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| Name | Class |
|---|---|
| Cyprus Anticancer Society | UNKNOWN |
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This is a randomized control trial to test the effectiveness of therapeutic massage on the sleep quality and the stress levels in women that have completed their treatment for breast cancer.
The period following the completion of treatment for breast cancer (but also for any other type of cancer as well) is once that is accompanied by an increased uncertainty. This can often trigger increased anxiety levels and sleep disturbances. This trial tests the effectiveness of therapeutic massage as a non pharmaceutical intervention that can increase the management of stress and sleep disturbances during this period of time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapeutic massage | Experimental | Women will undertake sessions of therapeutic massage |
|
| Sham massage | Sham Comparator | Women will undertake sessions of sham massage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic massage | Other | Massage therapy involves the administration of combinations of specific physical manipulations applied in a systematic way, with varying intensity, direction, rate, and rhythm, to the soft tissues of the body. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Disturbances (insomnia) | Athens insomnia scale (The AIS is a self-assessment psychometric instrument designed for quantifying sleep difficulty based on the ICD-10 criteria. It consists of eight items: the first five pertain to sleep induction, awakenings during the night, final awakening, total sleep duration, and sleep quality; while the last three refer to well-being, functioning capacity, and sleepiness during the day). Each item of the AIS can be rated 0-3, (with 0 corresponding to no problem at all and 3 to very serious problem); thus, the total score ranges from 0 (absence of any sleep-related problem) to 24 (the most severe degree of insomnia). | Change from baseline total score at 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety | Hamilton Anxiety Rating Scale (HAM-A). The scale consists of 14 items. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. | Change from baseline total score at 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Women with Breast Cancer
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Charalambous, PhD | Cyprus University of Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Centre | Nicosia | 2006 | Cyprus |
Demographic information can be shared
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| ID | Term |
|---|---|
| D020447 | Parasomnias |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008405 | Massage |
| ID | Term |
|---|---|
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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therapeutic massage vs sham massage
| Sham massage | Other | Sham massage involves only light touch massage in a non systematic way |
|
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |