Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

The standard program consisted of 1 session in the fitness room and 1 session in the sports hall/week during 12 weeks.

standard 12-week rehabilitation program

The hydrotherapy group receives 1.5h additional hydrotherapy/week in addition to the standard program.

extra session hydrotherapy

The ground exercise group, receives 1.5h ground exercises/week in addition to the standard program.

extra session ground exercises

An De Groef, Prof

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.

The Added Value of a Third Supervised Training Session to a Standard 12-week Rehabilitation Program After Breast Cancer: Pilot Study

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

Shoulder Range of Motion (ROM) is measured with a Dr. Rippstein Plurimeter-V analogue inclinometer

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.

Handgrip strength is measured with the Jamar Handheld Dynamometer

The Sit and reach test is one of the linear flexibility tests which helps to measure the extensibility of the hamstrings and lower back.

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.

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.

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

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

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

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

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

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

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

By attendance we mean the number of times the participant was present during the rehabilitation.

Universitaire Ziekenhuizen KU Leuven

Symptoms and General Pathology

Hot Flashes

Amenorrhea

Menstruation Disturbances

Menopause

immediate start of hydrotherapy (self treatment) in immediate treatment group (SBG)

start of hydrotherapy (self treatment) after waiting period of 12 weeks

2-5 applications of hydrotherapy according to Kneipp rules (self application) per day

hydrotherapy according to Kneipp rules

Bernhard Uehleke, Dr.med. Dr.rer.nat. (PhD)

Breast cancer survivors often suffer from climacteric symptoms caused by treatment or diagnosis of their disease.

Hormone replacement therapy is contraindicated and other pharmacological options may also include the risk of stimulating hormone receptors. Hydrotherapy following the guidelines of naturopathy by S. Kneipp is a non-pharmacological treatment option which may influence climacteric symptoms by affecting the regulation of body temperature. In this study, the regular self application of hydrotherapy after initial training by a professional will be evaluated for its efficacy, practicability, and compatibility.

Patients should use 2-5 different treatment options per day and fulfill a diary for symptoms and adherence to self-treatment for 12 weeks.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Added Value of a Third Supervised Training Session to a Standard 12-week Rehabilitation Program After Breast Cancer: Pilot Study	NCT05455385	Breast Cancer	standard 12-wee... extra session h... extra session g...	18 Years -	Universitaire Ziekenhuizen KU Leuven
Hydrotherapy Against Menopausal Symptoms in Breast Cancer Survivors	NCT00243607	Amenorrhea Hot Flashes	hydrotherapy ac...	18 Years -	Heidelberg University
The Added Value of a Third Supervised Training Session to a Standard 12-week Rehabilitation Program After Breast Cancer: Pilot Study	NCT05455385	Breast Cancer	standard 12-wee... extra session h... extra session g...	18 Years -	Universitaire Ziekenhuizen KU Leuven

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