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Not yet recruiting NCT07364760

The Effect of Group and Mobile Wellness Coaching Given to Women With Breast Cancer on the Disease

No phase Interventional Breast Cancer Females

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Wellness coaching program with mobile application, Group Wellness Coaching Program, Mobile app and group wellness coaching program.
Who it may be relevant to
Registry conditions: Breast Cancer Females. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effect of Wellness Coaching and Mobile Application Given To Women Newly Diagnosed With Breast Cancer on Their Psychosocial Adjustment to The Disease and Their Well-Being

Overview

It is believed that this study will serve as a model for a Wellness Coaching program delivered to patients newly diagnosed with breast cancer via a mobile application and contribute to the literature. No other studies have been found in the literature examining the effects of a model-based Wellness Coaching program on the psychosocial adjustment to the disease and well-being of patients newly diagnosed with breast cancer. This demonstrates the originality of this study. In all these respects, it is believed that the study will contribute to the literature and serve as a guide for future studies on the subject. The purpose of this doctoral dissertation is to determine the effects of Mobile Wellness Coaching and Group Wellness Coaching programs on the psychosocial adjustment to the disease and well-being of women newly diagnosed with breast cancer.

Detailed description

Breast cancer is among the most common types of cancer worldwide. While more common in women, it can also occur in men. According to WHO data, 2.3 million women were diagnosed with breast cancer worldwide in 2022, resulting in 670,000 deaths. The International Agency for Research on Cancer (IARC) predicts that 1 in 20 women worldwide will be diagnosed with breast cancer, with 3.2 million breast cancer cases and 1.1 million breast cancer-related deaths by 2050. In Turkey, breast cancer ranks first among women. According to cancer statistics from the Ministry of Health, 29.3% of women were diagnosed with breast cancer in 2019. According to GLOBOCAN Turkey data, 23.5% (25,249) of women were newly diagnosed with breast cancer in 2022, while 5.7% (7,360) died from breast cancer. Despite increased survival rates thanks to early diagnosis and treatment options, breast cancer poses a multifaceted crisis for women diagnosed with it. The period between a new diagnosis and the first treatment is one of the most stressful times for women with breast cancer. It affects women's physical, psychological, social, and sexual aspects, creating a significant source of stress. Managing stress in women with new breast cancer is crucial for improving the course of the disease, facilitating treatment compliance, ensuring their adaptation to the disease, and improving their overall well-being. Qualitative and descriptive studies conducted with women diagnosed with breast cancer in the literature have identified complex experiences such as pain, anger, anxiety, and life challenges. Having a coach who can help patients going through this complex and challenging process feel they are not alone and who can share positive examples from similar situations with both the client/patient and their family as a companion can foster healthy behavioral changes, increased treatment engagement, and increased belief in recovery and motivation. In a study conducted by Çınar et al., women with breast cancer received mobile app-based education and individual counseling for 12 weeks regarding breast cancer, symptom diaries, and lifestyle recommendations (adequate and balanced nutrition, regular physical activity, stress management, etc.). It was found that the women's quality of life increased and their stress levels decreased. Another study demonstrated that a spiritual nursing care model improved spiritual well-being and the quality of spiritual care in cancer patients. An examination of these practices reveals that healthcare professionals, especially oncology nurses, naturally act as health coaches in this process. A wellness coaching program also evaluates patients holistically, mentally, physically, and spiritually. The goal of the wellness coaching program is to enhance the well-being of breast cancer patients by focusing on their concerns, such as stress, health and illness, life challenges, acceptance of illness, social relationships, physical appearance, and more.

Today, mobile technologies are an important tool for interacting with individuals. Healthcare professionals worldwide have begun to use mobile technology as a tool to reach larger audiences and improve their health. Some studies indicate that mobile apps have the potential to intervene in health behavior changes. Therefore, it is important for nurses to incorporate mobile health apps into the nursing process. There are no mobile apps available in the app markets for Android and iOS operating systems that include a Wellness Coaching program. This thesis aims to provide wellness coaching to patients diagnosed with breast cancer through a mobile app and in person.

Interventions

  • Other Wellness coaching program with mobile application
    Participants will be provided with wellness coaching training via the mobile application.
  • Other Group Wellness Coaching Program
    Participants will be provided wellness coaching training by the researcher in groups of 5-6.
  • Other Mobile app and group wellness coaching program
    Participants will receive wellness coaching training both via the mobile app and in groups of 5-6 people, provided by the researcher.

Primary outcome measures

  • pre-test application [Time frame: 1st month]
Secondary outcome measures (3)
  • final test application [Time frame: 8th week]
  • 3rd follow-up [Time frame: 12th week]
  • 4th follow-up [Time frame: 20th week]

Eligibility criteria

Inclusion criteria

  • Being 18 years of age or older,
  • Having recently been diagnosed with breast cancer,
  • Not having attended any coaching training since being diagnosed with breast cancer,
  • Being fluent in Turkish,
  • Literate patients,
  • Owning a smartphone.

Exclusion criteria

  • Being under 18 years of age,
  • Refusing to participate in the study,
  • Having a visual or hearing impairment,
  • Being unable to use a smartphone,

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Double blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Ghorbani M, Mohammadi E, Aghabozorgi R, Ramezani M. The effect of applying Spiritual Care Model on well-being and quality of care in cancer patients. Support Care Cancer. 2021 May;29(5):2749-2760. doi: 10.1007/s00520-020-05781-7. Epub 2020 Sep 29. PMID 32995997
  • Lally RM. Acclimating to breast cancer: a process of maintaining self-integrity in the pretreatment period. Cancer Nurs. 2010 Jul-Aug;33(4):268-79. doi: 10.1097/NCC.0b013e3181d8200b. PMID 20467302
  • Mendiola MF, Kalnicki M, Lindenauer S. Valuable features in mobile health apps for patients and consumers: content analysis of apps and user ratings. JMIR Mhealth Uhealth. 2015 May 13;3(2):e40. doi: 10.2196/mhealth.4283. PMID 25972309
  • Sherman DW, Haber J, Hoskins CN, Budin WC, Maislin G, Shukla S, Cartwright-Alcarese F, McSherry CB, Feurbach R, Kowalski MO, Rosedale M, Roth A. The effects of psychoeducation and telephone counseling on the adjustment of women with early-stage breast cancer. Appl Nurs Res. 2012 Feb;25(1):3-16. doi: 10.1016/j.apnr.2009.10.003. Epub 2010 May 6. PMID 20974079
  • Wheaton N, Lenehan J, Amir LH. Evaluation of a Breastfeeding App in Rural Australia: Prospective Cohort Study. J Hum Lact. 2018 Nov;34(4):711-720. doi: 10.1177/0890334418794181. Epub 2018 Sep 20. PMID 30235043

Identifiers

NCT: NCT07364760 · SaglikBilimleriU-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