Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Women will be educated about lifestyle factors which increase breast cancer risk. They will also be guided through an online goal setting process.

Lifestyle intervention to reduce breast cancer risk

Jennifer Rusby

A randomised controlled trial in which women discharged from the symptomatic breast clinic, who are above population risk (according to Tyrer Cuzick) will be asked to create lifestyle related goals. They will be told their estimated risk of developing breast cancer and will be randomised to one of three interventions:

* Breast cancer risk leaflet only
* lifestyle website
* lifestyle website plus group coaching.

Fifty per cent of women will also be randomised to have Single Nucleotide Polymorphisms (SNPs) performed, and these will be incorporated into their risk score.

The primary end point will be whether or not women achieve their lifestyle goal.

PIONEER Study of Lifestyle Intervention to Reduced Breast Cancer Risk

Pilot of Lifestyle InterventiON to reducE brEast Cancer RiSk (PIONEER)

Whether women have achieved their lifestyle goals. Proportion answering "yes" to a binary question: Did you achieve the goal you set? Compared between the three arms.

Proportion of women approached who go on to join the study

Attrition rate after randomisation within each group

Goal achievement in SNP group compared with goal achievement in non-SNP group.

Goal achievement compared between leaflet only group, website group and website + coaching group.

Change in Cancer Worry Scale (Revised) score from 0 to 3 months. Cancer Worry score is measured between 8 and 32 with 32 being the highest level of anxiety.

Cancer Worry score compared with goal achievement. Cancer Worry score is between 8 and 32 with 32 being the highest level of anxiety.

Proportion of women still taking chemoprevention at close of study compared between the three arms.

Administration time required for each group; Average goal achievement compared to average cost of each intervention.

National Institute for Health Research, United Kingdom

Royal Marsden NHS Foundation Trust

Symptoms and General Pathology

Digestive System Diseases

Body Weight

Body Weight Changes

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

A meeting where an expert illustrates the scientific basis of a proper diet. Moreover, clear and practical indications for dietary habits improvement and for suggested food purchase are provided. After having completed the basic module, participants are offered the opportunity of deepening the educational process through an advanced module:hree theoretical and practical cooking meetings (total of 10 hours) held by cooks with an expertise in natural cuisine and by trained dieticians.

Diet group

A meeting where an expert illustrates the benefits of a constant PA. Moreover, indications are given on sport opportunities and walking groups in the city organised by public authorities. After having completed the basic module, participants are offered the opportunity of deepening the educational process through an advanced module: three theoretical and practical lessons (total of 10 hours) held by expert physical trainers.

Physical activity group

A meeting where the indications given to the previous groups are presented simultaneously. Particular attention is paid to the interaction between the two activities. After having completed the basic module, participants are offered the opportunity of deepening the educational process through an advanced module: four theoretical and practical meetings (total of 12 hours), two lessons focus on diet and two on PA.

Physical activity and diet group

Nereo Segnan, MD MSc Epi

The main study objective is to determine the feasibility and impact (effectiveness) of intervention models for lifestyle changing (diet and physical activity) on health outcomes. Women 50 to 54-year-old attending the local breast cancer screening and 58-year-old people (both sexes) undergoing colorectal cancer screening are invited to participate in the study. Compliers are randomized into 3 intervention groups (Diet, Physical Activity, and Physical Activity and Diet) and into the 'usual care' Control group. Biological sampling (blood and saliva) is collected from all participants. All participants undergo also anthropometric measurements and fill in a self-administered validated questionnaire on their dietary and physical activity habits. All enrolled subjects receive a booklet with basic information about diet and physical activity. Subjects randomized to the 3 intervention groups are also offered one theoretical and three training courses. The courses are specifically designed for the different interventions proposed and aimed at reinforcing the educational counseling and at supporting behavioral changes.

Follow-up is performed at 8 (intermediate follow-up) and 12-14 (final follow-up) months for repeating anthropometric measurements and questionnaire filling and blood sampling (at the final one).

The study aims to evaluate the effectiveness of intervention models on diet and physical activity.

The study randomizes eligible subjects into four groups: Diet group, Physical Activity group, Physical Activity and Diet group and "Usual Care" control group. To each group a specific intervention is delivered, consisting of counselling, informative material, and dedicated training.

All participants (with the exception of the control group) receive a basic counselling by field experts. Afterwards they are offered an advanced training including more specific and detailed actions.

An information booklet specifically developed for this study is distributed to all participants. The booklet contains general information on primary prevention, based on the most reliable and updated bibliographic sources on diet and physical exercise.

Together with the letter of screening invitation eligible men and women receive the proposal to participate in the STI.VI. study. Participation to screening is not considered a prerequisite for study participation. A direct phone number and e-mail address are given for extra information.

At the time of screening A screening receptionist asks people who received the STI.VI. invitation (identified through a flag) whether they are interested in the STI.VI. study and therefore refers them to the STI.VI. desk.

At the STI.VI. desk, trained research assistants give further explanations and additional material (patient information sheet, informed consent form and the STI.VI. questionnaire). If informed consent is signed, an appointment is fixed for anthropometric measurements and for taking blood and saliva samples.

People are asked to fill in the questionnaire and to hand it back at the time of the blood sampling.

The STI.VI. questionnaire consists of 5 sections (physical activity, dietary habits, smoking habits, general health conditions, and general information) in order to collect baseline information on lifestyle habits. Type, amount and frequencies of dietary consumptions and physical activities are collected. The questionnaire also investigates the perception of one's own lifestyle and an motivation towards change.

In this study phase all participants are randomly allocated to the 4 study groups.

This is achieved through a permuted block design with block size of 12, 16, and 20 units width (W.F. Rosenberger, J. Lachin. Randomization in clinical trials: theory and practice. Wiley and sons, 2002, pag. 57). This method allows an almost complete uniform distribution of the randomisation groups in every moment of the study; this is necessary in order to simplify the subsequent courses management (see below). Participants are told about their group allocation at the time of biological sampling / anthropometric measurements, only.

At baseline appointment.

Participant subjects undergo anthropometric measurements. The following information are collected:

* Reproductive and eventual menopause history (women only)
* Eventual drug therapy under way,
* Height,
* Body composition,
* Waist circumference
* Arterial pressure. Then participants undergo blood drawing. Two types of blood samples are drawn: one for immediate biochemical analysis and another to be frozen. The freshly blood is used for instantaneous examinations for the following clinic-biochemical parameters: Insulin, Glucose, Total Cholesterol, LDL,HDL, Triglycerides, Minerals (Sodium, Potassium, Calcium, Iron), IGF-I, Testosterone, 17-ß-Estradiol, SHBG. These analyses are made for women invited to mammography screening while for people invited to colorectal screening supplemental tests are made also for vitamin D, 25 OH, PRC and high sensitive PRC.

Cryopreserved blood samples are stored in a bio-bank for epigenetic, metabolomics and metabonomics analyses. Bio-banking includes a security system and a data base specifically implemented for samples storage and traceability.

About 3 ml of saliva are also collected to investigate variations in genetic and metabolic parameters. Saliva samples are cryopreserved with the same modalities as blood samples.

Immediately after biological sampling / anthropometric measurements a short counselling takes place. Trained counsellors answer all eventual questions on the study posed by participants and inform them on the next steps. They also deliver to all participants a basic booklet containing general information on primary prevention, based on the most reliable and updated bibliographic sources on diet and physical exercise (World Cancer Research Fund/American Institute for Cancer Research. Food, nutrition, physical activity, and the prevention of cancer: a global perspective. Washington, DC: AICR, 2007; WHO, Move for Health, 2002; EU Working Group "Sport and Health", EU Physical Activity Guidelines, 2008).

