Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Gland and Hormone Related Diseases

Symptoms and General Pathology

Rare Diseases

Prostatic Neoplasms

Breast Neoplasms

Pancreatic Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Genetic Predisposition to Disease

Disease Susceptibility

Endometrial Neoplasms

Urogenital Neoplasms

Genital Diseases

Urogenital Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Uterine Neoplasms

Uterine Diseases

Pancreatic Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Participants are provided with a link to the Michigan Department of Health and Human Services (MDHHS) informational website and are instructed to follow up with their oncology provider about genetic testing.

Participants receive access to an online genetics tool, the virtual genetics navigator, to help learn why and how to seek out genetic testing for hereditary cancer syndromes.

Participants receive up to 2 phone calls from trained genetics health coaches who provide information about genetic testing and use motivational interviewing to encourage participants to seek out clinical genetic testing.

Participants may view the publicly available Michigan Department of Health and Human Services (MDHHS) website as they wish.

Publicly available genetic testing resources

A mobile-optimized website/online genetic tool developed by investigators from the University of Michigan's Center for Health Communications Research (CHCR).

Virtual genetics navigator

At least 2 phone calls delivered by trained genetic health coaches using motivational interviewing and providing genetic testing information.

Motivational interviewing (MI)

Cancer AnswerLine

Elena Stoffel, MD, MPH

The primary purpose of this study is to compare three interventions, two experimental and one standard of care (usual care), to see if the experimental interventions will increase the likelihood of a participant obtaining guideline-concordant genetic testing. Eligible participants will be randomized (assigned) to one of the following interventions: 1) Virtual genetics navigator, a mobile-optimized website, designed by the investigators, that delivers tailored messages and content; 2) two motivational interviewing (MI) telephone calls delivered by trained genetics health coaches; or 3) usual care.

This trial will be conducted in partnership with the Michigan Department of Health and Human Services (MDHHS) and a network of oncology practices in Michigan, the Michigan Oncology Quality Consortium (MOQC).

As of April 2023 we were approved by our IRB to expand our inclusion criteria and recruitment cohort. This expansion will enhance our reach to individuals who are not in the acute stages of clinical care as well as individuals who are not in oncology care currently yet still qualify for genetic testing based on their family history of cancer alone or in combination with any personal cancer history. These expansions will also support the unburdening of oncology practices - who continue to face downstream, resource-limiting affects from the COVID-19 pandemic - across the state. The goal and aims of the study remain the same.

Methods for Increasing Genetic Testing Uptake in Michigan

The primary outcome is completion of genetic testing (yes/no) at 6 months after randomization by patient self-report.

Participants who have completed genetic testing (before the 6- or 12-month time point for this survey) will be asked to respond to this 7-item, study-specific survey, developed by the investigators to assess the importance of specific barriers that were identified in a previous, observational study. Each item is scored on a scale from 1-5 (1=not at all; 5=extremely). The mean score for each question, across all participants who completed genetic testing, will be calculated in order to rank the barriers in importance. A higher mean score indicates greater importance of that specific barrier.

Participants who have not yet completed genetic testing (before the 6- or 12-month time point for this survey) will be asked to respond to this 23-item, study-specific survey, developed by the investigators to assess the importance of specific barriers that were identified in a previous, observational study. Each item is scored on a scale from 1-5 (1=not at all, 5=strongly agree). The mean score for each question, across all participants who have not yet completed genetic testing, will be calculated in order to rank the barriers in importance. A higher mean score indicates greater importance of that specific barrier.

Participants who have completed genetic testing (before the 6- or 12-month time point for this survey) will be asked to respond to this 5-item, study-specific survey, developed by the investigators to assess the importance of specific motivators for future testing. Each item is scored on a scale from 1-5 (1=not at all; 5=extremely). The mean score for each question, across all participants who completed genetic testing, will be calculated in order to rank the motivators in importance. A higher mean score indicates greater importance of that specific motivator.

Participants who have not yet completed genetic testing (before the 6- or 12-month time point for this survey) will be asked to respond to this 5-item, study-specific survey, developed by the investigators to assess the importance of specific motivators for future testing. Each item is scored on a scale from 1-5 (1=not at all, 5=strongly agree). The mean score for each question, across all participants who have not yet completed genetic testing, will be calculated in order to rank the motivators in importance. A higher mean score indicates greater importance of that specific motivator.

