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두경부암 생존자의 금주

2026년 10월 2일 업데이트: Northwell Health

두경부암 생존자의 금주: 맞춤형 문자 메시지 기반 개입의 파일럿 RCT

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:

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
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).

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

The primary goal of the proposed work is to assess the acceptability of the proposed intervention, to estimate effect sizes for the two arms, as well as to determine feasibility of a future RCT. For the estimation of effect sizes for the primary measure of alcohol cessation, the needed sample size is 138 survivors, equally divided among AF and the intervention arm (n = 69 each) across the two sites. The sample size is not powered to detect a statistically significant difference between the intervention and AF arms. It will provide investigators, however, with effect size estimates to power a future RCT. The current sample size is based on well-established literature that pilot studies should accrue at least 10% of the patients needed for a fully powered trial. Based on the prior literature, the investigators assume that the rate of abstinence in the AF arm will be 20%, and among the text arm 30%. Thus, the investigators estimate an average effect size of 10% between AF and the text conditions. These effect sizes are considered small (h=0.2) and would be clinically meaningful.

연구 유형

중재적

등록 (실제)

126

단계

해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

미국
- New York
  - Manhasset, New York, 미국, 11030
    - Feinstein Institutes for Medical Research

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

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.

Exclusion Criteria:

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

주 목적: 건강 서비스 연구
할당: 무작위
중재 모델: 병렬 할당
마스킹: 없음(오픈 라벨)

팔의 수

무기와 개입

참가자 그룹 / 팔	개입 / 치료
활성 비교기: Control Usual Care	행동: Usual Care Control condition will consist of a provider-delivered alcohol cessation intervention with usual-care-advice.
실험적: Intervention Text Message Based Program	행동: Alcohol Cessation Text Messages 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Alcohol Cessation Six Months From Baseline 기간: 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

2차 결과 측정

결과 측정	측정값 설명	기간
Alcohol Cessation Three Months From Baseline 기간: Three Months From Baseline	Survivors will self-report the amount of alcohol they are consuming at the 3 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.	Three Months From Baseline
Quality Of Life (QoL) at Baseline 기간: Baseline	Quality of life will be assessed with the Head and Neck Quality of Life instrument, a 20-item Likert scale measure that evaluates quality of life related to eating, communication, pain, and emotion in the last 4 weeks. This measure has been validated with both civilian and VA populations. This survey will be administered via phone or electronic survey during the baseline assessment. Univariate and descriptive analyses will be performed and normalizing and/or variance stabilizing transformations will be conducted. The investigators will examine the data for outliers and use descriptive and inferential statistical techniques for data characterization. Lower scores indicate less impairment on quality of life.	Baseline
Quality Of Life (QoL) Three Months From Baseline 기간: Three Months From Baseline	Quality of life will be assessed with the Head and Neck Quality of Life instrument, a 20-item Likert scale measure that evaluates quality of life related to eating, communication, pain, and emotion in the last 4 weeks. This measure has been validated with both civilian and VA populations. This survey will be administered via phone or electronic survey during the 3 month follow-up assessment. Univariate and descriptive analyses will be performed and normalizing and/or variance stabilizing transformations will be conducted. The investigators will examine the data for outliers and use descriptive and inferential statistical techniques for data characterization. Lower scores indicate less impairment on quality of life.	Three Months From Baseline
Quality Of Life (QoL) Six Months From Baseline 기간: Six Months From Baseline	Quality of life will be assessed with the Head and Neck Quality of Life instrument, a 20-item Likert scale measure that evaluates quality of life related to eating, communication, pain, and emotion in the last 4 weeks. This measure has been validated with both civilian and VA populations. This survey will be administered via phone or electronic survey during the 6 month follow-up assessment. Univariate and descriptive analyses will be performed and normalizing and/or variance stabilizing transformations will be conducted. The investigators will examine the data for outliers and use descriptive and inferential statistical techniques for data characterization. Lower scores indicate less impairment on quality of life.	Six Months From Baseline
Depression at Baseline 기간: Baseline	Depression will be evaluated with the Patient Health Questionnaire (PHQ) 2-item version, a brief and accurate measurement of the core symptoms/signs of depression and will be used to help assess patients' quality of life. This survey will be administered via phone or electronic survey during the baseline assessment. Univariate and descriptive analyses will be performed and normalizing and/or variance stabilizing transformations will be conducted.The investigators will examine the data for outliers and use descriptive and inferential statistical techniques for data characterization. Higher scores indicate increased symptoms of depression.	Baseline
Depression Three Months From Baseline 기간: Three Months From Baseline	Depression will be evaluated with the Patient Health Questionnaire (PHQ) 2-item version, a brief and accurate measurement of the core symptoms/signs of depression and will be used to help assess patients' quality of life. This survey will be administered via phone or electronic survey during the 3 month follow-up assessment. Univariate and descriptive analyses will be performed and normalizing and/or variance stabilizing transformations will be conducted.The investigators will examine the data for outliers and use descriptive and inferential statistical techniques for data characterization. Higher scores indicate increased symptoms of depression.	Three Months From Baseline
Depression Six Months From Baseline 기간: Six Months From Baseline	Depression will be evaluated with the Patient Health Questionnaire (PHQ) 2-item version, a brief and accurate measurement of the core symptoms/signs of depression and will be used to help assess patients' quality of life. This survey will be administered via phone or electronic survey during the 6 month follow-up assessment. Univariate and descriptive analyses will be performed and normalizing and/or variance stabilizing transformations will be conducted.The investigators will examine the data for outliers and use descriptive and inferential statistical techniques for data characterization. Higher scores indicate increased symptoms of depression.	Six Months From Baseline
Social Isolation Baseline 기간: Baseline	Social isolation will be evaluated with the 6-item Lubben Social Network Scale, a validated instrument designed to gauge social isolation in older samples by measuring the number and frequency of social contacts with friends and family members. This survey will be administered via phone or electronic survey during the baseline assessment. Univariate and descriptive analyses will be performed and normalizing and/or variance stabilizing transformations will be conducted. The investigators will examine the data for outliers and use descriptive and inferential statistical techniques for data characterization. Higher scores indicate a larger social network.	Baseline
Social Isolation Three Months From Baseline 기간: Three Months From Baseline	Social isolation will be evaluated with the 6-item Lubben Social Network Scale, a validated instrument designed to gauge social isolation in older samples by measuring the number and frequency of social contacts with friends and family members. This survey will be administered via phone or electronic survey during the 3 month assessment. Univariate and descriptive analyses will be performed and normalizing and/or variance stabilizing transformations will be conducted. The investigators will examine the data for outliers and use descriptive and inferential statistical techniques for data characterization. Higher scores indicate a larger social network.	Three Months From Baseline
Social Isolation Six Months From Baseline 기간: Six Months From Baseline	Social isolation will be evaluated with the 6-item Lubben Social Network Scale, a validated instrument designed to gauge social isolation in older samples by measuring the number and frequency of social contacts with friends and family members. This survey will be administered via phone or electronic survey during the 6 month assessment. Univariate and descriptive analyses will be performed and normalizing and/or variance stabilizing transformations will be conducted. The investigators will examine the data for outliers and use descriptive and inferential statistical techniques for data characterization. Higher scores indicate a larger social network.	Six Months From Baseline
Loneliness at Baseline 기간: Baseline	Loneliness will be evaluated with the 6-item De Jong Gierveld Loneliness Scale, a reliable and valid continuous measure for overall, emotional and social loneliness. This survey will be administered via phone or electronic survey during the baseline assessment. Univariate and descriptive analyses will be performed and normalizing and/or variance stabilizing transformations will be conducted. The investigators will examine the data for outliers and use descriptive and inferential statistical techniques for data characterization. Higher scores indicate increased loneliness.	Baseline
Loneliness Three Months From Baseline 기간: Three Months From Baseline	Loneliness will be evaluated with the 6-item De Jong Gierveld Loneliness Scale, a reliable and valid continuous measure for overall, emotional and social loneliness. This survey will be administered via phone or electronic survey during the 3 month assessment. Univariate and descriptive analyses will be performed and normalizing and/or variance stabilizing transformations will be conducted. The investigators will examine the data for outliers and use descriptive and inferential statistical techniques for data characterization. Higher scores indicate increased loneliness.	Three Months From Baseline
Loneliness Six Months From Baseline 기간: Six Months From Baseline	Loneliness will be evaluated with the 6-item De Jong Gierveld Loneliness Scale, a reliable and valid continuous measure for overall, emotional and social loneliness. This survey will be administered via phone or electronic survey during the 6 month assessment. Univariate and descriptive analyses will be performed and normalizing and/or variance stabilizing transformations will be conducted. The investigators will examine the data for outliers and use descriptive and inferential statistical techniques for data characterization. Higher scores indicate increased loneliness.	Six Months From Baseline

