Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Endometrial Neoplasms

Breast Neoplasms

Colonic Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Breast Diseases

Skin Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Patients of the motivational interviewing group will receive standard care alongside motivational interviewing to change their behavior regarding physical activity.

Patients of the control group will receive standard care alone.

the patients of the motivational interviewing group will receive 12 motivational interviewing sessions within 12 weeks: 2 face-to-face sessions and 10 phone call sessions. The first and the seventh motivational interviewing sessions will be face-to-face sessions. An intervention is considered valid if a minimum of 10 sessions has been completed. The face-to-face motivational interviewing sessions will be administered at the Luxembourg Institute of Health (Strassen, Luxembourg). They generally last up to 30 minutes, while the motivational interviewing phone calls generally last up to 15 minutes. Thereby, patients in the motivational interviewing group will receive a total of approximately 3.5 hours of contact time over a period of 12 weeks.

Motivational interviewing techniques will explore self-assessed confidence, ambivalence, and personal values concerning changes in active lifestyle.

Motivational interviewing

Laurent Malisoux, PhD

Alexis Lion, PhD

Physical activity is not only efficient for primary prevention of several cancer types, but it also plays an important role in cancer survivors. Physical activity after a cancer diagnosis has been associated with reduced overall and cancer-specific mortality. It has significant positive effects on physical fitness and several cancer-related symptoms including fatigue, sleep disturbance, depression and anxiety. The evidence is considerable and consistent for breast, colorectal and endometrial cancers. However, patients are generally insufficiently active, and participation rates in physical activity opportunities offered by specialized organizations are low. This pilot study will evaluate the feasibility, efficacy and cost-effectiveness of an intervention seeking to increase active lifestyle and physical activity participation of cancer patients. To encourage this behavioural change, motivational interviewing will be used, a patient-centred approach aimed at increasing the patients' motivation for a behavioural change through open-ended discussions.

Seventy patients with breast, colorectal or endometrial cancer will be recruited within a time period of 12 months. Patients will be randomly assigned to an intervention or a control group. The intervention group will receive standard care alongside 12 motivational interviewing sessions within 12 weeks. The control group will receive standard care only. Physical activity behaviour (3D-accelerometer) and physical fitness (cardiovascular and strength fitness) will be measured in the week preceding and following the intervention. Additionally, a subgroup from both study arms will be assessed 12 weeks after the completion of the intervention. The investigators hypothesize that sedentary time will decrease and time spent in moderate and vigorous physical activity, physical fitness and quality of life of cancer survivors will increase to a greater extent in the intervention group than in the control group. Furthermore, health-related quality of life and resource use (intervention and healthcare costs, out of pocket costs) will be measured to evaluate the cost-effectiveness of the intervention.

All recruited patients will receive the same standard care, only those who will be allocated to the experimental group will receive the intervention. This project will run over total period of 21 months. Patients will be offered to join the project over a duration of 12 months. With the help of oncologists and surgeons, an oral agreement will be collected from the eligible patients who agree to be contacted by an investigator of the study. Once the patients have entered the study, they will be followed for 26 weeks, including 12 weeks of intervention or control period and 12 weeks of follow-up to evaluate if the expected intervention-induced behavioural change is maintained:

