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

Primary Purpose

Hematopoietic Stem Cell Transplant, Hematologic Diseases, Physical Activity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise

Prehabilitation Education

About this trial

This is an interventional prevention trial for Hematopoietic Stem Cell Transplant focused on measuring Exercise, Hematopoietic Stem Cell Transplant, Physical function, Quality of Life

Eligibility Criteria

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

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

Sites / Locations

Penn State Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Home-Based Prehabilitation

Prehabilitation Education

Arm Description

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.

Will be offered a prehabilitation and stem cell education class at the Penn State Hershey Cancer Institute.

Outcomes

Primary Outcome Measures

Feasibility of the exercise intervention: 50% of included patients actually complete at least one third of the exercise sessions

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.

Acceptability of the exercise intervention: more than 50% of the patients approached

The exercise intervention will be considered acceptable if more than 50% of the patients approached agree to receive at least the first exercise session.

Safety of the exercise intervention: questionnaire

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

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)

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.

Bone Marrow Transplant-related Quality of Life: EORTC QLQ-HDC29

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.

Fatigue

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.

Sleep

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.

Depression

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.

Short Questionnaire to Assess Health-Enhancing Physical Activity

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.

Godin Physical Activity Questionnaire

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

Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events

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.

Body Pain: Brief Pain Inventory- Short form

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.

Physical Function: Short Physical Performance Battery

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.

Aerobic Capacity: Six Minute Walk Test

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.

Physical Function: Timed-Up-and-Go Test

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.

Fall Risk

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

Full Information

NCT ID

NCT03886909

First Posted

March 12, 2019

Last Updated

July 9, 2023

Sponsor

Milton S. Hershey Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03886909

Brief Title

Impact of Prehabilitation in Oncology Via Exercise- Bone Marrow Transplant

Acronym

IMPROVE-BMT

Official Title

The Effects of a Prehabilitation Exercise Program in Adults Receiving a Hematopoietic Stem Cell Transplant

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

June 28, 2019 (Actual)

Primary Completion Date

April 13, 2023 (Actual)

Study Completion Date

April 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Milton S. Hershey Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hematopoietic Stem Cell Transplant, Hematologic Diseases, Physical Activity, Prehabilitation

Keywords

Exercise, Hematopoietic Stem Cell Transplant, Physical function, Quality of Life

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Home-Based Prehabilitation

Arm Type

Active Comparator

Arm Description

Arm Title

Prehabilitation Education

Arm Type

Active Comparator

Arm Description

Will be offered a prehabilitation and stem cell education class at the Penn State Hershey Cancer Institute.

Intervention Type

Behavioral

Intervention Name(s)

Exercise

Intervention Description

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).

Intervention Type

Behavioral

Intervention Name(s)

Prehabilitation Education

Intervention Description

Participant will receive a prehabilitation and stem cell education class which will be held at the Penn State Cancer Institute.

Primary Outcome Measure Information:

Title

Feasibility of the exercise intervention: 50% of included patients actually complete at least one third of the exercise sessions

Description

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.

Time Frame

Through study completion, an average of 18 months

Title

Acceptability of the exercise intervention: more than 50% of the patients approached

Description

The exercise intervention will be considered acceptable if more than 50% of the patients approached agree to receive at least the first exercise session.

Time Frame

During recruitment

Title

Safety of the exercise intervention: questionnaire

Description

Time Frame

Through the study completion, an average of 18 months

Secondary Outcome Measure Information:

Title

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)

Description

Time Frame

Through study completion, an average of 18 months

Title

Bone Marrow Transplant-related Quality of Life: EORTC QLQ-HDC29

Description

Time Frame

Through study completion, an average of 18 months

Title

Fatigue

Description

Time Frame

Through study completion, an average of 18 months

Title

Sleep

Description

Time Frame

Through study completion, an average of 18 months

Title

Depression

Description

Time Frame

Through study completion, an average of 18 months

Title

Short Questionnaire to Assess Health-Enhancing Physical Activity

Description

Time Frame

Through study completion, an average of 18 months

Title

Godin Physical Activity Questionnaire

Description

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

Time Frame

Through study completion, an average of 18 months

Title

Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events

Description

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.

Time Frame

Through study completion, an average of 18 months

Title

Body Pain: Brief Pain Inventory- Short form

Description

Time Frame

Through study completion, an average of 18 months

Title

Physical Function: Short Physical Performance Battery

Description

Time Frame

Through study completion, an average of 18 months

Title

Aerobic Capacity: Six Minute Walk Test

Description

Time Frame

Through study completion, an average of 18 months

Title

Physical Function: Timed-Up-and-Go Test

Description

Time Frame

Through study completion, an average of 18 months

Title

Fall Risk

Description

Time Frame

Through study completion, an average of 18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kathryn Schmitz, PhD

Organizational Affiliation

Penn State College of Medicine, Hershey

Official's Role

Principal Investigator

Facility Information:

Facility Name

Penn State Cancer Institute

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Impact of Prehabilitation in Oncology Via Exercise- Bone Marrow Transplant

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