NCT06505538

Brief Summary

Background: The use of the Nurse-Led Mobile App (NL-Mapp) is a current and important option for educating patients about the symptoms that may arise from breast cancer surgery. Introduction: Given the precise information and counseling services offered to breast cancer patients, NL-Mapp is considered an appropriate choice to support postoperative self-care. Methods: This quasi-experimental study aimed to determine the impact of NL-Mapp on breast cancer patients after surgery. The study included 45 patients in the intervention group and 45 patients in the control group. First, NL-Mapp was developed by the research team. Patients were then taught how to use the app to manage their symptoms after breast cancer surgery, and online counseling was provided for patients' questions. The intervention started before surgery, and follow-up visits were made before discharge and in the first month.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2024

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 17, 2024

Completed
Last Updated

July 17, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

March 1, 2024

Last Update Submit

July 10, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Function of the affected arm

    ASES Shoulder Rating Scale

    three months

  • Body image and sexual adjustment scale

    Sexual Adjustment and Body Image Scale

    three months

  • Pain scale

    Visual Analog Scale

    three months

Secondary Outcomes (1)

  • Quality of life scale

    one year

Study Arms (2)

Intervention

EXPERIMENTAL
Device: NL-Mapp

Control

NO INTERVENTION

Interventions

NL-MappDEVICE

Mobile applicaiton

Intervention

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Speaking the national language,
  • The presence of primary breast cancer,
  • The utilization of a smartphone for a minimum of one year,
  • An age of 20 years

You may not qualify if:

  • An uncontrollable medical problem,
  • Having speech problems,
  • Having hearing problems,
  • Vision impairment,
  • A psychiatric diagnosis/ongoing treatment
  • Previous treatment due to a different type of cancer
  • Rheumatological diseases,
  • Fractures,
  • Health problems leading to joint limitation,
  • Amputation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gumushane University

Gümüşhane, Turkey (Türkiye)

Location

Related Publications (1)

  • Aydin A, Gursoy A. Nurse-Led Mobile App Effect on Quality of Life in Breast Cancer Patients After Surgery: Nonrandomized Controlled Prospective Cohort Study (Step 3). Cancer Nurs. 2024 Nov 20. doi: 10.1097/NCC.0000000000001418. Online ahead of print.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc, PhD, RN, Associate Professor

Study Record Dates

First Submitted

March 1, 2024

First Posted

July 17, 2024

Study Start

January 1, 2019

Primary Completion

January 1, 2020

Study Completion

January 1, 2021

Last Updated

July 17, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations