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This study will use polysomnography, alongside other methodologies such as questionnaires, actigraphic measurements and salivary melatonin samples used in previous studies to investigate sleep quality in patients with i) localized, locally advanced or metastatic hormone sensitive prostate cancer or ii) with full-resected early (stage I-III) epithelial breast cancer. The measurements will be taken before androgen deprivation therapy (ADT - for prostate cancer patients) or endocrine therapy (for breast cancer patients) is initiated, at 6 months and some measures again at 12 months.The groups, defined by cancer type and whether or not treatment includes ADT / endocrine therapy, will be compared to see if there are differences in the prevalence of the lowered sleep quality in the groups.
The main outcomes of this pilot study can be summarised as:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Group A1 consists of patients with prostate cancer receiving ADT as part of their standard care for either locally advanced or metastatic disease. Group A1 consists of a combination of two groups; B1, metastatic patients receiving ADT both with and without an oral AR targeted agent, and not receiving radiotherapy and B2, locally advanced patients receiving ADT alongside radiotherapy |
| |
| A2 | patients with localised prostate cancer receiving radiotherapy only |
| |
| YET | Breast cancer survivors receiving endocrine therapy |
| |
| NET | Breast cancer survivors not receiving endocrine therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| polysomnography, actigraphy, questionnaires | Device | sleep quality recording |
|
| Measure | Description | Time Frame |
|---|---|---|
| difference in sleep quality | The two groups considered will be group A1, and group A2. This will demonstrate whether there is a difference in sleep quality between these two groups of patients. The difference between time points will establish correlation between treatment initiation and symptom onset, the between group analysis will test whether the link seems to be radiotherapy alone or whether ADT further decreases sleep quality | 1 year |
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Inclusion Criteria for prostate cancer patients:
Exclusion Criteria for prostate cancer patients:
Inclusion criteria for breast cancer patients
Exclusion criteria for breast cancer patients
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i) Patients with localized, locally advanced or metastatic hormone-sensitive prostate cancer receiving standard of care treatment (including radiotherapy with or without androgen-deprivation treatment (ADT) or ADT alone +/- androgen receptor targeted agent) dependent on disease stage ii) Patients with full-resected early (stage I-III) epithelial BC, ductal carcinoma in situ or lobular carcinoma in situ, without evidence of residual disease
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ursula Vogl, MD | Contact | +419181113308463 | ursula.vogl@eoc.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IOSI | Recruiting | Bellinzona | 6500 | Switzerland |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D017286 | Polysomnography |
| D056044 | Actigraphy |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D008991 | Monitoring, Physiologic |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D061725 | Accelerometry |
| D008919 | Investigative Techniques |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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