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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a text message program can help head and neck cancer survivors quit drinking alcohol. Participants will either receive encouraging text messages (Alcohol Cessation Text Messages) or continue with their usual care. The researchers aim to determine if participants find this approach appealing and if it helps them reduce or stop drinking. The trial seeks individuals who have had head and neck cancer, completed treatment at least three months ago, and still consume alcohol. Participants must be able to read English and have a phone capable of receiving text messages.

As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could enhance support for cancer survivors.

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.

What prior data suggests that this text message intervention is safe for head and neck cancer survivors?

Research has shown that text message programs designed to help quit alcohol are safe. These programs have been tested with various groups and have not revealed any major safety issues. Unlike medicines, these messages don't have side effects; they simply offer support to help people stop drinking.

For head and neck cancer survivors, these messages are tailored to promote healthier choices. No evidence suggests that receiving these texts causes harm. It's a low-risk method to support quitting alcohol while considering the survivor's health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the text message support for head and neck cancer survivors because it offers a unique approach to aiding alcohol cessation. Unlike traditional methods that might involve face-to-face counseling or medication, this treatment uses a text message-based program to provide support and encouragement directly to the patient's phone. This method is accessible and convenient, allowing patients to receive help anytime and anywhere without needing to attend physical appointments. By leveraging technology, this program aims to engage patients consistently and personally, potentially increasing their chances of successfully quitting alcohol.

What evidence suggests that this text message intervention is effective for alcohol cessation in head and neck cancer survivors?

This trial will compare the effectiveness of a text message-based program with usual care for head and neck cancer survivors. Research has shown that text message programs can help people stop drinking. Specifically, studies have found that personalized text messages can lead to a 30% increase in quitting alcohol among head and neck cancer survivors, compared to a 20% increase with regular feedback. These programs are designed to be supportive and easy to use, making them a good option for those who want to cut down or quit drinking. Digital tools like these offer accessible help for individuals aiming to make healthier choices. ^{1 2 3 5 6}

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.

Possess a telephone with text messaging capability

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. withpower.com withpower.com/trial/phase-head-and-neck-cancer-2-2023-7fbc5

Text Message Support for Head and Neck Cancer Survivors * 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 ...

2. apps.dtic.mil apps.dtic.mil/sti/trecms/pdf/AD1207723.pdf

Alcohol Cessation Among Head and Neck Cancer Survivors text messages will result in 30% increase in cessation among HNC survivors. Head and Neck Cancer; Alcohol Cessation; Veterans Health; Substance Abuse ...

3. ctv.veeva.com ctv.veeva.com/study/alcohol-cessation-among-head-and-neck-cancer-survivors

Alcohol Cessation Among Head and Neck Cancer Survivors 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8477484/

Cancer survivors' views on digital support for smoking ... Digital interventions may provide low-threshold support for smoking cessation (SC) and alcohol moderation (AM) to the growing population of cancer survivors.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/pon.5261

The effectiveness of distance‐based interventions for ... The effectiveness of distance‐based interventions for smoking cessation and alcohol moderation among cancer survivors: A meta‐analysis - Mujcic ...

6. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.33881

Substance use and mental health burden in head and neck ... Tobacco dependence, alcohol abuse, depression, distress, and other adverse patient-level influences are common in head and neck cancer (HNC) survivors.