CancerCCKNCT04528615
Testing the Effectiveness of Coping With Cancer in the Kitchen
A study testing CCK In-Person Sessions and CCK Printed Materials in people with Cancer and Nutrition Aspect of Cancer, run by American Institute for Cancer Research at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Nutrition Aspect of Cancer
- What is being tested?
- CCK In-Person Sessions and CCK Printed Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2019to 8 Oct 2019
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Support Community Los Angeles
Los Angeles, California, 90025
About this study
Official title: 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.
- Conditions
- Cancer, Nutrition Aspect of Cancer
- Being tested
- CCK In-Person Sessions, CCK Printed Materials
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCK In-Person SessionsBehavioural
This group attended eight weeks of nutrition education-focused experiential learning.
CCK Printed MaterialsBehavioural
This group did not attend any in-person sessions and was only provided with select CCK written materials.
| Study group | Role | What they receive |
|---|---|---|
| CCK In-Person Sessions | Experimental | This group received the in-person CCK intervention. Receives: Behavioral: CCK In-Person Sessions |
| CCK Printed Materials | Active comparator | This group received select printed CCK materials. Receives: Behavioral: CCK Printed Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge about the role of a plant-based diet in cancer risk reduction
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).
Measured: 9 weeks
Knowledge about the role of a plant-based diet in cancer risk reduction
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).
Measured: 15 weeks
Confidence preparing a variety of plant-based foods
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).
Measured: 9 weeks
Confidence preparing a variety of plant-based foods
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).
Measured: 15 weeks
Skills to practice a plant-based diet
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).
Measured: 9 weeks
Skills to practice a plant-based diet
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).
Measured: 15 weeks
Barriers to eating more fruits and vegetables and whole grains
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.
Measured: 9 weeks
Barriers to eating more fruits and vegetables and whole grains
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.
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start30 Apr 2019
- Primary completion12 Aug 2019
- Study completion8 Oct 2019
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Institute for Cancer Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa Miller, PhD, Principal investigator, American Institute for Cancer Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528615
- Sponsor's protocol ID
- 19048-01
- Acronym
- CCK
- Status last verified
- Aug 2020
- First submitted
- 17 Aug 2020
- Last updated
- 27 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Test the Effectiveness of Coping With Cancer in the Kitchen, a Nutrition Education Program From Diagnosis and Beyond
- ClinicalTrials.gov ID
- NCT04528615
- Acronym / sponsor ID
- CCK / 19048-01
- Conditions
- Cancer, Nutrition Aspect of Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- American Institute for Cancer ResearchUniversity, hospital or other
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 12 Aug 2019 (actual)
- Study completion
- 8 Oct 2019 (actual)
- First posted
- 27 Aug 2020 (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 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CCK In-Person Sessions | Experimental | Behavioral: CCK In-Person SessionsThis group received the in-person CCK intervention. |
| CCK Printed Materials | Active comparator | Behavioral: CCK Printed MaterialsThis group received select printed CCK materials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (4 listed)
- 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)
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 |
|---|---|---|
| CCK In-Person SessionsThis group attended eight weeks of nutrition education-focused experiential learning. | Behavioural | CCK In-Person Sessions |
| CCK Printed MaterialsThis group did not attend any in-person sessions and was only provided with select CCK written materials. | Behavioural | CCK Printed Materials |
Primary outcome
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).
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).
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).
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).
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).
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).
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.
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.
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 27 Aug 2020.
- Related InfoLink provided by the sponsor.
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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.
Melissa Miller, PhD principal investigator
American Institute for Cancer Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CCK In-Person Sessions and CCK Printed Materials in people with Cancer and Nutrition Aspect of Cancer, run by American Institute for Cancer Research 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 1 inclusion and 4 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 27 Aug 2020. 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?
Knowledge about the role of a plant-based diet in cancer risk reduction (time frame: 9 weeks). The study lists 8 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 Aug 2020.