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NCT05570851Completed

Alcohol Cessation Among Head and Neck Cancer Survivors

Alcohol Cessation Among Head and Neck Cancer Survivors: A Pilot RCT of a Tailored Text Message Based Intervention

Source: ClinicalTrials.gov · Last updated 5 Oct 2026

Brief summary (registry, in English)

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).

Status (registry)
Completed
Study type
Interventional
Enrollment
126 (actual)
First submitted
4 Oct 2022
Start date
1 Dec 2023
Primary completion date
23 Mar 2026
Lead sponsor
Northwell Health
NCT number
NCT05570851

What you commit to

  • Study type: Interventional
  • Participants enrolled: 126
  • From 1 Dec 2023 to the primary completion date, 23 Mar 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previously enrolled in adaption phase focus-groups to determine intervention content

Other

  • Non-English speaker
  • Non-drinker
  • Clinically significant depression, as indicated by an assessment of ≥ 16 on the CES-D 11-item Iowa short form scale

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Feinstein Institutes for Medical Research
Coordinator of this site? Confirm its status
ManhassetUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.