기타 결과 측정

결과 측정	측정값 설명	기간
Acceptability Three Months From Baseline 기간: Three Months From Baseline	The investigators will evaluate acceptability of the intervention, defined as a positive evaluation of the intervention as indicated by a mean value of 4 on a 5-point scale, with higher values indicating higher acceptability.	Three Months From Baseline
Acceptability Six Months From Baseline 기간: Six Months From Baseline	The investigators will evaluate acceptability of the intervention, defined as a positive evaluation of the intervention as indicated by a mean value of 4 on a 5-point scale, with higher values indicating higher acceptability.	Six Months From Baseline
Feasibility of future RCT Three Months From Baseline 기간: Three Months From Baseline	The investigators will evaluate feasibility of conducting a future, large-scale efficacy RCT, defined as a recruitment rate of 70% (number of survivors recruited over approached) in this pilot RCT.	Three Months From Baseline
Feasibility of future RCT Six Months From Baseline 기간: Six Months From Baseline	The investigators will evaluate feasibility of conducting a future, large-scale efficacy RCT, defined as a recruitment rate of 70% (number of survivors recruited over approached) in this pilot RCT.	Six Months From Baseline

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Northwell Health

협력자

United States Department of Defense

VA Medical Center-Brooklyn

수사관

수석 연구원: Michael Diefenbach, PhD, Northwell Health

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 12월 1일

기본 완료 (실제)

2026년 3월 23일

연구 완료 (실제)

2026년 3월 23일

연구 등록 날짜

최초 제출

2022년 10월 4일

QC 기준을 충족하는 최초 제출

2022년 10월 4일

처음 게시됨 (실제)

2022년 10월 7일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 2일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

22-0362
W81XWH-22-1-0186 (기타 보조금/기금 번호: United States Department of Defense)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Researchers can contact the PI in order to request de-identified individual participant data (IPD).

IPD 공유 기간

These materials will become available before enrollment of first patient.

IPD 공유 액세스 기준

Access to IPD will only be given for researchers who contact the PI requesting de-identified data.

IPD 공유 지원 정보 유형

연구_프로토콜
수액
ICF

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

두경부암 생존자의 금주