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NCT05570851 · ClinicalTrials.gov registry record · NA
Alcohol Cessation Among Head and Neck Cancer Survivors
A NA study of Head and Neck Cancer and Alcohol Use, Unspecified, sponsored by Northwell Health.
- Active
- Registry status
- NA
- Development phase
- 138
- Enrollment target
- 1
- Study location
NCT05570851: Active NA study of Head and Neck Cancer and Alcohol Use, Unspecified, sponsored by Northwell Health.
NCT05570851 is a NA study of Head and Neck Cancer and Alcohol Use, Unspecified that is active but no longer recruiting, run by Northwell Health. The registered enrollment target is 138 participants, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (47% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05570851, a NA study of Head and Neck Cancer and Alcohol Use, Unspecified, is active but no longer recruiting, sponsored by Northwell Health.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 138 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
Survivors will self-report the amount of alcohol they are consuming at the 6 month follow-up assessment using the Time-Line Follow Back (TFLB) interview, a semi-structured interview designed to collect information about survivors' daily substance use. The TLFB was validated in 1996 and has demonstrated good test-retest reliability, convergent validity, and agreement with collateral reports of alcohol abuse. Participants will be asked to report their substance use over the prior 4 weeks via phone
Conditions Studied
Interventions
- BEHAVIORAL Usual Care
- BEHAVIORAL Alcohol Cessation Text Messages
Study Locations (1)
New York
- Feinstein Institutes for Medical Research - Manhasset
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2023-12-01 |
| Est. Completion | 2026-03-31 |
| Phase | NA |
What the registry record for NCT05570851 still lists
NCT05570851 is an interventional study that assigns participants to a tested intervention. The registered 138 participants enrollment target is mid-sized for trials with a published cap, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (47% lower).
The record links to 2 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 2 interventions - of which Usual Care is the first listed.
NCT05570851 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05570851 about?
NCT05570851 is a clinical study titled "Alcohol Cessation Among Head and Neck Cancer Survivors". 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 facto...
What is the current status of trial NCT05570851?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 138 participants. The study started on 2023-12-01. Estimated completion is 2026-03-31.
What conditions does trial NCT05570851 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Alcohol Use, Unspecified.
What interventions are being tested in trial NCT05570851?
The interventions under investigation include: Usual Care (BEHAVIORAL), Alcohol Cessation Text Messages (BEHAVIORAL).
Who is sponsoring clinical trial NCT05570851?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05570851 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05570851's enrollment target sits among peer trials
138 67th of 250 higher than 184 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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