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Cancer PatientsPhase 2NCT01603316

Food: A Three-Arm Study Examining Food Insecurity Interventions

A Phase 2 study testing surveys and Focus groups in people with Cancer Patients, run by Memorial Sloan Kettering Cancer Center at 10 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The investigators have found that many patients getting treatment for cancer have trouble getting enough to eat, or do not always have enough money for food. When a patient has these problems it can lead to difficulties with completing cancer treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer Patients
What is being tested?
surveys and Focus groups
Could I receive a placebo?
No, everyone receives an active treatment
How many people
606 participants
Where
10 sitesUnited States
Study dates
8 May 2012to May 2027
Phase
Phase 2
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

  • Focus Groups Inclusion Criteria:
  • Breast cancer patient, Stage 1,2, or 3
  • Currently undergoing treatment with chemotherapy and/or radiation
  • Food insecure: score in the range of "very low" or "low" food security status on the USDA Household Food Security Module (score of 3 or higher)
  • Language spoken: English or Spanish
  • Age 18 or over
Show all 22Show fewer
  • Intervention Inclusion Criteria:
  • Enrolled in ICCAN (for the original arms only: pantry only, pantry + delivery, pantry + voucher)
  • Within one month (+/- 1 month) of starting chemotherapy or within two weeks (+/- 2 weeks) of starting radiation therapy) (may be prior to or after starting treatment)
  • Score in the range of 'very low' or 'low' food security status on the USDA Household Food Security Module (score of 3 or higher)
  • Living independently (no patient in an assisted living facility)
  • Age 18 or over
  • Able to provide informed consent and respond to questionnaires in either English, Spanish or Mandarin (Mandarin for the original arms only: pantry only, pantry + delivery, pantry + voucher)
  • Breast or gynecologic cancer diagnosis, Stage 1, 2, or 3 (for the updated arms only: 1) Food Voucher Program (Voucher); 2) Home Grocery Delivery Program (Delivery); and 3) Medically-tailored, Hospital-based Food Pantry (Pantry)
  • Clinician is eligible if he/she:
  • Has an MD or DO degree
  • Is the treating physician providing care to a patient enrolled to the study
  • Secondary Aim 6 Needs Assessment eligibility criteria:
  • Current or past breast cancer diagnosis
  • Living independently (no patient in an assisted living facility)
  • Age 18 or over
  • Able to provide informed consent and respond to questionnaires in either English, or Spanish

Who cannot join

  • Focus Groups Exclusion Criteria:
  • Has a household member who has already participated (or agreed to participate)
  • Intervention Exclusion Criteria:
  • Significant psychiatric disturbance verified by medical record sufficient to preclude completion of the assessment measures, interview or informed consent (i.e. acute psychiatric symptoms which require individual treatment)
  • Presence of cognitive impairment disorder (i.e. delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection
  • Can not speak English, Spanish or Mandarin (Mandarin for the original arms only: pantry only, pantry + delivery, pantry + voucher)
Show all 14Show fewer
  • Has physical limitations that would prevent participation (e.g. blindness)
  • Patient's household is currently receiving or applying for SNAP benefits (formerly known as Food Stamps) (for the original arms only: pantry only, pantry + delivery,pantry + voucher)
  • Secondary Aim 6 Needs Assessment Exclusion criteria:
  • Significant psychiatric disturbance verified by medical record enough to preclude completion of the assessment measures, interview or informed consent (i.e. acute psychiatric symptoms which require individual treatment)
  • Presence of cognitive impairment disorder (i.e. delirium or dementia) enough to preclude meaningful informed consent and/or data collection
  • Cannot speak English or Spanish
  • Has physical limitations that would prevent participation (e.g. blindness)
  • Patient or family member has participated in other MSK IHCD trials related to social determinants of health

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Brooklyn Hospital Center

    Brooklyn, New York, 11201

  • Queens Hospital Center

    Jamaica, New York, 11432

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Bellevue Hospital Center

    New York, New York

  • Ralph Lauren Center for Cancer Care and Prevention

    New York, New York

  • St. Barnabas Medical Center

    The Bronx, New York, 10457

  • Jacobi Medical Center

    The Bronx, New York, 10465

  • Montefiore Health System (Montefiore Medical Center)

    The Bronx, New York, 10467

  • New York Cancer & Blood Specialists (Data collection only)

    The Bronx, New York, 10469

  • Lincoln Medical and Mental Health Center

    The Bronx, New York

Other trials in United States

About this study

Official title: Food: A Three-Arm Randomized Controlled Study Examining Food Insecurity Interventions

The investigators have found that many patients getting treatment for cancer have trouble getting enough to eat, or do not always have enough money for food. When a patient has these problems it can lead to difficulties with completing cancer treatment. Across New York City, there are many hospitals that offer their patients food pantry services on location. The investigators would like to compare how food pantries within the hospital and two other food assistance options: monthly food vouchers and weekly grocery deliveries maybe possible solutions to this problem. The patient will be randomly assigned to one of the three different food program groups, which means everyone has an equal chance in being in any group, like a flip of a coin. The investigators hope to learn how to best help patients with trouble getting food and to see if this will help with completing cancer treatment.

