Behaviors and Mental Disorders

All Conditions

Anxiety Disorders

Depressive Disorder

Depression

Behavioral Symptoms

Group will receive 8-week online program including CBT in combination with mindfulness and problem-based therapy in addition to treatment as usual. The content will reflect challenges cancer and palliative patients face through the course of treatment and developed into interactive and engaging therapy modules. All online sessions and interactions will occur through a secure online platform. Pre-designed therapy modules are assigned to the patients, accessible to them at any time throughout the week. Each module consists of approximately 30 slides, which take 45-50 minutes to complete. Each module highlights a different topic and includes general information, an overview of skills, and homework that is to be completed within that week. This homework can be directly submitted through the platform to the clinician who will then provide personalized feed-back to the patient. The average time spent per week by a clinician with a particular patient is about 15 minutes.

The control group will receive treatment as usual in the first 8 weeks; if still significantly symptomatic (less than 50% response to treatment from baseline), they will then be offered the 8-week e-psychotherapy program. They will be instructed to continue with any lifestyle activities (i.e., diet, exercise, medication, etc.)

e-CBT

Nazanin Alavi

Nazanin Alavi, MD FRCPC

The demand for mental health problems, particularly depression and anxiety, is three times greater in Oncology and Palliative Care Centres than in the general population. There are unique factors in this population that make them more susceptible to mental health challenges. The disease itself, the adjustment to a chronic/fatal diagnosis, and the treatment options can all perpetuate the development of mental illness. Despite the well-established association, there have been barriers to access suitable treatment for these patients.

Online Psychotherapy is an effective treatment option that may address many of these barriers. This modality has been proven effective in addressing depression and anxiety in other populations. To date, there has been no psychotherapy module developed specifically for oncology and palliative care patients to our knowledge. The aim is to establish the first academic e-psychotherapy treatment option to address mood and anxiety disorders in oncology and palliative care patients. The investigators will use the Online Psychotherapy Tool (OPTT), a secure cloud-based platform for online delivery of e-CBT, developed by the PI.

The proposed study aims to establish the feasibility and effectiveness of delivering online psychotherapy to oncology and palliative care patients who have a comorbid depressive or anxiety disorder. The patients will be enrolled in an 8-week program with a combination of cognitive behavioural therapy (CBT) and Mindfulness techniques delivered via a series of modules. They will receive individualized feedback from a trained therapist weekly. It is hypothesized that delivering this psychotherapeutic intervention in this manner will have great adherence. The aim is to prove that it will improve the quality of life and decrease symptoms of depression and anxiety in this underserved patient population.

Sixty patients (n=60) diagnosed with depressive or anxiety disorder due to another medical condition in the context of cancer or palliative care, will be recruited to the study through referrals from health care professionals at Kingston Health Sciences Centre (KHSC) including cancer centre, Providence Care Hospital (PCH), family physicians, and other health care providers or self-referrals. After consenting to take part in the study, a complete assessment will be done by one of the psychiatrists on the team to confirm the diagnosis. Inclusion criteria include 18-55 years of age at the start of the study, diagnosed with depression or anxiety secondary to a general medical condition (in the context of cancer or palliative condition) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) by one of the psychiatrists on the team, competence to consent and participate, ability to speak and read English, and consistent and reliable access to the internet. Exclusion criteria include acute hypomanic/manic episodes, acute psychosis, severe alcohol or substance use disorder, and active suicidal or homicidal ideation or if they have received CBT in the past year or are currently receiving CBT. Participants will then be randomly assigned to two groups: e-psychotherapy group (online CBT+ mindfulness + problem solving) or treatment as usual (TAU, i.e., medication, psychiatric consultation and referrals to in-person activities/groups) arms of the study (n=30 for each group). The TAU arm acts as the control group of the study.

