CancerNCT07196241
Comprehensive Care for AYA: Needs Assessment Survey
An observational study of Cancer and Young Adult Cancer, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial summary
The goal of this observational study is to assess gaps in education about exercise, sexual health, fertility, survivorship, financial issues, interpersonal relationships, and clinical trial participation among adolescents and young adults with cancer. Participants will be asked to complete a series of questionnaires. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Cancer, Young Adult Cancer, Adolescent Cancer
- What is being tested?
- Survey using a questionnaire.
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Apr 2026to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants diagnosed with cancer between the ages of 15 and 39 and who received or are receiving treatment for their cancer at one of the centers participating in this research study.
Who may be able to join
- Individuals diagnosed with cancer between the ages of 15-39 per self-report. Participants may be enrolled at any age provided diagnosis was between ages 15-39.
- Individuals who have received or are receiving cancer-directed treatment (chemotherapy, immunotherapy, surgery and/or radiation) at one of the participating centers per self-report.
Who cannot join
- Severe emotional distress or anxiety that would limit compliance with study requirements per self-report.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Atrium Health Levine Cancer
Charlotte, North Carolina, 28204
Erin Trovillion, MD, 704-381-9900, Erin.Trovillion@advocatehealth.org
- Recruiting
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
Anne Wofford, MD, 336-716-3684, anne.wofford@advocatehealth.org
About this study
The goal of this observational study is to assess gaps in education about exercise, sexual health, fertility, survivorship, financial issues, interpersonal relationships, and clinical trial participation among adolescents and young adults with cancer.
Participants will be asked to complete a series of questionnaires.
Read the detailed description
This descriptive study aims to assess current needs of adolescents and young adults with cancer.
Participants who were diagnosed with cancer between the ages of of 15-39 will be asked to complete questionnaires to provide information on their cancer treatments and follow-up care, fertility preservation, clinical trial participation, emotional health and interpersonal relationships, financial burden, mental health and additional general information (health related, sexual orientation, perceived needs for support, resources, programs and activities).
- Conditions
- Cancer, Young Adult Cancer, Adolescent Cancer
- Being tested
- Survey using a questionnaire.
- Keywords
- Adolescent, Young Adult, Cancer, AYA, Questionnaire, Needs assessment
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey using a questionnaire.Other
Questionnaires regarding cancer treatment and follow-up care, fertility preservation, clinical trial participation, general information (education on health- related topics, gender, and sexual orientation, perceived needs for resources, support areas, programs and activities.), emotional health and interpersonal relationships, financial burden and mental health status.
| Study group | Role | What they receive |
|---|---|---|
| Adolescents and Young Adults with cancer | Participants diagnosed with cancer between the ages of 15-39 who have received or are receiving cancer-directed treatment at one of the participating centers per self-report. Receives: Other: Survey using a questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deficits in Education
The general information survey collects data on participants surrounding education on health-related topics, gender, and sexual orientation, as well as perceived needs for resources, support areas, programs and activities. The general information survey contains 12 items.
There is no formal statistical analysis to be performed only summary statistics on completed survey items for observation thus there is no scoring needed or range of scores. Results will be observed using descriptive statistics. Due to the categorical nature of all variables, results will be reported in frequencies and percentages.
Measured: At study enrollment
Preferred Format for Education
The General Information Survey collects data on participants surrounding education on health-related topics, gender, and sexual orientation, as well as perceived needs for resources, support areas, programs and activities. The general information survey contains 12 items.
There is no formal statistical analysis to be performed only summary statistics on completed survey items for observation thus there is no scoring needed or range of scores. Results will be observed using descriptive statistics. Due to the categorical nature of all variables, results will be reported in frequencies and percentages.
Measured: At study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start16 Apr 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Atrium Health Wake Forest Baptist, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Anne Wofford, MD, Principal investigator, Atrium Health Wake Forest Baptist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196241
- Sponsor's protocol ID
- IRB00136539
- Other IDs
- P30CA012197, ONC-CCS-2505
- Status last verified
- Oct 2026
- First submitted
- 19 Sep 2025
- Last updated
- 27 Oct 2026
- 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Care for AYA: Needs Assessment Survey
- ClinicalTrials.gov ID
- NCT07196241
- Acronym / sponsor ID
- IRB00136539
- Conditions
- Cancer, Young Adult Cancer, Adolescent Cancer
- Keywords
- Adolescent, Young Adult, Cancer, AYA, Questionnaire, Needs assessment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Atrium Health Wake Forest Baptist, National Cancer Institute (NCI)
- Study start
- 16 Apr 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 29 Sep 2025 (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.
The goal of this observational study is to assess gaps in education about exercise, sexual health, fertility, survivorship, financial issues, interpersonal relationships, and clinical trial participation among adolescents and young adults with cancer.
Participants will be asked to complete a series of questionnaires.
Detailed description
This descriptive study aims to assess current needs of adolescents and young adults with cancer.
Participants who were diagnosed with cancer between the ages of of 15-39 will be asked to complete questionnaires to provide information on their cancer treatments and follow-up care, fertility preservation, clinical trial participation, emotional health and interpersonal relationships, financial burden, mental health and additional general information (health related, sexual orientation, perceived needs for support, resources, programs and activities).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescents and Young Adults with cancer | – | Other: Survey using a questionnaire.Participants diagnosed with cancer between the ages of 15-39 who have received or are receiving cancer-directed treatment at one of the participating centers per self-report. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants diagnosed with cancer between the ages of 15 and 39 and who received or are receiving treatment for their cancer at one of the centers participating in this research study.
Key inclusion criteria (2 listed)
- Individuals diagnosed with cancer between the ages of 15-39 per self-report. Participants may be enrolled at any age provided diagnosis was between ages 15-39.
- Individuals who have received or are receiving cancer-directed treatment (chemotherapy, immunotherapy, surgery and/or radiation) at one of the participating centers per self-report.
Key exclusion criteria (1 listed)
- Severe emotional distress or anxiety that would limit compliance with study requirements per self-report.
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 |
|---|---|---|
| Survey using a questionnaire.Questionnaires regarding cancer treatment and follow-up care, fertility preservation, clinical trial participation, general information (education on health- related topics, gender, and sexual orientation, perceived needs for resources, support areas, programs and activities.), emotional health and interpersonal relationships, financial burden and mental health status. | Other | Adolescents and Young Adults with cancer |
Primary outcome
Deficits in Education
Time frame: At study enrollment
The general information survey collects data on participants surrounding education on health-related topics, gender, and sexual orientation, as well as perceived needs for resources, support areas, programs and activities. The general information survey contains 12 items. There is no formal statistical analysis to be performed only summary statistics on completed survey items for observation thus there is no scoring needed or range of scores. Results will be observed using descriptive statistics. Due to the categorical nature of all variables, results will be reported in frequencies and percentages.
Preferred Format for Education
Time frame: At study enrollment
The General Information Survey collects data on participants surrounding education on health-related topics, gender, and sexual orientation, as well as perceived needs for resources, support areas, programs and activities. The general information survey contains 12 items. There is no formal statistical analysis to be performed only summary statistics on completed survey items for observation thus there is no scoring needed or range of scores. Results will be observed using descriptive statistics. Due to the categorical nature of all variables, results will be reported in frequencies and percentages.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- 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.
Anne Wofford, MD principal investigator
Atrium Health Wake Forest Baptist
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Young Adult Cancer, run by Wake Forest University Health Sciences at 2 sites 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 2 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Wofford, MD (336-716-3684, anne.wofford@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deficits in Education (time frame: At study enrollment). The study lists 2 primary outcomes in all. 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 27 Oct 2026.