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NCT Number: NCT06065423

Evaluation of Home Program and Telerehabilitation for the Treatment Process in Patients With Breast Cancer-Related Lymphedema

During the Covid-19 pandemic, rehabilitation services for all patients were affected, and a term that was previously in use but gained popularity during the pandemic entered our vocabulary: 'Telerehabilitation'. The purpose of our study is to evaluate the treatment process and adherence of patients undergoing telerehabilitation.

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Key information

Conditions

Breast Cancer Related Lymphedema Breast Cancer Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Telerehabilitation

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Canan Şanal-Toprak, Istanbul, Turkey (Türkiye)

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About this study

Our study is a randomized single-blind prospective study. Patients aged 18 to 75 years with stage 1-2 lymphedema associated with breast cancer and upper extremity lymphedema, who had undergone breast surgery at least 3 months prior, were included in the study. Group 1: Patients were given a brochure explaining the massage and exercises they should perform. They were periodically contacted by a physiotherapist and clinician to remind them of their tasks. Group 2: Patients underwent telerehabilitation exercises and massages three times a week guided by a physiotherapist and clinician, and on the remaining days, they continued their self-administered tasks. Patients were evaluated three times: before treatment, at weeks 5 and 8 after treatment. During each visit, patients' inter-limb volume difference, Quick DASH and Life Impact Scale scores, pain, tension, stiffness, and heaviness sensations were assessed.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients who had undergone breast surgery at least 3 months ago
  • Had stage 1-2 lymphedema
  • Had upper extremity lymphedema associated with breast cancer

Exclusion criteria

  • Signs of infection such as lymphangitis, cellulitis, fungal infections
  • Those with documented lymph node metastases
  • Those with bilateral lymphedema
  • Those with other diseases affecting upper extremity functions
  • Those with a history of previous surgery related to the upper extremity

Treatment and study plan

Manuel Lymphatic Drainage(MLD), Exercises

Other

MLD:It is a unique massage technique that uses specific hand movements to provide a gentle pumping effect on the skin.

Massage movements follow the direction of lymph flow and produce rapid results. The aim of this method is to achieve maximum skin tightening effect with minimum pressure.

Exercise, on the other hand, increases physical performance, improves body composition, and provides an increase in quality of life by providing acute and chronic reductions in fatigue. Both aerobic exercises and strengthening exercises have been found effective on physical performance. It shows that a mixed program consisting of components such as aerobics, strengthening, coordination and stretching can positively affect flexibility, pain and energy expenditure in breast cancer patients.

Primary outcomes

  1. Volume Measurements

    Time frame: Time Frame: Day 0

    Arm measurement was measured with a tape measure at 4 cm intervals and calculated using the cone method in cm3

  2. Volume Measurements

    Time frame: Time Frame: 5 weeks

    Arm measurement was measured with a tape measure at 4 cm intervals and calculated using the cone method in cm3

  3. Volume Measurements

    Time frame: Time Frame: 8 weeks

    Arm measurement was measured with a tape measure at 4 cm intervals and calculated using the cone method in cm3

  4. Symptom Severity

    Time frame: Time Frame: Day 0

    Shoulder pain, tightness, sensation of heaviness, and stiffness were evaluated using a numerical scale (1 to 10 points)

  5. Symptom Severity

    Time frame: Time Frame: 5 weeks

    Shoulder pain, tightness, sensation of heaviness, and stiffness were evaluated using a numerical scale (1 to 10 points)

  6. Symptom Severity

    Time frame: Time Frame: 8 weeks

    Shoulder pain, tightness, sensation of heaviness, and stiffness were evaluated using a numerical scale (1 to 10 points)

  7. Functionality

    Time frame: Time Frame: Day 0

    Ouick Disabilities of the Arm, Shoulder and Hand (Quick DASH) questionnaire

  8. Functionality

    Time frame: Time Frame: 5 weeks

    Ouick Disabilities of the Arm, Shoulder and Hand (Quick DASH) questionnaire

  9. Functionality

    Time frame: Time Frame: 8 weeks

    Ouick Disabilities of the Arm, Shoulder and Hand (Quick DASH) questionnaire

  10. Efficacity

    Time frame: Time Frame: Day 0

    Lymphedema Quality of Life Impact Scale

  11. Efficacity

    Time frame: Time Frame: 5 weeks

    Lymphedema Quality of Life Impact Scale

  12. Efficacity

    Time frame: Time Frame: 8 weeks

    Lymphedema Quality of Life Impact Scale

Secondary outcomes

  1. Patient satisfaction with the treatment

    Time frame: Time Frame: 5 weeks

    Responses were gathered on a scale of very satisfied - satisfied - somewhat satisfied - unsatisfied

  2. Patient satisfaction with the treatment

    Time frame: Time Frame: 8 weeks

    Responses were gathered on a scale of very satisfied - satisfied - somewhat satisfied - unsatisfied

  3. patients were asked to compare their hand functionality to before the injury

    Time frame: Time Frame: 5 weeks

    Responses were gathered on a scale of 'much better - somewhat better - same - somewhat worse - much worse

  4. patients were asked to compare their hand functionality to before the injury

    Time frame: Time Frame: 8 weeks

    Responses were gathered on a scale of 'much better - somewhat better - same - somewhat worse - much worse

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Oct 3, 2023
Registry last updated
Oct 3, 2023

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

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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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