Behaviors and Mental Disorders

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Neoplasms

Rare Diseases

Alcohol Drinking

Calculi

Gallstones

Cholelithiasis

Cholecystolithiasis

Gallbladder Neoplasms

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Gallbladder Diseases

Drinking Behavior

Gallbladder Cancer

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Ethanol

Gallbladder cancer case group was defined as newly diagnosed gallbladder cancer diagnosed as GBC at the Department of Internal Medicine in Cheju Halla General Hospital, Jeju, Korea from 2009 to 2013.

Age and sex matched control group was determined as age-sex matched subjects selected from the participants of Health Promotion Center in the same institute from 2009 to 2012.

Byung Hyo Cha, M.D.

This case-control study matched by age and sex was performed to evaluate the region specific risk factors for gallbladder cancer in Jeju island, Korea.

In order to estimate region-specific risk factors for gallbladder cancer (GBC) in Jeju island, Korea the investigators performed a case-control study. Among 124 GBC patients and 7088 health controls, the investigators randomly selected 78 cases and 78 age-sex matched controls (1:1 matching) and compared their demographic features, combined diseases, and personal histories about known risk factors until now.

Alcohol Consumption and Gallbladder Cancer

Alcohol Consumption and Gallbladder Cancer: Case-control Study in Jeju Island, Korea.

Cheju Halla General Hospital

Director of Digestive Disease Center

Skin and Connective Tissue Diseases

Breast Neoplasms

Women who drink seven or more drinks per week

Individuals who eat fewer than five servings of fruits and vegetables per day, on average, based on an NCI screener for fruit and vegetable consumption.

Individuals who exercise (moderate or vigorous intensity) less than 75 minutes per week.

William M Klein, Ph.D.

Background:

- People respond differently when asked about their values. They also respond differently when they learn about how their actions affect their lives and health. Researchers want to learn more about these differences. This can help them improve public health messages.

Objective:

- To see how people respond differently to questions about their values and to information about alcohol and breast cancer.

Eligibility:

Study 1

- Women age 18 and older.

Study 2 \& Study 3

-Women and men aged 18 and older to take part in these studies if they do not meet the US recommendations of eating 5 or more servings of fruits and vegetables per week.

Design:

* This study will take place online.
* Participants will be randomly assigned to a group that will complete a certain task.
* Researchers will ask participants to complete 2 small studies:
* Values Study. Some participants may write briefly about a value that is important to them or to someone they are close to. Some participants will complete a short questionnaire instead of the writing exercise.
* Study 1:

Alcohol and Breast Cancer Study. Participants will read a health message. This will be about the link between alcohol use and increased breast cancer risk. Participants will then answer questions about what they read and their beliefs about alcohol and breast cancer.

-Study 2:

Fruit and Vegetable Consumption and Health Study. Participants will read a health message about the fruit and vegetable consumption. Participants will then answer questions about what they read and their beliefs about fruit and vegetable consumption.

-Study 3:

Fruit and Vegetable Consumption and Health Study. Participants will read a health message about the fruit and vegetable consumption. Participants will then answer questions about what they read and their beliefs about fruit and vegetable consumption. Complete a follow-up survey that will be emailed to you through the mTurk system a week after you complete the main study.

* Both studies in either Study 1, Study 2 and Study 3 should take about 30 minutes.

Self-affirmation, a process by which individuals reflect on cherished personal values is a potent means of augmenting the effectiveness of threatening health communications. Individuals tend to be defensive against information suggesting their behavior puts them at risk for disease or negative health. Previous evidence suggests that self-affirmation may reduce defensiveness to threatening health information, increasing openness to the message and resulting in increased disease risk perceptions, disease-related worry, intentions to engage in preventive behavior, and actual behavioral change. Understanding the mechanisms that explain these robust effects would yield evidence important for dissemination, including ways to refine self-affirmation interventions and make them more potent, which could change the ways that public health messages are constructed. Thus, we aim to elucidate potential mechanisms underlying the effectiveness of self-affirmation, including self-activation, general affirmation, and domain-specific affirmation. In study 1, female human subjects will be randomly assigned to one of eleven affirmation or self- activation conditions. Following the affirmation or activation task, subjects will read about the documented link between alcohol and breast cancer. Finally, they will be asked a series of questions about their intentions to reduce drinking, their perceived risk of breast cancer, and their worry about breast cancer. Study 2 will replicate study 1, but in a different behavioral domain (physical activity) and a different sample (both males and females who do not meet physical activity recommendations). Study 3 will extend Studies 1 and 2 by examining whether the most effective self-affirmations identified in these studies produce short-term increases in fruit and vegetable consumption. Drawing on previous research, we hypothesize these inductions will be effective to the degree that they involve a self-affirmation, but will not be effective if they involve only other-affirmation or self-activation.

