Food: A Three-Arm Study Examining Food Insecurity Interventions

Cancer Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01603316
• Other study ID #: 12-099
• Status: Recruiting
• Phase: Phase 2
• Start date: May 8, 2012
• Est. completion date: May 2026

Study information

• Verified date: May 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Francesca Gany, MD, MS
• Phone: 646-888-8054
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 668
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

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

Exclusion Criteria:

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)

• 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

Related Conditions & MeSH terms

• Cancer Patients

Intervention

Behavioral:
• surveys
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 groups
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.

Locations

Country	Name	City	State
United States	Jacobi Medical Center	Bronx	New York
United States	Lincoln Medical and Mental Health Center	Bronx	New York
United States	Montefiore Health System (Montefiore Medical Center)	Bronx	New York
United States	New York Cancer & Blood Specialists (Data collection only)	Bronx	New York
United States	St. Barnabas Medical Center	Bronx	New York
United States	Brooklyn Hospital Center	Brooklyn	New York
United States	Queens Hospital Center	Jamaica	New York
United States	Bellevue Hospital Center	New York	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Ralph Lauren Center for Cancer Care and Prevention	New York	New York

Sponsors (10)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Columbia University, Jacobi Medical Center, Lincoln Medical and Mental Health Center, Montefiore Health System, NYU Langone Health, Queens Cancer Center of Queens Hospital, Roswell Park Cancer Institute, St. Barnabas Medical Center, The Brooklyn Hospital Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Secondary	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).	2 years

External Links

•   Memorial Sloan Kettering Cancer Center