Study of the Effectiveness of Supervised vs. Non-Supervised Therapeutic Exercise in Cancer Patients
Primary Purpose
Breast Cancer, Colon Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Education program on healthy habits
Sponsored by
![Universidad Complutense de Madrid](https://trials-media.s3.amazonaws.com/orgs/universidad-complutense-de-madrid.jpeg)
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring Quality of life, Terapeutic exercise, Cancer
Eligibility Criteria
Inclusion Criteria:
- Age between 18-70 years.
- Oncological stage I, II or III.
- Completed adjuvant treatment between 3 months to 2 years. ECOG 1-2.
- Sign informed consent
Exclusion Criteria:
- Inability to read, understand and complete questionnaires, read and understand a brochure explanatory, understand and follow verbal orders (example; illiteracy, dementia or blindness).
- Musculoskeletal disorders that prevent the exercise of the exercise bike, elliptical, march tape.
- Important neurological disorders that involve impaired balance, coordination, ataxia.
- Sporting activity at moderate intensity exceeding 150mnts / week.
- Symptomatic anemia.
- Fecal incontinence
- Patient with a digestive ostomy.
- Decompensated heart disease,
- Uncontrolled hypertension
- Heart failure.
- Musculoskeletal pathology (except for upper limb pathology in cancer patients of mom)
- Cardio-respiratory pathology that limits physical activity
Sites / Locations
- Hospital Universitario Infanta Leonor
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Supervised exercise group
Not supervised exercise group
Arm Description
Supervised intervention group: 3 weekly sessions of 1 hour during 6 weeks of therapeutic exercise in which aerobic physical activity will be combined with exercise strength of different muscle groups plus stretches on a supervised basis and strengthening of self-care.
Unsupervised intervention group: The same therapeutic exercise protocol will be scheduled which will be carried out autonomously without supervision with telephone tracking.
Outcomes
Primary Outcome Measures
Changes in Health Related Quality of Life: EORTC QLQ-30
Quality of life assessed with the questionnaire measured with the European questionnaire Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30.
(EORTC QLQ-30). The QLQ-C30 questionnaire is a specific questionnaire for cancer, it is composed of 30 questions or items that assess the quality of life in relation to physical, emotional, social aspects and in general the level of functionality of patients diagnosed with cancer. The QLQ-C30 questionnaire is assigned values between 1 and 4 (1: not at all, 2: a little, 3: a lot, 4: a lot) according to the patient's responses to the item, only in items 29 and 30 are assessed with score from 1 to 7 (1: bad, 7: excellent). The scores obtained are standardized and a score between 0 and 100 is obtained, 0 being the worst possible and 100 the best.
Secondary Outcome Measures
Fatigue
Fatigue measurement with FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) questionaire.
The FACIT-F 13-item scale is designed on a 5-point Likert scale (0 = nothing; 1 = little; 2 = something; 3 = a lot; 4 = very much). The FACIT-F scale is designed so that a high score is good, the possible score is 0 to 52, 0 being the worst possible and 52 the best.
Funtional capacity
The 6-minute walk test consists of measuring the maximum distance that the patient is able to walk in 6 minutes, on a tour short in a hallway, simultaneously assessing heart rate, oxygen saturation and degree of dyspnea. Usually healthy people can walk between 400 and 700 meters in 6 minutes, depending on age, height and sex
Valuation of the measured force
Valuation of the measured force with manual hydraulic dynamometer and 5- test repetition sit-to-stand. The test assesses the act of sitting and standing for five repetitions as quickly as possible, in a chair without arms with a seat height of 43 cm. The participant crosses his arms over his chest and sits with his back against the vertical back of the chair. The performance of the test is based on its duration; Consequently, the shorter the time it takes for the patient to perform the test, the better it will be.
Full Information
NCT ID
NCT04348188
First Posted
February 28, 2020
Last Updated
May 12, 2020
Sponsor
Universidad Complutense de Madrid
Collaborators
Hospital Universitario Infanta Leonor
1. Study Identification
Unique Protocol Identification Number
NCT04348188
Brief Title
Study of the Effectiveness of Supervised vs. Non-Supervised Therapeutic Exercise in Cancer Patients
Official Title
Study of the Effectiveness of Supervised vs. Non-Supervised Therapeutic Exercise in Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 2020 (Anticipated)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
November 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Complutense de Madrid
Collaborators
Hospital Universitario Infanta Leonor
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
AIM:To evaluate the effectiveness of a therapeutic exercise program (PET) in cancer patients in improving the quality of life and the need for supervision by health professionals during the performance of same after 6 weeks of intervention. DESIGN: Randomized and controlled clinical trial, parallel groups with active control group. With masking of randomization, patient evaluation and analysis of the data. SUBJETS OF STUDY: 58 patients diagnosed with breast and colon cancer and treated up to 2 years later, both with surgery, chemotherapy and hormonal treatments (inhibitors of aromatase, tamoxifen). INTERVENTION: both groups the treatment will be a common work-based therapeutic exercise program aerobic, strength-resistance and self-stretching, in addition to a reinforcement in recommendations usual self-care. The study includes two phases, phase of supervised work and phase of tracing. One of the groups will be supervised in the realization of PET for a period of 6weeks and the other group will do it autonomously and without supervision. The patients will be followed for 1 year, with five blind evaluations: at the beginning of the study, after 6 weeks of intervention, 3, 6 and 12 months after the start of the study.MEASUREMENTS: Principal: Quality of life assessed with the questionnaire measured with the European questionnaire Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-30). Pre-post intervention measure, 3, 6 and 12 months. Secondary: Cancer-related fatigue evaluated with the Functional Assessment of scale Chronic Illness Therapy - Fatigue (FACIT-F). Pre-post Measurement intervention, 3, 6 and 12 months. Functional capacity measured with the Test 6 minutes walking test. Pre-post Measurement intervention, 3, 6 and 12 months. Valuation of the measured force with manual hydraulic dynamometer and 5- test repetition sit-to-stand. Pre-post intervention measure, 3, 6 and 12 months.COST: effectiveness and cost / incremental utility associated to the program wil be estimated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Colon Cancer
Keywords
Quality of life, Terapeutic exercise, Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Supervised exercise group
Arm Type
Experimental
Arm Description
Supervised intervention group: 3 weekly sessions of 1 hour during 6 weeks of therapeutic exercise in which aerobic physical activity will be combined with exercise strength of different muscle groups plus stretches on a supervised basis and strengthening of self-care.