Self-Affirmation: Construct Validity

National Cancer Institute (NCI)

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urinary Bladder Neoplasms

Postoperative Complications

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Tin Fluorides

Standard treatment is information about benefits of stopping drinking and smoking before surgery and if wanted, advice about who to contact to get support.

5 meetings within 6 weeks containing education and pharmacologic support

Educational programme for smoking and alcohol cessation

Hanne Tønnesen, Professor

Radical cystectomy provides the best cancer-specific survival for muscle-invasive urothelial cancer. However the postoperative morbidity remains at 11-68 %. Smoking and alcohol consumption above two drinks per day is associated with an increased risk of postoperative morbidity. Six-eight weeks of smoking and alcohol abstinence prior to elective surgery is recommended to reduce this risk, but for cancer patients the preoperative period is often very short. This randomised clinical trial (STOP-OP) will reach a conclusion on the effect of a new Gold Standard Programme for both smoking and alcohol cessation Intervention using the Gold Standard Programme (GSP) on the frequency and severity of postoperative complications after bladder cancer surgery.

The study is a multicentre randomised clinical trial involving 110 patients with a risky alcohol intake (exceeding 21 alcohol units (252 g ethanol) per week or/ and daily smoking scheduled for bladder cancer surgery. Patients will be randomised to the 6-weeks GSP or treatment as usual (control). The GSP combines patient education and pharmacologic strategies. The GSP includes benzodiazepine therapy for withdrawal symptoms, controlled disulfiram therapy, and Nicotine replacement.

Intensive Smoking and Alcohol Cessation Intervention in Bladder Cancer Surgery Patients

Randomised Controlled Multicenter Study.Effect of an Intensive Smoking- and/or Alcohol Cessation Intervention Placed Shortly Before and 5 Weeks After Bladder Cancer Surgery on Postoperative Complications

Both number of patients with postoperative complications and number of postoperative complications according to the Clavien Dindo classification will be measured

Frederiksberg University Hospital

Aalborg University Hospital

Copenhagen University Hospital at Herlev

Odense University Hospital

Aarhus University Hospital

Karolinska Institutet

Rigshospitalet, Denmark

MEd, PhD student

Anxiety Disorders

Depressive Disorder

Depression

Breast Diseases

Skin Diseases

MBSR including brief information session and assessments

MBSR is an 8-week course covering a total of 24 contact hours where the group of patients meet with an clinical psychologist certified as mindfulness instructor. The group will train the ability of mindfulness by specific awareness improving practises (body-scan) guided meditations and soft yoga. Between group-sessions participants are recommended to practice 45 minutes daily and to go through instructions in MBSR hand-outs. Participants will be given audio-CDs containing instructions and guides to support home practice.

mindfulness based stress reduction (MBSR)

Christoffer Johansen, M.D., Ph.D.

The number of Danish women treated for breast cancer rise every year, though survival rates have improved, women can still expect to experience the diverse late effects reported by this group of patients. Mindfulness labels the ability to be aware of the present moment - thereby avoiding speculations about both past and present. Mindfulness based stress-reduction (MBSR) is an 8-week program, covering 24 contact-hours and 45 minutes daily home practice. The program aims at developing participants' coping resources and developing participants' mindful awareness. Thus the program consists of guided meditations, guided body scan(a specific awareness exercise)and through meditation, yoga and psychoeducation concerning stress and stress-reactions, while meditation and bodyscan is practiced at home by the use of specific audio-CDs guiding the patient. The MBSR-program have shoved promising results among patients with anxiety-disorders, depression and chronic pain. Smaller studies have also found positive effects of the program among cancer patients. The investigators want to evaluate the effect of the MBSR program on levels of anxiety and depression as well as the possible influence of mindfulness training on health behaviors and existential concerns. The study are based on the following hypotheses:

* report of anxiety and depression will decrease among cases
* better compliance will lead to more decrease in levels of anxiety and depression
* cases will make lifestyle changes suitable with recommendations for BC patients in post-treatment phase of the illness
* decreased level of anxiety and depression will reflect improved spiritual well-being
* improved spiritual wellbeing will lead to decreased report of physical symptoms

All participants in this randomized controlled trial will fill out questionnaires at enrollment and as 1, 6 and 12 months follow-up. Based on results from this trial clinicians and patients will be able to make decisions regarding post-treatment psychosocial intervention and researchers will have initial evidence of the effect of the intervention and thus possible indications for research on mindfulness among patients diagnosed with cancer at other stages or sites.