Follow-up phase

Two follow-ups are planned:

• Intermediate, after 8 months since biological sampling / anthropometric measurements (the exact date is reckoned calculating 6 months + the average intervention duration ± 2 weeks, for managing reasons): it consists of repeating anthropometric measurements and questionnaire filling, and counselling.

All participants are contacted by letter and/or telephone, inviting them to contact the study secretariat in order to fix an appointment for repeating anthropometric measurements and questionnaire filling; during the follow-up visit trained counsellors verify participants' compliance with the provided recommendations, examine eventual encountered difficulties and provide support if needed.

• Final, after 6 months from intermediate follow-up (i.e., after 14 months since biological sampling / anthropometric measurements): it consists of repeating anthropometric measurements, biological sampling, and questionnaire filling, and counselling.

All participants are contacted by letter and/or telephone, inviting them to contact the study secretariat in order to fix an appointment for repeating once again anthropometric measurements, questionnaire filling and also biological sampling.

STI.VI. Study: How to Improve Lifestyles in Screening Contexts

Pilot RCT on Lifestyles Impact on Health Outcomes in the General Population Invited to Mammography and Colorectal Cancer Screening Programmes. (STI.li di VI.ta - Lifestyles) STI.VI.

initial participation rate overall and stratified by intervention group, age, and gender;

compliance to lifestyle recommendations and their maintenance assessed through the STI.VI. questionnaire;

comparison of metabolic parameters (insulin, glucose, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, IGF-1, testosterone)

evaluation of potential genetic and/or metabolic biomarkers in cancer development;

screening participation rate in subjects enrolled in the STI.VI. study and, viceversa, STI.VI. participation rate in screened subjects;

evaluation of breast and colorectal screening outcomes among STI.VI. participants

number of blood sample and saliva sample cryopreserved at baseline and at final follow up

investigate whether selected circulating miRNAs previously found associated to brast and colorectal risk are significantly altered in the plasma of cancer patients compared to matched healthy controls and if they satisfy pre-specified true- and false positive rates that are considered minimally acceptable in the screening setting.

Azienda Sanitaria Locale Torino 1

Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

Director, S.C. Epidemiologia, Screening e Registro Tumori Centre for Cancer Prevention, Principal investigator

Respiratory Tract (Lung and Bronchial) Diseases

Behaviors and Mental Disorders

Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Quality of Life

This is a single arm, quasi-experimental, pre- and post- test study design to test the feasibility and acceptability of a multiple risk factor, lifestyle intervention in patients receiving surgical treatment for lung cancer or those suspected of having lung cancer.

Lifestyle counseling

Mary E. Cooley, PhD, RN, FAAN

The objective of this proposal is to test the feasibility and acceptability of a lifestyle risk reduction intervention for patients with lung cancer receiving surgical treatment. This study will provide the preliminary data needed to conduct a larger randomized controlled trial that tests an innovative, multidisciplinary intervention that has the potential to transform the standard of care for patients receiving surgical treatment for lung cancer.

Healthy Directions After Lung Surgery Pilot

Feasibility and Acceptability of a Lifestyle Intervention for Patients Receiving Surgical Treatment for Lung Surgery

The primary outcome measures to establish feasibility and acceptability of the intervention for this study are enrollment rates.

The primary outcome measures to establish feasibility and acceptability patient's use of intervention materials

The primary outcome measures to establish feasibility and acceptability of the completion of self-monitoring

The primary outcome measures to establish feasibility and acceptability of the intervention for this study completion of nurse-patient contacts.

The secondary outcome measures of interest for this study are lifestyle risk reduction and Health Related-Quality of Life.

The secondary outcome measures of interest for this study is an interview to evaluate the intervention will be conducted with the participant and the partner at the conclusion of the study.

