NCT05992441

Brief Summary

In this study, the aim is to develop a scale that assesses the awareness levels of particularly short and/or long-term effects, especially related to physiotherapy, in individuals diagnosed with high incidence and survival rates of breast cancer.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

April 23, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 15, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

7 months

First QC Date

July 11, 2023

Last Update Submit

August 7, 2023

Conditions

Keywords

breastcancerphysiotherapyawareness

Outcome Measures

Primary Outcomes (1)

  • Awareness Scale Related To Physıotherapy ın Indıvıduals with Breast Cancer

    Thanks to this scale, which will be created as a result of the scale development study, the awareness of individuals with breast cancer about physiotherapy will be evaluated. The main purpose of scale development is to reveal this awareness. The questions in the scale are usually about lymphedema, pain, fatigue, musculoskeletal problems, heart-lung problems. It is a 5-point Likert-type scoring system and the point values are '1' for strongly disagree and '5' for strongly agree. Since the scale is not finalized, the score values are not clear, but higher scores mean higher awareness level.

    through study completion, an average of 1 year".

Study Arms (1)

breast cancer

This group will consist of women who have received breast cancer and will be based on participant volunteerism.

Other: SCALE DEVELOPMENT STUDY

Interventions

The study to be carried out is a scale development study. The steps to be followed for the scale development study are as follows; 1. Creating an item pool by making use of the literature review on the subject, 2. Questioning the relevance of the prepared question pool to the subject to be measured with the "Expert Evaluation Form" by experts in the field, 3. Pilot application, 4. Switching to the main study after the pilot application, 5. After the factor and item analyzes, the final arrangements regarding the item and form of the scale will be completed. As a result of this study, an awareness scale related to physiotherapy will be created for individuals with breast cancer.

breast cancer

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The participant group of this research will consist of women aged 18 and over who have been diagnosed with breast cancer, and participation will be on a voluntary basis.

You may qualify if:

  • Be over 18 years old
  • Be woman
  • Being diagnosed with breast cancer (individuals diagnosed with breast cancer who will start, start or have completed breast cancer treatment)
  • Being able to read and understand the Turkish language

You may not qualify if:

  • Having a cognitive impairment that interferes with answering questions
  • Be man

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fenerbahce Unıversty

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • pınar kaya ciddi

    medıpol unıversty

    STUDY DIRECTOR

Central Study Contacts

Nergis Yılmaz, licence

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator-Physiotherapy and rehabilitation Department-Research assistant

Study Record Dates

First Submitted

July 11, 2023

First Posted

August 15, 2023

Study Start

April 23, 2023

Primary Completion

November 15, 2023

Study Completion

December 15, 2023

Last Updated

August 15, 2023

Record last verified: 2023-08

Locations