Neoplasms

All Conditions

Musculoskeletal Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Sarcoma

Osteosarcoma

Sarcoma, Ewing

Chondrosarcoma

Bone Neoplasms

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Bone Diseases

Soft Tissue Sarcoma

Ewing Sarcoma

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Morphine

Participants undergoing osseous reconstructive surgery (RegOS) for bone neoplasm. Study visits for post-op assessments will be annually after month-36.

Participants undergoing other reconstructive surgery for bone neoplasm. Study visits for post-op assessments will be annually after month-36.

Participant-reported outcome score. For lower extremities, this is a 33 item questionnaire containing 32 5 point Likert scale items and 1 open ended response item. For upper extremities, this is a 31 item questionnaire containing 31 5 point Likert scale items and 1 open ended response item. Individual item responses range from 1-5 with higher values indicating a task is easier to complete. A total questionnaire score can also be calculated by taking the sum of the scores minus the number of total items answered, and dividing this by the maximum possible score based on the number of items answered. This results in a range from 0 -100% with higher values indicating greater ability to complete tasks 31. This scoring allows for the fact that some items may not be answered if they do not apply to an individual. It is anticipated that it will take 20 minutes to complete. Scores for the lower extremity and upper extremity may be combined, but we intend to treat them separately for analysis.

Toronto Extremity Salvage Score

Clinician-reported global score. For lower extremities, this is a 6 item questionnaire containing 6 point Likert scale items which cover pain, function, emotional acceptance, walking ability, gait, and necessary support. Individual item scores range from 0-5 with higher values indicating greater function, less pain, or more positive emotional acceptance. For upper extremities, this is a 6 item questionnaire containing 6 point Likert scale items which cover pain, function, emotional acceptance, hand positioning, manual dexterity, and lifting ability. Individual item scores range from 0-5 with higher values indicating greater function, less pain, or more positive emotional acceptance. A total questionnaire score which is defined as the sum of the individual items divided by the maximum possible score (5 times the number of items) may also be computed. It is represented as a percentage from 0 - 100%.

Musculoskeletal Tumor Society Score

Validated functional measurement, for lower extremities only. The patient is observed and timed while s/he rises from an arm chair, walks 3 meters, turns, walks back, and sits down again. The test predicts the patient's ability to go outside alone safely and quantifies functional mobility. The test requires no special equipment and will take less than one minute to complete.

Timed Get Up and Go Test

The distance of bone transport is measured, accounting for calibration of the radiographs. The presence of bone regenerate between the transported segment is determined by the presence of continuous calcified callus from the proximal segment to the distal segment. Each of the orthogonal radiographs is used to visualize two cortices: the AP radiographs visualizes the medial and lateral cortices and the lateral radiograph measures the anterior and posterior cortices. Each continuous calcified cortex is counted with a range from 0 to 4 cortices intact.

Orthogonal Radiographs

As part of the current standard of care, patients are asked to stand on a scale with the affected lower extremity on the scale and the unaffected extremity on a block which is level with the scale. The patient is asked to place as much weight as possible on the affected extremity and this weight Is recorded. Each patient's total weight is then measured and the percent of weight bearing is calculated as the amount of weight bearing over the total body weight.

Weight Bearing for lower extremities only

As part of the current standard of care, the joints of the affected extremity are assessed for passive range of motion at each follow up visit by the clinician. If surgery is on the femur, the hip and knee joints are assessed for range of motion. Whereas for the tibia, the knee and ankle joints are assessed. These assessments would be measured using a goniometer placed alongside the extremity and recorded for each direction of movement. Hip range of motion includes flexion, extension, abduction, internal rotation and external rotation. Knee range of motion includes flexion and extension. Ankle range of motion includes dorsiflexion and plantarflexion.

Range of Motion

Daniel Prince, MD, MPH

John Healey, MD

Daniel Prince, MD

The purpose of this study is to look at the amount of function that returns in participants that have reconstruction with bone graft or artificial device and in participants who have tumor surgery plus regenerative osseous surgery.

The study will look at the level of function for a period of 3 years after the surgery. Another purpose of this study is to look at how well the bone heals in participants undergoing regenerative surgery

Assessment of Healing and Function After Reconstruction Surgery for Bone Sarcomas

Assessment of Healing and Function After Surgical Reconstruction for Neoplasms Involving Bone

The primary objective is to assess early recovery level of function of all participants undergoing reconstructive surgery after resection of osseous neoplasms. The early time frame is considered at one year from the neoplasm resection surgery.

The primary objective is to assess mid-recovery level of function of all participants undergoing reconstructive surgery after resection of osseous neoplasms. The mid-recovery time frame is considered at one year from the neoplasm resection surgery.

Memorial Sloan Kettering Cancer Center

Patients complete a 6-minute walk test and a timed get up and go test on the day of hospital admission, on days 0 (day of stem cell transplant) and 21, the day of discharge, and day 100. Patients also complete surveys over 10 minutes about quality of life and fatigue levels on the day of hospital admission, on days 0 (day of stem cell transplant) and 21, the day of discharge, and day 100. Patients who are able and allowed to, may also walk and participate in other intense physical activities to earn stickers. Patients who are unable to walk have tailored goals created by a physical/occupational therapist to earn stickers and participate in physical activity as prescribed by their therapist.