Brigham and Women's Hospital

University of Massachusetts, Boston

Dana-Farber Cancer Institute

Nurse Scientist, PhD, CRNP, FAAN

Nutritional and Metabolic Diseases

Rare Diseases

Chronic Disease

Obesity

Malnutrition

Disease Attributes

Nutrition Disorders

Chronic Graft Versus Host Disease

Fear appeal, video message to reduce sugar consumption or risk death

Video of spoken word poem from The Bigger Picture project, "Hear No" by Joshua Merchant; images of African-American male poet interspersed with images of environment

Video of spoken word poem from The Bigger Picture Project, "The Longest Mile" by Tassiana Willis; images of African-American female poet interspersed with images of environment

Video of spoken word poem from The Bigger Picture Project, "A Taste of Home" by Monica Mendoza; images of Hispanic female poet interspersed with images of environment

Video of spoken word poem from The Bigger Picture Project, "Lost in Translation" by Yosimar Reyes; images of Hispanic male poet interspersed with images of environment

Video of spoken word poem from The Bigger Picture Project, "Bottled Up" by Eileen Torrez; images of Hispanic female poet interspersed with images of environment

Video of spoken word poem from The Bigger Picture Project, "The Corner" by Jose Vadi; images of Hispanic male poet interspersed with images of environment

Video of spoken word poem from The Bigger Picture Project, "Thin Line" by Ivori Holson; images of African-American female poet interspersed with images of environment

Spoken word poems set to images performed by youth who wrote the poems. Videos were produced by The Bigger Project and were posted publicly to the Bigger Picture Project website and YouTube. Duration of videos ranges from 2 minutes to 6 minutes.

Health Communication

A randomized controlled trial to test the effects of culturally appropriate nutrition communication for Mexican American women.

An unbalanced randomized controlled trial with pre-test and immediate post-test was employed to test the effects of different types of message features and appeals. The study was conducted online with Mexican American women aged 18-29 years old. Messages focused on sugary beverage consumption and the main outcomes were acceptance and receptivity to the message (i.e., perceived effectiveness), perceptions of social norms, and knowledge. The investigators also measured a number of hypothesized mediators and moderators of the effects.

Culturally Appropriate Nutrition Communication for Mexican American Women

Culturally Appropriate Nutrition Communication for Mexican American Women: A Randomized Controlled Trial

Perceived effectiveness of the message is known to affect intention to engage in a given health behavior. Therefore, perceived effectiveness of the stimuli was assessed as a proxy measure for intention to reduce sugary beverage consumption using a 5-point, 13-item Likert scale with responses ranging from Strongly Agree=5 to Strongly Disagree=1. This scale comprised 3 subscales namely (1) Message Acceptance - 2 items, (2) Argument Strength - 4 items, (3) Personalized Perceived Effectiveness - 7 items. Greater scores on this scale represented greater levels of perceived effectiveness of the message.

responses ranging from Strongly Agree=5 to Strongly Disagree=1. Two sample items from the scale are, "During viewing, I felt I could really get inside the person's head", and "At key moments in the video, I felt I knew exactly what they were going through". Greater scores on this scale represent greater degree of identification with the character in the video.

Activation of social justice values was measured using a 5-point, 2-item Likert scale with responses ranging from Strongly Agree=5 to Strongly Disagree=1. The two items are, "The message made me think that when I choose to eat healthy, I'm helping to make the world a better place" and "The message made me think that when I eat healthy, I'm doing my part to protect people who are being manipulated by sugary beverage companies". Greater scores on this scale represent greater levels of activation of social justice values.

Sugary beverage related media literacy was measured using a 5-point, 8-item Likert scale with responses ranging from Strongly Agree=5 to Strongly Disagree=1. This scale measured how much the participants understood the ways in which sugary beverage industry used media to influence and manipulate their sugary beverage consumption behaviors. Some sample items are as follows: "Certain sugary drink brands are designed to appeal to people like me", "Sugary drink ads show a healthy lifestyle to make people forget about the health risks, such as weight gain and diabetes" and "Sugary drink ads link drinking these beverages to things people want, like love, good looks, and power". Greater scores on this scale represent greater levels of sugary beverage media literacy.