Upon completion of the initial assessment, if eligible for the study, participants will randomly be assigned to one of the two arms of the study. Patients in the e-CBT group will receive an 8-week online program including CBT in combination with mindfulness and problem-based therapy in addition to treatment as usual. The content of this program will be customized to reflect challenges cancer and palliative patients face through the course of their treatment and developed into interactive and engaging therapy modules. All online sessions and interactions will occur through a secure online platform (i.e. OPTT). Through the platform, the pre-designed therapy modules are assigned to the patients, accessible to them at any time throughout the week. Each module consists of approximately 30 slides, which take an average of 45-50 minutes to complete. Each weekly module highlights a different topic and includes general information, an overview of skills, and homework that is to be completed within that week. This homework can be directly submitted through the platform to the clinician who will then provide personalized feed-back to the patient. The average time spent per week by a clinician with a particular patient is about 15 minutes. The control group will receive treatment as usual in the first 8 weeks; if still significantly symptomatic (less than 50% response to treatment from baseline), they will then be offered the 8-week e-psychotherapy program.

Randomly allocated to either treatment or control

Developing and Implementing E-psychotherapy Program for Mental Health Challenges in Oncology and Palliative Care

Developing and Implementing an Online Psychotherapy Program to Address Mental Health Challenges in Oncology and Palliative Care

Clinically validated symptom questionnaire. Scale of 0-4, 4 is worse.

Clinically validated symptom questionnaire. Scale of 0-3, 3 is worse.

Clinically validated symptom questionnaire. Scale of 0-5, 5 is better.

Online PsychoTherapy Clinic

Dr. Nazanin Alavi

Principal Investigator, Assistant Professor

After completing the baseline assessment, all pilot participants will have access to the PreCharge pilot program for 30 days. At the end of the 30 day pilot, they will be directed to the follow-up assessment.

PreCharge is an intervention for Hereditary Cancer Syndrome Previvors that administers brief assessments and uses multivariate algorithms and tailoring technology to provide timely, individualized, bi-directional text messages to improve resilience and coping. The program uses proven approaches to behavior change tailoring to increase resilience by promoting a positive mindset, strong social connections, and a deep sense of meaning and purpose. It will also proactively provide access to online tools prior to medical appointments to address scanxiety (e.g., management of emotion tips; mindfulness meditation; communication scripts; breathing exercises). At any time, users will be able to text a trigger word to indicate that they need extra support and will receive just-in-time assistance via text message.

PreCharge

Kerry E Evers, Ph.D.

Madison Gilmore

Kerry E Evers, PhD

It is estimated that 1 in 279 people may be carriers of a Hereditary Cancer Syndromes (HCS), a cancer risk that is associated with germline mutations (inherited genetic mutations passed directly from a parent to a child that create a genetic predisposition to certain types of cancer). Individuals with an HCS who have never been diagnosed with cancer (Previvors) have up to an 80% lifetime risk of developing cancer and are at an increased risk of developing multiple primary cancers during their lifetime, often with onset at an early age. Previvors face multiple forms of adversity, including a multitude of annual cancer screenings and the uncertainty of not only their own health but the health of affected family members. This study will examine the acceptability and preliminary effects of PreCharge, a resilience-boosting solution specifically designed for Previvors and delivered primarily via bi-directional text messaging. PreCharge uses proven approaches to behavior change tailoring to increase resilience by promoting a positive mindset, strong social connections, and a deep sense of meaning and purpose while also proactively addressing scanxiety. Up to 150 Hereditary Cancer Previvors will be recruited for a 30-day pilot test. Participants will complete a baseline assessment, and then be provided with 30 days of access to the PreCharge program. At the end of the 30 days, they will be prompted to complete a follow-up assessment. Outcomes include 1) acceptability of the program, as evidenced by obtaining 75% endorsement that users would recommend the program to a fellow Previvor; (2) engagement as evidenced by continued receipt of text messages and one or more interactions with the online tools by at least 70% of participants; and (3) benefit from the program, evidenced by statistically significant pre-post improvement on the Connor Davidson Resilience Scale.

Previvors Recharge: A Resilience Program for Cancer Previvors

The PHQ-2 inquires about the frequency of depressed mood, with a score ranging from 0 to 6. The authors identify a cut-off score of 3 as the optimal cut point for screening purposes, and stated that a cut point of 2 would enhance sensitivity.

The PHQ-2, comprising the first 2 items of the PHQ-9, inquires about the degree to which an individual has experienced depressed mood and anhedonia over the past two weeks.