National Cancer Institute (NCI)

University of Michigan Rogel Cancer Center

Nervous System Diseases

Pain

Chronic Pain

Breast Diseases

Skin Diseases

Neurologic Manifestations

Chronic Graft Versus Host Disease

Breast cancer survivors assigned to the experimental intervention will participate in 1 online PNE session followed by 3 PNE + MI sessions spread over 4 weeks. Each session will last for approximately 45 minutes and all sessions will be held in one-on-one format, allowing to individually tailor content to the patient's maladaptive beliefs and perceived injustice. After the first live session, breast cancer survivors will receive a perceived injustice-targeted PNE information leaflet that they need to read carefully at home.

Breast cancer survivors assigned to the experimental intervention will participate in 1 online biomedically-focused education session followed by 3 biomedically-focused education sessions spread over 4 weeks. Each session will last for approximately 45 minutes and all sessions will be held in one-on-one format in order to balance nonspecific treatment effects between treatment arms, the duration, format and number of sessions as well as the didactical approach will be identical in both treatment groups. After the first live session, breast cancer survivors will receive an information leaflet from 'Kom op tegen Kanker' regarding 'Pain in and after treatment' that they need to read carefully at home.

PNE is a cognitive behavioural intervention, including educating patients that pain is an output product of the brain resulting from input from multiple central and peripheral nervous system processes and leading to threat perception. Transferring that knowledge to patients, allows them to understand, accept and effectively cope with their pain. In order to obtain the targeted behavioural change, motivational interviewing is used as the communication process throughout PNE.

Pain Neuroscience Education (PNE)

Motivational interviewing is a directive, collaborative, patient-centered communication approach for eliciting and enhancing motivation for behaviour change by helping clients to resolve ambivalence and uncertainty.

Motivational Interviewing (MI)

The traditional biomedical-focused education programme explains patient's pain experience from a tissue (injured versus healthy tissue) and biomechanical perspective.

Biomedically-focused education

Laurence Leysen, Prof. Dr.

Eva Roose, Dra.

Brenda De Petter, Dr.

Jo Nijs, Prof. Dr.

Annick Timmermans, Prof. Dr.

Carine De Rop, Dr.

Breast cancer is the most frequently diagnosed cancer in women worldwide. An important portion of the breast cancer survivors will face chronic pain complaints. These pain complaints do not only impact the patient's quality of life but also prevents resumption of activities, leading to huge economic costs. 30% of all breast cancer survivors with pain present with perceived injustice which has been conceptualized as a multidimensional appraisal process characterized by a tendency to interpret one's losses as severe and irreparable, to attribute blame to others for one's suffering and to experience a sense of unfairness. Perceived injustice is also associated with increased opioid prescription and use, urging the need for targeted interventions to diminish perceived injustice.

Despite the fact that specific treatment plans for perceived injustice are not yet proven, pain neuroscience education (PNE) is proven to reassure and encourage towards activity. In order to obtain the targeted behavioural change, motivational interviewing (MI) is used as the communication process throughout PNE.

A multi-centre, parallel, two-arm, investigator-blinded study with 4-weeks intervention and two years follow-up will be conducted in 156 BCS with PI and pain. These will be randomly assigned to the intervention or usual care group. The groups will receive 1 online session, an information leaflet and 3 live sessions of education spread over 4 weeks. Pain neuroscience education in combination with motivational interviewing will be given in the experimental group and biomedically-focused education to the control group.

The primary scientific objective of the study is to examine whether perceived injustice-targeted PNE is superior to biomedically-focused pain education in reducing pain after 12 months in breast cancer survivors with perceived injustice and pain.

The secondary objectives of the study are to examine whether perceived injustice-targeted PNE, compared to biomedically-focused pain education, results in improving health-related quality of life, reducing perceived injustice and opioid use after 24 months in breast cancer survivors with perceived injustice and pain, and to conduct a health-care cost analysis which will finally result in a recommendation concerning the use of perceived injustice-targeted PNE in breast cancer survivors with perceived injustice and pain.

