Cancer Clinical Trial
Official title:
Effect of a Telerehabilitation-exercise Intervention in Oncology Patients in the Covid-19 Pandemic
The aim is to analyze the feasibility and effect of an online Therapeutic Exercise and Education programme (TEEP) in cancer patient and survivors
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 2024 |
Est. primary completion date | November 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Metastatic breast patient, gynecological cancer patient, or breast cancer survivor under adjuvant treatment after surgical intervention. - Having given informed consent to participate voluntarily in the program and to be in contact via telematics (email or messaging platform). - Have a good internet connection - Be accompanied by an adult on the day of assessment. - Availability to access the computer on during the intervention. Exclusion Criteria: - Technophobia - Domatophobia or self-report of adversity to be at home. - Lack of logistical requirements (Internet and lack of skill in its use). |
Country | Name | City | State |
---|---|---|---|
Spain | Antonio Cuesta Vargas | Málaga |
Lead Sponsor | Collaborator |
---|---|
University of Malaga |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Suitability of exercise intensity | Patients are asked before each session to mark in a numerical scale how are they feeling that day to push themselves and get their session well done. From 0 (very well) to 10 (very badly). Higher scores mean a worse feeling. | Through study completion, an average of 3 months | |
Primary | Verification of exercise intensity | Patients are asked to score the feeling of perceived effort after the session with the Borg Perceived Exertion scale (6-20). Higher scores mean a worse perceived exertion. | Through study completion, an average of 3 months | |
Primary | Total attendance | Total of days of attendance | After intervention, an average of 3 months | |
Primary | Absence type | Reasons of absence, categorized as: personal matter, visit the oncology, medical appointment (no related to oncology treatment), health problem, connection problem or unknown. | Through study completion, an average of 3 months | |
Primary | Attendance type | Attendance type, categorized as: full attendance, partly attendance because of lack of time, partly attendance because of internet connection problem | Through study completion, an average of 3 months | |
Secondary | Change from Cancer-Related Fatigue (CRF) | The Spanish version of the Piper Fatigue Scale-Revised (PFS-R) will be used. Its total score is the sum of all items (from 0 to 220), with higher values indicate a higher level of fatigue (worse outcome) | Prior and after intervention, an average of 3 months | |
Secondary | Change from Functional capacity | It will be tested by 30-second Sit-To-Stand Test (30-STS), number of repetitions completed. | prior and after intervention, an average of 3 months | |
Secondary | Change from Upper limb functionality (%) | the Spanish version of Upper Limb Functional Index (ULFI) questionnaire will be filled online | prior and after intervention, an average of 3 months | |
Secondary | Change from Lower limb functionality (%) | the Spanish version of Lower Limb Functional Index (LLFI) questionnaire will be filled online | prior and after intervention, an average of 3 months | |
Secondary | Change from Quality of life (self-reported questionnaire) | It will be assessed by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0. EORTC QLQ-C30 comprises 30 items and contains five functional scales, three symptom scales, a global health status/QoL scale, and six single items. Raw scores can be linearly converted to a 0-100 scale with higher scores reflecting higher levels of function (better outcome) and higher levels of symptom show bigger problems (worse outcome). | prior and after intervention, an average of 3 months | |
Secondary | Change from specific Breast Cancer Quality of life (self-reported questionnaire) | It will be assessed by The European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life questionnaire (EORTC QLQ-BR23). This is a breast cancer module of EORTC QLQ-C30 which contains 23 items that assess disease symptom, side effects of treatment, body image, sexual functioning, and future perspective. All items are rated on a 4-point scale (from 1- not at all, to very much). Higher scores represent better functioning (better outcome), and higher scores of symptom show bigger issues (worse outcome) | prior and after intervention, an average of 3 months |
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