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Completed

NCT Number: NCT03498157

IMpact of PRehabilitation in Oncology Via Exercise - Breast Cancer

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.

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Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Motor Activity Neoplasms Neoplasms by Site Physical Activity Prehabilitation Skin Diseases Skin and Connective Tissue Diseases Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Cancer Institute

Hershey, Pennsylvania, 17033, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Unilateral or bilateral primary carcinoma of the breast, confirmed histologically by core biopsy
  • Not metastatic (stage <4)
  • 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 PS of ≤ 2
  • Scheduled for lump- or mastectomy at Penn State Cancer Institute
  • ≥ 2 weeks till primary treatment
  • Primary attending surgeon approval

Exclusion criteria

  • Receiving neoadjuvant chemotherapy, radiotherapy or hormone therapy
  • Not fluent in written and spoken English
  • Evidence in the medical record of an absolute contraindication (e.g. Heart insufficiency > NYHA III or uncertain arrhythmia; uncontrolled hypertension; severe renal dysfunction (GFR < 30%, Creatinine> 3mg/dl; insufficient hematological capacity like either hemoglobin value below 8 g/dl or thrombocytes below 30.000/µL; reduced standing or walking ability) for exercise
  • Pregnant women
  • Engaging in systematic intense exercise training (at least 1h twice per week)

Treatment and study plan

Exercise

Behavioral

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).

Prehabilitation Education

Behavioral

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

Primary outcomes

  1. Safety of the exercise intervention (assessed by standardized questionnaire)

    Time frame: Through study intervention, an average of 3 weeks

    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).

  2. Feasibility of the exercise intervention (assessed via exercise logs)

    Time frame: Through study intervention, an average of 3 weeks

    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.

  3. Acceptability of the exercise intervention (assessed via patient flow diagram)

    Time frame: During Recruitment till first intervention is delivered (with one week after enrolment)

    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.

Secondary outcomes

  1. Health-Related Quality of Life: EORTC QLQ-C30, version 3.0

    Time frame: Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery

    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).

  2. Breast cancer-related symptoms and quality of Life

    Time frame: Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery

    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

  3. Fatigue

    Time frame: Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery

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

  4. Sleep

    Time frame: Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery

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

  5. Depression

    Time frame: Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery

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

  6. Shoulder Problems

    Time frame: Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery

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

  7. Physical activity behavior

    Time frame: Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery

    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

  8. Symptoms

    Time frame: Weekly from baseline to 6 weeks after Surgery

    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.

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Acronym: IMPROVE-B

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 13, 2018
Registry last updated
Jan 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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