Quality of Life in Breast Cancer Survivors Who Were Pregn... | NCT07191496

Studies
Quality of Life in Breast Cancer Survivors Who Were Pregnant During Their Cancer Treatment

NCT07191496

Sponsor

M.D. Anderson Cancer Center

Status

Terminated

Last Update Posted

Apr 17, 2026Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Breast Cancer Survivor
Pregnant Women
Quality of Lifte

Interventions

Questionnaire

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

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2025-06866	Other Identifier	NCI-CTRP Clinical Registry

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

<75% participation

Expanded Access Info

Start Date

Oct 1, 2025Actual

Primary Completion Date

Apr 9, 2026Actual

Completion Date

Apr 9, 2026Actual

First Submitted Date

Sep 16, 2025

First Submission Date that Met QC Criteria

Sep 22, 2025

First Posted Date

Sep 24, 2025Actual

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

Apr 14, 2026

Last Update Posted Date

Apr 17, 2026Actual

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

To assess the quality of life for women who were pregnant during their breast cancer treatment.

Detailed Description

Primary Objectives Provide preliminary data to describe the current QOL of breast cancer survivors who received cancer treatment while pregnant.

Secondary Objectives Identify the relationship between QOL and anxiety, depression, fear of cancer recurrence, and social support in breast cancer survivors, who received treatment while pregnant.

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

30Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Other	The questionnaires include the Ferrans and Powers QLI, EORTC QLQ-C30, FCR-7 Scale, HADS, and MOS Social Support Survey.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
QOL Questionnaires		Through study completion; an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Female, any current age and any age at diagnosis
Documented diagnosis of breast cancer during pregnancy
Documentation of receiving chemotherapy during pregnancy
Alive with no evidence of disease at time of recruitment
Able to reach and speak English

Exclusion Criteria

Any woman who delayed and received their chemotherapy after delivery.
Any woman who was diagnosed with breast cancer before or after their pregnancy.
Any woman whom there is documentation of inability to provide consent in the medical record

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Females

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

MD Anderson Cancer Center

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eileen Hacker, MD	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MD Anderson Cancer Center		Houston	Texas	77030	United States

Label	URL
MD Anderson Cancer Center	View source

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	Aug 22, 2025	Apr 14, 2026	ICF_000.pdf

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided