Clinical trial NCT05245162: Fertility Changes Due to Cancer: an Investigation of Meaning, Psychological Distress, and Psychologi
Official title: Fertility Changes Due to Cancer: an Investigation of Meaning, Psychological Distress, and Psychological Support Needs of Young Women With Breast Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Breast Cancer Female
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female. Ages 18 to 45. Ambulatory outpatient oncology.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Establishing distress level using questionnaires
timeFrame: 6 months
Secondary outcomes:
measure: Establish supports needs from established questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Health
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Elissa Kolva, PhD
role: PRINCIPAL_INVESTIGATOR
References: