NCT07364760

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Jan 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jan 2026May 2026

First Submitted

Initial submission to the registry

September 17, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Expected
Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

September 17, 2025

Last Update Submit

January 16, 2026

Conditions

Keywords

Breast CancerMobile ApplicationWellness CoachingPsychosocial AdaptationWellness

Outcome Measures

Primary Outcomes (1)

  • pre-test application

    First follow-up before intervention A pre-test will be administered to participants before the intervention. Patients who agree to participate in the study will be administered the "Descriptive Information," "Information About the Disease," "Psychosocial Adjustment to the Illness-Self-Report Scale," pre-tests in a room in the outpatient clinic. "Psychosocial Adjustment to Illness-Self-Report Scale" The scale consists of 46 items, including subscales for adjustment to healthcare, occupational environment, family environment, sexual relationships, extended family relationships, social environment, and psychological pressure. The minimum score on the scale is 0, and the maximum is 138. Scores below 35 indicate good psychosocial adjustment, scores between 35 and 51 indicate moderate psychosocial adjustment, and scores above 51 indicate poor psychosocial adjustment. A Wellness Self-Assessment Form will be administered. Participants will be asked to rate the 8 sub-levels of We

    1st month

Secondary Outcomes (3)

  • final test application

    8th week

  • 3rd follow-up

    12th week

  • 4th follow-up

    20th week

Study Arms (4)

Experimental Group 1

EXPERIMENTAL

Patients assigned to Experimental Group 1 will be administered a mobile health application. Patients will be given a pre-test of "Descriptive Information," "Information About the Illness," "Psychosocial Adjustment to the Illness-Self-Report Scale," in a room in the outpatient clinic. The mobile health application will then be introduced and downloaded to their phones. The application will be installed on the phone, and the participant will be asked to create a username and password. User registration to the mobile health application will be conducted in the presence of the researcher. Participants will be provided with a Secret Question/Secret Answer feature to access their account if their username or password is forgotten. During this process, participants will be instructed on how to use the mobile health application. Participants will be encouraged to begin using the mobile health application from the first meeting.

Other: Wellness coaching program with mobile application

Experimental Group 2

EXPERIMENTAL

Patients assigned to Experimental Group 2 will be initiated through the Group Wellness Coaching program. A pretest will be administered in a designated room for the patients, which includes "Descriptive Information," "Information About the Illness," "Psychosocial Adjustment to the Illness-Self-Report Scale." The researcher conducting the study will participate in Wellness Coaching training provided by the Zenith Well Health Academy and receive a certificate. Following the training, the content of the Wellness Coaching program will be planned in more detail. The planned Wellness Coaching program will then be implemented for eight weeks, once a week, for a total of eight sessions. Each week, patients will receive training through group sessions. Six groups are planned: five in each group and one group of six. At the end of the eighth week, a survey link will be sent to the patients via Google Forms.

Other: Group Wellness Coaching Program

Experimental Group 3

EXPERIMENTAL

Patients assigned to Experimental Group 3 will be initiated using the Mobile App + Group Wellness Coaching Program. A pretest will be administered in a designated room to assess the patients' "Descriptive Information," "Information About the Illness," "Psychosocial Adjustment to the Illness-Self-Report Scale." The planned Group Wellness Coaching program will then be implemented once a week for eight weeks, with a total of eight sessions per week. Patients will also have access to the Mobile App Wellness Coaching program. Wellness Coaching training will be provided both through the mobile app and through group sessions. Group sessions will be held weekly with patients. The plan is to create six groups of five and one group of six. At the end of the eighth week, a survey link will be sent to patients via Google Forms. A post-test will be administered by sending the "Psychosocial Adjustment to Illness-Self-Report Scale.

Other: Mobile app and group wellness coaching program

Group 4

NO INTERVENTION

Participants in the control group will not receive any intervention. Participants will be given a pre-test of "Descriptive Information," "Information About the Illness," "Psychosocial Adjustment to the Illness-Self-Report Scale" in a room in the outpatient clinic. At the end of eight weeks, a survey link will be sent to patients via Google Forms. The "Psychosocial Adjustment to the Illness-Self-Report Scale" will be sent, followed by a post-test. The Mobile App Wellness Coaching program will be introduced and information will be provided through a brochure. Those who wish will have access to the mobile application. Follow-up tests will be conducted at the end of the first and third months. For control tests, the "Psychosocial Adjustment to Illness-Self-Report Scale" will be filled out by sending a survey link via Google Forms.

Interventions

Participants will be provided with wellness coaching training via the mobile application.

Experimental Group 1

Participants will be provided wellness coaching training by the researcher in groups of 5-6.

Experimental Group 2

Participants will receive wellness coaching training both via the mobile app and in groups of 5-6 people, provided by the researcher.

Experimental Group 3

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Eylül Yeşilyurt

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: The study sample will be determined according to inclusion and exclusion criteria. The study groups will consist of 124 individuals who meet the inclusion criteria and have approved the consent form. Patients accepted to participate in the study will be assigned to four groups: Experimental Group 1 Mobile App Wellness Coaching Program group, Experimental Group 2 Group Wellness Coaching Program group, Experimental Group 3 Mobile App + Group Wellness Coaching Program group, and a control group. To avoid bias, participants will be randomly selected according to the order of their arrival.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

September 17, 2025

First Posted

January 23, 2026

Study Start

January 1, 2026

Primary Completion

March 1, 2026

Study Completion (Estimated)

May 30, 2026

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

We can share whatever data the journal editor wants to publish.

Shared Documents
STUDY PROTOCOL, SAP, ICF