The Generalized Anxiety Disorder two questions scale (GAD-2) is an ultra brief and easy to perform initial screening tool for Generalized Anxiety Disorder (GAD). The two questions are rated on a zero to three scale for a total score of zero to six with greater scores indicating higher likelihood of Generalized Anxiety Disorder. A score of 3 points is the preferred cut-off for identifying possible cases and in which further diagnostic evaluation for generalized anxiety disorder is warranted.

The short version of the Cancer Behavior Inventory (CBI-B: 12 items) measures self-efficacy for coping which has been shown to have a positive impact on wellbeing, quality of life, anxiety, and depression in cancer patients, even after treatment. Each item is rated on a 1 to 9 scale for a total score range of 12-108 with higher scores indicating higher levels of confidence.

The Net Promoter Score (NPS) measures program users' experience and predicts the growth of program use. It is a widely accepted single-item satisfaction measure, "How likely is it that you would recommend this program to a friend or colleague?" will be responded to on a scale from 0=extremely unlikely to 10=extremely likely by users.

This 10-item scale assesses five factors related to resilience. Each item is rated on a 5-point scale with higher scores reflecting greater resilience. Scores range from 0-40. There are well-established norms across a variety of populations and the scale has been used as an outcome measure to evaluate a variety of different intervention programs.

In its World Poll administered in 150 countries, Gallup, Inc. uses the 2-item Cantril Self-Anchoring Scale and a simple scoring algorithm to assess subjective well-being. Respondents are asked to rate their current life-and then to rate their future life, "say about five years from now"-on a ladder where 0 represents the worst possible life and 10 best possible life. Individuals who rate their current life a "7" or higher AND their future life an "8" or higher are classified as "thriving." Individuals who rate their current and future lives a "4" or lower are classified as "suffering." All others are "struggling." Previous research has shown that those classified as thriving experience less depressive symptoms, higher physical and emotional health and have fewer health risk behaviors than those in struggling and suffering.

The Acceptance and Action Questionnaire - version 2 (AAQII), is the most widely used measure of psychological flexibility. Higher total scores on the 7-item scale indicate higher psychological inflexibility, experiential avoidance, and more potential psychological distress. Lower total scores mean more psychological flexibility and normative values are available. Scores range from 7 to 49.

Pro-Change Behavior Systems

Co-President and CEO, Principal Investigator

Symptoms and General Pathology

Nervous System Diseases

Rare Diseases

Chronic Disease

Chronic Pain

Pain

Neurologic Manifestations

Disease Attributes

Chronic Graft Versus Host Disease

Michelle Speaks, MBA

Sunil K Aggarwal, MD, PhD

Therry Eparwa, DNP

Leanna J Standish, ND, PhD

Therry Eparwa, DNP, FNP-BC

Leanna J Standish, ND, PhD, LAc

This epidemiologic research is being conducted as an observational prospective case series outcomes study of the use of advanced integrative specialty medical care and its effect on adult and pediatric patients with chronic or serious illnesses or mental health disorders.

There is growing interest in providing integrative medical care in conjunction with specialty medical care to expand the reach of integrative care to more chronically and seriously ill patient populations. At the AIMS Institute, the core specialties are naturopathy, palliative care, psychiatry, physiatry, and naturopathic oncology practiced via coordinated, team-based care by allopathic medical and psychiatric specialists, psychotherapists, specialized naturopathic physicians, advanced practice nurses, and targeted health educators, with the majority of care covered by insurance. Additionally incorporated are novel 'advanced' approaches, such as drug-assisted psychotherapy, medical cannabis education, sympathetic blocks, and some intravenous therapies.

This is an uncontrolled, prospective case series outcomes study of health-related quality of life outcomes in patients who receive care at AIMS Institute. A clinic-wide chart audit of patient characteristics and outcomes will be conducted prior to the start of enrollment.

AIMS Medical Outcomes Study

Measure quality of life using GAD-7, PHQ-9, and short form questionnaire.

Describe treatments prescribed and provided by AIMS Institute physicians abstracted from chart review.

