Breast CancerNCT05455385
The Added Value of a Third Supervised Training Session to a Standard 12-week Rehabilitation Program After Breast Cancer: Pilot Study
A study testing standard 12-week rehabilitation program, extra session hydrotherapy and extra session ground exercises in people with Breast Cancer, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Breast cancer is the most common type of cancer diagnosed in women. A good rehabilitation program is essential for a good recovery after breast cancer, both physically and mentally. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- standard 12-week rehabilitation program, extra session hydrotherapy and extra session ground exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Jun 2021to 31 Jan 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men and women after surgery for breast cancer (mastectomy/breast-conserving and/or axillary gland resection/sentinel biopsy)
- possible (neo)adjuvant chemotherapy and radiotherapy have been completed
- hormone and/or immunotherapy may still be ongoing
Who cannot join
- comorbidities that make hydrotherapy impossible, i.e. open wounds or allergy to chlorine
- oncological unstable disease
- terminal patients
- severe physical disabilities
- severe mental disabilities
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Added Value of a Third Supervised Training Session (Ground Exercises or Hydrotherapy) to a Standard 12-week Rehabilitation Program After Breast Cancer: Pilot Study
Breast cancer is the most common type of cancer diagnosed in women. A good rehabilitation program is essential for a good recovery after breast cancer, both physically and mentally. The aim of this study is to determine if there is an added value of a third supervised training session within a standard 12-week rehabilitation program to improve physical and mental functioning after breast cancer. The investigators also want to determine the added value of hydrotherapy as a third training session within a 12-week rehabilitation program compared to a third training session with ground exercises to improve physical and mental functioning after breast cancer.
- Conditions
- Breast Cancer
- Being tested
- standard 12-week rehabilitation program, extra session hydrotherapy, extra session ground exercises
- Keywords
- rehabilitation, hydrotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard 12-week rehabilitation programOther
The standard program consisted of 1 session in the fitness room and 1 session in the sports hall/week during 12 weeks.
extra session hydrotherapyOther
The hydrotherapy group receives 1.5h additional hydrotherapy/week in addition to the standard program.
extra session ground exercisesOther
The ground exercise group, receives 1.5h ground exercises/week in addition to the standard program.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Not described Receives: Other: standard 12-week rehabilitation program |
| Hydrotherapy group | Experimental | Not described Receives: Other: standard 12-week rehabilitation program; Other: extra session hydrotherapy |
| Ground exercise group | Experimental | Not described Receives: Other: standard 12-week rehabilitation program; Other: extra session ground exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder mobility
Shoulder Range of Motion (ROM) is measured with a Dr. Rippstein Plurimeter-V analogue inclinometer
Measured: 12 weeks
Arm volume
Arm circumference measurements are performed bilaterally using a perimeter, a flexible stainless-steel rod with a measuring tape attached every 4 cm and a 20 g weight at the end.Arm circumference is measured at the level of the olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal to the olecranon. The volume of the arm is calculated using a formula. The relatively excessive arm volume is then calculated as follows: (volume of operated limb - volume of non-operated limb) / volume of non-operated limb) x 100.
Measured: 12 weeks
Force based on handgrip strength
Handgrip strength is measured with the Jamar Handheld Dynamometer
Measured: 12 weeks
Flexibility by means of the sit-and-reach test
The Sit and reach test is one of the linear flexibility tests which helps to measure the extensibility of the hamstrings and lower back.
Measured: 12 weeks
Exercise capacity based on 6-minute walk test
The 6-minute walk test is used to assess patients' gait pattern, walking speed and cardiorespiratory endurance. It measures the maximum distance the patient can comfortably cover in 6 minutes.
Measured: 12 weeks
Body image using the Body Image Scale
The BIS is a patient-reported outcome measure to evaluate the body image during and after cancer treatment. The BIS consists of 10 items and measures cognitive, affective and behavioral symptoms of body image. It uses a 4-point scale, where 0 = not at all and 3 = very much. The total score ranges from 0 to 30 and can be calculated by adding the 10 items together. The higher the score, the higher the level of body image disturbance.