* Week 1: inclusion and first visit. The patients will be contacted (phone call) by an investigator who will provide explanations about the study. Notably, the investigator will explain that the patients will be allocated randomly to one of two study arms and that they may not chose which one they will be allocated to. In addition, the investigator will check eligibility through a brief questionnaire-based interview. Patients who meet the inclusion criteria will be invited to come to the Luxembourg Institute of Health (Strassen, Luxembourg) for the first visit. During this first visit (duration: 90 min), patients will be asked to sign the written informed consent. Then, patients will be asked to fill in several questionnaires available in English, French, German and Portuguese: three background questionnaires and one cancer-specific health related quality of life (HRQoL) questionnaire (EORTC-QLQ30). Height and weight will be measured. Patients will subsequently perform physical fitness tests, including ramped Bruce protocol test on a treadmill, leg strength and grip strength tests. Finally, patients will receive a 3D-accelerometer (Actigraph) measuring physical activity behaviour, which they will have to wear for one week. Further details one these methodologies are provided below.
* End of week 1: phone call. An investigator will call the patients one day before the end of the recording period of physical activity to remind them to send back the accelerometer. Furthermore, patients will reply by telephone to the generic HRQoL questionnaire (EQ-5D-5L questionnaire, please see details of this questionnaire in the "Cost-effectiveness of the intervention" section). This questionnaire will be administered repetitively throughout and at the end of the intervention.
* Week 2 to week 13: intervention. During a period of 12 weeks, the patients in the intervention group will attend 2 face-to-face and 10 telephone motivation interviewing sessions (please see details in the "Intervention" section). The patients entering the control group will not receive this specific treatment during that period.
* Week 5: phone call. The patients will be called to answer the EQ-5D-5L questionnaire.
* Week 9: phone call. The patients will be called to answer the EQ-5D-5L questionnaire.
* Week 13: phone call. Patients will be called for a reminder of the second visit date (already determined during the first visit).
* Week 14: second visit. Patients will be invited to come to the Luxembourg Institute of Health (Strassen, Luxembourg). During this second visit (duration: 70 min), patient will fill in the EORTC-QLQ30 questionnaire and the cost questionnaire (please see details of this questionnaire in the "Cost-effectiveness of the intervention" section). Height and weight will be measured. Patients will perform the same physical fitness tests as during the first visit (ramped Bruce protocol on a treadmill, leg strength and grip strength). Patients will be handed out the accelerometer to be worn during one week to evaluate their physical activity behaviour.
* End of week 14: phone call. An investigator will call the patients one day before the end of the recording period of physical activity to remind them to send back the accelerometer and to answer the EQ-5D-5L questionnaire.
* Week 14 to week 25: follow-up.
* Week 25: Phone call. Patients will be called for a reminder of the third visit date (already determined during the second visit).
* Week 26: third visit. Patients will be invited to come to the Luxembourg Institute of Health (Strassen, Luxembourg). During this third visit (duration: 70 min), patient will fill in the EORTC-QLQ30 questionnaire and the cost questionnaire. Height and weight will be measured. Patients will perform the same physical fitness tests as during the first and second visits (ramped Bruce protocol on a treadmill, leg strength and grip strength). Patients will be handed out the accelerometer to be worn during one week to evaluate their physical activity behaviour.
* End of week 26: phone call. An investigator will call the patients one day before the end of the recording period of physical activity to remind them to send back the accelerometer and to answer the EQ-5D-5L questionnaire.

The patients will be randomly assigned to the experimental group with motivational interviewing or the control group. Group assignment will be done by a motivational interviewing counsellor using randomization lists generated by the Competence Center in Methodology and Statistics (Luxembourg Institute of Health). For each type of cancer, a separate randomisation list will be used.

Every patient will be given a person-specific code and every information collected will be pseudonymised.

The group assignment will be hidden to the investigator and to the scientific collaborators who will collect, record and analyse the data. However, both patients and the two motivational interviewing counsellors will be aware of the group assignment.

Motivational Interviewing to Increase Physical Activity Behaviour in Cancer Patients

Motivational Interviewing to Increase Physical Activity Behaviour in Breast, Endometrial and Colorectal Cancer Patients in the Grand-Duchy of Luxembourg: a Pilot Randomized Controlled Trial

An objective measurement of the patients' physical activity behaviour will be conducted using the ActiGraph™ GT3X+, a validated 3D-accelerometer, which will be used together with the corresponding ActiLife 6™ data analysis software. Physical activity behaviour will be measured three times (week 1, week 14 and week 26).

The main outcome is the change between week 1 and week 14.

Body mass index will be calculated based on height and weight, combined to report BMI in kg/m\^2. Height will be measured with a height gauge. Weight will be measured with a weighing machine.

patients will start to walk at an initial speed set at 1.6 km/h on the treadmill on a horizontal position. Subsequently, the speed and the slope will be increased progressively according to the stages of a predefined protocol. The outcome will be the exercise stage reached at 85% of the maximal heart rate.

Patients will rise to a full standing position and then sit back down again, repeating this movement for 30 seconds. The total number of repetitions will be recorded.

The best of six grip strength measurements will be used in statistical analyses.

A decision analytic model will be developed to calculate the cost-effectiveness of motivational interviewing based on quality of life and cost questionnaires.

Fondation Cancer

Luxembourg Institute of Health

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Gland and Hormone Related Diseases

Overweight

Syndrome

Obesity

Polycystic Ovary Syndrome

Overnutrition

Nutrition Disorders

Body Weight

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Gonadal Disorders

Endocrine System Diseases

The women in this group will receive motivational interviews approximately once every 2 weeks for half a year.

The women in this group will have the usual guidance in weightloss with a booklet on the seven health tips from the danish government. They will not be contacted ind the half year between study onset and finish.

Motivational interview is an interview form based on the patients own thoughts of motivation. It will be conducted by a nurse who is specially trained in this interview type.

Motivational interview

Pernille Ravn, MD

The aim of the study is to examine if motivational interviewing can have a positive effect on weight loss over a 6 month period. By losing weight, the investigators assume the patients will have a positive effect on quality of life, and also that weight loss will help to regulate the factors that are present with polycystic ovary syndrom (PCOS); such as menstrual disorders and infertility.

Participants will be randomly assigned to a treatment group and a control group.

Both groups will be followed as normal with blood samples and other tests such as scans of the ovaries and measurement of height and weight at the beginning of the study and after six months.

In addition, there will be a small hair sample taken from the neck at the first consultation and after 6 months. This is done to measure the stress hormone cortisol in the body over the duration of the experiment.

The treatment group receive individual motivational interviews by a nurse every 14 days for a period of six months. After half a year, tests are repeated to see if there are significant differences between the groups.

Main Hypothesis: Overweight women with PCOS receiving motivational interviewing lose at least 1.5 kg more than the control group during the 6 months.

Hypothesis: weight loss leads to positive changes in biochemical parameters, quality of life, and the stress levels assessed by cortisol levels in hair.

Research Plan:

The project began on october 1, 2014 at Odense University Hospital, gynecological and obstetric department. Women referred to the gynecology outpatient clinic for examination of PCOS was examined in the gynecological clinic at the appointment. The women who subsequently are diagnosed with PCOS and have a BMI\> 30 kg/m2, who said yes to participation in the trial was randomized to motivational interviews or normal course of treatment.

Both groups: questionnaires and hair samples in both randomized groups. The investigators take about 150 strands of hair of 3 cm length twice in the experiment. Attendance for Biochemistry and objective examinations like the usual procedures for patients with PCOS, ie. this is performed whether the patient is involved in the trial or not. There will be two blood counts during the experiment, one at the start and one at 6 months. Blood sampling is carried out whether the patient is involved in the trial or not. Parameters measured at baseline and after 6 months:

Study program as usual (all patients with PCOS):

* anamneses of menstruation, fertility, use of oral contraceptives, medicine and disease ect.
* anthropometry: height, weight, body mass index (BMI), waist and hip circumference. Blood pressure.
* Biochemistry: fasting blood glucose, HbA1c, insulin, Lutropin hormone (LH), folicle stimulation hormone (FSH), estradiol, free and total testosterone,dehydroepiandrosteron (DHEAS),sex hormon binding globulin (SHBG), prolactin, thyroid stimulating hormone (TSH), 17-OH-progesterone, lipid profile, hemoglobin, 25-OH vitamin D.
* gynecological assessment: Ultrasound scanning of the uterus and ovaries.

Project participants:

* Questionnaires; SF-36, VAS score, major depression score (MDI), the world health organization WHO-five well-being index.
* hair sample for the detection of cortisol

Practical course:

First examination in the clinic: If the patient meets the inclusion criteria an in-depth information about the trial is given. If the patient wants to participate, the patient is issued a written statement of consent and is pre booked an appointment with a nurse At the first visit to the nurse: the consent form is signed, if wish for participation in the study is maintained the patient is randomized. The patient fill out questionnaires and a hair sample is taken. All patients are provided with information on weight loss from the Health Protection Agency advice about diet and exercise as above. Patients who are randomized to motivational interviews starts a course of interviews. Participant data is imported into a spreadsheet for later determination.

