Neoplasms

Digestive System Diseases

All Conditions

Behaviors and Mental Disorders

Mouth and Tooth Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Esophageal Neoplasms

Alcohol Drinking

Mouth Neoplasms

Laryngeal Diseases

Laryngeal Neoplasms

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Drinking Behavior

Otorhinolaryngologic Neoplasms

Respiratory Tract Diseases

Respiratory Tract Neoplasms

Otorhinolaryngologic Diseases

Esophageal Cancer

Oral Cancer

Lip and Oral Cavity Cancer

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Ethanol

Participants in this arm will be presented with three narrative pictorial warning labels for alcoholic beverages.

Participants in this arm will be presented with three non-narrative pictorial warning labels for alcoholic beverages.

Pictorial warning labels consisting of text and narrative imagery (e.g., photos of cancer patients) conveying the risk of alcohol for oral cancer, esophageal cancer, and larynx cancer.

Narrative pictorial warning labels for alcoholic beverages

Pictorial warning labels consisting of text and non-narrative imagery (e.g., images of diseased organs) conveying the risk of alcohol for oral cancer, esophageal cancer, and larynx cancer.

Non-narrative pictorial warning labels for alcoholic beverages

Zexin Ma, Ph.D.

The goal of this study is to determine the effectiveness of pictorial warning labels (PWLs) featuring narrative (vs. non-narrative) content in communicating the cancer risk of alcohol. Participants will be randomized to view either three narrative or non-narrative PWLs. Key outcome variables include visual attention, message reactance, risk perceptions, and intentions to reduce and stop drinking.

The goal of this study is to determine the effectiveness of pictorial warning labels (PWLs) featuring narrative (vs. non-narrative) content in communicating the cancer risk of alcohol. Participants will be recruited from online panels. Participants will first be invited to participate in an online screening survey. Eligible participants will be invited to participate in the main experiment. In the main experiment, participants will first answer questions concerning baseline alcohol consumption and other background information. Then they will engage with a webcam-based eye-tracking task through Sticky by Tobii. Participants will first read instructions and tips related to completing the eye-tracking task. They will complete a brief calibration procedure and be presented with either three narrative PWLs or three non-narrative PWLs. Sticky by Tobii will record participants' gaze, thereby measuring visual attention to each PWL. After viewing each PWL, participants will answer a few questions. After viewing all three PWLs, they will answer questions based on all images combined. Upon study completion, participants will be compensated. A follow-up survey will be sent to participants after two weeks, which includes questions about their drinking behaviors, information seeking behaviors, and social interactions.

Evaluations of Alcohol Warning Labels

The de-identified dataset, study protocol, sample informed consent, and data dictionary will be made available to the research community free of charge through ICPSR (https://www.openicpsr.org/).

Self-reported attention will be measured by one question, "How much did this warning grab your attention?" Participants will respond on a five-point scale (1=Not at all, 2=Very little, 3=Somewhat, 4=Quite a bit, 5=A great deal).

Self-reported avoidance will be measured by one question, "How much did this warning make you want to look away?" Participants will respond on a five-point scale (1=Not at all, 2=Very little, 3=Somewhat, 4=Quite a bit, 5=A great deal).

Narrative construction will be measured with four questions, such as "How much did you try to tell yourself a story when viewing this warning?" Participants will respond on a five-point scale (1=Not at all, 2=Very little, 3=Somewhat, 4=Quite a bit, 5=A great deal).

Processing fluency will be measured with two questions, such as "How easy or difficult was it to process the information shown in the warnings?"Participants will respond on a five-point scale (11=Very difficult, 2=Somewhat difficult, 3=Neither difficult nor easy, 4=Somewhat easy, 5=Very easy).

Participants will report how they felt while viewing the labels. Fear, disgust, anger, sadness, and sympathy will be measured using established scales. Participants will respond on a five-point scale (1=Not at all, 2=Very little, 3=Somewhat, 4=Quite a bit, 5=A great deal).