Advanced Integrative Medical Science Institute

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Neoplasms

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Diabetes Mellitus

Breast Neoplasms

Diabetes, Gestational

Metabolic Diseases

Glucose Metabolism Disorders

Altered metabolic milieu is defined as a fasting glucose level \>100 mg/dL at the first trimester of pregnancy by national guidelines. Altered metabolic milieu during the second trimester (24-28 weeks of pregnancy) is defined as a fasting glucose levels \> 92 mg/dL and/or plasma glucose levels \> 153 mg/dL two hours after load in the oral glucose tolerance test according to ADA guidelines or a fasting glucose \>100 mg/dL and/or \> 140 mg/dL two hours after load in the oral glucose tolerance test according to national guidelines. The COVID-19 pandemic is considered as a natural nutritional and mental health exposure.

Nutrition and mental health during pregnancy

María L Garmendia, PhD

Camila L Corvalán Aguilar, PhD

María F Mujica Coopman, PhD

The Chilean Maternal \& Infant Cohort Study II (ChiMINCs II) is an ongoing cohort that is part of the Chilean Maternal and Infant Nutrition Observatory of the South-East area of Santiago, Chile. In total, 1927 pregnant women beneficiaries of the public health systems and their offspring were recruited before 12 weeks of gestation and are followed across pregnancy (\<15, 26-28, and 35-37 weeks of gestation) and up to 2 years of age of their offspring. Two studies are currently nested in ChiMINCs II: 1) Breast Cancer Risk Assessment in Mothers (BRECAM) study, and 2) the ChiMINCs-COVID study. The primary objective of BRECAM study is to test the association between maternal metabolic indicators (i.e., insulin, glucose, IGF-1, and HbAc1 concentrations) at early pregnancy (i.e., \<15 and 26-28 weeks of gestation) and breast density 3 months after the cessation of lactation. For this purpose, we collect maternal obstetric, lifestyle, dietary intake, anthropometric, and biochemical information. The aim of the ChiMINCs-COVID study is to assess dietary-related risks and mental health problems derived from the COVID-19 pandemic and their influence on maternal and infant's health and nutrition. Thus, we collected detailed information on dietary behaviors, mental health and COVID-related information at each trimester, along with neonatal and infant nutritional information. The purpose of the present work is to describe the design, methods, and descriptive information at recruitment of ChiMINCs-II, also discussing the implications that this study can have to better understand maternal and infant nutrition and health during the COVID-19 era.

Additional fasting venous samples will be collected during routine public health care blood extractions and at delivery (maternal venous and umbilical cord blood samples). Also, feces samples of newborn will be collected after delivery. Whole blood, plasma, buffy coat, serum and red blood cells will be separated by centrifugation within the next 3 hours. Biological specimens will be aliquot and keep to -80ºC until the determination of metabolic markers, growth factors and hormones.

Chilean Maternal & Infant Cohort Study II (CHiMINCs-II)

The Chilean Maternal and Infant Nutrition Cohort Study II

Data and blood samples that will be collected in this study will be under the custody of the principal investigator and a human subject protection review board will regulate its use. Others researchers may access the data by contacting to María Luisa Garmendia (Principal Investigator).

Pontificia Universidad Catolica de Chile

Servicio de Salud Metropolitano Sur Oriente

Instituto de Nutrición y Tecnología de los Alimentos

Associate Professor

Head and Neck Neoplasms

BRIGHT is a manualized theory-based video tele-cognitive behavioral therapy (CBT) intervention delivered one-on-one by a licensed clinical psychologist.

The attention control arm is a manualized video tele-supportive care intervention that addresses non-body image aspects of HNC survivorship.

BRIGHT is a manualized theory-based tele-CBT intervention consisting of 6 weekly 60-minute sessions. BRIGHT is delivered one-on-one by a licensed clinical psychologist at each site via standard video tele-CBT platform. BRIGHT session topics include (1) psychoeducation about the cognitive model of body image, (2) self-monitoring about thoughts, feelings, and body image behaviors, (3) cognitive restructuring to identify and challenge unhelpful automatic HNC body image thoughts, (4) positive body image coping strategies, (5) social support and identifying personal value, and (6) thinking ahead and planning for setbacks.

BRIGHT

AC is a manualized video-tele-supportive care intervention that addresses non-body image aspects of HNC survivorship. Identical to BRIGHT, AC consists of 6 weekly 60-minute sessions delivered by a trained empathic interventionist via standard video-telemedicine platform. AC session topics include (1) Introduction to HNC survivorship, (2) Post-Treatment Side Effects (3) Psychosocial Aspects of HNC, (4) Health Promotion and Nutritional Challenges, (5) Financial Distress and Return to Work, and (6) Cancer Recurrence. AC controls for professional attention (i.e., ensuring that findings are not driven by simply interacting with an empathic interventionist), common factors, dose, and delivery method while not providing the active, behavior change mechanism in BRIGHT.

