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NCT Number: NCT07529496

The Effect of Psychosocial Support on Improving Breast Cancer 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.

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?

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Key information

Conditions

Breast Cancer - Female

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tala MZ Abu Awad, Medical student /study coordin

CONTACT

[email protected]

+972 586044430

Sponsors and collaborators

Lead sponsor

Al-Quds University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 14, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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