Cognitive elaboration will be measured by four questions, such as "How much did the warnings make you think about reasons for not drinking?" Participants will respond on a five-point scale (1=Not at all, 2=Very little, 3=Somewhat, 4=Quite a bit, 5=A great deal).

Retrospective reflection will be measured by three questions, such as "When viewing, the warnings reminded you of some of your personal experiences?" Participants will respond on a five-point scale (1=Not at all, 2=Very little, 3=Somewhat, 4=Quite a bit, 5=A great deal).

Attention 1 to each label will use the eye-tracking metrics time until noticed, which measures the time between stimulus onset and the arrival of the participant's gaze into a specific area of interest.

Attention 2 to each label will use the eye-tracking metrics time viewed, which measures the average amount of time spent on an area of interest.

Attention 3 to each label will use the eye-tracking metrics number of visits, which measures the total number of unique times the area of interest was viewed.

Reactance will be measured with three questions, such as "How much did the warning try to manipulate you?" on a five-point scale (1=Not at all, 2=Very little, 3=Somewhat, 4=Quite a bit, 5=A great deal).

Affective risk perceptions will be assessed by asking participants to indicate how worried they are about getting a specific type of cancer if they keep drinking the amount of alcohol like they do now. Participants will respond on a five-point scale (1 = Not at all worried, 2=Slightly worried, 3=Moderately worried, 4=Very worried, 5=Extremely worried).

Experiential risk perceptions will be assessed by asking participants to indicate how vulnerable they feel about getting a specific type of cancer if they keep drinking the amount of alcohol like they do now. Participants will respond on a five-point scale (1 = Not at all vulnerable, 2=Slightly vulnerable, 3=Moderately vulnerable, 4=Very vulnerable, 5=Extremely vulnerable).

Perceived susceptibility will be assessed by asking participants to indicate how likely it is that they will get a specific type of cancer if they keep drinking the amount of alcohol like they do now. Participants will respond on a five-point scale (1 = Not at all likely, 2=A little likely, 3=Somewhat likely, 4=Very likely, 5=Extremely likely).

Comparative risk will be assessed by asking participants to indicate compared to an average person their age, race, and sex, how likely do they think they will get a specific type of cancer if they keep drinking the amount of alcohol like they do now. Participants will respond on a five-point scale (1=Much less likely, 2=Less likely, 3=About as likely, 4=More likely, 5=Much more likely).

Perceived severity of harm will be assessed by asking participants to indicate how much getting a specific type of cancer because of drinking would affect their life. Participants will respond on a five-point scale (1=Not at all, 2=Very little, 3=Somewhat, 4=Quite a bit, 5=A great deal).

Intentions to reduce drinking will be assessed with three questions such as "How interested are you in reducing drinking in the next 6 months?" Participants will respond to these questions on an appropriately labeled 5-point scale (e.g., 1 = Not at all interested, 2=Slightly interested, 3=Moderately interested, 4=Very interested, 5=Extremely interested).

Intentions to stop drinking will be assessed with three questions such as "How interested are you in stopping drinking in the next 6 months?" Participants will respond to these questions on an appropriately labeled 5-point scale (e.g., 1 = Not at all interested, 2=Slightly interested, 3=Moderately interested, 4=Very interested, 5=Extremely interested).

Attitudes toward alcohol will be assessed by three semantic differential items on a five-point scale. Participants will be presented with a statement (i.e., Now, please think about how you feel about alcohol at this moment. Do you think drinking alcohol is ____) followed by adjectives such as "Bad/Good," "Unenjoyable/Enjoyable," and "Harmful/Beneficial."

Intentions to avoid the warnings will be assessed by three questions, such as "If all alcoholic beverages had these warnings on them, how likely is it that you would cover them up?" Participants will respond on a five-point scale (1=Not at all likely, 2=Slightly likely, 3=Somewhat likely, 4=Very likely, 5=Extremely likely).

