Food Insecurity Interventions in Improving Treatment Completion in Patients with Cancer Undergoing Chemotherapy or Radiation Therapy
This randomized phase II trial studies how well food insecurity interventions work in improving treatment completion in patients with cancer undergoing chemotherapy or radiation therapy. Food insecurity interventions may help patients who have trouble getting food and help them complete cancer treatment.
Inclusion Criteria
- FOCUS GROUPS: * 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 United States Department of Agriculture (USDA) Household Food Security Module (score of 3 or higher) * Language spoken: English or Spanish
- Age 18 or over
- INTERVENTION INCLUSION CRITERIA
- Enrolled in the Internet Corporation for Assigned Names and Numbers (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)
- Intervention inclusion criteria: 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: Has a Doctor of Medicine (MD) or Doctor of Osteopathic Medicine (DO) degree
- CLINICIAN: Is the treating physician providing care to a patient enrolled to the study
- AIM 6 NEEDS ASSESSMENT: Current or past breast cancer diagnosis
- AIM 6 NEEDS ASSESSMENT: Living independently (no patient in an assisted living facility)
- AIM 6 NEEDS ASSESSMENT: Age 18 or over
- AIM 6 NEEDS ASSESSMENT: Able to provide informed consent and respond to questionnaires in either English, or Spanish
Exclusion Criteria
- FOCUS GROUPS: * 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
- Cannot 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 Supplemental Nutrition Assistance Program (SNAP) benefits (formerly known as food stamps) (for the original arms only: pantry only, pantry + delivery, pantry + voucher)
- AIM 6 NEEDS ASSESSEMENT: 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)
- AIM 6 NEEDS ASSESSEMENT: Presence of cognitive impairment disorder (i.e. delirium or dementia) enough to preclude meaningful informed consent and/or data collection
- AIM 6 NEEDS ASSESSEMENT: Cannot speak English or Spanish
- AIM 6 NEEDS ASSESSEMENT: Has physical limitations that would prevent participation (e.g. blindness)
Additional locations may be listed on ClinicalTrials.gov for NCT01603316.
Locations matching your search criteria
United States
New York
Bronx
New York
Shirley
PRIMARY OBJECTIVE:
I. To utilize a three arm randomized controlled trial to determine whether participation in the food insecurity interventions leads to improvements in cancer treatment completion.
SECONDARY OBJECTIVES:
I. To utilize a three arm randomized controlled trial to determine whether participation in the interventions leads to improvements or lesser decreases in quality of life, food security, nutrition risk, weight/body mass index (BMI), protein and fruit/vegetable intake.
Ia. To explore the extent to which depressive symptoms improve.
Ib. To describe differences in occurrences of treatment interruptions across intervention arms.
II. To measure and compare patient utilization and satisfaction with the hospital-based food pantry, food voucher program, and grocery delivery program.
III. To assess the impact of clinician non-English language proficiency, non-English language use, and interpreter use on completion of cancer treatment among a population of limited English proficiency (LEP) cancer patients. (For phase I only)
IV. To estimate the incremental costs of the food to overcome outcome disparities (FOOD) interventions.
V. To determine the extent to which ameliorating food insecurity mediates cancer treatment completion.
VI. To determine food security, treatment completion, and patient socioeconomic needs during the coronavirus disease 2019 (COVID-19) pandemic. (Exploratory)
OUTLINE:
FOCUS GROUP: Patients participate in focus groups over 2 hours to tailor the written materials and nutrition education sessions.
INTERVENTION: Patients are randomized to 1 of 3 arms.
ARM I: Patients receive access to a hospital-based food pantry once weekly. As of July 2018 (phase II), patients receive food vouchers once monthly for 6 months.
ARM II: Patients receive access to a hospital-based food pantry once weekly and food vouchers once monthly. As of July 2018 (phase II), patients receive home grocery delivery once weekly for 6 months.
ARM III: Patients receive access to a hospital-based food pantry and grocery delivery once weekly. As of July 2018 (phase II), patients receive access to a medically-tailored, hospital-based food pantry once weekly for 6 months.
After completion of study, patients are followed up periodically.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorFrancesca Gany
- Primary ID12-099
- Secondary IDsNCI-2016-01753
- ClinicalTrials.gov IDNCT01603316