The original RCT composed of study arms: 1) hospital -based food pantry (control), 2) food voucher program plus access to the food pantry, and 3) grocery delivery program plus access to the food pantry will remain open to accrual at Ralph Lauren Cancer Center. The other three sites of the original RCT, Lincoln Hospital, Queens Cancer Center and Brooklyn Hospital, have reached target accrual. Our modified RCT, to be carried out among an expanded cohort of cancer patients is composed of study arms : 1) Food Voucher Program (Voucher); 2) Home Grocery Delivery Program (Delivery); and 3) Medically-tailored, Hospital-based Food Pantry (Pantry).

For this RCT, we will enroll patients across Bronx hospitals- Jacobi Medical Center, St. Barnabas Hospital, and Montefiore Medical Center. For the new study arms, we will enroll patients across Lincoln Medical and Mental Health Center, Jacobi Medical Center, St. Barnabas Medical Center, Montefiore Health System, New York Cancer \& Blood Before Specialists, and Bellevue Hospital. Before conducting the RCT across Lincoln Medical and Mental Health Center and the new sites in the Bronx, we will refine written educational materials to be used in the intervention through focus groups.

Conditions
Cancer Patients
Being tested
surveys, Focus groups
Keywords
Food pantry, Food voucher, Grocery delivery, 12-099

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • surveysBehavioural

    Each survey will take about 45 minutes.Surveys will include questions on medical treatment, health insurance, work-related information, overall health and well being, eating habits, and satisfaction/use of the food program provided. 3 and 6-month follow-up. All participants will be asked to complete the study contact form. Need Assessment surveys will be administered via telephone or in person. The content of the needs assessment questionnaire has been informed by themes generated through IHCD's ongoing research and community outreach and service activities with the cancer patient population at our participating institutions. The survey will ask participants about the impact on their cancer care and their socioeconomic needs of the COVID-19 crisis.

  • Focus groupsBehavioural

    Prior to conducting the updated RCT design with the expanded cohort, we will conduct 4-6 focus groups (to saturation) with underserved breast cancer patients to optimally tailor the written materials, via mail, MSK Secure email, or in person and nutrition education sessions.

Study groups in NCT01603316
Study groupRoleWhat they receive
Food Voucher Program (Voucher)Active comparatorFood Voucher arm, each participant will receive a debit card specifically created for this program. Each month for the duration of study participation (6 months), the debit card will be credited with $128 \& given to the patient in person or via mail. Patients will be instructed to use these cards only for food purchases. If patients are not able to use the debit card at their local grocery stores, patients will be provided with a money order of the same dollar value instead of the debit card. They will be counseled on using their vouchers only for healthful foods, in a way that stretches their food dollars. Purchases will be tracked by having patients bring their receipts in for review each month when they come in to pick-up their next monthly vouche, or by providing electronic copies of receipts. Patients will be provided with a receipt holder to assist in storing receipts for review. For voucher cards sent via mail, patients will receive a mailing letter accompanying each card.
Receives: Behavioral: surveys; Behavioral: Focus groups
Home Grocery Delivery (Delivery)ExperimentalIn the Home Grocery Delivery arm, each participant will receive home grocery delivery from PeaPod grocery delivery service or from FreshDirect (depending on the participant"s zip code), worth $128 per month, for the duration of study participation (6 months). Patients in the Delivery arm will review a list of food categories and a subset of items in each category with a COA.
Receives: Behavioral: surveys; Behavioral: Focus groups
Medically-Tailored Hospital-Based Food Pantry (Pantry)ExperimentalPatients in this arm will have access to the pantry for the duration of their study participation (6 months). Those accessing the medically-tailored food pantry will pick-up a pantry bag weekly or bi-weekly (per patient preference) at the hospital, either during one of their medical appointments or at another preferred time. Each patient's food prefereces will be assessed once during baseline and they will be given food bags, tailored when possible and when available to these preferences and to their medical needs and cultural preferences.
Receives: Behavioral: surveys; Behavioral: Focus groups

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. treatment completion

    Completion of prescribed treatment, increase from 75% to 94%, as assessed by chart review (for the period from recruitment to study completion at 6 months). To determine whether participation in the interventions leads to improvements in cancer treatment completion.

    Measured: 2 years

Secondary outcomes (1)

  1. Quality of life

    The primary analytic approach for these secondary outcome variables will be a series of Linear Mixed-Effects Models (LMMS) modeling the change scores from baseline to each of the follow-up assessments, separately for each of the questionnaire outcome variables [51]. Analyses based on change scores have the advantage of creating easily interpretable results and clearly indicating the direction of individual change (e.g., increased protein intake).

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2012 (estimated)
  2. Study start8 May 2012
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

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 2
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
606 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01603316
Sponsor's protocol ID
12-099
Status last verified
Jun 2026
First submitted
16 May 2012
Last updated
9 Jun 2026
Results posted
No

Publications

  • Gany F, Melnic I, Wu M, Li Y, Finik J, Ramirez J, Blinder V, Kemeny M, Guevara E, Hwang C, Leng J. Food to Overcome Outcomes Disparities: A Randomized Controlled Trial of Food Insecurity Interventions to Improve Cancer Outcomes. J Clin Oncol. 2022 Nov 1;40(31):3603-3612. doi: 10.1200/JCO.21.02400. Epub 2022 Jun 16.

    PubMed 35709430

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing surveys and Focus groups in people with Cancer Patients, run by Memorial Sloan Kettering Cancer Center at 10 sites 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 22 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

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?

treatment completion (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01603316, which also lists 1 linked publication.

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 2026.

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