Intervention: appointments of interview are scheduled individually, but should be around one interview every 14 days of about 20 minutes.

After 6 months, all patients are examined again as mentioned above as part of the usual control of PCOS.

Motivational Interviewing as an Intervention for PCOS

Motivational Interviewing as an Intervention for Women With Polycystic Ovary Syndrome and BMI Above 30 kg/m2

The plan is to publish the results by the end of 2016. Individual participant data will be available by request

Measured as change in kg, body mass index and hip to waist circumference

Assessed by questionnaires: WHO five score, major depression index, a VAS score of 10 and a PCOS questionnaire.

Measured in change in androgen hair growth of body and face, menstruation, acne, pain, hormone levels

Odense University Hospital

Doktor med.

Emergencies

Rectal Diseases

Disease Attributes

Subjects will engage in a brief motivational interview to establish an action plan and discuss follow-up interviews a 3 and 6 months post ED visit

Subjects will be provided a standard of care colorectal cancer screening brochure at the time of ED visit

A lay health advisor will engage the subject in a motivational interview to promote the importance of colorectal cancer screening

A lay health advisor will provide the subject with a brochure promoting the importance of colorectal cancer screening

Standard of care

Jennifer Hatcher, RN, PhD

This trial will compare the effects of a culturally targeted intervention designed to assist participants to identify and overcome individual barriers to colorectal cancer (CRC) and to promote CRC screenings using motivational interviewing (Ml) delivered by a lay health advisor (LHA) compared to the current standard-of-care (distribution of a brochure describing CRC screening services offered by the hospital) on CRC screening compliance.

The specific aim of this project is to adapt and pilot a tailored intervention to promote CRC screenings in a rural Appalachian Kentucky emergency department (ED) in order to: (a) evaluate the feasibility of providing a cancer screening promotion intervention in an emergency department (ED) that serves a rural Appalachian community; and (b) assess the effects of the intervention on barriers to CRC screening, stage of readiness to screen and CRC screening engagement. The first phase of the project will involve the adaptation and pretesting of the intervention. This phase will take approximately 6 months. The second phase of the project will involve piloting the intervention and evaluating its efficacy and feasibility and will take place over the following 18 months. We will conduct a randomized controlled trial to examine the efficacy and feasibility of delivering the LHA delivered MI intervention to promote CRC screening in persons waiting in a rural Appalachian emergency department (ED) for non urgent complaints. We will evaluate efficacy by measurement of CRC screening status at baseline and three and six months post intervention.

Promoting Colorectal Cancer Screening in Rural Emergency Departments

Number of participants that seek out colorectal cancer screening after a motivational interview with a lay health advisor compared to standard of care (being provided a screening brochure)

University of Kentucky

Principal Investigator

education tailored to baseline beliefs by trained counselor over phone

Tailored counseling

motivational interview by trained MI counselors by phone

Motivational Interview

Usha Menon, PhD

Colorectal cancer screening remains lower than optimal. The purpose of this study was to test the efficacy of phone-based motivational interviewing versus tailored communication versus usual care in increasing CRC screening in primary care clinics.

Regular screening reduces both morbidity and mortality from colorectal cancer (CRC). Screening rates, however, remain low suggesting the need for innovative research designed to increase screening behavior. The purpose of this study is to compare the effectiveness of two interventions (Tailored Health Communication \[THC\] and Motivational Interviewing \[MI\]) in increasing CRC screening behavior. Both interventions are based on a strong conceptual framework derived from the Health Belief Model (HBM) and Transtheoretical Model (TTM), allowing us to explore the underlying mechanisms through which these interventions impact behavior change.