Original Research Protocol, Copenhagen January 2007 Cancer and Mindfulness: A prospective, randomized trial of a psychosocial intervention among women operated for breast cancer

Background From the time of diagnosis cancer patients have a need for psychological support. Many patients handle the situation by the help of friends and family, while others need professional support to come to terms with different phases of life as a cancer patient. Only few randomized trials have been conducted in order to determine what kinds of professional support patients will benefit from. These studies conclude that the prevalence of anxiety and depression in reduced. This is of major importance as depending of cancer type, treatment modality, age and gender, a total of 10-50 % of Danish cancer patients reports such well-defined psychosocial symptoms following the diagnosis of cancer.

Mindfulness meditation aims to increase the experience of presence and an increased relation to several emotional and sensory experiences. Instead of being a technique aimed to control and change unwanted psychological states the method is rather a way to stay present in the here and now without judging and as such it has been developed into a stress reduction method: mindfulness based stress reduction (MBSR). The method is taught within a group setting by an instructor guiding the patients during a week long program. The method has been evaluated within a variety of settings and has been found to effectively reduce symptoms related to different stress and pain conditions i.e. psoriasis, chronic pain, HIV/AIDS, anxiety and depression.2 Based on these experiences several programs have been developed and the program developed by Williams and Kabatt-Zinn has gained status as the most commonly applied and best validated. Within recent years the program has been included into cognitive-behavioral therapy. But with potential effects not only as reduction of symptoms but further opens the opportunity for participants to approach spiritual and existential themes. The potential effect is therefore not limited to simple reduction of symptoms but includes increased meaningfulness, quality of life and sense of coherence.

Nine studies of the effect of MBSR haw been conducted, including 10- 157 adult cancer patients being taught MBSR in groups of mainly breast cancer patients, but only three of these trials have been conducted as randomized controlled trials. I these trials patients have self-referred (selection bias), analysis have not been adjusted for biological status of the cancer disease (confounding), samples have been small (n=10-157) (type 2 error) and patients have differed with regard to time since diagnosis (misclassification). Despite these methodological limitations a tendency of positive effects of MBSR participation on psychological and physiological outcomes has been observed.

Yet it is still not determined whether MBSR will provide cancer patients benefit improving their daily life with cancer. Some important aspects have not been addressed in previous studies: When MBSR is applied as an intervention dose-response relation has only been observed among patients with a moderate level of symptoms. Thus sensitivity of MBSR in relation to stages of cancer, levels of pain or negative effects of treatments. We still do not know whether all cancer patients will profit from this type of intervention. Further the influence of patient compliance and working alliance is still not explored.

The diagnosis of cancer accentuates existential dimensions as spirituality and quality of life. Yet we do not know how MBSR can support patients in dealing with such themes. Be review of literature regarding patients coping with cancer the patients demand for interventions supporting their need to deal with existential themes is striking.

Aim We will conduct a randomized controlled trial among women diagnosed with primary breast cancer in order to evaluate the effect of MBSR on depression, anxiety quality of life, health behavior and psychological well-being.

Research questions

* We do not know whether all types of cancer patients will benefit from MBSR. Especially patients compliance must be empirically documented
* Cancer accentuates an array of existential concerns and the effect of MBSR on these subjective concerns must be examined

Inclusion All patient diagnosed with primary breast cancer in Department of Breast Surgery, Copenhagen Hospital Herlev, will be invited to participate in the study and in the randomization allocating patients to either MBSR intervention or treatment as usual control. Patients diagnosed and in active treatment for major psychiatric disease, patients with musculoskeletal disease and cardiovascular disease hindering MBSR participation, and patients previously diagnosed with other cancers than non-melanoma skin cancer will be excluded. A project nurse will contact eligible patients, deliver oral and written information and collect informed consent. If the patient consents baseline questionnaire will be administered.

Randomization will then take place. The project nurse will up-load patient data on secured project home-page. Computer generated sequence will automatically assign a unique study number to each patient indicating which study group she is allocated to. Result of the randomization will be delivered to the patient by the project nurse and potential disappointment will be handles at this point, and information regarding optional counseling provided by the Danish Cancer Society will also be given.

Intervention group MBSR will be delivered in groups of maximum 20 participants. The course will follow an 8 week schedule with 2-2½ hour sessions each week and instruction to practice 45 minutes daily at home. Upon conclusion of the course each group will participate in a full-day course (8 hours). The courses will be delivered by a manual (including audio CDs) developed by Antonia Sumbundu (see attached file). The group must meet in a quiet room large enough to room 20 persons lying down, as well as mats, carpets and chairs. The courses will be delivered in locations not affiliated with a hospital.

