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The goal of this clinical trial is to evaluate the effect of psychosocial therapy on improving treatment response among breast cancer patients receiving chemotherapy. Participants will be randomized to receive standard medical treatment alone or combined with structured psychosocial therapy. Outcomes include treatment response, psychological well-being, and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psychosocial intervention | Experimental |
| |
| Standard medical treatment | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychosocial Therapy | Behavioral | The psychosocial therapy consists of structured, individual, in-person counseling sessions designed to provide emotional support, enhance coping skills, and address psychological and social challenges experienced by breast cancer patients during treatment. The intervention is delivered by trained mental health professionals and focuses on improving patients' psychological well-being and treatment response. |
| Measure | Description | Time Frame |
|---|---|---|
| Breast cancer-specific quality of life assessed by the Functional Assessment of Cancer Therapy - Breast (FACT-B) | Breast cancer-specific quality of life will be assessed using the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire. The FACT-B is a 37-item instrument assessing physical, social/family, emotional, functional well-being, and additional breast cancer concerns. Total scores range from 0 to 148, with higher scores indicating better quality of life. | Baseline and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety level assessed by the Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A) | Psychological distress will be assessed using the Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item questionnaire consisting of two subscales: anxiety and depression. Each subscale score ranges from 0 to 21, with higher scores indicating greater psychological distress and worse outcomes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tala MZ Abu Awad, Medical student /study coordin | Contact | +972 586044430 | talaabuawad2003@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al-Quds university | East Jerusalem | Palestinian Territories |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18706078 | Result | Sriram KB, Thornton A, Antic R. Spontaneous mode non-invasive ventilation fails to treat respiratory failure in a patient with Multi-mincore disease: a case report. Cases J. 2008 Aug 15;1(1):93. doi: 10.1186/1757-1626-1-93. | |
| 4092690 | Result | Ho PS, Frederick CA, Quigley GJ, van der Marel GA, van Boom JH, Wang AH, Rich A. G.T wobble base-pairing in Z-DNA at 1.0 A atomic resolution: the crystal structure of d(CGCGTG). EMBO J. 1985 Dec 16;4(13A):3617-23. doi: 10.1002/j.1460-2075.1985.tb04125.x. |
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| Standard Medical Treatment | Other | Standard oncological medical treatment for breast cancer as prescribed by the treating physician, which may include chemotherapy, radiotherapy, hormonal therapy, or targeted therapy according to clinical guidelines. |
|
| Baseline and 6 weeks |
| Health-related quality of life assessed by the 36-item short form health survey (SF-36) | Health-related quality of life will be assessed using the Short Form-36 Health Survey (SF-36). The SF-36 is a 36-item questionnaire measuring eight domains of physical and mental health. Domain scores are transformed to a scale ranging from 0 to 100, with higher scores indicating better health-related quality of life. | Baseline and 6 weeks |
| 23341516 | Result | Corry J, Peters L, Kleid S, Rischin D. Larynx preservation for patients with locally advanced laryngeal cancer. J Clin Oncol. 2013 Mar 1;31(7):840-4. doi: 10.1200/JCO.2012.46.9197. Epub 2013 Jan 22. |