NCT07529496

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. 1.Do psychosocial interventions affect the response to breast cancer treatment?
  2. 2.How do societal attitudes toward psychological and social care influence the willingness of breast cancer patients in Palestine to seek psychosocial interventions?

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Expected
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2026

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2027

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

January 22, 2026

Last Update Submit

April 7, 2026

Conditions

Breast Cancer - Female

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and 6 weeks

Secondary Outcomes (2)

  • Anxiety level assessed by the Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A)

    Baseline and 6 weeks

  • Health-related quality of life assessed by the 36-item short form health survey (SF-36)

    Baseline and 6 weeks

Study Arms (2)

Psychosocial intervention

EXPERIMENTAL
Behavioral: Psychosocial TherapyOther: Standard Medical Treatment

Standard medical treatment

ACTIVE COMPARATOR
Other: Standard Medical Treatment

Interventions

Psychosocial TherapyBEHAVIORAL

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.

Psychosocial intervention
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.

Psychosocial interventionStandard medical treatment

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Quds university

East Jerusalem, Palestinian Territories

Location

Related Publications (3)

  • Sriram KB,Thornton A,Antic R

    RESULT

  • Ho PS,Frederick CA,Quigley GJ,van der Marel GA,van Boom JH,Wang AH,Rich A

    RESULT

  • 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: 23341516RESULT

Central Study Contacts

Tala MZ Abu Awad, Medical student /study coordin

CONTACT

+972 586044430talaabuawad2003@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Psychologist and Psychotherapist

Study Record Dates

First Submitted

January 22, 2026

First Posted

April 14, 2026

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

August 20, 2026

Study Completion (Estimated)

January 15, 2027

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)