Control group The control group will receive treatment as usual and thus follow the standard control program applied by the surgical department.

* Questionnaire Prior to randomization and as follow-up after 6 and 12 months both study groups will be mailed questionnaires containing validated psychometric
* Hospital charts Descriptions of breast cancer operation, pathology of tumor as well as day to day entries will be collected.
* Administrative registries Data regarding comorbidity of all eligible patients will be collected in National Patient Registry and Central Psychiatric Registry upon finalization of the project.
* Qualitative outcomes Data collected by standardized self-report instruments will be supplemented by qualitative interviews inviting the intervention group participants to present themselves by giving an account of the treatment and a personal evaluation of the potential benefit.

Analysis

* Quantitative data Data will be stores in a database at the institute. Logistic regression analysis will be applied to evaluate which background variables effects participation. Analysis of outcomes will be conducted by applying multiple regressions at each time point. For simultaneous analysis of all follow-up times a linear mixed model with random effects of persons will be fitted. Outcomes as relapse and death among intervention group in comparison to both control group and non-participants will be analyzed by use of Cox regression model, controlling for the effect of biological and demographic variables. Analysis will be conducted under supervision of a senior statistician at the Department of Statistics and Epidemiology at the Institute.
* Qualitative data Based on the qualitative interviews a set of data-driven categories will be developed. These categories will be quantitatively evaluated. The transcript of the patient's self-presentation (approximately 2 pages) will be analyzed by use of qualitative methods, allowing for grouping of content categories as expressed by the patients. Statistical analysis will be applied to evaluate these categories.

Ethics Application of permission to conduct the study will be submitted to the The National Committee on Health Research Ethics and to the Danish Data Protection Agency. In information to patients regarding the study it will be stressed that participation is voluntary and that patients withdraw without any explanation at any time, and that withdrawal will have no influence on treatments delivered. Both written and oral consent must be given prior to participation. A short report will be mailed to all participants upon conclusion of the study. Vital status of participants will be checked in Central Persons Registry prior to any sending of study questionnaire. Data kept in the study database will be encrypted ensuring that only authorized scientific staff will be able to identify individuals. The encryption code will be kept by study manager. Results will be reported as tables and figures hindering identification of individuals. Also in the reporting of qualitative data will the quoted participants be kept anonymous.

Reference List

1. Ross L, Boesen E, Dalton S, Johansen C. Mind and cancer: does psychological intervention improve suvival and psychological well-being? European Journal of Cancer 2001.
2. Ott MJ, Norris RL, Bauer-Wu SM. Mindfulness meditation for oncology patients: a discussion and critical review. Integr Cancer Ther 2006; 5(2):98-108.
3. Bower JE, Ganz PA, Desmond KA, Rowland JH, Meyerowitz BE, Belin TR. Fatigue in Breast Cancer Survivors: Occurrence, Correlates, and Impact on Quality of Life. J Clin Oncol 2000; 18(4):743.
4. Bower JE, Ganz PA, Desmond KA et al. Fatigue in long-term breast carcinoma survivors: a longitudinal investigation. Cancer 2006; 106(4):751-758.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Alcohol Consumption and Gallbladder Cancer	NCT02326948	Gallbladder Can...		-	Cheju Halla General Hospital
Self-Affirmation: Construct Validity	NCT02317367	Risk Reduction ...		18 Years -	National Institutes of Health Clinical Center (CC)
Intensive Smoking and Alcohol Cessation Intervention in Bladder Cancer Surgery Patients	NCT02188446	Bladder Cancer Smoking Alcohol Consump...	Educational pro...	18 Years - 100 Years	Rigshospitalet, Denmark
Alcohol Consumption and Gallbladder Cancer	NCT02326948	Gallbladder Can...		-	Cheju Halla General Hospital
Intensive Smoking and Alcohol Cessation Intervention in Bladder Cancer Surgery Patients	NCT02188446	Bladder Cancer Smoking Alcohol Consump...	Educational pro...	18 Years - 100 Years	Rigshospitalet, Denmark
Intensive Smoking and Alcohol Cessation Intervention in Bladder Cancer Surgery Patients	NCT02188446	Bladder Cancer Smoking Alcohol Consump...	Educational pro...	18 Years - 100 Years	Rigshospitalet, Denmark
Self-Affirmation: Construct Validity	NCT02317367	Risk Reduction ...		18 Years -	National Institutes of Health Clinical Center (CC)
Mindfulness and Cancer Mamma - Clinical Trial MBSR Among Women Operated for Breast Cancer	NCT00990977	Breast Cancer	mindfulness bas...	18 Years - 75 Years	Danish Cancer Society

Spots Global Cancer Trial Database for alcohol consumption