PI-targeted PNE+MI Compared to BIOMEDICAL Education in BCS

The Effect of Perceived Injustice Targeted Pain Neuroscience Education and Motivational Interviewing Compared to Biomedical Focused Education in Breast Cancer Survivors

After the project, the data will be archived in the VUB University Archive with restricted access. Data sharing is only permitted if all involved parties agree, and a Data Sharing Agreement has been signed.

Open Access will not be possible due to the high degree of confidentiality of the pseudonymized medical data, although all requests regarding sharing the research data will be considered by the parties.

The university server is equipped with user-level access permission management. Participants' personal data will be coded, and system encryption will be used to protect the coded data.

No costs are expected, but project and/or research group funds will cover any potential data sharing costs.

Pittsburgh Sleep Quality Index (PSQI): is a self-rated questionnaire to measure sleep quality and disturbance over 1 month. It is based on 19 items which generate a global score, ranging between 0 and 21, and 7 component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Scores above 5 signifies a poor sleeper. It is a reliable and valid measurement tool and internal consistency is acceptable in breast cancer population (Cronbach's alpha = 0.80).

Insomnia Severity Index (ISI): is a questionnaire to detect cases of insomnia and asses the insomnia severity of both night-time and daytime components of insomnia. It is based on 7 items measured on a 5-point Likert scale (0-4) which generates a total score ranging from 0 (no insomnia) to 28 (great insomnia severity). The cut-off score of 10 is optimal for detecting insomnia cases and a change score of -8.4 points is associated with a moderate improvement. ISI is a valid and reliable instrument in cancer patients and had an adequate concurrent validity of (r = 0,65).

Fatigue Severity Scale (FSS): is used to evaluate global fatigue severity in a number of chronic medical conditions such as palliative cancer. It is a short questionnaire with 9-items and the total score ranges between 9 (no fatigue) and 63 (maximum fatigue). The FSS is a reliable and valid measurement in cancer patients. The internal consistency of the FSS is highly acceptable (Cronbach's alpha = 0.96).

Pain Catastrophizing Scale (PCS): is a self-reported questionnaire to assess catastrophic thoughts or feelings accompanying the previously experienced pain. It is a 13-item measure that evaluates 3 subscales of catastrophizing: rumination, magnification and helplessness on a 5-point Likert scale. This scale ranges from 0 (not at all) to 4 (all the time) with a total score between 0 and 52. The PCS factor scales are valid and reliable.

Brief Illness Perceptions Questionnaire-Dutch Language Version (Brief IPQ-DLV): measures five illness perceptions and consists nine items. Five items assess cognitive illness (consequences, personal control, treatment control and identity), two items assess emotional perceptions (concern and emotions), one item assesses illness comprehensibility and one item assesses causal perception. The first eight items are rated on a 10-point Likert scale and the ninth item is rated as an open-ended question which asks to list three most important causal factors in the illness. The Brief IPQ-DLV has acceptable psychometric properties. The Smallest Detectable Change (SDC) is 3 point for item 1 to 8.

Pain Vigilance and Awareness Questionnaire (PVAQ): is designed to consider behaviour over the last 2 weeks in chronic pain patients. It consists 16-items that assesses attention to pain. The frequency of each item is rated on a 6-point Likert scale ranging from 0 (never) to 5 (always) with a total score ranges between 0 and 90. The higher the score, the more suggestive for a higher degree of vigilance and awareness to pain. It is highly correlated with pain-related measures such as catastrophizing, and weakly correlated with measures of unrelated constructs, such as trait anxiety. The PVAQ is a reliable and valid measurement in chronic patients.

Depression, Anxiety, Stress Scale 21 items (DASS-21): is an instrument that is used to assess anxiety and depression. Twenty-one items are subdivided in 3 categories: depression (7 items), anxiety (7 items) and stress (7 items). Each item is scored on a 4-point Likert scale ranging from 0 (not at all) to 3 (most of the time). The higher the item score, the more severe symptom of psychological distress is identified. The total score, used for the interpretation, is the sum of all items multiplied by two. The DASS-21 is a valid and reliable assessment tool in cancer patients.

State-Trait Anger Expression Inventory-II (STAXI-II): is a self-reported 57-item questionnaire that assesses the level and frequency of anger experience, expression and control. It consists three parts: (a) how angry the examinee currently feels, (b) how angry the examinee generally feels, and (c) how the examinee reacts when angry. Every item in each subscale is assessed on a 4-point Likert-scale. The validity and reliability of the STAXI-II questionnaire are satisfactory supported.

