Evaluation of Rumination, Frailty and Tanatophobia in Can... | NCT05350007

Studies
Evaluation of Rumination, Frailty and Tanatophobia in Cancer Patients Over 65 Years of Age

NCT05350007

Sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Status

Unknown status

Last Update Posted

Jun 22, 2022Actual

Enrollment

180Estimated

Phase

Not provided

Conditions

Cancer
Death
Rumination
Frailty

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 25, 2022Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Apr 18, 2022

First Submission Date that Met QC Criteria

Apr 22, 2022

First Posted Date

Apr 27, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2022

Last Update Posted Date

Jun 22, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Elif Yıldırım Ayaz, Principal Investigator, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyPrincipal Investigator

Lead Sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to evaluate tanatophobia and rumination in individuals over 65 years of age receiving cancer chemotherapy and to determine the related factors.

Detailed Description

No studies were found in the literature evaluating the relationship between frailty and lack of social support with tanatophobia and rumination. The aim of this study is to evaluate tanatophobia and rumination in individuals over 65 years of age receiving cancer chemotherapy and to determine the related factors.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rumination	Evaluation of rumination in patients over 65 years of age receiving cancer chemotherapy	1 week
Tanatophobia	Evaluation of tanatophobia in patients over 65 years of age receiving cancer chemotherapy	1 week

Secondary Outcomes

Measure	Description	Time Frame
fraility	Evaluation of fraility in patients over 65 years of age receiving cancer chemotherapy	1 month
lack of social support	Evaluation of lack of social support in patients over 65 years of age receiving cancer chemotherapy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

65 years or older
Conscious and no communication problems
Being literate
Willing to participate in our study voluntarily
Cancer patient receiving active chemotherapy treatment

Exclusion Criteria:

Not being willing to participate in the research
Serious life-threatening condition (critical illness, intensive care unit stay, acute complication)
Dementia, Alzheimer's, cognitive dysfunction
Major psychiatric illness

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Cancer patients aged 65 and over receiving chemotherapy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Elif Yıldırım Ayaz, M.D.	Contact	+905325148300		drelifyildirim@hotmail.com

Overall Officials

Name	Affiliation	Role
Elif Yıldırım Ayaz, M.D.	Sultan Abdülhamid Training And Research Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sultan Abdülhamid Training and Research Hospital	Recruiting	Üsküdar	Istanbul	34660	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D003643	Death
D000079562	Rumination Syndrome
D000073496	Frailty

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided