Quality of LifeNCT02887235
Food as Medicine: An RCT to Study the Effect of Home Delivered, Medically Tailored Meals on Patients With Metastatic Cancer
A study testing Home Delivered, Medically Tailored Meals (HDTM) in people with Quality of Life, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to determine whether medically tailored meals (HDTM) can improve quality of life for patients with metastatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life
- What is being tested?
- Home Delivered, Medically Tailored Meals (HDTM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 8 Aug 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of pathologically confirmed metastatic pancreatic, hepatobiliary, esophageal, or lung cancer, either newly metastatic or metastatic at presentation (M1+) and enrollment within 6 weeks of diagnosis; measurable disease need not be present.
- Pain Score (PS) 0-3
- Age>18
- Both male and female subjects eligible
- All ethnicities eligible
- Access to refrigerator or freezer
Who cannot join
- Diagnosis of metastatic cancer no greater than 6 weeks prior to expected study enrollment
- Currently receiving home delivered meals from other sources
- Evidence of any alimentary tract obstruction or other condition preventing oral alimentation
- Requirement for enteral or parenteral nutrition at time of diagnosis
- Incarcerated individuals
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Perlmutter Cancer Center
New York, New York, 10016
About this study
Official title: Food as Medicine: A Phase III Randomized Controlled Trial of Home Delivered, Medically Tailored Meals (HDMTM) on Quality of Life in Metastatic Lung and Non-colorectal GI Cancer Patients
The purpose of this study is to determine whether medically tailored meals (HDTM) can improve quality of life for patients with metastatic cancer.
Read the detailed description
The current standard of care at the cancer center is for all patients receiving cytotoxic therapy to undergo a nutritional consultation and evaluation with a registered oncology dietitian. The goal of this consultation is to prevent nutritional deficiencies, promote optimal nutritional intake, hydration, and weight maintenance, as well as maintain lean body mass.
All patients on this study will receive standard of care nutritional services including nutrition consult, evaluation, and as needed follow-ups. However, patients randomized to arm 2 will receive home delivered, medically tailored meals in addition to the standard nutritional care.
- Conditions
- Quality of Life
- Being tested
- Home Delivered, Medically Tailored Meals (HDTM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Delivered, Medically Tailored Meals (HDTM)Other
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SOC) Meals | No intervention | Patient assigned in this arm will receive standard of care nutritional services including nutrition consult, evaluation, and as needed follow-ups. |
| Medically tailored meals | Active comparator | Patient assigned in this arm will receive home delivered, medically tailored meals (HDMTM) in addition to the standard nutritional care. Receives: Other: Home Delivered, Medically Tailored Meals (HDTM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life measurement
Quality of life will be assessed using the Functional Assessment in Cancer Therapy - General (FACT-G). Developed by Cella et al. the FACT-G is a well validated and widely used multi-dimensional health related quality of life measure for cancer patients. It consists of 28 self-assessment items on a 5 point Likert scale that address four domains:
physical well-being, social/family well-being, emotional well-being, and functional well-being. Scores are calculated for each sub-scale per FACT scoring instructions and summed for a total score ranging between 0 and 108 with higher scores indicating a higher quality of life.
Measured: At 12 weeks follow up
Secondary outcomes (5)
Change in mood assessment
The Hospital Anxiety Depression Survey will be utilized to assess patient mood on this study. It is a validated, 14 item self-assessment tool used to assess severity of anxiety and depression symptoms in patients. Two 7 item subscales assess anxiety and depression in the past one week. Item responses are integer values between 0-3 and values for each subscale are added to give a subscale score. Scores on each subscale can range from 0 to 21 and a score greater than 11 is considered consistent with anxiety or depression. Scores of 7 or less are considered normal and scores of 8 to 10 are borderline. A score of 8 or greater on the anxiety subscale has a sensitivity of 0.9 and specificity of 0.78 for anxiety. Similarly, a score of 8 or greater on the depression subscale has a sensitivity of 0.83 and specificity of 0.79 for depression.
Measured: From baseline to 12 weeks
Patient weight assessment
Weight is measured at each physician visit per hospital policy. Weight at each interval will be recorded in the electronic medical record (EMR). Should the patient not have a scheduled visit with their primary oncologist or registered dietitian within the required visit window, any weight recorded in the EMR within the visit window can be used. The changes in weight from baseline to 12 weeks,will be measured using the Abridged Patient Generated Subjective Global Assessment (abPG-SGA) in the 2 arms.
Measured: From baseline to 12 weeks
Nutritional status assessment
The change in nutritional status from baseline will be measured using the Abridged Patient Generated Subjective Global Assessment (abPG-SGA) in the 2 arms.
Measured: From baseline to 12 weeks
Financial toxicity assessment
In 2014 a novel instrument to assess subjective financial toxicity, the Financial Toxicity Patient-Reported Outcome in Cancer measure (COST) was designed and recently validated. It is an 11 item assessment with 5 point Likert scale responses developed by de Souza et al reference to assess the levels of financial distress experienced by cancer patients. Each item response is scored 0-4 and then all individual item scores are summed. For incomplete surveys, the sum score is multiplied by 11 and then divided by the number of items answered. Total scores can range from 0-44 with higher scores representing higher subjective patient financial toxicity.
Measured: From baseline to 12 weeks
Food security assessment plus HDMTM from baseline to 12 weeks
U.S. Adult Food Security Survey module to assess food security.It is a 10 item questionnaire developed by the US Department of Agriculture to specifically assess food insecurity in adults. Affirmative responses to each item are given one point. Total raw scores are calculated by adding all points (affirmative responses) and can range from 0-10. A raw score of zero is considered high food security. A raw score 1-2 is considered marginal food security. A raw score 3-5 is considered low food security and raw scores 6-10 are very low food security.
Measured: From baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startMar 2016
- Primary completion8 Aug 2019
- Study completion8 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Schiff, MD, PhD, Principal investigator, NYU Perlmutter Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887235
- Sponsor's protocol ID
- s15-00708
- Status last verified
- Jun 2020
- First submitted
- 8 Aug 2016
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food as Medicine: A Phase III Randomized Controlled Trial of Home Delivered, Medically Tailored Meals (HDMTM) on Quality of Life in Metastatic Lung and Non-colorectal GI Cancer Patients
- ClinicalTrials.gov ID
- NCT02887235
- Acronym / sponsor ID
- s15-00708
- Conditions
- Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- 8 Aug 2019 (actual)
- Study completion
- 8 Aug 2019 (actual)
- First posted
- 2 Sep 2016 (estimated)
- 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 determine whether medically tailored meals (HDTM) can improve quality of life for patients with metastatic cancer.
Detailed description
The current standard of care at the cancer center is for all patients receiving cytotoxic therapy to undergo a nutritional consultation and evaluation with a registered oncology dietitian. The goal of this consultation is to prevent nutritional deficiencies, promote optimal nutritional intake, hydration, and weight maintenance, as well as maintain lean body mass.
All patients on this study will receive standard of care nutritional services including nutrition consult, evaluation, and as needed follow-ups. However, patients randomized to arm 2 will receive home delivered, medically tailored meals in addition to the standard nutritional care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SOC) Meals | No intervention | –Patient assigned in this arm will receive standard of care nutritional services including nutrition consult, evaluation, and as needed follow-ups. |
| Medically tailored meals | Active comparator | Other: Home Delivered, Medically Tailored Meals (HDTM)Patient assigned in this arm will receive home delivered, medically tailored meals (HDMTM) in addition to the standard nutritional care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of pathologically confirmed metastatic pancreatic, hepatobiliary, esophageal, or lung cancer, either newly metastatic or metastatic at presentation (M1+) and enrollment within 6 weeks of diagnosis; measurable disease need not be present.
- Pain Score (PS) 0-3
- Age>18
- Both male and female subjects eligible
- All ethnicities eligible
Key exclusion criteria (5 listed)
- Diagnosis of metastatic cancer no greater than 6 weeks prior to expected study enrollment
- Currently receiving home delivered meals from other sources
- Evidence of any alimentary tract obstruction or other condition preventing oral alimentation
- Requirement for enteral or parenteral nutrition at time of diagnosis
- Incarcerated individuals
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 |
|---|---|---|
| Home Delivered, Medically Tailored Meals (HDTM) | Other | Medically tailored meals |
Primary outcome
Quality of life measurement
Time frame: At 12 weeks follow up
Quality of life will be assessed using the Functional Assessment in Cancer Therapy - General (FACT-G). Developed by Cella et al. the FACT-G is a well validated and widely used multi-dimensional health related quality of life measure for cancer patients. It consists of 28 self-assessment items on a 5 point Likert scale that address four domains: physical well-being, social/family well-being, emotional well-being, and functional well-being. Scores are calculated for each sub-scale per FACT scoring instructions and summed for a total score ranging between 0 and 108 with higher scores indicating a higher quality of life.
5 secondary outcomes
Change in mood assessment
Time frame: From baseline to 12 weeks
Patient weight assessment
Time frame: From baseline to 12 weeks
Nutritional status assessment
Time frame: From baseline to 12 weeks
Financial toxicity assessment
Time frame: From baseline to 12 weeks
Food security assessment plus HDMTM from baseline to 12 weeks
Time frame: From baseline to 12 weeks
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 9 Jun 2020.
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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.
Peter Schiff, MD, PhD principal investigator
NYU Perlmutter Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Delivered, Medically Tailored Meals (HDTM) in people with Quality of Life, run by NYU Langone Health 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 6 inclusion and 5 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 9 Jun 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?
Quality of life measurement (time frame: At 12 weeks follow up). 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 9 Jun 2020.