Women Diagnosed with Cancer & Reproductive Concerns & Watson's Human Caring Theory &Counselling

The Effect of Counseling Grounded in Watson's Human Caring Theory on Reproductive Concerns in Women Diagnosed with Cancer: a Randomized Controlled Study

This is a single-blind randomized controlled experimental study with a pre-test post-test design to examine the effects of counseling based on Watson's Human Caring Theory given to women between the ages of 18-45 diagnosed with cancer on fertility concerns.

Study Overview

• Status: Completed
• Conditions: Reproductive Health
• Intervention / Treatment: Other: Counseling education based on Watson's Theory of Human Caring

Detailed Description

Reproductive concerns, one of the important problems affecting the quality of life of women diagnosed with cancer, is becoming a critical problem that needs to be addressed with both psychological and social dimensions when combined with concerns about the future. This study aims to examine the effect of counseling on reproductive concerns in women diagnosed with cancer, based on Watson's Human Caring Theory and an interview guide prepared by the researcher.

A randomized controlled experimental study with a pre-test-post-test design was conducted to examine the effects of counseling based on Watson's Human Caring Theory given to women between the ages of 18-45 diagnosed with cancer on reproductive concerns. The universe of the study consisted of female patients diagnosed with cancer between the ages of 18-45 who applied to the Department of Obstetrics and Gynecology (Family Planning and Infertility Research and Application Center and Gynecology Oncology Clinic), Oncology Department and General Surgery Department of Ege University Hospital. The research was conducted in the designated clinics of Ege University Faculty of Medicine Hospital between January 1, 2024 and September 15, 2024. The sample of the research consisted of 50 women diagnosed with cancer, 25 intervention and 25 controls. In the data collection process of the study, a "Participant Information Form" and a " "Reproductive Concerns After Cancer Scale" will be administered in the pre-test for both intervention and control groups. For the control group, four weeks after the pre-test, the "Reproductive Concerns After Cancer Scale" and the "Patient Satisfaction Evaluation Form According to Watson's Healing Processes" will be applied. For the intervention group, counseling sessions grounded in Watson's Human Caring Theory will be conducted in three sessions, and a post-test will be administered four weeks later.

The study, it was determined that the reproductive concerns levels of women in the intervention group who received counseling education based on Watson's Theory of Human Caring were significantly lower (p < 0.05). The patient satisfaction assessment scores based on the improvement processes showed a statistically significant difference between the intervention and control groups. The scores of the intervention group were found to be higher compared to the control group (p < 0.05). The Patient Satisfaction Evaluation Form scores based on Watson's Processes of Healing showed a statistically significant difference between the intervention and control groups. The scores of the intervention group were found to be higher compared to the control group (p < 0.05). Counseling based on Watson's Theory of Human Caring was found to reduce reproductive concerns and improve patient satisfaction based on Watson's Processes of Healing in women diagnosed with cancer.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey
    • Ege University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Being of reproductive age between 18-45 years,
• Not starting chemotherapy and radiotherapy treatment,
• Having no vision, hearing or mental problems,
• Knowing how to read and write and speaking Turkish,
• Agreeing to participate in the study voluntarily.

Exclusion Criteria:

• Being in menopause,
• Having had a hysterectomy,
• Being in Stage IV of the cancer diagnosed.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Counseling for reproductive concerns in women diagnosed with cancer; In this study, a total of 75 interviews were conducted with 25 participants in the intervention group in three sessions. During the interviews, counseling training based on Watson IBK developed by the researchers was applied. Each session lasted between 30-45 minutes per participant. The first session was conducted face-to-face, and the second and third sessions were conducted using online platforms within the scope of telehealth applications. Sessions were structured according to the individual needs of the participants and the durations were arranged flexibly when necessary. Immediately after the sessions of counseling training based on Watson IBC were applied, the "the Reproductive Concerns After Cancer Scale " and "the Patient Satisfaction Evaluation Form Based on Watson's Processes of Healin" were applied as interim tests to measure the effect of counseling on reproductive concerns levels of the patients. These tests were repeated 4 weeks after the end of the training.	Other: Counseling education based on Watson's Theory of Human Caring; In this study, a total of 75 interviews were conducted with 25 participants in the intervention group in three sessions. During the interviews, counseling training based on Watson IBK developed by the researchers was applied. Each session lasted between 30-45 minutes per participant. The first session was conducted face-to-face, and the second and third sessions were conducted using online platforms (Zoom, Microsoft Teams, WhatsApp video call) within the scope of telehealth applications. Sessions were structured according to the individual needs of the participants and the durations were arranged flexibly when necessary. Telehealth applications provided easy access to the participants during the counseling process and supported the continuity of individual counseling services.
No Intervention: Control; No intervention was made to the participants in the control group after the pre-test was applied as part of the data collection process. The women in the control group received the standard counseling service routinely applied in the clinic. After the patients were met, detailed information about the study was given, their informed consent was obtained and the contact information of the researcher was provided to them. 4 weeks after the pre-test, "the Reproductive Concerns After Cancer Scale" and "the Patient Satisfaction Evaluation Form Based on Watson's Processes of Healing" were applied to the participants in the control group as a post-test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Reproductive Concerns After Cancer Scale	The scale assesses fertility and parenting concerns. It consists of 18 items. The lowest total score from the scale is 18 and the highest is 90. As the score increases, the level of reproductive concerns increases.	Change from before implementation and 4th week of practice.
The Patient Satisfaction Evaluation Form Based on Watson's Processes of Healing	It is used to evaluate nursing care based on Watson's Human Caring Theory. It consists of 6 questions. The total highest score from this evaluation form is 35, and the lowest score is five.	Change from 4th week of practice.

Collaborators and Investigators

• Sponsor: Ege University

Publications and helpful links

General Publications

• Qiu J, Tang L, Li P, Fu J. An investigation into the reproductive concerns of young women with breast cancer. Asia Pac J Oncol Nurs. 2022 Mar 24;9(6):100055. doi: 10.1016/j.apjon.2022.03.007. eCollection 2022 Jun.
• Xiao Y, Li J, Lei J, Li X, Hu M, Zhao J, Han L, Chen O. Qualitative study of the fertility information support experiences of young breast cancer patients. Eur J Oncol Nurs. 2023 Feb;62:102275. doi: 10.1016/j.ejon.2023.102275. Epub 2023 Jan 25.
• Young K, Shliakhtsitsava K, Natarajan L, Myers E, Dietz AC, Gorman JR, Martinez ME, Whitcomb BW, Su HI. Fertility counseling before cancer treatment and subsequent reproductive concerns among female adolescent and young adult cancer survivors. Cancer. 2019 Mar 15;125(6):980-989. doi: 10.1002/cncr.31862. Epub 2018 Nov 29.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): February 8, 2024
• Study Completion (Actual): September 15, 2024

Study Registration Dates

• First Submitted: December 24, 2024
• First Submitted That Met QC Criteria: December 24, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Cancer; Counseling; Women; Reproductive Concerns
• Other Study ID Numbers: E-1669200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The researchers plan to publish it as an article.
• IPD Sharing Time Frame: from July 2025
• IPD Sharing Access Criteria: It is planned to be published in an open access journal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No