Policy support will be measured by three questions, such as "If the U.S. required that these warnings appeared on alcoholic beverages, to what extent would you support or oppose this policy?" Participants will respond to these questions on an appropriately labeled 5-point scale (e.g., 1 = Strongly oppose, 5 = Strongly support).

Self-reported behavior change due to labels will be measured with one question, "In the past two weeks, has the amount of alcohol you are drinking changed as a result of the alcohol warning labels you previously saw? Are you drinking ...?" Participants will respond on a five-point scale (1=Much less, 2=A bit less, 3=Same amount, 4=A bit more, 5=Much more).

Information seeking will be measured by two question, such as "In the past two weeks, how many times did you talk to a doctor or other health professional about the cancer risks of alcohol?" Participants will respond on a five-point scale (1=Never, 2=1-2 times, 3=3-4 times, 4=5-9 times, 5=10 or more times).

Social interactions will be measured by four questions, such as"In the past two weeks, how many times did you talk to people other than your doctor about the cancer risks of alcohol?" Participants will respond on a five-point scale (=Never, 2=1-2 times, 3=3-4 times, 4=5-9 times, 5=10 or more times).

Oakland University

National Cancer Institute (NCI)

University of Connecticut

Assistant Professor

Symptoms and General Pathology

Body Weight

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Written, standardized individually tailored lifestyle feedback based on participants responses to a lifestyle questionnaire, and a leaflet on healthy lifestyle mailed to the participant.

A leaflet on healthy lifestyle mailed to the participant.

The written, standardized individually tailored lifestyle feedback includes feedback on consumption of fruit, berries and vegetables and alcohol, physical activity, smoking and body mass index.

Individually tailored lifestyle feedback

The leaflet is The Norwegian Cancer Society's one-page information brochure on healthy lifestyle behaviours for low cancer risk, including non-smoking, healthy body weight, physical activity, diet, moderate alcohol consumption, moderate sun exposure etc.

Standard leaflet

Paula Berstad, PhD

This randomized controlled trial aims to investigate the effect of an individually tailored lifestyle feedback letter and a leaflet on lifestyle in the context of sigmoidoscopy screening.

Cancer screening may be used as a teachable moment for healthy lifestyle behaviours. This study aims to investigate the effect of minimal, but individually tailored lifestyle advice and a standard leaflet on healthy lifestyle given at a colorectal cancer screening context on one-year changes in these behaviours in a population-based sample of men and women.

Individuals invited to sigmoidoscopy screening in the piloting of Norwegian Bowel Cancer Screening are additionally invited to this lifestyle intervention study. Changes in lifestyle are measured by a brief lifestyle questionnaire administered at prescreening and after one year. The intervention to the intervention arms is given after completion of the prescreening lifestyle questionnaire.

A computer programme designed by the research team IT developer carried out the randomization. The recruitment and the contact between the investigators and the participants was mailed. There was no face-to-face contact.

Tailored Written Lifestyle Feedback in Colorectal Cancer Screening

A Randomized Trial of Tailored Written Lifestyle Feedback in Colorectal Cancer Screening

A score variable ranging from 0 (least favorable) to 6 (most favorable), calculated as the sum of self-reported favorable lifestyle factors assessed by a questionnaire; non-smoking (1 score point), body mass index less than 25 kg/m2 (1 score point), a minimum of seven physical activity sessions of 30 minutes per a week (1 score point), a maximum of four dinner servings of red and processed meat per a week (1 score point), a minimum of three servings of fruit, berries and vegetables per a day (0.5 score point) and a minimum of one serving of fatty fish per a week (0.5 score points)

Self-reported smoking status (smoking vs. non-smoking), assessed by a questionnaire

Self-reported consumption of alcoholic beverages (glasses/week), assessed by a questionnaire

Self-reported weekly time spent in physical activity (number of 30-minute activity sessions per week), assessed by a questionnaire

