- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07724314
Effects of a Web-Based Alopecia Education Program in Women With Breast Cancer
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Chemotherapy-induced alopecia is a visible and potentially distressing adverse effect of breast cancer treatment that may affect women's body image, self-esteem, quality of life, and psychological well-being. Providing timely, structured, and accessible information may support women in preparing for hair loss and managing its psychosocial consequences.
This study was conducted as a single-blind, parallel-group randomized controlled trial. Women with breast cancer who were receiving chemotherapy for the first time were allocated to a web-based alopecia education program or routine care. The education program was developed to provide evidence-based information about chemotherapy-induced alopecia, expected changes in hair and scalp, strategies for preparation and self-care, options for managing appearance-related concerns, and approaches for coping with the emotional and social effects of hair loss. Participants were able to access the educational content through the web during their chemotherapy treatment. The study examined whether the web-based education program improved body image, self-esteem, alopecia-related quality of life, and psychological well-being compared with routine care. The usability of the web-based program was also evaluated among participants who received the intervention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Samsun
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Samsun, Samsun, Turkey (Türkiye), 55105
- Samsun Training and Research Hospital
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Web-Based Alopecia Education Group
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.
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A structured web-based educational and supportive care program designed for women with breast cancer receiving chemotherapy.
The program included information about chemotherapy-induced alopecia, the expected course of hair loss and regrowth, preparation before hair loss, hair and scalp care, use of wigs and head coverings, appearance-related concerns, and strategies for coping with emotional and social effects.
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No Intervention: Routine Care Control Group
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Image Scale Score
Time Frame: Baseline (immediately before the first chemotherapy cycle); Week 3 (immediately before the second chemotherapy cycle); and Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
|
Body image was assessed using the 40-item Body Image Scale.
Each item is scored from 1 to 5, yielding a total score ranging from 40 to 200.
Higher scores indicate greater satisfaction with body image, whereas scores below 135 indicate lower body-image satisfaction.
Changes in scores over time and differences between the web-based alopecia education group and the routine-care control group were evaluated.
|
Baseline (immediately before the first chemotherapy cycle); Week 3 (immediately before the second chemotherapy cycle); and Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
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|
Rosenberg Self-Esteem Scale Score
Time Frame: Baseline (immediately before the first chemotherapy cycle); Week 3 (immediately before the second chemotherapy cycle); and Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
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Self-esteem was assessed using the 10-item self-esteem subscale of the Rosenberg Self-Esteem Scale.
Items are scored from 0 to 3, yielding a total score ranging from 0 to 30, with higher scores indicating higher self-esteem.
Changes in scores over time and differences between the intervention and control groups were evaluated.
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Baseline (immediately before the first chemotherapy cycle); Week 3 (immediately before the second chemotherapy cycle); and Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
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WHO-5 Well-Being Index Score
Time Frame: Baseline (immediately before the first chemotherapy cycle); Week 3 (immediately before the second chemotherapy cycle); and Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
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Psychological well-being was assessed using the World Health Organization-Five Well-Being Index Score (WHO-5 Well-Being Index Score).
Each item is scored from 0 to 5, yielding a raw score ranging from 0 to 25.
The raw score was multiplied by four to obtain a percentage score ranging from 0 to 100.
Higher scores indicate better psychological well-being, whereas scores below 50 indicate low well-being and the need for further evaluation.
Changes in scores over time and differences between the web-based alopecia education group and the routine-care control group were evaluated.
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Baseline (immediately before the first chemotherapy cycle); Week 3 (immediately before the second chemotherapy cycle); and Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
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Chemotherapy-Induced Alopecia Quality of Life Scale Score
Time Frame: Week 3 (immediately before the second chemotherapy cycle) and Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
|
Alopecia-related quality of life was assessed using the 19-item Chemotherapy-Induced Alopecia Quality of Life Scale.
Each item is scored from 1 to 5, yielding a total score ranging from 19 to 95.
The scale comprises three subdomains: impact on general life, negative impact on inner life, and positive thoughts.
Items 2, 15, 16, and 17 are reverse scored.
Higher total scores indicate better alopecia-related quality of life, whereas lower scores indicate greater deterioration in quality of life.
The scale was administered before the second and final chemotherapy cycles; it was not administered before the first chemotherapy cycle because participants had not yet experienced chemotherapy-induced alopecia.
Changes in scores over time and differences between the web-based alopecia education group and the routine-care control group were evaluated.
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Week 3 (immediately before the second chemotherapy cycle) and Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alopecia Information Form-1
Time Frame: Week 3 (immediately before the second chemotherapy cycle; each chemotherapy cycle was 21 days).
|
Alopecia Information Form-1 (Alopecia Characteristics and Self-Care Practices) was a researcher-developed questionnaire based on the literature.
It assessed chemotherapy-induced alopecia severity using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 (NCI-CTCAE v4.03); scalp condition; distribution and onset of scalp hair loss; hair loss in other body regions; timing of hair loss in different body regions; and practices used to prevent, reduce, or manage hair loss.
The form also included items on employment status during treatment and the perceived impact of treatment-related expenses on the participant's budget.
The form did not generate a total score.
Responses were recorded as categorical variables and summarized as frequencies and percentages for the intervention and control groups.
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Week 3 (immediately before the second chemotherapy cycle; each chemotherapy cycle was 21 days).
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Alopecia Information Form-2
Time Frame: Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
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Alopecia Information Form-2 (Alopecia Management and Psychosocial Responses) was a researcher-developed questionnaire based on the literature.
It assessed chemotherapy-induced alopecia severity using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 (NCI-CTCAE v4.03); hair loss in other body regions; use of wigs, scarves, hats, or other appearance-management and camouflage methods; practices intended to promote hair regrowth; changes in mirror-viewing frequency; and thoughts and emotional responses related to scalp and body-hair loss.
The form did not generate a total score.
Responses were recorded as categorical variables and summarized as frequencies and percentages for the intervention and control groups.
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Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
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Web-Based Alopecia Education Program Evaluation Form
Time Frame: Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
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The acceptability and perceived usefulness of the web-based alopecia education program were assessed in the intervention group using a four-item researcher-developed Web-Based Alopecia Education Program Evaluation Form.
The form assessed whether the program helped participants cope with chemotherapy-induced alopecia, which section of the program was perceived as most helpful, whether any section was considered unhelpful, and whether participants would recommend the program to other women experiencing chemotherapy-induced alopecia.
The form did not generate a total score.
Responses were recorded as categorical variables and summarized as frequencies and percentages.
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Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
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System Usability Scale Score
Time Frame: Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
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The perceived usability of the web-based alopecia education program was assessed in the intervention group using the 10-item System Usability Scale.
Each item was rated on a 5-point response scale from 0 to 4. Negatively worded items were reverse scored.
Adjusted item scores were summed and multiplied by 2.5 to obtain a total score ranging from 0 to 100, with higher scores indicating greater perceived usability.
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Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
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Website Use
Time Frame: From baseline (immediately before the first chemotherapy cycle) through Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
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Website engagement was recorded through the administrative panel.
Measures included the total number of website visits and the cumulative duration of website use in minutes during the intervention period.
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From baseline (immediately before the first chemotherapy cycle) through Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gulay Akman, PhD, Faculty of Health Sciences, Ondokuz Mayıs University, Samsun, Turkey
- Study Chair: Hatice Balci Yangin, PhD, Faculty of Nursing, Akdeniz University, Antalya, Turkey
Publications and helpful links
General Publications
- Akman, G. (2019). Meme kanseri olan kadınlara uygulanan web tabanlı alopesi eğitim programının beden imajına, benlik saygısına, yaşam kalitesine ve iyilik durumuna etkisi [The effect of a web-based alopecia education program on body image, self-esteem, quality of life, and well-being among women with breast cancer] [Doctoral dissertation, Akdeniz University]. Council of Higher Education National Thesis Center.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIA-EDU-WEB-RCT-2019-01
- 54 (Other Identifier: Ondokuz Mayis University Clinical Research Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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