Attention Control

Evan M Graboyes, MD

Taylor McLeod, MPH

Steven Chang, MD

Patrik Pipkorn, MD, MSCI

Evan M Graboyes, MD, MPH

In this multi-center randomized clinical trial, head and neck cancer (HNC) survivors with clinically significant body image distress (BID) (N=180) will be randomized to BRIGHT (a brief video tele-cognitive behavioral therapy intervention) or Attention Control (AC, a manualized tele-supportive care intervention that controls for professional attention, dose, delivery method, and common factors). HNC survivors will complete IMAGE-HN (a validated patient-reported outcome measure \[PROM\] of HNC-related body image distress \[BID\]; primary endpoint), measures of psychological and social well-being and quality of life (QOL), and measures of theory-derived mechanisms of change underlying BRIGHT (mediators).

We will perform a multi-site randomized clinical trial (RCT) comparing BRIGHT with AC to test our hypotheses that BRIGHT reduces BID and improves psychological and social well-being and QOL at 2, 3, 6, and 9-months post-randomization by enhancing body image coping skills and decreasing unhelpful automatic thoughts. HNC survivors with clinically significant BID (N=180) from the Medical University of South Carolina (MUSC), Washington University School of Medicine (WUSM), and Henry Ford Health (HFH) will be randomized 1:1 to BRIGHT or AC. We will conduct semi-structured interviews with key stakeholders (n=10/site) and in-depth site visits to assess barriers and facilitators of the adoption of BRIGHT and develop an implementation toolkit to enhance the future adoption of BRIGHT into routine clinical care.

Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) Multi-Site RCT

A Multi-Site, Parallel-Group, Randomized Clinical Trial Comparing a Brief Tele-Cognitive Behavioral Therapy Intervention (BRIGHT) With Attention Control for the Reduction of Body Image-Related Distress Among Head and Neck Cancer Survivors

Research materials will include baseline data and study outcomes from trial participants. Data will be raw or minimally processed.

Data will be available following final database lock, reporting to clinicaltrials.gov, and presentation and publication of study findings describing key primary and secondary objectives.

De-identified data available will be available to users under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate technology; and (3) a commitment to destroying or returning the data after analyses are completed. All data sharing will comply with laws, regulations, and policies privacy governing data derived from human subjects.

The IMAGE-HN is a 24-item, validated patient-reported outcome measure (PROM) of HNC-related BID. Items are rated on a 5-point Likert scale from 'Never' (0) to 'Always' (4). The total global score is calculated by summing item responses across 21 items (all items except 3, 4, and 19). Total IMAGE-HN scores on the global domain (21 questions) range from 0-84; higher scores indicate worse HNC-related BID. An IMAGE-HN score of \> 22 indicates clinically-significant HNC-related BID and a change in IMAGE-HN score of \> 9 points is clinically meaningful.

The Shame and Stigma Scale is a 20-item, validated, unidimensional PROM that measures four domains (shame with appearance, stigma, regret, and social/speech concerns) in patients with HNC over the prior 7 days. Items are rated on a 5-point Likert scale from 'Never' (0) to 'All the time' (4). The total score is calculated by summing the individual responses (except for 4 questions which are reverse scored). Shame and Stigma Scale scores range from 0-80; higher scores reflect worse HNC-related shame and stigma.

The PROMIS SF v1.0-Depression 8a is an 8-item validated measure developed by the NIH to assess patient-reported negative mood, views of self, and decreased positive affect and engagement. Responses rate the strength of agreement with statements about depressive symptoms using a scale that ranges from 1-5. The total raw score is calculated by summing the individual responses. The PROMIS SF v1.0-Depression 8a raw score ranges from 8-40; a higher score reflects more severe depressive symptoms. The PROMIS SF v1.0-Depression 8a total raw score is translated into a T-score for each participant according to the PROMIS Scoring manual. The T-score provides a standardized score with a mean of 50 and a standard deviation of 10.

