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

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• Conditions: Breast Cancer Female

• Registration Number: NCT05245162
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study Start: 2021-01-11
• Primary Completion: 2021-08-11
• Study Completion: 2021-08-11
• Study First Submitted: 2021-09-23
• Study First Submitted QC: 2022-02-08
• Study First Posted: 2022-02-17
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Establishing distress level using questionnaires	6 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Colorado Health; 🇺🇸 Aurora, Colorado, United States