Neoplasm, UterineNCT06550791
Evaluating the Anticancer Learning Circle Lifestyle Program in Endometrial Cancer Survivors
A study testing Anticancer Learning Circle in people with Neoplasm, Uterine, run by University of Virginia at 1 site in United States.
Trial summary
The purpose of this study is to promote positive lifestyle change among endometrial cancer survivors by using a group-based intervention. Endometrial cancer survivors are at an increased risk of other health conditions like heart disease, diabetes, and other cancers. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Neoplasm, Uterine
- What is being tested?
- Anticancer Learning Circle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2024to 28 Sep 2025
- Phase
- Interventional
- 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
Who may be able to join
- History of stage I-IV endometrial cancer, any histologic subtype
- Completed cancer treatment, and in surveillance
- Have no evidence of endometrial cancer as determined by primary oncologist
- Be at least 18 years of age
- Be able to read and communicate in English
- Have a smartphone with access to cellular service or computer access with internet service
- Must have technological competency/proficiency to use their Smartphone and/or computer, as self-reported by potential subject
- Stated willingness to comply with all study procedures and availability for the duration of the study.
Who cannot join
- Pregnant women
- Prisoners
- Subject is blind
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
About this study
Official title: A Prospective Feasibility Study Evaluating the Implementation of the Anticancer Lifestyle Program in Endometrial Cancer Survivors
The purpose of this study is to promote positive lifestyle change among endometrial cancer survivors by using a group-based intervention. Endometrial cancer survivors are at an increased risk of other health conditions like heart disease, diabetes, and other cancers. The study team at the University of Virginia wants to explore new ways to lower these risks. This study will be evaluating the Anticancer Lifestyle program, which takes a more holistic approach and uses web-based learning modules along with weekly group sessions to discuss each topic of the web-based learning modules.
- Conditions
- Neoplasm, Uterine
- Being tested
- Anticancer Learning Circle
- Keywords
- Endometrial Cancer, Holistic Cancer Treatment, Lifestyle Change
- Medical subject headings
- Uterine Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticancer Learning CircleBehavioural
All participants will partake in the Anticancer Learning Circle, a lifestyle modification program. All participants will complete web-based learning modules focused on improving diet, lowering stress, increasing fitness, and reducing exposure to toxins in the home environment. Each week, all participants will meet as a group to discuss the learning topic of the web-based learning module for the week.
| Study group | Role | What they receive |
|---|---|---|
| Anticancer Learning Circle Participant | Experimental | Not described Receives: Behavioral: Anticancer Learning Circle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that complete the program
The proportion of participants completing the program as defined by the number of those who participated in at least 75% of online sessions.
Measured: Week 7
Secondary outcomes (6)
Change from Week 0 of the Automated Self-administered 24-hour Dietary Assessment (ASA24) at Week 7
The Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool is a free, web-based tool created by the National Cancer Institute to assess nutritional intake. ASA24 enables multiple, automatically coded, self-administered 24-hour diet recalls and/or single or multi-day food records, also known as food diaries.
Overall nutrition will be assessed at week 0 and week 7 to compare and evaluate changes in dietary patterns of participants.
Measured: 7 weeks
Change from Week 0 of Generalized Anxiety Disorder (GAD-7) Survey from Baseline at Week 32
The GAD-7 is a validated, self-reported survey assessing feelings of anxiety. Possible scores range from 0 (minimal anxiety) to 21 (severe anxiety).
Scores will be evaluated at weeks 0, 4, 7, and 32 with overall primary endpoint evaluating change between week 0 and week 32.
Change = (Week 32 Score - Week 0 score)
Measured: 32 weeks
Change from Week 0 of the Godin Leisure-Time Exercise Questionnaire (GLTEQ) from Baseline at Week 32
The GLTEQ is a validated, self-reported scale assessing physical activity. Participants self-report the number of times per week they engage in strenuous, moderate, and mild/light physical activity. The self-reported number is multiplied by 9 for strenuous exercise, 5 for moderate exercise, and 3 for mild/light exercise. Scores can range from less than 14 units (insufficiently Active/Sedentary) to 24 units of more (Active).
Scores will be evaluated at weeks 0, 4, 7, and 32 with overall primary endpoint evaluating change between week 0 and week 32.
Change = (Week 32 score - Week 0 score)
Measured: 32 weeks
Change from Week 0 of the Cancer Worry Scale (CWS) to Week 32
The CWS scale is a validated, self-reported scale assessing participants worries about developing or reoccurring cancer. Scores can range from 8 (seldom or never worried) to 32 (worried a lot/almost all the time).
Scores will be evaluated at weeks 0, 4, 7, and 32 with overall primary endpoint evaluating change between week 0 and week 32.
