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Not yet recruiting NCT07529496

The Effect of Psychosocial Support on Improving Breast Cancer Patients Response to Medical Treatment

No phase Interventional Breast Cancer - Female

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Psychosocial Therapy, Standard Medical Treatment.
Who it may be relevant to
Registry conditions: Breast Cancer - Female. Basic parameters: 20 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Palestinian Territories
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Randomized Controlled Trial Assessing the Effect of Psychosocial Support on Improving Breast Cancer's Patients Response to Medical Treatment

Overview

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

  • Behavioral Psychosocial 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.
  • Other Standard 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.

Primary outcome measures

  • Breast cancer-specific quality of life assessed by the Functional Assessment of Cancer Therapy - Breast (FACT-B) [Time frame: Baseline and 6 weeks]
Secondary outcome measures (2)
  • Anxiety level assessed by the Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A) [Time frame: Baseline and 6 weeks]
  • Health-related quality of life assessed by the 36-item short form health survey (SF-36) [Time frame: Baseline and 6 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Palestinian Territories · 1 center
  • Al-Quds university — East Jerusalem

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. PMID 18706078
  • 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. PMID 4092690
  • 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. PMID 23341516

Identifiers

NCT: NCT07529496 · 640/REC/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