Acceptance and Action Questionnaire - II (AAQ-II): is a self-reported 7-item questionnaire that assesses the amount of acceptance and experiential avoidance, or its opposite: psychological flexibility. Every item is a statement that is scored on a 7-point Likert-scale in which one can indicate to what extent these are applicable. The higher the total score, the lower the acceptance and the higher the experiential avoidance. The psychometric qualities of the Dutch translation of the AAQ-II are good with an internal reliability of 0.87 and a construct validity of -0.67 to -0.79 for oppression and psychological complaints.

Patients' attendance at treatment sessions will be recorded. Patient adherence for the treatment sessions will be calculated as the ratio of the number of treatment sessions that were actually carried out versus the number of prescribed sessions. For the home sessions (incl. working with the information leaflet), patients will be asked to record the sessions' content in a personal log book. Treatment adherence will be calculated as a ratio of the number of sessions that were actually carried out at home versus the total number of prescribed home sessions. Patient drop-out and the reason for withdrawal will be registered.

Co-interventions will be closely monitored. Medical consumption, including the type, dose, method of administration and frequency of medication, as well as any other interventions will be recorded.

Personal characteristics including date of birth, nationality, race/ethnicity, level of education, professional situation, family income, relationship status, physical activity, smoking status, alcohol consumption, Body Mass Index (BMI), comorbidities, lymphedema, type of surgery, hormone therapy, chemotherapy, radiotherapy, immunotherapy, time since onset of complaints, time since complement of treatment, and treatment expectations will be collected at baseline.

Participants will be excluded if they are suffering from dementia or cognitive impairment (unable to understand the test instructions and/or a result of ≤11, corresponding with MMSE ≤23, on the Six-item Cognitive Impairment Test (6-item CIT) is a short questionnaire containing 6 items.

The Brief Pain Inventory is a 14-item questionnaire assessing worst pain, pain severity, and pain interference in cancer patients over the past week, reported on a scale of 0 to 10. Pain interference is measured as the average of the 7 interference items, such as walking, mood, and sleep. The Brief Pain Inventory is the most common, reliable and valid outcome measure to assess pain in cancer survivors (Cronbach's alfa and test-retest reliability score \> 0.80).

The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) is a 30-item cancer-specific questionnaire developed for the assessment of quality of life in cancer patients. The EORTC QLQ-C30 is widely used in cancer studies, has been translated and validated in over 100 languages and shows acceptable psychometric properties. The internal consistence measured by Cronbach's resulted in 0.94.

The 12-item Injustice Experience Questionnaire (IEQ) will be used to assess perceived injustice. Participants have to rate the frequency of 12 different pain-related statements on a 5-point Likert scale ranging from 0 (not at all) to 4 (all the time). The sum of all items gives the total score which ranges from 0 to 48. The cut off score of 19 is suggestive for a clinically relevant case of perceived injustice.

This questionnaire obtains two correlated factors: severity/irreparability of loss and blame/unfairness. The Dutch version of the IEQ has good (test-retest) reliability (ICC = 0.86-0.87). The scores obtained using the IEQ are valid.

Medical consumption, the type, dose, method of administration and frequency of analgesic, NSAID or symptom-modifying medication, as well as surgeries will be recorded. Health care use will be evaluated using the combination of three questionnaires (online):

1. the Medical Consumption Questionnaire (MCQ)
2. the Productivity Cost Questionnaire (PCQ)
3. the EuroQol EQ-5D

The combination of these questionnaires is advised by the Institute for Medical Technology Assessment, Erasmus University Rotterdam (the Netherlands).

