Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Will be offered an initial one week (5 days for 3 hours each) supervised exercise prehabilitation program including a two hour group-based prehabilitation class at Penn State Rehabilitation Hospital, Hummelstown. The following weeks till surgery the learned exercise program should be done home-based for 5 times a week. A weekly phone call during this period will help to support and adapt the exercise program.

Will be offered an individual one-on-one appointment for an exercise introduction session with an exercise and cancer specialist and weekly 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 surgery. Furthermore, a two hour group-based prehabilitation class at the Penn State Hershey Cancer Institute will be offered.

Will be offered a two hour group-based prehabilitation class at the Penn State Hershey Cancer Institute.

Added comparison group: Women who are ineligible on the basis of 'engaging in systematic intense exercise training (at least 1h twice a week) will be recruited to complete measures only, with no randomization

The exercise intervention is an at least 2 weeks lasting (till the day surgery is taking place) 5-times weekly resistance training intervention combined with aerobic exercise (mostly walking).

Exercise

Participate will receive a 2 hour group-based prehabilitation class which will be held at the Penn State Cancer Institute, Hershey

Prehabilitation Education

Kathryn M Schmitz, PhD

Joachim Wiskemann, PhD

The purpose of this study is to determine whether patients are able to participate in a so called prehabilitation program (prior to the beginning of cancer treatment) which includes (1) a supervised and home-based exercise program plus one educational session or (2) just home-based exercise plus one educational session or (3) just one educational session.

Breast cancer surgery may have potential for several side effects, including functional (e.g. flexibility in the affected arm, lymphedema \[swelling that generally occurs in the arms or legs that occurs as a result of the removal of or damage to lymph nodes as a part of cancer treatment\], shoulder pain) and psychosocial (e.g. reduced quality of life, increased fatigue) aspects.

Evidence shows that exercise is considered to be an effective treatment approach in breast cancer 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 exits with regard to prehabilitation exercise in breast cancer patients.

IMpact of PRehabilitation in Oncology Via Exercise - Breast Cancer

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).

The exercise intervention will be considered feasible if 50% of included patients actually do at least half of the exercise sessions prescribed for 2 weeks or more.

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

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

In addition to the EORTC-QLQ-C30 specific breast cancer-related symptoms will be assessed with the validated 23-item breast cancer specific module (EORTC QLQ-BR23). It will assess common problems of breast cancer patients, e.g. with the affected breast or arm

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

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

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

The Penn Shoulder Score (PSS) is a 100-point shoulder-specific self-report questionnaire consisting of 3 subscales of pain, satisfaction, and function.

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

The revised Edmonton symptom assessment scale is a 10-item patient-rated symptom visual numeric scale developed for use in assessing symptoms of patients receiving palliative care/cancer treatment.

Milton S. Hershey Medical Center

Professor, Public Health Sciences

Blood and Lymph Conditions

Behaviors and Mental Disorders

Hematologic Diseases

Quality of Life

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.

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).

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

Kathryn Schmitz, PhD

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.

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.

Impact of Prehabilitation in Oncology Via Exercise- Bone Marrow Transplant

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

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.

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

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.

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 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 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.

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.

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.

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 (PRO-CTCAE) will be used to collect information on severity and interference of symptoms and adverse events.

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.

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.

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.

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.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
IMpact of PRehabilitation in Oncology Via Exercise - Breast Cancer	NCT03498157	Breast Cancer Prehabilitation Physical Activi... Surgery	Exercise Prehabilitation...	18 Years -	Milton S. Hershey Medical Center
Impact of Prehabilitation in Oncology Via Exercise- Bone Marrow Transplant	NCT03886909	Hematopoietic S... Hematologic Dis... Physical Activi... Prehabilitation	Exercise Prehabilitation...	18 Years -	Milton S. Hershey Medical Center
IMpact of PRehabilitation in Oncology Via Exercise - Breast Cancer	NCT03498157	Breast Cancer Prehabilitation Physical Activi... Surgery	Exercise Prehabilitation...	18 Years -	Milton S. Hershey Medical Center

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