6 Minute Walk Functional Test

Participate in walking and other activities

Behavioral Intervention

Survey Administration

Priti Tewari

Victor Aquino, MD

This clinical trial studies how well an exercise program (Totally Excited About Moving, Mobility, and Exercise \[TEAM Me\]) affects the exercise and dietary habits of pediatric and adolescents and young adults with cancer undergoing a blood stem cell transplant. TEAM Me is an exercise program that reinforces behavior, such as walking and other activities, using "tokens" (i.e. stickers) that can be redeemed for rewards. Participating in the exercise program may result in increased physical fitness, physical activity level, quality of life, and function in pediatric and adolescents and young adult patients with cancer.

PRIMARY OBJECTIVE:

I. To evaluate the feasibility and tolerability of this exercise program using a token economy system in hospitalized pediatric and adolescent and young adult (AYA) undergoing hematopoietic stem cell transplant (HSCT).

SECONDARY OBJECTIVES:

I. To evaluate the impact of an exercise program using a token economy system in hospitalized pediatric and adolescent and young adult (AYA) cancer patients going through HSCT on measures of physical fitness.

II. To evaluate the impact of an exercise program using a token economy system in hospitalized pediatric and adolescent and young adult (AYA) cancer patients going through HSCT on physical activity.

III. To evaluate the impact of an exercise program using a token economy system in hospitalized pediatric and adolescent and young adult (AYA) cancer patients on quality of life, fatigue, sleep and function.

OUTLINE:

Patients complete a 6-minute walk test and a timed get up and go test on the day of hospital admission, on days 0 (day of stem cell transplant) and 21, the day of discharge, and day 100. Patients also complete surveys over 10 minutes about quality of life and fatigue levels on the day of hospital admission, on days 0 (day of stem cell transplant) and 21, the day of discharge, and day 100. Patients who are able and allowed to, may also walk and participate in other intense physical activities to earn stickers. Patients who are unable to walk have tailored goals created by a physical/occupational therapist to earn stickers and participate in physical activity as prescribed by their therapist.

Exercise Program (TEAM Me) for the Improvement of Movement and Mobility in Pediatric and Adolescent and Young Adult Patients With Cancer Undergoing a Blood Stem Cell Transplant

TEAM Me (Totally Excited About Moving, Mobility, and Exercise) Clinical Research Protocol

Will consider the program feasible if 75% of patients approached about the study will agree to enroll and 80% of the enrolled subjects will participate in physical activity and complete the serial measures for 70% of their inpatient days until day +21. Will report the percentage with 95% confidence interval of approached patients that agree to participate at the end of the study. Each patient's percentage of days that he/she complete the serial measures until day +21 will be calculated and percentage of all patients that finish 70% of the 21 day serial measures will be estimated with 95% confidence interval.

The program will be considered tolerable if \> 90% of the participants do not have any Common Terminology Criteria for Adverse Events defined adverse events that are greater than grade 2. Serious adverse event will be defined using Common Terminology Criteria for Adverse Events version 5.0 or higher.

Will be estimated from descriptive statistics: mean, standard deviation, median and range for each group and be compared using Wilcoxon rank sum test when appropriate. Baseline will be defined as the initial measures conducted at time of admission. Wilcoxon signed rank test may also be applied to test any change that is significantly different from 0. Repeated measure analysis may be applied to evaluate the changes of this measure over time, adjusting for other important covariates such as age, gender, weight, disease stage, performance status, etc. All testing will be 2-sided with a significance level of 0.05.

Will be estimated from descriptive statistics: mean, standard deviation, median and range for each group and be compared using Wilcoxon rank sum test when appropriate. Baseline will be defined as the initial measures conducted at time of admission. Wilcoxon signed rank test may also be applied to test any change that is significantly different from 0. Repeated measure analysis may be applied to evaluate the changes of this measure over time, correlation between this scale and the 6MWT, adjusting for other important covariates such as age, gender, weight, disease stage, performance status, etc. All testing will be 2-sided with a significance level of 0.05.

Will be recorded thru their co-enrollment on MD Anderson Cancer Center protocol PA18-0130. Will be estimated from descriptive statistics: mean, standard deviation, median and range for each group and be compared using Wilcoxon rank sum test when appropriate. Baseline will be defined as the initial measures conducted at time of admission. Wilcoxon signed rank test may also be applied to test any change that is significantly different from 0. Repeated measure analysis may be applied to evaluate the changes of this measure over time, correlation between this scale and the 6MWT, adjusting for other important covariates such as age, gender, weight, disease stage, performance status, etc. All testing will be 2-sided with a significance level of 0.05.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Assessment of Healing and Function After Reconstruction Surgery for Bone Sarcomas	NCT03442465	Bone Sarcoma Osteosarcoma Chondrosarcoma Ewing's Sarcoma Osseous Sarcoma Bone Neoplasm	Toronto Extremi... Musculoskeletal... Timed Get Up an... Orthogonal Radi... Weight Bearing ... Range of Motion	4 Years -	Memorial Sloan Kettering Cancer Center
Exercise Program (TEAM Me) for the Improvement of Movement and Mobility in Pediatric and Adolescent and Young Adult Patients With Cancer Undergoing a Blood Stem Cell Transplant	NCT04678427	Hematopoietic a... Malignant Solid...	6 Minute Walk F... Behavioral Inte... Survey Administ... Timed Get Up an...	6 Years - 29 Years	M.D. Anderson Cancer Center
Exercise Program (TEAM Me) for the Improvement of Movement and Mobility in Pediatric and Adolescent and Young Adult Patients With Cancer Undergoing a Blood Stem Cell Transplant	NCT04678427	Hematopoietic a... Malignant Solid...	6 Minute Walk F... Behavioral Inte... Survey Administ... Timed Get Up an...	6 Years - 29 Years	M.D. Anderson Cancer Center

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