Testing the Effectiveness of Coping With Cancer in the Kitchen (CCK)

August 24, 2020 updated by: American Institute for Cancer Research

A Randomized Controlled Trial to Test the Effectiveness of Coping With Cancer in the Kitchen, a Nutrition Education Program From Diagnosis and Beyond

The study was a two-arm, randomized controlled trial in which cancer survivors were evenly assigned to either receive the 8-week CCK in-person nutrition intervention immediately or to become the control group that received a selection of CCK printed materials. The aim was to test the effectiveness of CCK for implementing a healthy plant-based diet and improving quality of life.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
53

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90025
        • Cancer Support Community Los Angeles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

-

Exclusion Criteria:

  • Need to have ever been diagnosed with cancer to be eligible
  • Need to have not participated in a Living Plate cooking program
  • Need to be able to attend at least seven of the eight sessions of the series with mandatory first and last sessions
  • Need to have completed active cancer treatment (not including hormonal or other similar agents, e.g., tamoxifen)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CCK In-Person Sessions
This group received the in-person CCK intervention.
Behavioral: CCK In-Person Sessions
This group attended eight weeks of nutrition education-focused experiential learning.
Active Comparator: CCK Printed Materials
This group received select printed CCK materials.
Behavioral: CCK Printed Materials
This group did not attend any in-person sessions and was only provided with select CCK written materials.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Knowledge about the role of a plant-based diet in cancer risk reduction
Time Frame: 9 weeks
Change from baseline in knowledge about role of consuming a predominantly plant-based diet and cancer risk. Participants rated their agreement (1 = Strongly disagree; 5 = Strongly agree) with six custom items developed by the research team, e.g., "I understand the benefits of consuming whole grains versus processed grains". A composite score was calculated as the average of the 6 ratings (range 1-5; Cronbach's alpha=.80).
9 weeks
Knowledge about the role of a plant-based diet in cancer risk reduction
Time Frame: 15 weeks
Change from baseline in knowledge about role of consuming a predominantly plant-based diet and cancer risk. Participants rated their agreement (1 = Strongly disagree; 5 = Strongly agree) with six custom items developed by the research team, e.g., "I understand the benefits of consuming whole grains versus processed grains". A composite score was calculated as the average of the 6 ratings (range 1-5; Cronbach's alpha=.80).
15 weeks
Confidence preparing a variety of plant-based foods
Time Frame: 9 weeks
Change from baseline in confidence to prepare a variety of plant-based foods. Participants indicated "How sure are you that you could prepare the foods listed below in a tasty way?" (1 = Very unsure; 5 = Very sure). The 14-item scale included: 4 whole grains; 4 beans, seeds and legumes; 3 green leafy vegetables; and 3 mixed foods, e.g. healthy one-pot meals. A composite score was calculated as the average of the 14 items (range 1-5; Cronbach's alpha=.75).
9 weeks
Confidence preparing a variety of plant-based foods
Time Frame: 15 weeks
Change from baseline in confidence to prepare a variety of plant-based foods. Participants indicated "How sure are you that you could prepare the foods listed below in a tasty way?" (1 = Very unsure; 5 = Very sure). The 14-item scale included: 4 whole grains; 4 beans, seeds and legumes; 3 green leafy vegetables; and 3 mixed foods, e.g. healthy one-pot meals. A composite score was calculated as the average of the 14 items (range 1-5; Cronbach's alpha=.75).
15 weeks
Skills to practice a plant-based diet
Time Frame: 9 weeks
Change from baseline in skills to practice a plant-based diet. Participants rated their agreement (1 = Strongly disagree; 5 = Strongly agree) with five custom items developed by the research team, e.g., "I am confident that I can create a kitchen environment that makes it easier to store, prepare, and consume fruits, vegetables, whole grains, and beans."; the average of the five ratings was calculated to create a skills composite score (range 1-5; Cronbach's alpha=.88).
9 weeks
Skills to practice a plant-based diet
Time Frame: 15 weeks
Change from baseline in skills to practice a plant-based diet. Participants rated their agreement (1 = Strongly disagree; 5 = Strongly agree) with five custom items developed by the research team, e.g., "I am confident that I can create a kitchen environment that makes it easier to store, prepare, and consume fruits, vegetables, whole grains, and beans."; the average of the five ratings was calculated to create a skills composite score (range 1-5; Cronbach's alpha=.88).
15 weeks
Barriers to eating more fruits and vegetables and whole grains
Time Frame: 9 weeks
Change from baseline in barriers to eating more fruits and vegetables and whole grains. We adapted items from an existing barriers instrument to measure perceived barriers to eating more fruits and vegetables (F&V) (average score of 15 items; Cronbach's alpha = .89) and whole grains (average score of 14 items; Cronbach's alpha = .83). Participants were asked the general question, "Listed below are some common reasons why people don't eat more servings of vegetables and fruits each day. Indicate whether or not this is a reason for you by marking how much you agree or disagree." (1 = Strongly disagree; 5 = Strongly agree). In addition, using the same list of possible reasons (excluding spoil too quickly), participants indicated whether it was a common reason they didn't eat more servings of whole grains. Example reasons included: take too much time to prepare; my family doesn't like them; hard to find a variety of good ones.
9 weeks
Barriers to eating more fruits and vegetables and whole grains
Time Frame: 15 weeks
Change from baseline in barriers to eating more fruits and vegetables. We adapted items from an existing barriers instrument to measure perceived barriers to eating more fruits and vegetables (F&V) (average score of 15 items; Cronbach's alpha = .89) and whole grains (average score of 14 items; Cronbach's alpha = .83). Participants were asked the general question, "Listed below are some common reasons why people don't eat more servings of vegetables and fruits each day. Indicate whether or not this is a reason for you by marking how much you agree or disagree." (1 = Strongly disagree; 5 = Strongly agree). In addition, using the same list of possible reasons (excluding spoil too quickly), participants indicated whether it was a common reason they didn't eat more servings of whole grains. Example reasons included: take too much time to prepare; my family doesn't like them; hard to find a variety of good ones.
15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
American Institute for Cancer Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Melissa Miller, PhD, American Institute for Cancer Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 12, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 8, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19048-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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