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NCT07724314

Overview

NCT ID: NCT07724314
Lead Sponsor: Gulay AkmanOTHER
Official Title: Effect of a Web-Based Alopecia Education Program on Body Image, Self-Esteem, Quality of Life, and Well-Being Among Women With Breast Cancer: A Randomized Controlled Trial
Brief Summary: This randomized controlled trial evaluated the effects of a web-based alopecia education program on body image, self-esteem, chemotherapy-induced alopecia-related quality of life, and psychological well-being among women with breast cancer receiving chemotherapy. A total of 68 women were randomly assigned to the intervention or routine-care control group. Participants in the intervention group received access to a web-based educational and supportive care program throughout chemotherapy, whereas participants in the control group received routine care. Outcomes were assessed at predefined time points before the first, second, and final chemotherapy cycles.
Conditions: Breast Cancer
Chemotherapy-Induced Alopecia

Status and Timeline

Status: Completed
Last Update Posted: Jul 24, 2026Actual
Start Date: Jul 2, 2018Actual
Primary Completion Date: May 3, 2019Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Female participants aged 18 to 65 years.

Diagnosed with stage I or stage II breast cancer.

Receiving chemotherapy for the first time.

Scheduled to receive one of the following 21-day chemotherapy regimens: doxorubicin plus cyclophosphamide (AC); epirubicin plus cyclophosphamide (EC); docetaxel plus cyclophosphamide (TC); cyclophosphamide, doxorubicin, and fluorouracil (CAF); cyclophosphamide, epirubicin, and fluorouracil (CEF); or docetaxel, doxorubicin, and cyclophosphamide (TAC).

Scheduled to receive a chemotherapy regimen expected to cause grade 2 alopecia according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 (NCI-CTCAE v4.03).

Eastern Cooperative Oncology Group (ECOG), World Health Organization (WHO), or Zubrod performance status of 0 to 2.

Able to read, write, and communicate in Turkish.

Had access to a computer or internet-enabled mobile phone.

Willing to participate in the study and provide informed consent.

Exclusion Criteria:

Diagnosed with stage III or stage IV breast cancer.

History of another malignancy.

History of alopecia before the current chemotherapy treatment.

Previous mastectomy.

History of a disease or condition that caused a visible alteration in physical appearance.

Diagnosed psychiatric disorder.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 68Actual
Primary Purpose: Supportive Care
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: No data available
Locations: Samsun Training and Research Hospital

Similar Studies

Participant Group/Arms

Web-Based Alopecia Education GroupExperimental

Participants received routine care in addition to access to the web-based alopecia education program during chemotherapy. The program provided structured information and supportive guidance on chemotherapy-induced alopecia, preparation for hair loss, hair and scalp care, appearance management, and coping with the psychosocial effects of alopecia.

Behavioral: Web-Based Alopecia Education Program

Routine Care Control GroupNo Intervention

Participants received routine care provided by the chemotherapy unit and did not receive access to the web-based alopecia education program during the study period.