Clinical trial NCT06065423: Evaluation of Home Program and Telerehabilitation for the Treatment Process in Patients With Breast Cancer-Related Lymphedema
Official title: Evaluation of Home Program and Telerehabilitation for the Treatment Process in Patients With Breast Cancer-Related Lymphedema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Related Lymphedema
Telerehabilitation
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-10-03
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Volume Measurements
timeFrame: Time Frame: Day 0
measure: Volume Measurements
timeFrame: Time Frame: 5 weeks
measure: Volume Measurements
timeFrame: Time Frame: 8 weeks
measure: Symptom Severity
timeFrame: Time Frame: Day 0
measure: Symptom Severity
timeFrame: Time Frame: 5 weeks
measure: Symptom Severity
timeFrame: Time Frame: 8 weeks
measure: Functionality
timeFrame: Time Frame: Day 0
measure: Functionality
timeFrame: Time Frame: 5 weeks
measure: Functionality
timeFrame: Time Frame: 8 weeks
measure: Efficacity
timeFrame: Time Frame: Day 0
measure: Efficacity
timeFrame: Time Frame: 5 weeks
measure: Efficacity
timeFrame: Time Frame: 8 weeks
Secondary outcomes:
measure: Patient satisfaction with the treatment
timeFrame: Time Frame: 5 weeks
measure: Patient satisfaction with the treatment
timeFrame: Time Frame: 8 weeks
measure: patients were asked to compare their hand functionality to before the injury
timeFrame: Time Frame: 5 weeks
measure: patients were asked to compare their hand functionality to before the injury
timeFrame: Time Frame: 8 weeks
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Canan Şanal-Toprak
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine, Pendik Education and Research Hospital, Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Marmara University School of Medicine, Pendik Education and Research Hospital, Department of Physical Medicine and Rehabilitation
name: CANAN ŞANAL TOPRAK
role: STUDY_DIRECTOR
References: