NCT05245162

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

January 11, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 23, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 17, 2022

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

7 months

First QC Date

September 23, 2021

Last Update Submit

March 19, 2024

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Establish supports needs from established questionnaire

    6 months

Study Arms (2)

Participants

Study participants with breast cancer

Participants partner

Study participants partner

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Female. Ages 18 to 45. Ambulatory outpatient oncology.

You may qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Health

Aurora, Colorado, 80045, United States

Location

Study Officials

  • Elissa Kolva, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2021

First Posted

February 17, 2022

Study Start

January 11, 2021

Primary Completion

August 11, 2021

Study Completion

August 11, 2021

Last Updated

March 21, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)