Public health literacy is defined here as an understanding of the social determinants of health. This was measured using a 5-point and 7-item Likert scale with responses ranging from Strongly Agree=5 to Strongly Disagree=1. The seven items measured opinions about how much different external factors affect health because these best reflected an understanding of the social determinants of health: (1) money, (2) education, (3) safe and affordable housing, (4) early childhood experiences, and (5) government policies and programs (6) lifestyle choices and (7) consequences of system failure on the under-resourced. Greater scores on this scale represented greater levels of public health literacy.

Empowerment to engage in civic action was measured using a two-item index that assessed the perceived effectiveness of engaging in civic actions. Each question was a 4-point Likert item with responses ranging from "Very Effective=4" to "Very Ineffective=1". The two items were as follows, "How effective would it be to boycott sugary beverages as a way to convince corporations to stop pushing sugar to my community?" and "How effective would it be to use social media to convince corporations to stop pushing sugar to vulnerable groups?". Greater scores on this index represented greater levels of efficacy to engage in civic action.

Knowledge increases self-efficacy and empowers people to make better health choices for themselves and knowledge of the negative consequences of a given health behavior increases the intention to reduce that behavior. Therefore, better knowledge of the negative consequences of sugary beverage consumption directly impacts both individual level sugary beverage consumption as well as social level psychological empowerment to advocate for reduction in sugary beverage consumption at the community level. A sugary beverage knowledge scale comprised 6 true or false items adapted from multiple studies. The statements were as follows: Excessive sugar consumption causes, (1) health problems (2) weight gain (3) dental caries (4) diabetes (5) cancer and (6) heart disease". Greater scores on this scale represented greater levels of sugary beverage knowledge.

Engagement with the message was assessed with 2 items from the Narrative Transportation Scale (Green et al.).

Perceived similarity of the participant with the main character (poet/speaker) in the video was assessed with a 2-item scale adapted from Cohen and colleagues (2018).

Elaboration of the message arguments was assessed using a 4-point scale created by Kahlor and colleagues (2003) and a 3-point sugar-specific elaboration scale created by Dixon and colleagues (2015).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PIONEER Study of Lifestyle Intervention to Reduced Breast Cancer Risk	NCT04574063	Breast Cancer Lifestyle Risk ...	Lifestyle inter...	30 Years - 60 Years	Royal Marsden NHS Foundation Trust
STI.VI. Study: How to Improve Lifestyles in Screening Contexts	NCT03118882	Lifestyle Risk ... Weight Changes,... Breast Cancer Colorectal Canc...	Diet group Physical activi... Physical activi...	49 Years - 61 Years	Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Healthy Directions After Lung Surgery Pilot	NCT02135211	Carcinoma, Non ...	Lifestyle couns...	21 Years -	Dana-Farber Cancer Institute
Culturally Appropriate Nutrition Communication for Mexican American Women	NCT04352530	Lifestyle Risk ... Nutrition Poor Chronic Disease Obesity Cancer, Breast	Health Communic...	18 Years - 29 Years	University of California, Merced
Culturally Appropriate Nutrition Communication for Mexican American Women	NCT04352530	Lifestyle Risk ... Nutrition Poor Chronic Disease Obesity Cancer, Breast	Health Communic...	18 Years - 29 Years	University of California, Merced
PIONEER Study of Lifestyle Intervention to Reduced Breast Cancer Risk	NCT04574063	Breast Cancer Lifestyle Risk ...	Lifestyle inter...	30 Years - 60 Years	Royal Marsden NHS Foundation Trust
Culturally Appropriate Nutrition Communication for Mexican American Women	NCT04352530	Lifestyle Risk ... Nutrition Poor Chronic Disease Obesity Cancer, Breast	Health Communic...	18 Years - 29 Years	University of California, Merced

Spots Global Cancer Trial Database for lifestyle risk reduction