Breast Cancer FemaleNCT04035408
Facial Skin Health Tracking Feasibility in Breast Cancer Patients
An observational study of Breast Cancer Female, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This feasibility study will assess if tracking objective and subjective facial skin changes over time is acceptable to pre and perimenopausal women undergoing chemotherapy and/or endocrine therapy for breast cancer. There is no intervention arm and no control group. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Skin health assessment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2020to 13 Feb 2023
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Our baseline skin health self-assessment tool accounts for smoking status, sun exposure, and sunscreen use and this will factor into our assessments/comparison to age and ethnicity matched norms. Sun exposure will likely affect skin age differences at baseline but should not affect the skin aging over the duration of the study.
Who may be able to join
- Provision to sign and date the consent form
- Stated willingness to comply with all study procedures and be available for the duration of the study
- Be a pre or perimenopausal woman age 18 or over
- Be a patient with a new diagnosis of breast cancer who plans to undergo systemic chemotherapy or endocrine therapy, but who has not yet started treatment
Who cannot join
- Postmenopausal status (one year without a menstrual period)
- Pregnant women (pregnancy test not required)
- Prior cancer diagnosis of any type other than breast cancer
- History of prior treatment with chemotherapy or radiation therapy
- Chronic skin disease including scleroderma, discoid lupus, atopic dermatitis, rosacea, eczema, or psoriasis
- Use of a retinoid-based prescription facial skin product within the past 11 month
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Official title: Tracking the Natural History of Facial Skin Health in Pre and Peri Menopausal Breast Cancer Patients Undergoing Chemotherapy and / or Endocrine Therapies: A Feasibility Study
This feasibility study will assess if tracking objective and subjective facial skin changes over time is acceptable to pre and perimenopausal women undergoing chemotherapy and/or endocrine therapy for breast cancer. There is no intervention arm and no control group. Skin health will be assessed through the instruments described below, and subjective data will be collected with self-administered questionnaires.
Read the detailed description
There are no studies objectively assessing changes to facial skin health in this population, but tools exist to objectively measure changes thus we have chosen to use those tools to measure skin health. Before embarking on an intervention study showing improvement in skin health and patients' self-image and QOL, we first need to see if 1) it is feasible to measure changes in skin health in this population and 2) if skin health does objectively change over the course of therapy.
- Conditions
- Breast Cancer Female
- Being tested
- Skin health assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin health assessmentOther
Assess and measure the natural history of facial skin changes in pre and perimenopausal women undergoing chemotherapy and/or endocrine therapy for breast cancer
| Study group | Role | What they receive |
|---|---|---|
| All subjects | All the enrolled subjects will be considered for the assessment of the primary and secondary outcomes. Receives: Other: Skin health assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of compliance in each of the 4 assessment tools
defined as the percentage of patients completing all the scheduled assessments under each assessment tool. The percentage of compliance will be summarized and the associated 90% confidence interval reported. If the percentage of compliance is 80% or higher under each assessment tool, the study will be considered feasible.
Measured: 3 years
Secondary outcomes (2)
Changes in skin health over the duration of the study (4 assessment points)
Difference in skin health at each assessment from baseline will be calculated which will be divided by the standard deviation of the difference to obtain the effect size of the change at each assessment time post baseline
Measured: 3 years
Changes in body image / skin QOL at end of treatment compared to baseline
Skindex16 will be used to assess. Skin traits will be rated from 0 (never bothered) to 6 (always bothered). The max score being 96, the least being 0.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start24 Jan 2020
- Primary completion13 Feb 2023
- Study completion13 Feb 2023
Why it stopped: Low/No 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035408
- Sponsor's protocol ID
- 18-2444.cc
- Status last verified
- Aug 2023
- First submitted
- 10 Jul 2019
- Last updated
- 5 Sep 2023
- 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 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracking the Natural History of Facial Skin Health in Pre and Peri Menopausal Breast Cancer Patients Undergoing Chemotherapy and / or Endocrine Therapies: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04035408
- Acronym / sponsor ID
- 18-2444.cc
- Conditions
- Breast Cancer Female
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Low/No Accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 24 Jan 2020 (actual)
- Primary completion
- 13 Feb 2023 (actual)
- Study completion
- 13 Feb 2023 (actual)
- First posted
- 29 Jul 2019 (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.
This feasibility study will assess if tracking objective and subjective facial skin changes over time is acceptable to pre and perimenopausal women undergoing chemotherapy and/or endocrine therapy for breast cancer. There is no intervention arm and no control group. Skin health will be assessed through the instruments described below, and subjective data will be collected with self-administered questionnaires.
Detailed description
There are no studies objectively assessing changes to facial skin health in this population, but tools exist to objectively measure changes thus we have chosen to use those tools to measure skin health. Before embarking on an intervention study showing improvement in skin health and patients' self-image and QOL, we first need to see if 1) it is feasible to measure changes in skin health in this population and 2) if skin health does objectively change over the course of therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | – | Other: Skin health assessmentAll the enrolled subjects will be considered for the assessment of the primary and secondary outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Our baseline skin health self-assessment tool accounts for smoking status, sun exposure, and sunscreen use and this will factor into our assessments/comparison to age and ethnicity matched norms. Sun exposure will likely affect skin age differences at baseline but should not affect the skin aging over the duration of the study.
Key inclusion criteria (4 listed)
- Provision to sign and date the consent form
- Stated willingness to comply with all study procedures and be available for the duration of the study
- Be a pre or perimenopausal woman age 18 or over
- Be a patient with a new diagnosis of breast cancer who plans to undergo systemic chemotherapy or endocrine therapy, but who has not yet started treatment
Key exclusion criteria (6 listed)
- Postmenopausal status (one year without a menstrual period)
- Pregnant women (pregnancy test not required)
- Prior cancer diagnosis of any type other than breast cancer
- History of prior treatment with chemotherapy or radiation therapy
- Chronic skin disease including scleroderma, discoid lupus, atopic dermatitis, rosacea, eczema, or psoriasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin health assessmentAssess and measure the natural history of facial skin changes in pre and perimenopausal women undergoing chemotherapy and/or endocrine therapy for breast cancer | Other | All subjects |
Primary outcome
Percentage of compliance in each of the 4 assessment tools
Time frame: 3 years
defined as the percentage of patients completing all the scheduled assessments under each assessment tool. The percentage of compliance will be summarized and the associated 90% confidence interval reported. If the percentage of compliance is 80% or higher under each assessment tool, the study will be considered feasible.
2 secondary outcomes
Changes in skin health over the duration of the study (4 assessment points)
Time frame: 3 years
Changes in body image / skin QOL at end of treatment compared to baseline
Time frame: 3 years
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 5 Sep 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 4 inclusion and 6 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 5 Sep 2023. 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?
Percentage of compliance in each of the 4 assessment tools (time frame: 3 years). 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 5 Sep 2023.