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Completed

NCT Number: NCT05216302

Prehabilitation for Breast Cancer Surgery

Prehabilitation for women diagnosed with breast cancer is commonly not part of the clinical pathways as little time (usually a few days) is left between diagnosis and surgery. However, a great proportion of these patients will undergo neoadjuvant chemotherapy which provides a window opportunity to improve patients' physical status to withstand surgery and minimize post-operative musculoskeletal complications associated with surgery.

To this end, the aim of this study is to assess the efficacy of a prehabilitation program consisting of health education and a supervised nordic walking-based intervention in women diagnosed with breast cancer currently undergoing neoadjuvant chemotherapy to decrease post-operative musculoskeletal impairments and improve functionality of the affected arm.

The study is an open-label, single-blind randomised controlled trial conducted at one tertiary hospital. Women diagnosed with breast cancer scheduled for surgery and currently undergoing chemotherapy will be randomised to either usual care (UC) or prehabilitation (PREHAB). Patients will be assessed for eligibility during the fourth out of six course of chemotherapy. Those randomised to the PREHAB group will participate in a supervised group-based nordic walking intervention twice weekly during 8 weeks (approximately 16 sessions). In addition, participants will receive written information regarding the benefits of exercise during cancer treatment and surveillance. Patients will be assessed prior to surgery as well as at 1, 3 and 6 months postoperatively.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Santa Creu i Sant Pau

Barcelona, 08041, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of breast cancer scheduled for surgery with or without lymphadenectomy
  • Candidates to receive neoadjuvant chemotherapy
  • Not currently undergoing any other physical therapy therapies or treatments

Exclusion criteria

  • Cognitive impairment or inability to read Catalan or Spanish
  • Prior diagnosis of shoulder impairment or injury
  • Major musculoskeletal, neurological or cardiorespiratory limitations to prevent participation in the exercise program

Treatment and study plan

Group-based Nordic Walking Exercise Program

Behavioral

An exercise intervention based on nordic walking and health education of one hour and 15 minutes per session. Each session includes 10 min of health education followed by 15 minutes of warm-up exercises, 30 minutes of nordic walking and finally 15 min to cool-down. The intervention is meant to last during two months (last round of chemotherapy and one month pre-surgery), twice weekly for approximately a total of 16 sessions.

Primary outcomes

  1. Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH)

    Time frame: Pre-Surgery (one week)

    Functionality of the affected upper arm using the DASH questionnaire. The questionnaire compromises 11 items. Scoring ranges from 0 (no disability) to 100 (more severe disability)

  2. Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH)

    Time frame: One month post-surgery

    Functionality of the affected upper arm using the DASH questionnaire. The questionnaire compromises 11 items. Scoring ranges from 0 (no disability) to 100 (more severe disability)

  3. Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH)

    Time frame: Three months post-surgery

    Functionality of the affected upper arm using the DASH questionnaire. The questionnaire compromises 11 items. Scoring ranges from 0 (no disability) to 100 (more severe disability)

  4. Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH)

    Time frame: Six months post-surgery

    Functionality of the affected upper arm using the DASH questionnaire. The questionnaire compromises 11 items. Scoring ranges from 0 (no disability) to 100 (more severe disability)

Secondary outcomes

  1. Upper arm volume

    Time frame: Pre-Surgery (one week)

    Perimeter of the affected arm will be measured with a tape measure at hand, wrist, elbow and shoulder level

  2. Upper arm volume

    Time frame: One month post-surgery

    Perimeter of the affected arm will be measured with a tape measure at hand, wrist, elbow and shoulder level

  3. Upper arm volume

    Time frame: Three months post-surgery

    Perimeter of the affected arm will be measured with a tape measure at hand, wrist, elbow and shoulder level

  4. Upper arm volume

    Time frame: Six months post-surgery

    Perimeter of the affected arm will be measured with a tape measure at hand, wrist, elbow and shoulder level

  5. Range of Movement (ROM)

    Time frame: Pre-Surgery (one week)

    Range of movement of the affected arm in three axes using a goniometer

  6. Range of Movement (ROM)

    Time frame: One month post-surgery

    Range of movement of the affected arm in three axes using a goniometer

  7. Range of Movement (ROM)

    Time frame: Three months post-surgery

    Range of movement of the affected arm in three axes using a goniometer

  8. Range of Movement (ROM)

    Time frame: Six months post-surgery

    Range of movement of the affected arm in three axes using a goniometer

  9. Pain severity

    Time frame: Pre-Surgery (one week)

    Global pain assessed with a Visual Analog Scale (0 no pain to 10 maximum pain)

  10. Pain severity

    Time frame: One month post-surgery

    Global pain assessed with a Visual Analog Scale (0 no pain to 10 maximum pain)

  11. Pain severity

    Time frame: Three months post-surgery

    Global pain assessed with a Visual Analog Scale (0 no pain to 10 maximum pain)

  12. Pain severity

    Time frame: Six months post-surgery

    Global pain assessed with a Visual Analog Scale (0 no pain to 10 maximum pain)

  13. Health-Related Quality of Life

    Time frame: Pre-Surgery (one week)

    Health-Related Quality of Life will be assessed with the questionnaire developed by the European Organization for Research and Treatment (EORTC) Quality of Life (QLQ) questionnaire (EORTC QLQ C30). Scores range from 0 to 100 with higher values associated with better overall quality of life

  14. Health-Related Quality of Life

    Time frame: One month post-surgery

    Health-Related Quality of Life will be assessed with the questionnaire developed by the European Organization for Research and Treatment (EORTC) Quality of Life (QLQ) questionnaire (EORTC QLQ C30). Scores range from 0 to 100 with higher values associated with better overall quality of life

  15. Health-Related Quality of Life

    Time frame: Three months post-surgery

    HHealth-Related Quality of Life will be assessed with the questionnaire developed by the European Organization for Research and Treatment (EORTC) Quality of Life (QLQ) questionnaire (EORTC QLQ C30). Scores range from 0 to 100 with higher values associated with better overall quality of life

  16. Health-Related Quality of Life

    Time frame: Six months post-surgery

    Health-Related Quality of Life will be assessed with the questionnaire developed by the European Organization for Research and Treatment (EORTC) Quality of Life (QLQ) questionnaire (EORTC QLQ C30). Scores range from 0 to 100 with higher values associated with better overall quality of life

  17. Handgrip Strength

    Time frame: Pre-Surgery (one week)

    Handgrip strength will be determined using an hydraulic dynamometer (Jamar). Both hands will be assessed and the better result out of three attempts will be used.

  18. Handgrip Strength

    Time frame: One month post-surgery

    Handgrip strength will be determined using an hydraulic dynamometer (Jamar). Both hands will be assessed and the better result out of three attempts will be used.

  19. Handgrip Strength

    Time frame: Three months post-surgery

    Handgrip strength will be determined using an hydraulic dynamometer (Jamar). Both hands will be assessed and the better result out of three attempts will be used.

  20. Handgrip Strength

    Time frame: Six months post-surgery

    Handgrip strength will be determined using an hydraulic dynamometer (Jamar). Both hands will be assessed and the better result out of three attempts will be used.

  21. Functional capacity

    Time frame: Pre-surgery (one week)

    Functional capacity will be measured with the distance covered by the 6-Minute Walk Test.

  22. Functional capacity

    Time frame: One month post-surgery

    Functional capacity will be measured with the distance covered by the 6-Minute Walk Test.

  23. Functional capacity

    Time frame: Three months post-surgery

    Functional capacity will be measured with the distance covered by the 6-Minute Walk Test.

  24. Functional capacity

    Time frame: Six months post-surgery

    Functional capacity will be measured with the distance covered by the 6-Minute Walk Test.

  25. Adherence

    Time frame: Pre-Surgery (one week)

    Adherence to the scheduled sessions will be registered in the Prehab group and will be reported as percentage of attended vs. scheduled.

  26. Physical Activity

    Time frame: Pre-surgery (one week)

    Physical activity levels will be measured using the short form of the International Physical Activity Questionnaire (IPAQ). Estimated METS per week will be calculated based on the available formulas.

  27. Physical Activity

    Time frame: One month post-surgery

    Physical activity levels will be measured using the short form of the International Physical Activity Questionnaire (IPAQ). Estimated METS per week will be calculated based on the available formulas.

  28. Physical Activity

    Time frame: Three months post-surgery

    Physical activity levels will be measured using the short form of the International Physical Activity Questionnaire (IPAQ). Estimated METS per week will be calculated based on the available formulas.

  29. Physical Activity

    Time frame: Six months post-surgery

    Physical activity levels will be measured using the short form of the International Physical Activity Questionnaire (IPAQ). Estimated METS per week will be calculated based on the available formulas.

Sponsors and collaborators

Lead sponsor

Raquel Sebio

Other

Collaborators

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Registry information

Official study title

Prehabilitation Program Based on Health Education and Nordic Walking to Reduce Musculoskeletal Impairments in Women Undergoing Breast Cancer Surgery

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jan 31, 2022
Registry last updated
Dec 6, 2024

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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