NCT07706192

Brief Summary

Prospective cohort and descriptive study aimed at identifying cancer patients experiencing food insecurity at Virginia Commonwealth University (VCU) Massey Comprehensive Cancer Center. The study will involve evaluating the impact of a food assistance intervention on treatment adherence and clinical outcomes among food-insecure patients on active treatment.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
110mo left

Started Jul 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Jul 2026Aug 2035

Study Start

First participant enrolled

July 6, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 15, 2026

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2035

Last Updated

July 15, 2026

Status Verified

July 1, 2026

Enrollment Period

9.2 years

First QC Date

July 9, 2026

Last Update Submit

July 9, 2026

Conditions

Keywords

Treatment AdherenceFood InsecurityCancer Patients on Active Treatment

Outcome Measures

Primary Outcomes (1)

  • Evaluate the impact of a food assistance intervention on treatment adherence and clinical outcomes among food-insecure patients on active treatment.

    Percent of participants that self-report of treatment completion

    6 months following enrollment

Secondary Outcomes (3)

  • Change in Food Insecurity Score

    Baseline and 6 month follow-up

  • Change in Quality of Life (QOL) using European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire (EORTC QLQ-30)

    Baseline and 6 month follow-up

  • Change in financial toxicity

    Baseline and 6 month follow-up

Study Arms (2)

Food Assistance Program

EXPERIMENTAL

Six month food assistance program-shelf-stable food boxes

Other: Food Assistance Program

Standard of Care

ACTIVE COMPARATOR

Usual-care referrals

Other: Standard of Care

Interventions

Participants will be enrolled and provided with structured food assistance (e.g., shelf stable food boxes, produce vouchers) for six months

Also known as: Intervention Cohort
Food Assistance Program

Participants who receive usual-care referrals but not food packages.

Also known as: Comparison Cohort
Standard of Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (≥18 years old) with a current diagnosis of cancer
  • Patients attending outpatient services at the VCU Massey Comprehensive Cancer Center
  • Patients who are willing to participate and provide informed consent
  • Responding "sometimes true" or "often true" to at least one of the two validate Hunger Vital Sign Screening questions

You may not qualify if:

  • Patients who are unable to provide informed consent due to cognitive impairment or language barriers
  • Patients who are enrolled in other clinical trials that prohibit participation in additional research
  • Patients who do not consent to being included in the food insecurity registry
  • Patients with medical conditions other than cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23286, United States

RECRUITING

MeSH Terms

Conditions

Treatment Adherence and Compliance

Interventions

Food AssistanceStandard of Care

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Public AssistanceFinancing, GovernmentFinancing, OrganizedEconomicsHealth Care Economics and OrganizationsQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Susan Hong, MD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Massey CTO CPC Team

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2026

First Posted

July 15, 2026

Study Start

July 6, 2026

Primary Completion (Estimated)

August 31, 2035

Study Completion (Estimated)

August 31, 2035

Last Updated

July 15, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

There are no current plans to share individual patient data.

Locations