Self-reported consumption of fruit, berries and vegetables (servings per day), assessed by a questionnaire

Self-reported body weight (whole kilograms), assessed by a questionnaire

Oslo University Hospital

Researcher

Skin and Connective Tissue Diseases

Anxiety Disorders

Breast Neoplasms

Inflammation

Cognitive Dysfunction

the physical activity intervention will be structured to increase light-intensity aerobic physical activity, to achieve a total of 150 minutes per week. The intervention will also include weekly support calls from research staff to improve compliance to physical activity

Participants randomized to the usual care control group will serve as the control group for 15 weeks, and receive no intervention during this time.

The physical activity program will focus on increasing physical activity, starting with a target of 100 minutes per week. The session durations will build over time to 150 minutes per week. Participants will be instructed to walk, or engage in other forms of light-intensity physical activity to achieve these goals. Participants will be instructed on the use of the ratings of perceived exertion scale (6-20). As the participants' health and fitness status improves, frequency, intensity, and session duration will be modified accordingly during weekly support calls. As participants will enter the study engaging in varying levels of physical activity, goals will be responsive to the most recent week's achieved minutes.

Physical Activity

Participants in the usual care group will receive no intervention

Usual Care

Brett R Gordon, PhD

Kathryn Schmitz, PhD

The Trial Assessing Light-Intensity Exercise on the Health of Older Breast Cancer Survivors pilot randomized controlled trial aims to evaluate the efficacy of a home-based, light-intensity physical activity intervention among 56 obese, older adult breast cancer survivors, in comparison to a usual care control condition.

The investigators will recruit 56 obese, older adult breast cancer survivors at least 1 year, and up to 10 years post-breast cancer treatment, and randomize them to either a 15 week light-intensity physical activity intervention, or usual care group.

Intervention: The participants will receive weekly support calls, and instructed to increase their light-intensity physical activity, to achieve at least 150 minutes per week. The frequency, intensity, time, and type of physical activity will be modified to maximize adherence and compliance. The support calls developed for this trial target older adults' capabilities, opportunities, and motivations for physical activity.

Trial Assessing Light Intensity Exercise on the Health of Older Breast Cancer Survivors

A cytokine multiplex will assess markers of inflammation, including C-reactive protein

A cytokine multiplex will assess markers of inflammation, including Interleukin 6

A cytokine multiplex will assess markers of inflammation, including Tumor Necrosis Factor Alpha

The Functional Assessment of Cancer Therapy-Cognitive Function-Perceived Cognitive Impairments scores range from 0-72, higher scores indicate better quality of life.

The Functional Assessment of Cancer Therapy-Cognitive Function-Impact of perceived cognitive impairments on quality of life scores range from 0-16, higher scores indicate better quality of life.

The Functional Assessment of Cancer Therapy-Cognitive Function-comments from others scores range from 0-16, higher scores indicate better quality of life.

The Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive abilities scores range from 0-28, higher scores indicate better quality of life.

State and trait anxiety are measured using the State and Trait subscales of the State-Trait Anxiety Inventory (Spielberger, 2010, Corsini Encycl of Psychol).The State-Trait Anxiety Inventory has 40 items, 20 items allocated to each of the subscales. State-Trait Anxiety Inventory varies from a minimum score of 20 to a maximum score of 80, higher scores indicate higher anxiety.

The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 - Anxiety subscale measures patient reported anxiety symptoms. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher anxiety

The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 - depression subscale measures patient reported depressive symptoms. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher depression

The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 - physical function subscale measures patient reported physical function. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher physical function

The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 - fatigue subscale measures patient reported fatigue. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher fatigue.

The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 - Sleep Disturbance subscale measures patient reported Sleep Disturbance. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviationof 10. Higher scores indicate higher Sleep Disturbance.

The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 - Sleep Disturbance subscale measures patient reported Sleep Disturbance. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher Sleep Disturbance.

