Alcohol Cessation Among Head and Neck Cancer Survivors

NCT05570851 | Completed

• 2 other identifiers: 22-0362W81XWH-22-1-0186
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Alcohol Use, Unspecified; Head and Neck Cancer

Keywords

Head and Neck Cancer; Veterans Health; Substance Abuse; Quality of life; Depression; Social Isolation; Loneliness; Alcohol Cessation; Alcohol Drinking

Outcome Measures

Primary Outcomes (1)

• Alcohol Cessation Six Months From Baseline

  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 or electronic survey. Responses will be converted to a binary outcome of drinking reported or no drinking reported. Fewer participants reporting alcohol use would be considered success.

  Six Months From Baseline

Secondary Outcomes (13)

• Alcohol Cessation Three Months From Baseline

  Three Months From Baseline

• Quality Of Life (QoL) at Baseline

  Baseline

• Quality Of Life (QoL) Three Months From Baseline

  Three Months From Baseline

• Quality Of Life (QoL) Six Months From Baseline

  Six Months From Baseline

• Depression at Baseline

  Baseline

Other Outcomes (4)

• Acceptability Three Months From Baseline

  Three Months From Baseline

• Acceptability Six Months From Baseline

  Six Months From Baseline

• Feasibility of future RCT Three Months From Baseline

  Three Months From Baseline

Study Arms (2)

Control

ACTIVE COMPARATOR

Usual Care

Behavioral: Usual Care

Intervention

EXPERIMENTAL

Text Message Based Program

Behavioral: Alcohol Cessation Text Messages

Interventions

Alcohol Cessation Text Messages BEHAVIORAL

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.

Intervention

Usual Care BEHAVIORAL

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Northwell Health: lead
• United States Department of Defense: collaborator
• VA Medical Center-Brooklyn: collaborator

Study Sites (1)

Feinstein Institutes for Medical Research

Manhasset, New York, 11030, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Alcohol Drinking; Substance-Related Disorders; Depression; Social Isolation

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Drinking Behavior; Behavior; Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Social Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Michael Diefenbach, PhD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study model is a randomized control pilot trial consisting of two arms, control and intervention group. Control condition will consist of a provider-delivered alcohol cessation intervention with usual-care-advice. The intervention condition will consist of a text based intervention designed to promote alcohol cessation in addition to usual-care-advice.

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 7, 2022
• Study Start: December 1, 2023
• Primary Completion: March 23, 2026
• Study Completion: March 23, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: These materials will become available before enrollment of first patient.
• Access Criteria: Access to IPD will only be given for researchers who contact the PI requesting de-identified data.

Locations

US (1)