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Not yet recruitingNCT07906990Updated Oct 30, 2026

Culinary And Lifestyle Medicine Education for Cancer Risk Reduction in Survivors of Breast Cancer

An interventional study of Living Cancer CALM education intervention in Breast Cancer, sponsored by Case Comprehensive Cancer Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Case Comprehensive Cancer Center · Not applicable, Interventional, and Supportive care

Updated Oct 30, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Breast Cancer

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Keywords

  • culinary medicine
  • breast cancer
  • living cancer CALM
03

In context

Breast Neoplasms

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

This study's planned enrollment of 44 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Case Comprehensive Cancer Center is the lead sponsor of 494 studies on the registry; 61 are open to participants now.

Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    Breast Cancer Survivors

    Eight 90 minute lessons delivered bi-weekly in the evenings in a hybrid format with alternating virtual and in-person lessons.

    Behavioral: Living Cancer CALM education intervention

Interventions

  • BehavioralLiving Cancer CALM education intervention

    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.

06

What researchers measure

Primary outcomes

  1. Rates of recruitment

    Feasibility and acceptability will be evaluated using rates of recruitment

    Time frame: up to 18 weeks

  2. Rates of retention

    Feasibility and acceptability will be evaluated using rates of retention

    Time frame: up to 18 weeks

  3. Rates of attendance

    Feasibility and acceptability will be evaluated using rates of attendance

    Time frame: up to 18 weeks

  4. Acceptability scores

    Feasibility and acceptability will be evaluated using acceptability scores

    Time frame: up to 18 weeks

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Jun 2027, 6 months later.

Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 6 months is below that.

Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 26, 2026
First posted
Oct 30, 2026
StartEst.
Nov 16, 2026
Primary completionEst.
Jun 3, 2027
CompletionEst.
Jun 3, 2027
Last update
Oct 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07906990
Responsible party
Sponsor
First posted
Oct 30, 2026
Start date
Nov 16, 2026 (estimated)
Primary completion
Jun 3, 2027 (estimated)
Completion
Jun 3, 2027 (estimated)
Last update
Oct 30, 2026

Study contacts

Herbert B Newton, MD, FAAN
Contact
Herbert.Newton@UHhospitals.org
216-844-6031
Ryanne Lachman, MS, RDN, IFNCP
Contact
Ryanne.Lachman@uhhospitals.org
440-376-3693

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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