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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Breast Cancer Female

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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Female. Ages 18 to 45. Ambulatory outpatient oncology.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Participants; Study participants with breast cancer
Participants partner; Study participants partner

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Elissa Kolva, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2021
• Primary Completion (Actual): August 11, 2021
• Study Completion (Actual): August 11, 2021

Study Registration Dates

• First Submitted: September 23, 2021
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 19-1812.cc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No