Fertility Changes Due to Cancer: an Investigation of Mean... | NCT05245162

Studies
Fertility Changes Due to Cancer: an Investigation of Meaning, Psychological Distress, and Psychologi

NCT05245162

Sponsor

University of Colorado, Denver

Status

Withdrawn

Last Update Posted

Mar 21, 2024Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Breast Cancer Female

Interventions

Not provided

Countries

United States

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

Mar 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Low accrual

Expanded Access Info

Start Date

Jan 11, 2021Actual

Primary Completion Date

Aug 11, 2021Actual

Completion Date

Aug 11, 2021Actual

First Submitted Date

Sep 23, 2021

First Submission Date that Met QC Criteria

Feb 8, 2022

First Posted Date

Feb 17, 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

Mar 19, 2024

Last Update Posted Date

Mar 21, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Establish the relationship between meaning and psychological distress in young women with breast cancer who experienced reproductive concerns due to cancer diagnosis and treatment and their partners.

Detailed Description

This research will focus on identifying avenues for improving the quality of life of young women with breast cancer who endorse reproductive concerns due to cancer diagnosis and treatment, as there is an increased likelihood of distress and decreased likelihood of receiving information and appropriate psychological care. Existential distress appears to play a role in coping with infertility due to cancer (8) and thus the relationship between this distress and the other types of reproductive concerns warrants further exploration. The proposed project will use a mixed methods design to characterize the relationship between sense of meaning and purpose and psychological distress and assess psychosocial support needs of these young women. It will also assess the experience of the identified partners of these young women.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participants		Study participants with breast cancer
Participants partner		Study participants partner

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Establishing distress level using questionnaires	Establish the relationship between meaning and psychological distress in young women with breast cancer who experienced reproductive concerns due to cancer diagnosis and treatment and their partners.	6 months

Secondary Outcomes

Measure	Description	Time Frame
Establish supports needs from established questionnaire	Clarify the psychosocial support needs of young women with breast cancer who experienced reproductive concerns due to cancer diagnosis and treatment and their partners	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Participant Inclusion Criteria:

Provision to complete the consent form.
Stated willingness to comply with all study procedures and be available for the duration of the study.
Able to confirm they have a valid and private email account and access to the internet.
Patients age 18 to 45 with a diagnosis of breast cancer. Patients will endorse that they experience reproductive concerns due to cancer as assessed by a single screening item.
Fluent and literate in English.

Partner participant inclusion criteria:

Provision to complete the consent form.
Stated willingness to comply with all study procedures and be available for the duration of the study.
Able to confirm they have a valid and private email account and access to the internet.
Be the identified supportive partner of a study participant.
Fluent and literate in English.

Exclusion Criteria:

An individual who fails to meet any of the inclusion criteria will be excluded from participation in this study.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Female. Ages 18 to 45. Ambulatory outpatient oncology.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elissa Kolva, PhD	University of Colorado, Denver	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Colorado Health		Aurora	Colorado	80045	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided