Breast CancerNCT07906990
Culinary And Lifestyle Medicine Education for Cancer Risk Reduction in Survivors of Breast Cancer
A study testing Living Cancer CALM education intervention in people with Breast Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
This study is for participants with a history of breast cancer. The purpose of this study is to determine if Case Western Reserve University Teaching Kitchen is able to deliver an out patient culinary medicine intervention in-person and via Zoom. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Living Cancer CALM education intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2026to 3 Jun 2027
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient at University Hospitals
- Aged 18 years old and older
- History of stage I, II, or III breast cancer
- Between three months and five years of completing active cancer treatment (IV or oral cytotoxic chemotherapy agents, surgery, radiation, and/or immunotherapy) *excluding hormonal therapy
- Completed the recommended portion of cancer treatment, determined through shared decision-making between the patient and the care team, and are now considered medically stable at the time of enrollment, defined as having no acute illness, hospitalization, or planned major change in cancer treatment that would preclude safe participation in the intervention, as determined by the treating oncology team
- Independently ambulatory
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- Willing to participate in full scope of program (virtual visits, teaching kitchen sessions, data collection visits)
- Has access to Wi-Fi, a reliable videoconferencing device (e.g. phone, tablet, laptop, and/or PC), and an active email address
- Has reliable access to a mobile device with active data plan at home and is comfortable accessing the internet and their email with this device
- Able to read and understand English
Who cannot join
- A diagnosis of stage IV breast cancer or no history of breast cancer
- Receiving active cancer treatment such (IV or oral cytotoxic chemotherapy agents, surgery, radiation, and/or immunotherapy)
- 5 or more years post active cancer treatment (excluding hormonal therapy)
- Considered medically unstable as determined by treating oncology team
- Currently pregnant or planning to become pregnant during the study period
- Significant hearing and/or visual impairment as documented in EHR, preventing patient from fully participating in intervention
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- Unable to independently provide consent (i.e., no proxy consent)
- Active suicidal ideation documented in Epic within past 6 months
- Severe psychological comorbidity (e.g., psychosis/schizophrenia) preventing patient from fully engaging in intervention
- Either (a) active substance abuse of cocaine, heroin, cannabis, or alcohol or (b) unmanaged opioid use disorder diagnosis in the last 6 months documented in EHR
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Herbert B. Newton, MD, FAAN, 216-844-6031, Herbert.Newton@UHhospitals.org
Herbert B. Newton, MD, FAAN
About this study
Official title: Living Cancer CALM: A Pilot Hybrid Culinary And Lifestyle Medicine (CALM) Education Program for Cancer Risk Reduction Among Survivors of Breast Cancer
This study is for participants with a history of breast cancer. The purpose of this study is to determine if Case Western Reserve University Teaching Kitchen is able to deliver an out patient culinary medicine intervention in-person and via Zoom. Participants will then apply the culinary and lifestyle cancer risk reduction strategies in between sessions. Surveys will be collected before and after the program.
Read the detailed description
There are gaps in care after cancer treatment, Many breast cancer survivors face ongoing challenges related to weight gain, metabolic dysfunction, reduced quality of life, and increased risk of chronic disease after finishing cancer treatment. Culinary interventions focusing on participants with breast cancer and survivors have been growing in popularity and and these studies show the positive effects that a healthy diet can have on the risk and recurrence, mortality, and quality of life.
These studies have laid the groundwork to develop the Cancer CALM (Culinary And Lifestyle Medicine) program for healthcare providers in training and serves as an education intervention. This program provides dietary and lifestyle cancer risk reduction (CRR) strategies using a lecture series and hands-on culinary experience. The long-term goal of this is to give future physicians the knowledge to use these strategies into their future clinical practice.
The purpose of this study is to determine if its is possible to deliver the Living Cancer Calm intervention and have participants apply risk reduction strategies between sessions. This study includes 4 in-person culinary medicine sessions and 4 virtual group nutrition education sessions. Participants will be asked to complete surveys before and after the program. 44 participants will be recruited in this study.
- Conditions
- Breast Cancer
- Being tested
- Living Cancer CALM education intervention
- Keywords
- culinary medicine, breast cancer, living cancer CALM
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Living Cancer CALM education interventionBehavioural
Eight 90-minute lessons delivered bi-weekly in the evenings in a hybrid format with alternating virtual and in-person lessons with each lesson focusing on specific nutrition and culinary skills.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer Survivors | Experimental | Eight 90 minute lessons delivered bi-weekly in the evenings in a hybrid format with alternating virtual and in-person lessons. Receives: Behavioral: Living Cancer CALM education intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of recruitment
Feasibility and acceptability will be evaluated using rates of recruitment
Measured: up to 18 weeks
Rates of retention
Feasibility and acceptability will be evaluated using rates of retention
Measured: up to 18 weeks
Rates of attendance
Feasibility and acceptability will be evaluated using rates of attendance
Measured: up to 18 weeks
Acceptability scores
Feasibility and acceptability will be evaluated using acceptability scores
Measured: up to 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start16 Nov 2026 (estimated)
- Primary completion3 Jun 2027 (estimated)
- Study completion3 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906990
- Sponsor's protocol ID
- CASE3126
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is an investigator initiated pilot trial examining the feasibility an acceptability of a culinary medicine intervention. When sharing IPD via open access, the lack of restrictions leads to greater risk of re-identifying individuals. Data could be inappropriately merged with other data to facilitate re-identification. Our small study population makes this more likely. On the other hand, sharing IPD via controlled access is burdensome. It requires resources that we do not have (setting up the infrastructure and policies, administering and reviewing data requests, preparing data and distributing data). The personnel time for such an endeavor was not budgeted, nor do we have the financial resources to include it in the study budget.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living Cancer CALM: A Pilot Hybrid Culinary And Lifestyle Medicine (CALM) Education Program for Cancer Risk Reduction Among Survivors of Breast Cancer
- ClinicalTrials.gov ID
- NCT07906990
- Acronym / sponsor ID
- CASE3126
- Conditions
- Breast Cancer
- Keywords
- culinary medicine, breast cancer, living cancer CALM
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 16 Nov 2026 (estimated)
- Primary completion
- 3 Jun 2027 (estimated)
- Study completion
- 3 Jun 2027 (estimated)
- First posted
- 30 Oct 2026 (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 study is for participants with a history of breast cancer. The purpose of this study is to determine if Case Western Reserve University Teaching Kitchen is able to deliver an out patient culinary medicine intervention in-person and via Zoom. Participants will then apply the culinary and lifestyle cancer risk reduction strategies in between sessions. Surveys will be collected before and after the program.
Detailed description
There are gaps in care after cancer treatment, Many breast cancer survivors face ongoing challenges related to weight gain, metabolic dysfunction, reduced quality of life, and increased risk of chronic disease after finishing cancer treatment. Culinary interventions focusing on participants with breast cancer and survivors have been growing in popularity and and these studies show the positive effects that a healthy diet can have on the risk and recurrence, mortality, and quality of life.
These studies have laid the groundwork to develop the Cancer CALM (Culinary And Lifestyle Medicine) program for healthcare providers in training and serves as an education intervention. This program provides dietary and lifestyle cancer risk reduction (CRR) strategies using a lecture series and hands-on culinary experience. The long-term goal of this is to give future physicians the knowledge to use these strategies into their future clinical practice.
The purpose of this study is to determine if its is possible to deliver the Living Cancer Calm intervention and have participants apply risk reduction strategies between sessions. This study includes 4 in-person culinary medicine sessions and 4 virtual group nutrition education sessions. Participants will be asked to complete surveys before and after the program. 44 participants will be recruited in this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Survivors | Experimental | Behavioral: Living Cancer CALM education interventionEight 90 minute lessons delivered bi-weekly in the evenings in a hybrid format with alternating virtual and in-person lessons. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient at University Hospitals
- Aged 18 years old and older
- History of stage I, II, or III breast cancer
- Between three months and five years of completing active cancer treatment (IV or oral cytotoxic chemotherapy agents, surgery, radiation, and/or immunotherapy) *excluding hormonal therapy
- Completed the recommended portion of cancer treatment, determined through shared decision-making between the patient and the care team, and are now considered medically stable at the time of enrollment, defined as having no acute illness, hospitalization, or planned major change in cancer treatment that would preclude safe participation in the intervention, as determined by the treating oncology team
Key exclusion criteria (10 listed)
- A diagnosis of stage IV breast cancer or no history of breast cancer
- Receiving active cancer treatment such (IV or oral cytotoxic chemotherapy agents, surgery, radiation, and/or immunotherapy)
- 5 or more years post active cancer treatment (excluding hormonal therapy)
- Considered medically unstable as determined by treating oncology team
- Currently pregnant or planning to become pregnant during the study period
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 |
|---|---|---|
| Living Cancer CALM education interventionEight 90-minute lessons delivered bi-weekly in the evenings in a hybrid format with alternating virtual and in-person lessons with each lesson focusing on specific nutrition and culinary skills. | Behavioural | Breast Cancer Survivors |
Primary outcome
Rates of recruitment
Time frame: up to 18 weeks
Feasibility and acceptability will be evaluated using rates of recruitment
Rates of retention
Time frame: up to 18 weeks
Feasibility and acceptability will be evaluated using rates of retention
Rates of attendance
Time frame: up to 18 weeks
Feasibility and acceptability will be evaluated using rates of attendance
Acceptability scores
Time frame: up to 18 weeks
Feasibility and acceptability will be evaluated using acceptability scores
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 30 Oct 2026.
- Individual participant dataSharing planned: No. This is an investigator initiated pilot trial examining the feasibility an acceptability of a culinary medicine intervention. When sharing IPD via open access, the lack of restrictions leads to greater risk of re-identifying individuals. Data could be inappropriately merged with other data to facilitate re-identification. Our small study population makes this more likely. On the other hand, sharing IPD via controlled access is burdensome. It requires resources that we do not have (setting up the infrastructure and policies, administering and reviewing data requests, preparing data and distributing data). The personnel time for such an endeavor was not budgeted, nor do we have the financial resources to include it in the study budget.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Living Cancer CALM education intervention in people with Breast Cancer, run by Case Comprehensive Cancer Center 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 10 inclusion and 10 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: opening soon, as of the sponsor's last update on 30 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 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?
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 Herbert B Newton, MD, FAAN (216-844-6031, Herbert.Newton@UHhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of recruitment (time frame: up to 18 weeks). The study lists 4 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 30 Oct 2026.