The PROMIS SF v1.0-Anxiety 8a is an 8-item, validated, developed by the NIH to assess patient-reported fear, worry, and hyperarousal. Responses rate the strength of agreement with statements about anxiety symptoms using a scale that ranges from 1-5. The total raw score is calculated by summing the individual responses. The PROMIS SF v1.0-Anxiety 8a raw score ranges from 8-40; a higher score reflects more severe anxiety symptoms. The PROMIS SF v1.0-Anxiety 8a total raw score is translated into a T-score for each participant according to the PROMIS Scoring manual. The T-score provides a standardized score with a mean of 50 and a standard deviation of 10.

The Beck Scale for Suicidal Ideation is a 21-item, validated, unidimensional rating scale that measures the current intensity of patients' specific attitudes, behaviors, and plans to commit suicide on the day of the interview. Each item consists of three options graded according to suicidal intensity on a 3-point scale ranging from 0 to 2. The ratings for the first 19 items are summed to yield a total score, ranging from 0 to 38. Higher scores represent more severe suicidal ideation.

PROMIS SF v2.0-Ability to Participate in Social Activities 8a is an 8-item, validated, unidimensional measure of patient-reported perceptions of participation in social activities. Items are scored using a 5-point Likert scale from 'Never' (1) to 'Always' (5). The total raw score is calculated by summing the individual responses. The total raw score ranges from 8-40; a higher score reflects more severe inability to participate in social activities. The total raw score is translated into a T-score for each participant according to the PROMIS Scoring manual. The T-score provides a standardized score with a mean of 50 and a standard deviation of 10.

The EORTC QLQ-Head Neck 35 Trouble with Social Eating Subscale is a 4-item, validated measure of trouble with social eating for patients with HNC. The subscale is composed of QLQ-H\&N35 items 19-22. Items are scored using a 4-point Likert scale from 'not at all' (0) to 'very much' (3). The total score is calculated by summing the individual responses. Total subscale scores range from 0-12; higher scores reflect more trouble with social eating.

The EORTC QLQ-HN35 Trouble with Social Contact Subscale is a 5-item, validated measure of trouble with social contact for patients with HNC. The subscale is composed of QLQ-H\&N35 items 18, 25-28. Items are scored using a 4-point Likert scale from 'not at all' (0) to 'very much' (3). The total score is calculated by summing the individual responses. Total subscale scores range from 0-15; higher scores reflect more trouble with social contact.

The BICSI is a 29-item, validated measure of the cognitive and behavioral responses to manage threats to body image. BICSI contains three sub-domains; (1) appearance fixing (altering appearance by covering, camouflaging, or correcting the perceived defect), (2) avoidance (an attempt to escape or avert stressful body-image situations), and (3) positive rational acceptance (acceptance of the challenging event and positive self-care or rational self-talk about one's appearance). Items are scored on a 4-point Likert scale from 'Definitely not like me' (0) to 'Definitely like me' (3). The score for each subscale is calculated by summing the values for the individual questions and thus ranges as follows: Appearance fixing (0-30), Avoidance (0-24), and Positive rational acceptance (0-33). For each subscale, higher scores indicate greater reliance on that type of body image coping strategy.

The Automatic Thoughts Questionnaire is a 15-item, validated, patient-reported measure of negative automatic thoughts. Items are scored using a 5-point Likert scale (1-5). The total score is calculated by summing the individual responses. Total scores range from 15-75; higher scores reflect more negative automatic thoughts.

National Cancer Institute (NCI)

Medical University of South Carolina

Associate Professor, Department of Otolaryngology- Head and Neck Surgery

Mental Disorders

Psychotic Disorders

Dermatologic Agents

All Drugs and Chemicals

Coal Tar

Group one consists of subjects who will participate in the Personalized Therapeutics Clinic where in which study doctors will make recommendations based on information found in both the subject's drug-drug interaction and drug-gene profiles. These recommendations will be given to participating providers. These recommendations will be communicated to healthcare providers who are directing the subject's care. These providers may work in hospitals, primary care, oncology, geriatrics, and mental and behavioral health. Each provider will have separately agreed to participate in this study. Subjects in this group will also learn about their drug-drug interaction and drug-gene profiles during educational visits with clinic staff.

