Breast CancerNCT04348188
Study of the Effectiveness of Supervised vs. Non-Supervised Therapeutic Exercise in Cancer Patients
A study testing Education program on healthy habits in people with Breast Cancer and Colon Cancer, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Breast Cancer, Colon Cancer
- What is being tested?
- Education program on healthy habits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2020to Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Infanta Leonor
Madrid, 28031
Pablo García, PhD, +34913947273, pablga25@ucm.es
About this study
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.
- Conditions
- Breast Cancer, Colon Cancer
- Being tested
- Education program on healthy habits
- Keywords
- Quality of life, Terapeutic exercise, Cancer
- Medical subject headings
- Breast Neoplasms, Colonic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education program on healthy habitsBehavioural
6-week supervised educational program with 12-month follow-up compared to the same unsupervised intervention
| Study group | Role | What they receive |
|---|---|---|
| Supervised exercise group | Experimental | 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. Receives: Behavioral: Education program on healthy habits |
| Not supervised exercise group | Active comparator | Unsupervised intervention group: The same therapeutic exercise protocol will be scheduled which will be carried out autonomously without supervision with telephone tracking. Receives: Behavioral: Education program on healthy habits |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Basal, 1.5, 3, 6, 12 months follow up
Secondary outcomes (3)
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.
Measured: Basal, 1.5, 3, 6, 12 months follow up
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
Measured: Basal, 1.5, 3, 6, 12 months follow up
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.
Measured: Basal, 1.5, 3, 6, 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study startJun 2020 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Infanta Leonor
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348188
- Sponsor's protocol ID
- 20/007-E_TFM
- Status last verified
- Feb 2020
- First submitted
- 28 Feb 2020
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effectiveness of Supervised vs. Non-Supervised Therapeutic Exercise in Cancer Patients
- ClinicalTrials.gov ID
- NCT04348188
- Acronym / sponsor ID
- 20/007-E_TFM
- Conditions
- Breast Cancer, Colon Cancer
- Keywords
- Quality of life, Terapeutic exercise, Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Hospital Universitario Infanta Leonor
- Study start
- Jun 2020 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised exercise group | Experimental | Behavioral: Education program on healthy habitsSupervised 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. |
| Not supervised exercise group | Active comparator | Behavioral: Education program on healthy habitsUnsupervised intervention group: The same therapeutic exercise protocol will be scheduled which will be carried out autonomously without supervision with telephone tracking. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education program on healthy habits6-week supervised educational program with 12-month follow-up compared to the same unsupervised intervention | Behavioural | Not supervised exercise group, Supervised exercise group |
Primary outcome
Changes in Health Related Quality of Life: EORTC QLQ-30
Time frame: Basal, 1.5, 3, 6, 12 months follow up
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.
3 secondary outcomes
Fatigue
Time frame: Basal, 1.5, 3, 6, 12 months follow up
Funtional capacity
Time frame: Basal, 1.5, 3, 6, 12 months follow up
Valuation of the measured force
Time frame: Basal, 1.5, 3, 6, 12 months follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education program on healthy habits in people with Breast Cancer and Colon Cancer, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pablo García (34913947273, pablga25@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Health Related Quality of Life: EORTC QLQ-30 (time frame: Basal, 1.5, 3, 6, 12 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020.