Breast Cancer FemaleNCT05245162
Fertility Changes Due to Cancer: an Investigation of Meaning, Psychological Distress, and Psychologi
An observational study of Breast Cancer Female, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Female
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2021to 11 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Female. Ages 18 to 45. Ambulatory outpatient oncology.
Who may be able to join
None listed.
Who cannot join
- An individual who fails to meet any of the inclusion criteria will be excluded from participation in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Health
Aurora, Colorado, 80045
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Study participants with breast cancer | |
| Participants partner | Study participants partner |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start11 Jan 2021
- Primary completion11 Aug 2021
- Study completion11 Aug 2021
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elissa Kolva, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245162
- Sponsor's protocol ID
- 19-1812.cc
- Status last verified
- Mar 2024
- First submitted
- 23 Sep 2021
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fertility Changes Due to Cancer: an Investigation of Meaning, Psychological Distress, and Psychological Support Needs of Young Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT05245162
- Acronym / sponsor ID
- 19-1812.cc
- Conditions
- Breast Cancer Female
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Low accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 11 Aug 2021 (actual)
- Study completion
- 11 Aug 2021 (actual)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants | – | –Study participants with breast cancer |
| Participants partner | – | –Study participants partner |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Female. Ages 18 to 45. Ambulatory outpatient oncology.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- An individual who fails to meet any of the inclusion criteria will be excluded from participation in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Establishing distress level using questionnaires
Time frame: 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.
1 secondary outcome
Establish supports needs from established questionnaire
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elissa Kolva, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishing distress level using questionnaires (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.