The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 - Ability to Participate in Social Roles and Activities subscale measures patient reported Ability to Participate in Social Roles and Activities. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher Ability to Participate in Social Roles and Activities

The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 - Pain interference subscale measures patient reported pain interference. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher Pain interference

The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 - Pain interference subscale measures patient reported pain interference. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher Pain intensity

A questionnaire probing the number of alcohol drinks consumed in the past 7 days

The six minute walking test will be administered to assess physical function. Participants will aim to walk as far as possible for 6 minutes.

Further distances indicate greater physical function

Ecological momentary assessment procedures for measuring both self-report and objective cognitive function will be used in 14 day bursts. These ecological momentary assessments protocols assess many of the same domains captured in other self-report and objective cognitive function measures, shortened and adapted for daily assessments.

Ecological momentary assessment procedures for measuring the number of drinks consumed in the past 24 hours will be assessed in 14 day bursts

The Alcohol Use Disorders Identification Test is a simple and effective method of screening for unhealthy alcohol use, defined as risky or hazardous consumption or any alcohol use disorder. A score of 8 or more is associated with harmful or hazardous drinking, a score of 13 or more in women, and 15 or more in men, is likely to indicate alcohol dependence.

The Telephone Interview for Cognitive Status is a brief, standardized test of cognitive functioning that was developed for use in situations where in-person cognitive screening is impractical or inefficient. The Telephone Interview for Cognitive Status will be used to screen for moderate-to-severe cognitive impairment. Scores 20 of lower indicate moderate-to-severe cognitive impairment

Age, height, weight, family income, education level, age at diagnosis, time since diagnosis, injury history, diabetic status, and whether they are currently receiving treatment for mental health will be assessed at baseline

The proportion of older adults who agree to participate among those deemed eligible.

The percentage of those randomized to the physical activity intervention that complete at least 50% of the physical activity intervention. Participants will be instructed by a project manager during weekly support calls to accumulate a specific amount of physical activity each week. Participants who self-report completing at least 50% of the physical activity, determined by the physical activity log, will be deemed compliant.

Milton S. Hershey Medical Center

Professor

Depressive Disorder

Depression

Quality of Life

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.

Alcohol Cessation Text Messages

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

Michael Diefenbach, PhD

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).

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.

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.

Alcohol Cessation Among Head and Neck Cancer Survivors

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

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

United States Department of Defense

VA Medical Center-Brooklyn

Northwell Health

Nutritional and Metabolic Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Obesity

Malnutrition

Postoperative Complications

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Urologic Diseases

Intervention: Patients allocated to the intervention group receive weekly counselling sessions in 6 weeks as an integrated prehabilitation program tailored to meet the individual patient's need for risk reduction at surgery. It is introduced via the surgical 'Engage in the process of change'. The smoking and alcohol cessation intervention follows the Gold Standard Programme and patients in the intervention group are introduced to a standardized exercise training programme taking individualized needs into account. Nutritional support is also individualized.

Treatment as ususal covers shorter interventions, e.g. advice, brief counselling, and handing out the national folders on smoking and alcohol and surgery. Patients are ensured that they are free to access support to lifestyle changes in the community.

Patients screened positive for minimun 1 SNAP factor will be offered enrollment in the study and have an individualized plan for the prehabilitation intervention.

Prehabilitation

Hanne Tønnesen, Professor MD

Susanne V Lauridsen, PhD

Hanne Tonnesen, Professor MD

Despite knowledge about the effect of preventive measures in lifestyle, smoking,nutrition, alcohol and physical activity (SNAP), there is a lack of systematic assessment of the overall lifestyle of the patient before surgery and knowledge about how lifestyle interventions can be organized in connection with cancer surgery. The intention with prehabilitation is to optimize the individual's risk factors and personal burdens that can affect the clinical and patient reported outcomes after surgery. The aim of this study is to evaluate the efficacy of intensive SNAP interventions compared to treatment as usual (TAU) in ptt undergoing urological cancer surgery on surgical risk reduction.

