NCT04839835

Brief Summary

investigating chemotherapy anxieties

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
106

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable breast-cancer

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2022

Completed
Last Updated

April 9, 2021

Status Verified

April 1, 2021

Enrollment Period

10 months

First QC Date

April 7, 2021

Last Update Submit

April 7, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • anxiety and stress measurements

    The State-Trait Anxiety Inventory (STAI) - Measuring anxiety with the Hospital Anxiety and Depression Scale (HADS)

    60-120 minutes

Study Arms (2)

standard waiting room

NO INTERVENTION

standard chemoterapy waiting room

waiting room enriched with art objects

EXPERIMENTAL

waiting room enriched with music, paintings and artificial plants

Other: waiting room enriched with music, paintings and artificial plants

Interventions

waiting room enriched with music, paintings and artificial plants

waiting room enriched with art objects

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to receive chemotherapy for breast cancer for the first time
  • give consent for the study

You may not qualify if:

  • not approving to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tekirdağ Namık Kemal ÜNiversitesi

Tekirdağ, 59100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast NeoplasmsAnxiety Disorders

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asoc. Prof.

Study Record Dates

First Submitted

April 7, 2021

First Posted

April 9, 2021

Study Start

November 1, 2020

Primary Completion

August 31, 2021

Study Completion

March 3, 2022

Last Updated

April 9, 2021

Record last verified: 2021-04

Locations