Change = (Week 32 score - Week 0 score)
Measured: 32 weeks
Change from Week 0 of the Patient Health Questionnaire (PHQ-9) to Week 32
The PHQ-9 is a validated, self-reported scale to assess symptoms of major depressive disorder. Scores can range from 0 (none-Minimal) to 27 (severe).
Scores will be evaluated at weeks 0, 4, 7, and 32 with overall primary endpoint evaluating change between week 0 and week 32.
Change = (Week 32 score - Week 0 score)
Measured: Baseline and Week 32
Assess Attitudes Toward Group-Based Lifestyle Therapy Program Utilizing Internal Scale at Week 7 and Week 32
Internal survey built to evaluate participants' satisfaction with the Anticancer Lifestyle Foundation's lifestyle program.
Quantitative measures are gathered utilizing a scale of Strongly Disagree to Strongly Agree to assess participant attitudes towards program satisfaction, usefulness of information learned, and to gauge if the participant feels they were able to make positive lifestyle changes through participation in the program.
Additional questions assess feelings towards preferences of group size, platform used, number of sessions, and length of program.
Qualitive measure allows participants to share any thoughts/concerns/or feedback regarding the program.
Measured: Week 7 and Week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start4 Sep 2024
- Primary completion24 Mar 2025
- Study completion28 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm, UterineStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kari Ring, MD, University of Virginia
- Investigators
- Kari Ring, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550791
- Sponsor's protocol ID
- HSR230435
- Status last verified
- Oct 2025
- First submitted
- 29 Jul 2024
- Last updated
- 24 Oct 2025
- 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 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Feasibility Study Evaluating the Implementation of the Anticancer Lifestyle Program in Endometrial Cancer Survivors
- ClinicalTrials.gov ID
- NCT06550791
- Acronym / sponsor ID
- HSR230435
- Conditions
- Neoplasm, Uterine
- Keywords
- Endometrial Cancer, Holistic Cancer Treatment, Lifestyle Change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 24 Mar 2025 (actual)
- Study completion
- 28 Sep 2025 (actual)
- First posted
- 13 Aug 2024 (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 purpose of this study is to promote positive lifestyle change among endometrial cancer survivors by using a group-based intervention. Endometrial cancer survivors are at an increased risk of other health conditions like heart disease, diabetes, and other cancers. The study team at the University of Virginia wants to explore new ways to lower these risks. This study will be evaluating the Anticancer Lifestyle program, which takes a more holistic approach and uses web-based learning modules along with weekly group sessions to discuss each topic of the web-based learning modules.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anticancer Learning Circle Participant | Experimental | Behavioral: Anticancer Learning Circle |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- History of stage I-IV endometrial cancer, any histologic subtype
- Completed cancer treatment, and in surveillance
- Have no evidence of endometrial cancer as determined by primary oncologist
- Be at least 18 years of age
- Be able to read and communicate in English
Key exclusion criteria (3 listed)
- Pregnant women
- Prisoners
- Subject is blind
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 |
|---|---|---|
| Anticancer Learning CircleAll participants will partake in the Anticancer Learning Circle, a lifestyle modification program. All participants will complete web-based learning modules focused on improving diet, lowering stress, increasing fitness, and reducing exposure to toxins in the home environment. Each week, all participants will meet as a group to discuss the learning topic of the web-based learning module for the week. | Behavioural | Anticancer Learning Circle Participant |
Primary outcome
Number of participants that complete the program
Time frame: Week 7
The proportion of participants completing the program as defined by the number of those who participated in at least 75% of online sessions.
6 secondary outcomes
Change from Week 0 of the Automated Self-administered 24-hour Dietary Assessment (ASA24) at Week 7
Time frame: 7 weeks
Change from Week 0 of Generalized Anxiety Disorder (GAD-7) Survey from Baseline at Week 32
Time frame: 32 weeks
Change from Week 0 of the Godin Leisure-Time Exercise Questionnaire (GLTEQ) from Baseline at Week 32
Time frame: 32 weeks
Change from Week 0 of the Cancer Worry Scale (CWS) to Week 32
Time frame: 32 weeks
Change from Week 0 of the Patient Health Questionnaire (PHQ-9) to Week 32
Time frame: Baseline and Week 32
Assess Attitudes Toward Group-Based Lifestyle Therapy Program Utilizing Internal Scale at Week 7 and Week 32
Time frame: Week 7 and Week 32
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2025.
- 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.
Kari Ring, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anticancer Learning Circle in people with Neoplasm, Uterine, run by University of Virginia 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 8 inclusion and 3 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: finished, as of the sponsor's last update on 24 Oct 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants that complete the program (time frame: Week 7). 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 24 Oct 2025.