The project contains three clinical intervention studies, in total including 100 urological cancer patients screened positive for at least 1 SNAP factor:

I. Efficacy and preferences of intensive SNAP-Interventions among patients with at least one SNAP factor and undertaking neo-adjuvant chemotherapy before radical cystectomy. A randomised controlled trial with nested interviews (42 patients).

II. Implementation and preferences of intensive SNAP-Interventions among patients with kidney cancer undergoing nephrectomy/partial nephrectomy. An implementation feasibility study including interviews (20 patients).

III. Reach out and effect as well as preferences of perioperative intensive smoking cessation intervention via the municipality clinic compared to the surgical department among smokers with non-invasive bladder cancer treated with Trans-Urethral Resection of the Bladder (TUR-B). A randomised controlled trial with nested interviews (38 patients).

The intervention groups receive minimum five educational sessions tailored to individual needs over six weeks perioperatively. The control groups receive standard care.

Randomised Controlled Trials, Implementation feasibilty trial, Interviews nested

Outcome assessors will not know if patients were allocated to intervention or control group

STRONG for Surgery & Strong for Life - Against All Odds: Intensive Prehabilitation for Risk Reduction in Cancer Surgery

STRONG for Surgery & Strong for Life - Against All Odds: Intensive Prehabilitation Including Smoking, Nutrition, Alcohol and Physical Activity for Risk Reduction in Cancer Surgery

Corresponding at least 1 step for 1 or more risky lifestyles (but only smoking in study III) on the ASA-score (American Society of Anaesthesiologists physical status classification from 1-5, lower is better)

Mean difference of HRQoL between groups measured with EQ5D (5 level quality of life score (level 1 =no problems, level 2-5 =problems)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluations of Alcohol Warning Labels	NCT06129487	Oral Cancer Esophageal Canc... Larynx Cancer Alcohol Drinkin...	Narrative picto... Non-narrative p...	21 Years -	University of Connecticut
Tailored Written Lifestyle Feedback in Colorectal Cancer Screening	NCT03396029	Lifestyle Diet Habit Smoking Cessati... Physical Activi... Alcohol Drinkin... Body Weight	Individually ta... Standard leafle...	50 Years - 74 Years	Oslo University Hospital
Tailored Written Lifestyle Feedback in Colorectal Cancer Screening	NCT03396029	Lifestyle Diet Habit Smoking Cessati... Physical Activi... Alcohol Drinkin... Body Weight	Individually ta... Standard leafle...	50 Years - 74 Years	Oslo University Hospital
Evaluations of Alcohol Warning Labels	NCT06129487	Oral Cancer Esophageal Canc... Larynx Cancer Alcohol Drinkin...	Narrative picto... Non-narrative p...	21 Years -	University of Connecticut
Trial Assessing Light Intensity Exercise on the Health of Older Breast Cancer Survivors	NCT04965246	Inflammation Cognitive Impai... Anxiety Alcohol Drinkin...	Physical Activi... Usual Care	65 Years - 84 Years	Milton S. Hershey Medical Center
Alcohol Cessation Among Head and Neck Cancer Survivors	NCT05570851	Head and Neck C... Alcohol Use, Un...	Alcohol Cessati... Usual Care	18 Years -	Northwell Health
Tailored Written Lifestyle Feedback in Colorectal Cancer Screening	NCT03396029	Lifestyle Diet Habit Smoking Cessati... Physical Activi... Alcohol Drinkin... Body Weight	Individually ta... Standard leafle...	50 Years - 74 Years	Oslo University Hospital
STRONG for Surgery & Strong for Life - Against All Odds: Intensive Prehabilitation for Risk Reduction in Cancer Surgery	NCT04088968	Risk Reduction Urological Canc... Surgery Life Style	Prehabilitation	18 Years - 100 Years	Bispebjerg Hospital

Spots Global Cancer Trial Database for alcohol drinking