Measured: 12 weeks
self-reported pain using the Brief Pain Inventory
The BPI measures the severity of pain symptoms and interference with daily functioning using an 11-point scale. It has 4 questions for pain (worst pain, least pain, average pain and pain right now) and 7 for pain-related functioning (general physical activity, mood, ability to walk, work and household tasks, relationships with others, sleep, vitality). The total score is calculated by averaging all the different questions. A higher score indicates a higher barrier
Measured: 12 weeks
Fatigue using the Functional Assessment of Chronic Illness Therapy - Fatigue Scale
FACIT-F scale measures the impact of fatigue caused by the treatment of chronic diseases. It consists of 13 items, with a score between 13 and 65. A higher score on the scale indicates more fatigue
Measured: 12 weeks
Anxiety and depression using the Hospital Anxiety and Depression Scale
The HADS measures core symptoms of anxiety and depression without including physical symptoms. It is a short questionnaire that is easy to use. It consists of an anxiety scale and a depression scale, both containing 7 items with a total score from 0-21 where the higher the score, the more complaints. A score higher than 8 can be an indication for a psychiatric condition
Measured: 12 weeks
Quality of life using the McGill Quality Of Life questionnaire
The McGill Quality of Life Questionnaire measures multiple dimensions and overall quality of life of people with a life-threatening illness. It measures quality of life according to 5 domains: physical symptoms, physical well-being, psychological, existential and support. A scale of 0-10 is used for each question with anchors at each end. The scores consist of three parts: (1) Part "A" is a Single-Item Scale (MQOL-SIS) that measures overall quality of life, (2) five subscales discussed above, and (3) a total score that is the average of the five subscales. Before calculating the MQOL scores, the scores for items 1, 2, 3, 5, 6, 7, and 8 must be converted by subtracting the raw score for each item from 10. For the results we only look at the third part, namely the total score. A higher score means a better quality of life
Measured: 12 weeks
Physical functioning using the Patient-Reported Outcomes Measurement Information System
The PROMIS-PF includes many questionnaires in the areas of physical, mental and social health that can be used in the general population and in individuals suffering from chronic conditions. In our study we use the PROMIS for Physical Functioning, which is a 5-point scale where 1 = effortless and 10 = impossible. The score range goes from 10 to 50. A higher PROMIS score represents more of the concept being measured. So the higher the score, the better the physical functioning
Measured: 12 weeks
Patient Specific Complaints
The PSC can be used to gain insight into the activities that a patient has difficulty with because of his/her symptoms. The patient is asked to name three activities in which he/she experiences discomfort in daily life or has difficulty with because of his/her symptoms or condition, and that he/she would like to improve with the therapy. The selected activities are scored on the amount of effort it takes him/her to perform this activity on an 11-point scale, where 0 = no effort at all and 10 = impossible. The total score is calculated by averaging the three individual scores. The higher the score, the more problems are experienced in performing the actions
Measured: 12 weeks
Global Perceived Effect
The GPE can be used to measure the patient's opinion of recovery. The GPE consists of 2 items that must be answered on a 7-point scale. The scale runs from fully recovered to worse than ever. The first item is about "To what extent have you recovered from your complaints since the start of the treatment?" where 7 = worse than ever and 0 = completely improved. The second item is about "How satisfied are you with your treatment?". This scale goes from 7 = absolutely dissatisfied and 0 = absolutely satisfied
Measured: 12 weeks
Attendance: number of times the participant was present
By attendance we mean the number of times the participant was present during the rehabilitation.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start5 Jun 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
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 Universitaire Ziekenhuizen KU LeuvenThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3-arm randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- An De Groef, Prof, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455385
- Sponsor's protocol ID
- s63338
- Status last verified
- Jun 2022
- First submitted
- 7 Jul 2022
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Added Value of a Third Supervised Training Session (Ground Exercises or Hydrotherapy) to a Standard 12-week Rehabilitation Program After Breast Cancer: Pilot Study
- ClinicalTrials.gov ID
- NCT05455385
- Acronym / sponsor ID
- s63338
- Conditions
- Breast Cancer
- Keywords
- rehabilitation, hydrotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 5 Jun 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 13 Jul 2022 (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.
Breast cancer is the most common type of cancer diagnosed in women. A good rehabilitation program is essential for a good recovery after breast cancer, both physically and mentally. The aim of this study is to determine if there is an added value of a third supervised training session within a standard 12-week rehabilitation program to improve physical and mental functioning after breast cancer. The investigators also want to determine the added value of hydrotherapy as a third training session within a 12-week rehabilitation program compared to a third training session with ground exercises to improve physical and mental functioning after breast cancer.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 3-arm randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: standard 12-week rehabilitation program |
| Hydrotherapy group | Experimental | Other: standard 12-week rehabilitation program, Other: extra session hydrotherapy |
| Ground exercise group | Experimental | Other: standard 12-week rehabilitation program, Other: extra session ground exercises |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- men and women after surgery for breast cancer (mastectomy/breast-conserving and/or axillary gland resection/sentinel biopsy)
- possible (neo)adjuvant chemotherapy and radiotherapy have been completed
- hormone and/or immunotherapy may still be ongoing
Key exclusion criteria (6 listed)
- comorbidities that make hydrotherapy impossible, i.e. open wounds or allergy to chlorine
- oncological unstable disease
- terminal patients
- severe physical disabilities
- severe mental disabilities
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 |
|---|---|---|
| standard 12-week rehabilitation programThe standard program consisted of 1 session in the fitness room and 1 session in the sports hall/week during 12 weeks. | Other | Control group, Ground exercise group, Hydrotherapy group |
| extra session hydrotherapyThe hydrotherapy group receives 1.5h additional hydrotherapy/week in addition to the standard program. | Other | Hydrotherapy group |
| extra session ground exercisesThe ground exercise group, receives 1.5h ground exercises/week in addition to the standard program. | Other | Ground exercise group |
Primary outcome
Shoulder mobility
Time frame: 12 weeks
Shoulder Range of Motion (ROM) is measured with a Dr. Rippstein Plurimeter-V analogue inclinometer
Arm volume
Time frame: 12 weeks
Arm circumference measurements are performed bilaterally using a perimeter, a flexible stainless-steel rod with a measuring tape attached every 4 cm and a 20 g weight at the end.Arm circumference is measured at the level of the olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal to the olecranon. The volume of the arm is calculated using a formula. The relatively excessive arm volume is then calculated as follows: (volume of operated limb - volume of non-operated limb) / volume of non-operated limb) x 100.
