Clinical trial NCT06757465: Women Diagnosed with Cancer & Reproductive Concerns & Watson's Human Caring Theory &Counselling
Official title: The Effect of Counseling Grounded in Watson's Human Caring Theory on Reproductive Concerns in Women Diagnosed with Cancer: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reproductive Health
Keywords: Cancer
Counseling
Reproductive Concerns
Women
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a single-blind, randomized controlled clinical trial, parallel
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Reproductive Concerns After Cancer Scale
timeFrame: Change from before implementation and 4th week of practice.
measure: The Patient Satisfaction Evaluation Form Based on Watson's Processes of Healing
timeFrame: Change from 4th week of practice.
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.