-item Center for Epidemiological Studies Depression Scale (CES-D).

    Zero for 'Rarely', 1 for 'Some or a little of the time', 2 for 'Occasionally or a moderate amount of time', 3 for 'Most or all of the time'. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.


  6. Short Questionnaire to Assess Health-Enhancing Physical Activity [ Time Frame: Through study completion, an average of 18 months ]

    Physical activity behavior in the domains of commuting activity, leisure time activities such as cycling, walking, and sports, household and occupational activity will be assessed via a standardized and validated questionnaire, the Short QUestionnaire to ASsess Health-enhancing Physical Activity (SQUASH).

    Household work and activities at work or school were prestructured for intensity. A basic intensity score of 2 and 5 for light and intense activities, respectively. Total minutes of activity are calculated for each question by multiplying frequency (days/week) by duration (min/day). Activity scores for separate questions are calculated by multiplying total minutes of activity by the intensity score. The total activity score is calculated by taking the sum of the activity scores for separate questions. Higher values equals more time spent completing the activity.


  7. Godin Physical Activity Questionnaire [ Time Frame: Through study completion, an average of 18 months ]

    Physical activity behavior in the domains of commuting activity, leisure time activities such as cycling, walking, and sports, household and occupational activity will be assessed via a standardized and validated questionnaire, the Godin Physical Activity Questionnaire.

    Total weekly leisure activity is calculated in arbitrary units by summing the products of the separate components, as shown in the following formula:

    Weekly leisure activity score = (9 × Strenuous) + (5 × Moderate) + (3 × Light) Higher activity score = more active


  8. Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events [ Time Frame: Through study completion, an average of 18 months ]
    Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) will be used to collect information on severity and interference of symptoms and adverse events.

  9. Body Pain: Brief Pain Inventory- Short form [ Time Frame: Through study completion, an average of 18 months ]

    Bodily pain will be assessed using the Brief Pain Inventory- Short form (BPI-SF).

    The BPI gives two main scores: a pain severity score and a pain interference score. The pain severity score is calculated from the four items about pain intensity. Each item is rated from 0, no pain, to 10, pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40. The pain interference score corresponds to the item on pain interference. The seven sub-items are rated from 0, does not interfere, to 10, completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70.


  10. Physical Function: Short Physical Performance Battery [ Time Frame: Through study completion, an average of 18 months ]

    Objectively-measured physical function will be assessed using the Short Physical Performance Battery (SPPB).

    The SPPB is an accumulation of balance tests, 4-meter gait speed, and 5-chair stands. Based on the time needed to complete the chair stands, a score is given. A summation of scores from all tests is taken, ranging from 0 -12. A higher score = Higher physical function.


  11. Aerobic Capacity: Six Minute Walk Test [ Time Frame: Through study completion, an average of 18 months ]

    Objectively-measured physical function will be assessed using the Six Minute Walk Test (6MWT).

    Distance walked during 6 minutes (measured in meters) is measured. Longer distance = higher aerobic capacity.


  12. Physical Function: Timed-Up-and-Go Test [ Time Frame: Through study completion, an average of 18 months ]

    Objectively-measured physical function will be assessed using the Timed-Up-and-Go test (TUG).

    Time taken to stand up from a chair, walk 10 meters around an obstacle, and return to seated position is measured in seconds. Lower time = better physical function.


  13. Fall Risk [ Time Frame: Through study completion, an average of 18 months ]

    Functional balance will be assessed using the Berg Balance Scale.

    Scoring: A five-point ordinal scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Score is summation of all items. Highest Total Score = 56 Interpretation: 0-20: Wheelchair bound; 21-40: Walking with assistance; 41-56: Independent




Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hematological cancer (e.g. Acute Myeloid Leukemia, Chronic Lymphocytic Leukemia, Multiple Myeloma, Non-Hodgkin Lymphoma, etc.)
  • Hematological cancer in remission
  • Females and males ≥18 years of age
  • Fluent in written and spoken English
  • Must be able to provide and understand informed consent
  • Must have an ECOG score of ≤ 2
  • Scheduled for an inpatient autologous or allogeneic stem cell transplant at Penn State Cancer Institute
  • ≥ 2 weeks until scheduled transplant
  • Primary attending physician approval

Exclusion Criteria:

  • Hematological cancer not in remission
  • Evidence in the medical record of an absolute contraindication (e.g. Heart insufficiency > NYHA III or uncertain arrhythmia; uncontrolled hypertension; reduced standing or walking ability) for exercise
  • Any other comorbidities or musculoskeletal complications that preclude participation in the exercise programs as deemed by the exercise interventionist
  • Uncontrolled hypertension
  • Receiving non-transplant related chemotherapy and/or radiotherapy
  • Not fluent in written and spoken English
  • Active infections, hemorrhages, and cytopenias that could place transplant patients at risk for further adverse events, deemed by the exercise interventionist, physician and/or nurse

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): NCT03886909


Contacts
Layout table for location contacts
Contact: Kathryn Schmitz, PhD 717-531-4387 kschmitz@phs.psu.edu
Contact: Melanie Potiaumpai, PhD 717-531-0003 ext 287621 mpotiaumpai@phs.psu.edu

Locations
Layout table for location information
United States, Pennsylvania
Penn State Cancer Institute Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Kathryn Schmitz, PhD    717-531-4387    kschmitz@phs.psu.edu   
Contact: Melanie Potiaumpai, PhD    717-531-0003 ext 287621    mpotiaumpai@phs.psu.edu   
Principal Investigator: Kathryn Schmitz, PhD         
Sub-Investigator: Melanie Potiaumpai, PhD         
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Kathryn Schmitz, PhD Penn State College of Medicine, Hershey
Layout table for additonal information
Responsible Party: Kathryn Schmitz, Professor, Public Health Science, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03886909    
Other Study ID Numbers: STUDY00010914
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: April 12, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kathryn Schmitz, Milton S. Hershey Medical Center:
Exercise
Hematopoietic Stem Cell Transplant
Physical function
Quality of Life
Additional relevant MeSH terms:
Layout table for MeSH terms
Hematologic Diseases