Force based on handgrip strength
Time frame: 12 weeks
Handgrip strength is measured with the Jamar Handheld Dynamometer
Flexibility by means of the sit-and-reach test
Time frame: 12 weeks
The Sit and reach test is one of the linear flexibility tests which helps to measure the extensibility of the hamstrings and lower back.
Exercise capacity based on 6-minute walk test
Time frame: 12 weeks
The 6-minute walk test is used to assess patients' gait pattern, walking speed and cardiorespiratory endurance. It measures the maximum distance the patient can comfortably cover in 6 minutes.
Body image using the Body Image Scale
Time frame: 12 weeks
The BIS is a patient-reported outcome measure to evaluate the body image during and after cancer treatment. The BIS consists of 10 items and measures cognitive, affective and behavioral symptoms of body image. It uses a 4-point scale, where 0 = not at all and 3 = very much. The total score ranges from 0 to 30 and can be calculated by adding the 10 items together. The higher the score, the higher the level of body image disturbance.
self-reported pain using the Brief Pain Inventory
Time frame: 12 weeks
The BPI measures the severity of pain symptoms and interference with daily functioning using an 11-point scale. It has 4 questions for pain (worst pain, least pain, average pain and pain right now) and 7 for pain-related functioning (general physical activity, mood, ability to walk, work and household tasks, relationships with others, sleep, vitality). The total score is calculated by averaging all the different questions. A higher score indicates a higher barrier
Fatigue using the Functional Assessment of Chronic Illness Therapy - Fatigue Scale
Time frame: 12 weeks
FACIT-F scale measures the impact of fatigue caused by the treatment of chronic diseases. It consists of 13 items, with a score between 13 and 65. A higher score on the scale indicates more fatigue
Anxiety and depression using the Hospital Anxiety and Depression Scale
Time frame: 12 weeks
The HADS measures core symptoms of anxiety and depression without including physical symptoms. It is a short questionnaire that is easy to use. It consists of an anxiety scale and a depression scale, both containing 7 items with a total score from 0-21 where the higher the score, the more complaints. A score higher than 8 can be an indication for a psychiatric condition
Quality of life using the McGill Quality Of Life questionnaire
Time frame: 12 weeks
The McGill Quality of Life Questionnaire measures multiple dimensions and overall quality of life of people with a life-threatening illness. It measures quality of life according to 5 domains: physical symptoms, physical well-being, psychological, existential and support. A scale of 0-10 is used for each question with anchors at each end. The scores consist of three parts: (1) Part "A" is a Single-Item Scale (MQOL-SIS) that measures overall quality of life, (2) five subscales discussed above, and (3) a total score that is the average of the five subscales. Before calculating the MQOL scores, the scores for items 1, 2, 3, 5, 6, 7, and 8 must be converted by subtracting the raw score for each item from 10. For the results we only look at the third part, namely the total score. A higher score means a better quality of life
Physical functioning using the Patient-Reported Outcomes Measurement Information System
Time frame: 12 weeks
The PROMIS-PF includes many questionnaires in the areas of physical, mental and social health that can be used in the general population and in individuals suffering from chronic conditions. In our study we use the PROMIS for Physical Functioning, which is a 5-point scale where 1 = effortless and 10 = impossible. The score range goes from 10 to 50. A higher PROMIS score represents more of the concept being measured. So the higher the score, the better the physical functioning
Patient Specific Complaints
Time frame: 12 weeks
The PSC can be used to gain insight into the activities that a patient has difficulty with because of his/her symptoms. The patient is asked to name three activities in which he/she experiences discomfort in daily life or has difficulty with because of his/her symptoms or condition, and that he/she would like to improve with the therapy. The selected activities are scored on the amount of effort it takes him/her to perform this activity on an 11-point scale, where 0 = no effort at all and 10 = impossible. The total score is calculated by averaging the three individual scores. The higher the score, the more problems are experienced in performing the actions
Global Perceived Effect
Time frame: 12 weeks
The GPE can be used to measure the patient's opinion of recovery. The GPE consists of 2 items that must be answered on a 7-point scale. The scale runs from fully recovered to worse than ever. The first item is about "To what extent have you recovered from your complaints since the start of the treatment?" where 7 = worse than ever and 0 = completely improved. The second item is about "How satisfied are you with your treatment?". This scale goes from 7 = absolutely dissatisfied and 0 = absolutely satisfied
Attendance: number of times the participant was present
Time frame: 12 weeks
By attendance we mean the number of times the participant was present during the rehabilitation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
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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.
An De Groef, Prof principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard 12-week rehabilitation program, extra session hydrotherapy and extra session ground exercises in people with Breast Cancer, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 14 Jul 2022. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder mobility (time frame: 12 weeks). The study lists 14 primary outcomes in all. 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 14 Jul 2022.