Brief 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.
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.
Brief Title
Food: A Three-Arm Study Examining Food Insecurity Interventions
Central Contacts
Central Contact Role
Contact
Central Contact Phone
646-888-8054
Central Contact Role
Contact
Central Contact Phone
646-888-4243
Completion Date
Completion Date Type
Estimated
Conditions
Cancer Patients
Eligibility Criteria
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
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
Inclusion Criteria
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
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
Gender
All
Gender Based
false
Keywords
Food pantry
Food voucher
Grocery delivery
12-099
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01603316
Org Class
Other
Org Full Name
Memorial Sloan Kettering Cancer Center
Org Study Id
12-099
Overall Status
Recruiting
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Food: A Three-Arm Randomized Controlled Study Examining Food Insecurity Interventions
Primary Outcomes
Outcome Description
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.
Outcome Measure
treatment completion
Outcome Time Frame
2 years
Secondary Outcomes
Outcome Description
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).
Outcome Time Frame
2 years
Outcome Measure
Quality of life
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Della Makower
Investigator Email
DMAKOWER@montefiore.org
Investigator Department
Medicine
Investigator Division
Oncology
Investigator Sponsor Organization
External
Study Department
Oncology (Medical/Hematologic)
Study Division
Medical and Hematologic Oncology
MeSH Terms
SURVEYS AND QUESTIONNAIRES
FOCUS GROUPS
DATA COLLECTION
EPIDEMIOLOGIC METHODS
INVESTIGATIVE TECHNIQUES
HEALTH CARE EVALUATION MECHANISMS
QUALITY OF HEALTH CARE
HEALTH CARE QUALITY, ACCESS, AND EVALUATION
PUBLIC HEALTH
ENVIRONMENT AND PUBLIC HEALTH