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

HNC survivors (baseline N=138) will be enrolled from Northwell Health and the Brooklyn VA Medical Center, at the 3-month post treatment completion follow-up visit, when alcohol resumption is most likely to occur according to pilot data. The investigators will randomize survivors to either the control condition (AF; n=69) or the text message arm, consisting of: AF plus HNC tailored texts for civilians (n=34) and AF plus HNC tailored texts for Veterans (n=35), for a total of n = 69. The investigators expect 15% attrition over 6 months for a final sample size of N=120. The study's primary outcome is alcohol cessation at 6 months post-baseline. Secondary outcomes are: feasibility of enrolling patients (consenting 70% of eligible approached patients), acceptability of the text messages (a score ≥4 on a 5-point Likert scale ranging from "not at all" to "extremely" acceptable), and improved psychosocial functioning (improved QOL, and decreased depression, social isolation, loneliness).

If patients are interested, the HNC survivor will meet with a member of the study team to give informed consent, record baseline data, and assess drinking patterns with the AUDIT questionnaire and the Time-Line Follow Back (TLFB) alcohol use assessment procedure. The study staff will access provide alcohol use feedback and randomize the participant to either the active comparator (usual care) or the intervention text messaging arm. Block randomization will occur to ensure that an even number of civilian and Veteran HNC survivors will be allocated to both conditions, and that even numbers per condition across sites are maintained overall.

Usual care at both study sites is to provide general information about smoking and alcohol. For the present study, the investigators will enhance this usual care by assessing alcohol use systematically with the AUDIT questionnaire and the TLFB to obtain an accurate assessment of drinking. Regardless of drinking level, the patient will receive feedback about the reported alcohol consumption. The feedback will emphasize that, according to leading medical associations, any consumption of alcohol is not advisable for cancer survivors, as continued alcohol use is associated with a higher risk of cancer recurrence and reduced quality of life. A sample feedback statement is "one or two drinks might not seem much, but it can increase the participant's chances of cancer recurrence". Non-drinkers will be told to continue to abstain from consuming alcohol. Smoking cessation information is also part of usual care. Patients will be urged to stop smoking and referred to a smoking cessation program if so desired. The investigators will further remind patients to complete two follow-up questionnaires, one at 3 and one at 6 months post baseline, during scheduled follow-up visits. No further effort will be required, but patients randomized to the control condition will be offered the HNC text messages after completing all study procedures.

Survivors randomized into the intervention condition will receive usual care (described above) plus HNC tailored alcohol cessation text messages tailored for the general public or specifically designed for veterans, depending on recruitment site (Northwell vs. VA, respectively). Survivors will receive messages three times a week, usually during the late afternoon/early evening period, when the risk of alcohol drinking is greatest. Messages will be delivered for 3 months.

Demographic information, personal and family health history, and treatment type will be assessed. Patient will report any alcohol and smoking cessation advice they might have received from physicians. Overall health will be assessed with the SF-12 questionnaire. In addition, the AUDIT and TLFB will be used to assess frequency of alcohol use during the previous three months. Feasibility of a future RCT will be assessed through the number of survivors recruited vs. approached (enrollment rate threshold of 70%), Acceptability of the intervention will be determined through a positive evaluation of intervention (mean value of 4 on a 5-point scale, with higher values = higher acceptability). The primary outcome will be assessed using the TFLB interview, which will be converted into a binary drinking/no-drinking variable. Secondary outcomes include quality of life, depression, social isolation, and loneliness.