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

Breast Cancer Female Clinical Trial

Official title:

Fertility Changes Due to Cancer: an Investigation of Meaning, Psychological Distress, and Psychological Support Needs of Young Women With Breast Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05245162
• Other study ID #: 19-1812.cc
• Status: Withdrawn
• Start date: January 11, 2021
• Est. completion date: August 11, 2021

Study information

• Verified date: March 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 11, 2021
• Est. primary completion date: August 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Locations

Country	Name	City	State
United States	University of Colorado Health	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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