Psychoeducation and Well-Being After Breast Cancer

NCT ID: NCT07284030

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2026-02-01

Brief Summary

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This randomized controlled trial evaluates the effectiveness of a web-based psychoeducation program on psychological well-being and quality of life in breast cancer survivors who completed active treatment at least one year earlier.

Seventy-two women will be randomly assigned to either a 6-week online psychoeducation program plus standard care or standard care alone. The intervention consists of weekly 30-45 minute online sessions focusing on coping strategies, psychosocial adjustment, quality of life, and psychological well-being.

Primary outcomes include psychological well-being, fear of cancer recurrence, quality of life, and hopelessness, assessed at baseline, post-intervention, and 2-month follow-up.

Detailed Description

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This randomized controlled study investigates the effects of a structured web-based psychoeducation program on psychological outcomes in breast cancer survivors who have completed active treatment and are in remission for at least one year.

Eligible participants will be randomly allocated to an intervention group or a control group. The intervention group will receive a 6-week web-based psychoeducation program in addition to standard care, while the control group will receive standard care alone. The program is delivered through the online platform www.onkodestek.org and includes weekly live sessions conducted via Zoom, each lasting approximately 30-45 minutes.

The psychoeducation program addresses coping with breast cancer survivorship, psychosocial challenges, enhancement of psychological well-being, improvement of quality of life, and development of hope and meaning in life.

Psychological well-being, fear of cancer recurrence, quality of life, and hopelessness will be assessed at baseline, immediately after the intervention, and at 2-month follow-up using validated self-report measures. After study completion, participants in the control group will be granted access to the psychoeducation platform.

This study aims to assess whether web-based psychoeducation provides measurable psychological benefits for breast cancer survivors during the post-treatment survivorship period.

Conditions

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Breast Cancer Breast Cancer Survivors Breast - Female Psycho-Oncology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-arm parallel group randomized controlled trial comparing web-based psychoeducation program plus standard care versus standard care alone in breast cancer survivors.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

This is an open-label study where masking is not feasible due to the nature of the intervention. Participants in the intervention group actively engage in weekly online psychoeducation sessions via Zoom and access the study website (www.onkodestek.org), while the control group receives standard care only. Both participants and researchers are aware of group allocation. The interactive nature of the psychoeducation program and direct participant-researcher contact during sessions make blinding impossible.

Study Groups

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Intervention Group

Participants receive a 6-week web-based psychoeducation program plus standard care

Group Type EXPERIMENTAL

Web-Based Psychoeducation Program

Intervention Type BEHAVIORAL

Six-week structured psychoeducation program delivered online through www.onkodestek.org website and weekly Zoom sessions. Topics include living with breast cancer, managing psychosocial issues, improving quality of life, psychological well-being, and finding hope and meaning. Each session lasts 30-45 minutes.

Control Group

Participants receive standard care only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Web-Based Psychoeducation Program

Six-week structured psychoeducation program delivered online through www.onkodestek.org website and weekly Zoom sessions. Topics include living with breast cancer, managing psychosocial issues, improving quality of life, psychological well-being, and finding hope and meaning. Each session lasts 30-45 minutes.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Female breast cancer survivors
* Completed active breast cancer treatment (surgery, chemotherapy, radiotherapy) at least 12 months ago
* Currently in remission (no evidence of active disease)
* Age between 18-65 years
* Able to read and write Turkish
* Access to computer or smartphone with internet connection
* Able to participate in online video sessions via Zoom
* Willing to provide informed consent

Exclusion Criteria

* Current cancer recurrence or metastatic disease
* Active psychiatric disorder requiring treatment
* Cognitive impairment that prevents participation in online sessions
* Currently receiving active cancer treatment (excluding hormonal therapy)
* Participation in another psychosocial intervention study
* No internet access or inability to use web-based platforms
* Male breast cancer patients
* Unable to commit to 6-week program schedule
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Yasemin Nazli

OTHER

Sponsor Role lead

Responsible Party

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Yasemin Nazli

Advanced Practice Nurse

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Breast Cancer Outpatient Clinic

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Yasemin Nazlı, Clinical Nurse Specialist

Role: CONTACT

+905325025158

Facility Contacts

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Yasemin Nazlı, MSc

Role: primary

+9005325025158

References

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Karsten MM, Roehle R, Albers S, Pross T, Hage AM, Weiler K, Fischer F, Rose M, Kuhn F, Blohmer JU. Real-world reference scores for EORTC QLQ-C30 and EORTC QLQ-BR23 in early breast cancer patients. Eur J Cancer. 2022 Mar;163:128-139. doi: 10.1016/j.ejca.2021.12.020. Epub 2022 Jan 20.

Reference Type BACKGROUND
PMID: 35066338 (View on PubMed)

Mateu P, Teixidor-Batlle C, Suarez-Alcazar MP, Salas-Medina P, Catala-Vilaplana I, Hernando-Domingo C, Muriach M, Collado-Boira E. A qualitative case study of body image in women with breast cancer participating in an exercise program. Support Care Cancer. 2025 Oct 1;33(10):893. doi: 10.1007/s00520-025-09963-z.

Reference Type BACKGROUND
PMID: 41032141 (View on PubMed)

Other Identifiers

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UskudarU 22.07.2024

Identifier Type: -

Identifier Source: org_study_id