Arm Title
Not supervised exercise group
Arm Type
Active Comparator
Arm Description
Unsupervised intervention group: The same therapeutic exercise protocol will be scheduled which will be carried out autonomously without supervision with telephone tracking.
Intervention Type
Behavioral
Intervention Name(s)
Education program on healthy habits
Intervention Description
6-week supervised educational program with 12-month follow-up compared to the same unsupervised intervention
Primary Outcome Measure Information:
Title
Changes in Health Related Quality of Life: EORTC QLQ-30
Description
Quality of life assessed with the questionnaire measured with the European questionnaire Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30.
(EORTC QLQ-30). The QLQ-C30 questionnaire is a specific questionnaire for cancer, it is composed of 30 questions or items that assess the quality of life in relation to physical, emotional, social aspects and in general the level of functionality of patients diagnosed with cancer. The QLQ-C30 questionnaire is assigned values between 1 and 4 (1: not at all, 2: a little, 3: a lot, 4: a lot) according to the patient's responses to the item, only in items 29 and 30 are assessed with score from 1 to 7 (1: bad, 7: excellent). The scores obtained are standardized and a score between 0 and 100 is obtained, 0 being the worst possible and 100 the best.
Time Frame
Basal, 1.5, 3, 6, 12 months follow up
Secondary Outcome Measure Information:
Title
Fatigue
Description
Fatigue measurement with FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) questionaire.
The FACIT-F 13-item scale is designed on a 5-point Likert scale (0 = nothing; 1 = little; 2 = something; 3 = a lot; 4 = very much). The FACIT-F scale is designed so that a high score is good, the possible score is 0 to 52, 0 being the worst possible and 52 the best.
Time Frame
Basal, 1.5, 3, 6, 12 months follow up
Title
Funtional capacity
Description
The 6-minute walk test consists of measuring the maximum distance that the patient is able to walk in 6 minutes, on a tour short in a hallway, simultaneously assessing heart rate, oxygen saturation and degree of dyspnea. Usually healthy people can walk between 400 and 700 meters in 6 minutes, depending on age, height and sex
Time Frame
Basal, 1.5, 3, 6, 12 months follow up
Title
Valuation of the measured force
Description
Valuation of the measured force with manual hydraulic dynamometer and 5- test repetition sit-to-stand. The test assesses the act of sitting and standing for five repetitions as quickly as possible, in a chair without arms with a seat height of 43 cm. The participant crosses his arms over his chest and sits with his back against the vertical back of the chair. The performance of the test is based on its duration; Consequently, the shorter the time it takes for the patient to perform the test, the better it will be.
Time Frame
Basal, 1.5, 3, 6, 12 months follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 18-70 years.
Oncological stage I, II or III.
Completed adjuvant treatment between 3 months to 2 years. ECOG 1-2.
Sign informed consent
Exclusion Criteria:
Inability to read, understand and complete questionnaires, read and understand a brochure explanatory, understand and follow verbal orders (example; illiteracy, dementia or blindness).
Musculoskeletal disorders that prevent the exercise of the exercise bike, elliptical, march tape.
Important neurological disorders that involve impaired balance, coordination, ataxia.
Sporting activity at moderate intensity exceeding 150mnts / week.
Symptomatic anemia.
Fecal incontinence
Patient with a digestive ostomy.
Decompensated heart disease,
Uncontrolled hypertension
Heart failure.
Musculoskeletal pathology (except for upper limb pathology in cancer patients of mom)
Cardio-respiratory pathology that limits physical activity
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pablo García
Phone
34913947273
Email
pablga25@ucm.es
Facility Information:
Facility Name
Hospital Universitario Infanta Leonor
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pablo García, PhD
Phone
+34913947273
Email
pablga25@ucm.es
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of the Effectiveness of Supervised vs. Non-Supervised Therapeutic Exercise in Cancer Patients
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