Breast Cancer - FemaleNCT07529496
The Effect of Psychosocial Support on Improving Breast Cancer Patients Response to Medical Treatment
A study testing Psychosocial Therapy and Standard Medical Treatment in people with Breast Cancer - Female, run by Al-Quds University at 1 site in Palestinian Territories.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Breast Cancer - Female
- What is being tested?
- Psychosocial Therapy and Standard Medical Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 1 May 2026to 15 Jan 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Palestinian Territories1 site
Al-Quds university
East Jerusalem
Hania Obaid, +972 599394786, Haniaessawi@gmail.com
About this study
Official title: A Randomized Controlled Trial Assessing the Effect of Psychosocial Support on Improving Breast Cancer's Patients Response to Medical Treatment
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.
- Do psychosocial interventions affect the response to breast cancer treatment?
- How do societal attitudes toward psychological and social care influence the willingness of breast cancer patients in Palestine to seek psychosocial interventions?
- Conditions
- Breast Cancer - Female
- Being tested
- Psychosocial Therapy, Standard Medical Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial TherapyBehavioural
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 TreatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Psychosocial intervention | Experimental | Not described Receives: Behavioral: Psychosocial Therapy; Other: Standard Medical Treatment |
| Standard medical treatment | Active comparator | Not described Receives: Other: Standard Medical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion20 Aug 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer - FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Quds University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Hania Obaid, Al-Quds University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529496
- Sponsor's protocol ID
- 640/REC/2025
- Status last verified
- Apr 2026
- First submitted
- 22 Jan 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18706078Ho 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.
PubMed 4092690Corry 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.
PubMed 23341516