The Added Value of a Third Supervised Training Session to a Standard 12-week Rehabilitation Program After Breast Cancer: Pilot Study
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
standard 12-week rehabilitation program
extra session hydrotherapy
extra session ground exercises
Sponsored by

About this trial
This is an interventional other trial for Breast Cancer focused on measuring rehabilitation, hydrotherapy
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- University Hospital Leuven
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Control group
Hydrotherapy group
Ground exercise group
Arm Description
Outcomes
Primary Outcome Measures
Shoulder mobility
Shoulder Range of Motion (ROM) is measured with a Dr. Rippstein Plurimeter-V analogue inclinometer
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.
Force based on handgrip strength
Handgrip strength is measured with the Jamar Handheld Dynamometer
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.
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.
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.
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
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
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
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
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
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
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
Attendance: number of times the participant was present
By attendance we mean the number of times the participant was present during the rehabilitation.
Secondary Outcome Measures
Full Information
NCT ID
NCT05455385
First Posted
July 7, 2022
Last Updated
July 13, 2022
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT05455385
Brief Title
The Added Value of a Third Supervised Training Session to a Standard 12-week Rehabilitation Program After Breast Cancer: Pilot 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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 5, 2021 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
January 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
rehabilitation, hydrotherapy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3-arm randomized controlled trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Title
Hydrotherapy group
Arm Type
Experimental
Arm Title
Ground exercise group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
standard 12-week rehabilitation program
Intervention Description
The standard program consisted of 1 session in the fitness room and 1 session in the sports hall/week during 12 weeks.
Intervention Type
Other
Intervention Name(s)
extra session hydrotherapy
Intervention Description
The hydrotherapy group receives 1.5h additional hydrotherapy/week in addition to the standard program.
Intervention Type
Other
Intervention Name(s)
extra session ground exercises
Intervention Description
The ground exercise group, receives 1.5h ground exercises/week in addition to the standard program.
Primary Outcome Measure Information:
Title
Shoulder mobility
Description
Shoulder Range of Motion (ROM) is measured with a Dr. Rippstein Plurimeter-V analogue inclinometer
Time Frame
12 weeks
Title
Arm volume
Description
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.
Time Frame
12 weeks
Title
Force based on handgrip strength
Description
Handgrip strength is measured with the Jamar Handheld Dynamometer
Time Frame
12 weeks
Title
Flexibility by means of the sit-and-reach test
Description
The Sit and reach test is one of the linear flexibility tests which helps to measure the extensibility of the hamstrings and lower back.
Time Frame
12 weeks
Title
Exercise capacity based on 6-minute walk test
Description
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.
Time Frame
12 weeks
Title
Body image using the Body Image Scale
Description
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.
Time Frame
12 weeks
Title
self-reported pain using the Brief Pain Inventory
Description
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
Time Frame
12 weeks
Title
Fatigue using the Functional Assessment of Chronic Illness Therapy - Fatigue Scale
Description
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
Time Frame
12 weeks
Title
Anxiety and depression using the Hospital Anxiety and Depression Scale
Description
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
Time Frame
12 weeks
Title
Quality of life using the McGill Quality Of Life questionnaire
Description
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
Time Frame
12 weeks
Title
Physical functioning using the Patient-Reported Outcomes Measurement Information System
Description
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
Time Frame
12 weeks
Title
Patient Specific Complaints
Description
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
Time Frame
12 weeks
Title
Global Perceived Effect
Description
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
Time Frame
12 weeks
Title
Attendance: number of times the participant was present
Description
By attendance we mean the number of times the participant was present during the rehabilitation.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
An De Groef, Prof
Organizational Affiliation
KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
The Added Value of a Third Supervised Training Session to a Standard 12-week Rehabilitation Program After Breast Cancer: Pilot Study
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