Alcohol Cessation Among Head and Neck Cancer Survivors

Summary

Head-and-neck cancers (HNC) account for 4 percent of cancer diagnoses in the United States and for more than 66,000 annual cancer diagnoses. The prevalence rate of HNC among Veterans is 150% higher than the rate in the general population. Together with smoking, alcohol drinking is a major risk factor for HNC, responsible for approximately one-third of the cases worldwide. Overwhelming evidence from population-based studies show that alcohol drinking significantly increases the risk of recurrence of the primary HNC and of second primary malignancies, as well as negatively impacts HNC survivors' psychosocial health. Hence, several organizations (i.e., American Cancer Society, American Society of Clinical Oncology, and the World Cancer Research Fund) have issued guidelines recommending that individuals with HNC reduce or avoid alcohol altogether. Despite these recommendations, a substantial proportion of HNC survivors continue to use alcohol.

The overall goal of the proposed research is to:

1. Adapt an existing evidence-based text message alcohol cessation intervention for HNC survivors in both civilian and VA settings (i.e., at two sites, Northwell Health and the Brooklyn VA Medical Center); and
2. Preliminarily evaluate, in a two-arm pilot RCT, the acceptability and preliminary efficacy of the intervention, as well as feasibility of conduct a future RCT.

The investigators hypothesize that:

* H1: The tailored text-message intervention will be 1) feasible to evaluate in a large-scale RCT, defined as achieving an enrollment rate of ≥70% in this pilot; and 2) acceptable to participants, defined as a score ≥4 on a 5-point Likert scale ranging from "not at all" to "extremely" acceptable.
* H2: Compared to the control condition of alcohol assessment and feedback (AF), the tailored text messages will result in a 30% increase in cessation among survivors (assuming also a 20% increase in cessation in the AF arm).

Conditions

• Head and Neck Cancer
• Alcohol Use, Unspecified

Interventions

BEHAVIORAL

Alcohol Cessation Text Messages

Intervention condition will consist of a text message program designed to promote alcohol cessation tailored to HNC patients and targeted to VA or Civilian populations in addition to usual-care-advice.

BEHAVIORAL

Usual Care

Control condition will consist of a provider-delivered alcohol cessation intervention with usual-care-advice.

Sponsors & Collaborators

• United States Department of Defense

  collaborator FED

• VA Medical Center-Brooklyn

  collaborator FED

• Northwell Health

  lead OTHER

Principal Investigators

• Michael Diefenbach, PhD · Northwell Health

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-01

Primary Completion

2026-03-23

Completion

2026-03-23

Countries

• United States

Study Locations