Telerehabilitation in Oncology Patients
- Conditions
- Cancer MetastaticSurvivorshipCancer
- Interventions
- Other: Therapeutic Exercise and Education
- Registration Number
- NCT04547634
- Lead Sponsor
- University of Malaga
- Brief Summary
The aim is to analyze the feasibility and effect of an online Therapeutic Exercise and Education programme (TEEP) in cancer patient and survivors
- Detailed Description
Current literature shows that Therapeutic Exercise has multiple benefits in oncology patients, such as improvements in function and quality of life, and ameliorates symptoms such as cancer-related fatigue. Furthermore, given the risk of obesity, both exercise and diet play a key role in recovery from cancer. In fact, current guidelines support the use of exercise with therapeutic purposes as a complement to cancer treatment.
As a consequence of the COVID-19 pandemic, oncology patients present more difficulties to attend programs, as the vast majority are immunosuppressed, and they are considered risk population. Therefore, new online (TEEP) must be developed to facilitate the benefits of these programs in the post-COVID Era. This study analyses the feasibility (in terms of suitability and verification of exercise prescription, absence and attendance type, and total days of attendance) and the effect (in weight, physical function, and symptoms) in cancer patients and survivors.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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.
- Technophobia
- Domatophobia or self-report of adversity to be at home.
- Lack of logistical requirements (Internet and lack of skill in its use).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Experimental Therapeutic Exercise and Education The sample will receive of a Therapeutic Exercise and Education programme
- Primary Outcome Measures
Name Time Method Suitability of exercise intensity Through study completion, an average of 3 months 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.
Verification of exercise intensity Through study completion, an average of 3 months 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.
Total attendance After intervention, an average of 3 months Total of days of attendance
Absence type Through study completion, an average of 3 months Reasons of absence, categorized as: personal matter, visit the oncology, medical appointment (no related to oncology treatment), health problem, connection problem or unknown.
Attendance type Through study completion, an average of 3 months Attendance type, categorized as: full attendance, partly attendance because of lack of time, partly attendance because of internet connection problem
- Secondary Outcome Measures
Name Time Method Change from Upper limb functionality (%) prior and after intervention, an average of 3 months the Spanish version of Upper Limb Functional Index (ULFI) questionnaire will be filled online
Change from Quality of life (self-reported questionnaire) prior and after intervention, an average of 3 months 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).
Change from Cancer-Related Fatigue (CRF) Prior and after intervention, an average of 3 months 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)
Change from Functional capacity prior and after intervention, an average of 3 months It will be tested by 30-second Sit-To-Stand Test (30-STS), number of repetitions completed.
Change from Lower limb functionality (%) prior and after intervention, an average of 3 months the Spanish version of Lower Limb Functional Index (LLFI) questionnaire will be filled online
Change from specific Breast Cancer Quality of life (self-reported questionnaire) prior and after intervention, an average of 3 months 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)
Trial Locations
- Locations (1)
Antonio Cuesta Vargas
🇪🇸Málaga, Spain