Vrije Universiteit Brussel

Kom Op Tegen Kanker

Hasselt University

Universitair Ziekenhuis Brussel

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Central Nervous System Stimulants

Nicotine

Nicotinic Agonists

Cholinergic Agents

Neurotransmitter Agents

Patients enrolled in group 1 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study

Patients enrolled in group 2 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study and 1 to 3 Motivational Interviewing (MI) after randomization

Patients enrolled in group 3 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study and 1 to 3 Motivational Interviewing (MI) after randomization and 6 sessions of CBT after Motivational Interviewing up to 6 months after

Patients enrolled in group 4 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study and 1 to 3 Motivational Interviewing (MI) after randomization and about 3 sessions of hypnotherapy up to 6 months after

1 to 3 Motivational Interviewing (MI) should be performed after randomization by a psychotherapist

6 Cognitive Behavioural Therapy (CBT) sessions should be performed after motivational interviewing up to 6 months by a psychotherapist

Cognitive Behavioural Therapy (CBT)

About 3 Hypnotherapy sessions should be performed after motivational interviewing up to 6 months by a hypnotherapist

Hypnotherapy

All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months

Nicotine Replacement Therapy (NRT)

This trial offers support and assistance to patients wishing to quit smoking in order to increase the success rate of smoking cessation and all the benefits associated with it. Patients will be monitored by a tobacco specialist and will be able to benefit from one or more therapies complementary to Nicotine Replacement Therapy (NRT): Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT) or Hypnotherapy.

The study RESPIRE is aiming to identify some interventions to be proposed as part of a smoking cessation programme for smokers with cancer requiring surgical treatment and wishing to stop smoking. We aim to compare different smoking cessation methods in addition to the currently recommended treatments: Nicotine Replacement Therapy (NRT). These procedures are: Cognitive Behavioural Therapy (CBT), Motivational Interviewing (MI) or hypnotherapy in order to improve the success rate of smoking cessation in this specific population.

All patients wishing to be supported to stop smoking will be randomized and will be followed by a tobacco specialist before and after surgery. They will receive NRT for 12 months.

Smoking assessment, exhaled CO measurement, questionnaires will be completed regularly to assess depression, anxiety and quality of life during the 12 months.

Patients randomized in group 2 will receive 1 to 3 MI. Patients randomized in group 3 will receive 1 to 3 MI and 6 CBT sessions by a psychotherapist.

Patients randomized in group 4 will receive 1 to 3 MI and at least 3 sessions oh hypnotherapy.

pilot study, monocentric, prospective, randomization according to Zelen's design

Evaluation of Different Smoking Cessation Protocols: Nicotine Replacement, Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT) or Hypnotherapy in Cancer Patients Scheduled for Surgery

Pilot Study in Cancer Patients Scheduled for Surgery Evaluating Different Smoking Cessation Protocols : Nicotine Replacement, Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT) or Hypnotherapy

Number of patients who completed all planned sessions out of the total number of patients randomised to each group

Percentage of patients with an exhaled Carbone Monoxide (CO) measurement \< 10 ppm at study visits.

Percentage of patients reporting no smoking during the last 7 days before the visit.

Number of cigarettes smoked per day from baseline

Percentage of patients reporting no smoking since surgery

Report all Grade \> 1 side effects of oncology treatments up to 3 months after the end of treatment or the end of the study

Report all surgical complications (Grade \> 1 according to Clavien Dindo classification) up to 1 month after surgery

Patient Depression and anxiety will be evaluated by using the Hospital Anxiety and Depression Scale (HADS)

Patient quality of life will be evaluated by using the Quality of Life Questionnaire (QLQ-C30)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Methods for Increasing Genetic Testing Uptake in Michigan	NCT05162846	Breast Cancer Colorectal Canc... Ovarian Cancer Prostate Cancer Pancreatic Canc... Endometrial Can... History of Canc...	Publicly availa... Virtual genetic... Motivational in...	18 Years -	University of Michigan Rogel Cancer Center
PI-targeted PNE+MI Compared to BIOMEDICAL Education in BCS	NCT04730154	Breast Neoplasm... Survivorship Pain, Chronic	Pain Neuroscien... Motivational In... Biomedically-fo...	18 Years -	Universitair Ziekenhuis Brussel
Evaluation of Different Smoking Cessation Protocols: Nicotine Replacement, Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT) or Hypnotherapy in Cancer Patients Scheduled for Surgery	NCT04899492	Breast Cancer Gynecologic Can... Digestive Cance... Melanoma	Motivational In... Cognitive Behav... Hypnotherapy Nicotine Replac...	18 Years -	Institut Cancerologie de l'Ouest

Spots Global Cancer Trial Database for motivational interviewing (mi)