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

NCT06757465 | Completed

• 1 other identifier: E-1669200
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Reproductive Health

Keywords

Cancer; Counseling; Reproductive Concerns; Women

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

Counseling for reproductive concerns in women diagnosed with cancer

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Counseling education based on Watson's Theory of Human Caring OTHER

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.

Counseling for reproductive concerns in women diagnosed with cancer

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University

Izmir, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 35615663 BACKGROUND

• 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.

  PMID: 36716530 BACKGROUND

• 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.

  PMID: 30489638 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The randomization list for the study sample size of 50 women was created by a statistician. According to the list, women were divided into two groups as intervention (A) and control (B). Data were collected by a fellow who was not in the study. The fellow responsible for the data collection process collected the data without knowing which group the participants belonged to. This approach was preferred to prevent bias in the measurements and to increase the reliability of the results.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Student

Model Details: a single-blind, randomized controlled clinical trial, parallel

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 3, 2025
• Study Start: January 1, 2024
• Primary Completion: February 8, 2024
• Study Completion: September 15, 2024
• Last Updated: January 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: from July 2025
• Access Criteria: It is planned to be published in an open access journal.

Locations

TU (1)