Text Message Support for Head and Neck Cancer Survivors

Overseen By Michael Diefenbach, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwell Health

Disqualifiers: Non-drinker, Non-English speaker, Depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

138 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on reducing or avoiding alcohol use among head and neck cancer survivors.

How does the treatment of Alcohol Cessation Text Messages differ from other treatments for head and neck cancer survivors?

This treatment is unique because it uses text messages to support alcohol cessation, which is crucial for improving outcomes in head and neck cancer survivors. Unlike traditional methods, this approach provides ongoing, accessible support to help patients reduce alcohol consumption, which is a significant risk factor for cancer recurrence and poor survival. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Alcohol Cessation Text Messages for head and neck cancer survivors?

Research shows that continued alcohol consumption after a head and neck cancer diagnosis significantly increases the risk of death. Therefore, efforts to stop drinking, such as through text message support, are important for improving survival in these patients. ^{2 3 5 6 7}

Who Is on the Research Team?

Michael Diefenbach, PhD

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had head and neck cancer, finished treatment at least 3 months ago, can read English, have a text-capable phone, and currently drink alcohol. It's not for non-English speakers, those with significant depression or people who don't drink.

Inclusion Criteria

Confirmation of alcohol consumption

I have finished all my cancer treatments.

I finished my last cancer treatment at least 3 months ago.

Exclusion Criteria

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

Non-English speaker

Non-drinker

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants meet with the study team to give informed consent, record baseline data, and assess drinking patterns with the AUDIT questionnaire and the TLFB alcohol use assessment procedure.

1 week

1 visit (in-person)

Intervention

Participants receive usual care plus HNC tailored alcohol cessation text messages three times a week for 3 months.

12 weeks

Follow-up

Participants are monitored for alcohol cessation and psychosocial outcomes at 3 and 6 months post-baseline.

6 months

2 visits (virtual or phone)

What Are the Treatments Tested in This Trial?

Interventions

• Alcohol Cessation Text Messages
• Usual Care

Trial Overview The study tests if personalized text messages help head and neck cancer survivors stop drinking alcohol compared to usual care. Participants will be randomly placed in two groups: one receiving the texts and the other getting standard advice on alcohol use.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Text Message Based Program

Group II: Control Active Control 1 Intervention

Usual Care

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

VA Medical Center-Brooklyn

Collaborator

Trials

1

Recruited

140+

Citations

1. England pubmed.ncbi.nlm.nih.gov

Cigarettes, alcohol, and depression: characterizing head and neck cancer survivors in two systems of care. [2015]

2. France pubmed.ncbi.nlm.nih.gov

[Smoking and alcohol cessation programs in patients with head and neck cancer]. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Alcohol and tobacco use prediagnosis and postdiagnosis, and survival in a cohort of patients with early stage cancers of the oral cavity, pharynx, and larynx. [2022]

4. Spain pubmed.ncbi.nlm.nih.gov

[Prevalence of tobacco and alcohol use following treatment in patients with head and neck squamous carcinoma: a cross-sectional study]. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Alcoholism, depression, and abnormal cognition in head and neck cancer: a pilot study. [2007]

6. England pubmed.ncbi.nlm.nih.gov

Informational and Support Needs of Patients with Head and Neck Cancer: Current Status and Emerging Issues. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Patterns of alcohol use among early head and neck cancer survivors: A cross-sectional survey study using the alcohol use disorders identification test (AUDIT). [2023]