Breast Cancer - Female
Conditions
Brief summary
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. 1. Do psychosocial interventions affect the response to breast cancer treatment? 2. How do societal attitudes toward psychological and social care influence the willingness of breast cancer patients in Palestine to seek psychosocial interventions?
Interventions
BEHAVIORALPsychosocial Therapy
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.
OTHERStandard Medical Treatment
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.
Sponsors
Al-Quds University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* age between 20-40 Being Palestinian female from west bank and Jerusalem * Diagnosed with stage I-III breast cancer. * Currently receiving active medical treatment. * Able to provide consent and participate in the intervention.
Exclusion criteria
* being male. * holding other nationalities than Palestinian or living outside the westbank or Jerusalem. * Younger than 20 or older than 40 years old. * Uncooperative with interviewer * Terminally ill (stage IV). * Receiving palliative care only.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breast cancer-specific quality of life assessed by the Functional Assessment of Cancer Therapy - Breast (FACT-B) | Baseline and 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety level assessed by the Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A) | Baseline and 6 weeks | 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. |
| Health-related quality of life assessed by the 36-item short form health survey (SF-36) | Baseline and 6 weeks | 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. |
Countries
Palestinian Territories
Contacts
CONTACTTala MZ Abu Awad, Medical student /study coordin
Outcome results
None listed