The primary aim of this study is to compare CRC screening test use among 804 participants randomly allocated to control or intervention conditions; participants will be recruited from the two sites (Chicago, IL, and Nashville, TN). The 3 study groups will receive (1) standard care, (2) tailored health communication, and (3) motivational interviewing. Eligibility criteria for study participants includes being 50 years or older, not having CRC, and being of average or moderate risk for CRC. Study participants will be surveyed by telephone about CRC-related beliefs pre-intervention (Time 1), 1 month postintervention (Time 2), and at 6 months postintervention (Times 3 and 4, respectively). Dichotomous behavioral outcomes (had screening test or not) and stages of CRC screening test adoption (based on the TTM) will be assessed, as well as sociodemographic and belief predictors of screening behavior. Binomial and multinomial logistic regression models will be used to evaluate screening test use and stage of test adoption. Sociodemographic and belief variables will be used as covariates, with intervention group as the primary independent predictor. Descriptive statistics and ANOVA will be employed to assess between intervention differences in amenable beliefs. Path (mediation) analysis will be performed to further explore the underlying mechanisms through which THC and MI may differentially affect CRC screening behavior.

Increasing Colorectal Cancer (CRC) Screening In Primary Care

Increasing CRC Screening in Primary Care Settings

University of Illinois at Chicago

Jesse Brown VA Medical Center

University of Utah

Vanderbilt University

Penn State University

Portland State University

Arizona State University

Faculty

All Drugs and Chemicals

Nicotine

Motivational interviewing session (1 hour in home) plus 2 follow-up phone calls

Standard care delivered using informational materials

30 - 45 minutes in-person session to deliver results of nicotine air monitor and discuss home smoking ban using motivational interview techniques

Usual best practices

Vaughan Rees, PhD

This study evaluates the effectiveness of a motivational interviewing intervention with families with young children ages 0-5 where smoking is happening in the home to adopt a smoke-free home plan and reduce child's second-hand smoke exposure.

Involuntary secondhand smoke (SHS) exposure in homes is an entirely preventable public health threat that disproportionately burdens young children in communities of low socioeconomic position. Breathe Free For Kids is a community-based participatory research (CBPR) initiative to evaluate the effectiveness of Ml compared with usual best practices (UBP) by having parents voluntarily adopt smoke-free home policies to protect children from SHS. The Motivational Interviewing intervention protocol was developed in conjunction with community partners, integrated into a health department-sponsored home visiting program for high-risk children and other community-based agencies serving children, and delivered by trained community health workers.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Motivational Interviewing to Increase Physical Activity Behaviour in Cancer Patients	NCT03210129	Cancer, Breast Cancer of Colon Endometrial Can...	Motivational in...	18 Years -	Luxembourg Institute of Health
Motivational Interviewing as an Intervention for PCOS	NCT02924025	Polycystic Ovar... Overweight and ... Motivation	Motivational in...	-	Odense University Hospital
Motivational Interviewing to Increase Physical Activity Behaviour in Cancer Patients	NCT03210129	Cancer, Breast Cancer of Colon Endometrial Can...	Motivational in...	18 Years -	Luxembourg Institute of Health
Motivational Interviewing as an Intervention for PCOS	NCT02924025	Polycystic Ovar... Overweight and ... Motivation	Motivational in...	-	Odense University Hospital
Promoting Colorectal Cancer Screening in Rural Emergency Departments	NCT03473587	Colorectal Canc...	Motivational in... Standard of car...	50 Years -	University of Kentucky
Increasing Colorectal Cancer (CRC) Screening In Primary Care	NCT01099826	Colorectal Canc...	Tailored counse... Motivational In...	50 Years - 75 Years	Arizona State University
MassCONECT (Massachusetts Community Networks to Eliminate Cancer Disparities Through Education) 4 Kids: Promoting Smoke-free Homes	NCT01537874	Tobacco Smoking...	Motivational In... Usual best prac...	17 Years -	Harvard School of Public Health (HSPH)
Increasing Colorectal Cancer (CRC) Screening In Primary Care	NCT01099826	Colorectal Canc...	Tailored counse... Motivational In...	50 Years - 75 Years	Arizona State University

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