The Effect of Psychosocial Support on Improving Breast Cancer Patients Response to Medical Treatment
Breast Cancer - Female
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 20 years - 65 years
- Sex eligible
- Female
- Healthy volunteers
- Not accepted
- Participants
- 160 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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?
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- age between 20-65 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 65 years old.
- Uncooperative with interviewer
- Terminally ill (stage IV).
- Receiving palliative care only.
Note Regarding the Modification of the Eligibility Criteria - Age Range
Please note that one of the study eligibility criteria has been revised, specifically the age range, which has been expanded from 20-65 years for several reasons.
First, the youth age group in Palestine is defined as individuals aged 18-65 years. Second, the disease affects patients across a broad range of ages rather than being limited to a specific age group. Finally, given the political and socioeconomic challenges facing our study, which may limit the availability and recruitment of patients across different age groups, particularly younger individuals, expanding the age range was considered necessary to facilitate patient recruitment and ensure a more representative study population.
Therefore, broadening the age eligibility criteria was deemed a practical and methodologically appropriate adjustment to address these challenges while improving the feasibility of the study.
Understand screeningTreatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- No masking
Psychosocial intervention
Not reported in this registry record.
Behavioral: Psychosocial Therapy · Other: Standard Medical Treatment
Standard medical treatment
Not reported in this registry record.
Other: Standard Medical Treatment
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.
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.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Breast cancer-specific quality of life assessed by the Functional Assessment of Cancer Therapy - Breast (FACT-B)
Time frame: 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 measures
Anxiety level assessed by the Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A)
Time frame: 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)
Time frame: 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.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Al-Quds universityEast Jerusalem, Palestinian TerritoriesStatus unknown
Study team and timeline
- Lead sponsor
- Al-Quds University
- Study start
- Jul 30, 2027 Estimated
- Primary completion
- Jun 15, 2028 Estimated
- Study completion
- Dec 30, 2028 Estimated
- First posted
- Apr 14, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
A Randomized Controlled Trial Assessing the Effect of Psychosocial Support on Improving Breast Cancer's Patients Response to Medical Treatment
Ask Wellness Clinical Research
Your message goes to WCR, including when this study is run by another organization. WCR may offer general guidance but may not operate this trial, have access to its team or be able to enroll you.
Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026
