Alcohol Cessation Among Head and Neck Cancer Survivors

Completed · Not applicable

Conditions studied: Head and Neck Cancer, Alcohol Use, Unspecified

In brief

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).

Key facts

Study ID: NCT05570851
Run by: Northwell Health
People needed: 126
Starts: 2023-12-01
Expected to finish: 2026-03-23
Last updated by the study team: 2026-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Adult male or female patients 18 years or older
Diagnosed with primary cancer of: pharynx (nasopharynx, oropharynx, hypopharynx), larynx (all subsites), oral cavity (all subsites)
Having completed surgical, radiation, and/or chemotherapy treatment;
Post-treatment completion status of at least 3 months;
Able to communicate and read in English;
Possess a telephone with text messaging capability; and
Confirmation of alcohol consumption.

You may not qualify if…

Non-English speaker
Non-drinker
Previously enrolled in adaption phase focus-groups to determine intervention content
Clinically significant depression, as indicated by an assessment of ≥ 16 on the CES-D 11-item Iowa short form scale

Where it is running

Feinstein Institutes for Medical Research — Manhasset, New York, United States

Full record on ClinicalTrials.gov

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