Participants will randomly (like by a flip of the coin) assigned to a group.

Group two consists of subjects who will participate in the Personalized Therapeutics Clinic where study doctors will make recommendations based on information only found in the subject's drug-drug interaction profile. Subjects in this group will also learn about their drug-drug interaction and drug-gene profiles during educational visits with clinic staff.

Participants will randomly (like by a flip of the coin) assigned to a group.

Group three consists of subjects who will not participate in the Personalized Therapeutics Clinic or receive recommendations. These subjects will not have any recommendations from regarding their drug-drug interaction or drug-gene profiles. Both drug-drug interaction and drug-gene profiles will be kept hidden from all of their treating providers-regardless of whether the providers directing their care have agreed to participate in this research. Subjects in this group will not learn about their drug-drug interaction or drug-gene profiles during educational visits with clinic staff.

Participants will randomly (like by a flip of the coin) assigned to a group.

A profile based on genetic testing that shows information about how the participant's medications they are taking interact with each other.

Drug-Drug Interaction Profile

A profile based on genetic testing that shows information about how the participant's genes interact with/respond to certain medications they are taking.

Drug-Gene Interaction Profile

The standard treatment and prescribing for the participant's specific type of cancer.

Standard of Care

Andre Hall

Mark Ratain

Mark Ratain, MD

The purpose of this study is to determine whether a consultation with a Personalized Therapeutics Clinic, or PTC, will help participants lower the risk for side effects (drug-drug interactions and drug-gene interactions) when taking many medications and help providers improve prescribing decisions for participants. A PTC is a clinical that will test your genes to gather information about your health that may help guide prescribing advice and offer you new information about your prescriptions. Doctors leading this study will look for variations (differences) in your genes that may suggest that you are at greater risk of having side effects or a greater chance of benefiting from certain medications. Individuals in this study will participate for roughly 9 months.

Evaluating Personalized Therapeutics Clinic (PTC) on Drug-Drug Interactions and Drug-Gene Interactions

Evaluating the Effectiveness of a Personalized Therapeutics Clinic (PTC) Intervention on Drug-Drug Interactions (DDIs) and Drug-Gene Interactions (DGIs)

The change in the composite rate of drug-drug interactions (DDIs) and drug-gene interactions (DGIs) from baseline (at beginning of study) and after each intervention compared between all three arms.

Reported as a percentage of total hospitalized participants

An implementation strategy for a site-specific Personalized Therapeutic Clinic (PTC) as assessed by evaluating which mediators and moderators who may be able to adopt PTC recommendations.

The rate of hospitalizations among participants in all three arms as assessed by study notes/clinical record.

Rate of emergency department visits among participants in all three arms as assessed by study notes/clinical record.

Rate of reported adverse drug events among participants in all three arms as assessed by study notes/clinical record.

Changes in participant knowledge and perceptions of the PTC will be assessed using surveys administered at baseline and after the first post-PTC visit with their primary treating provider.

Changes in provider knowledge and perceptions of the PTC as assessed by survey collected from providers at baseline and at the end of study.

University of Chicago

Youths (10-18 y) with newly diagnosed cancer, as well as their family members.

Youths (10-18 y) with a chronic somatic disease receiving care at a pediatric outpatient facility.

12 week of daily reflection and meditation exercises, delivered by mobile phone text messages, after 3-4 live introduction sessions.

Awareness and insight Modules (AiM)

Oskar Lundgren, MD, Phd, MSc

Oskar Lundgren, MD, PhD, MSc

Catrin Furuhjelm, MD, PhD

The purpose of the CROP study is to investigate the potential to cultivate psychological resources and resilience in childhood cancer patients and their family members using a mobile phone-based intervention.

The feasibility study aims to evaluate the implementation and participant experience of the digital intervention and register psychological outcome measures preliminary evidence for its acceptability, feasibility, and potential beneficial effects.

The feasibility study (CROP) will recruit 20 youths with newly diagnosed cancer (10-18 y) and family members for participation in a 12-week digital intervention to cultivate psychological resources.

Investigators will recruit an equal number of pediatric patients with other chronic conditions to an observational comparison group to indicate the influences on participation and outcome from the oncology care context.

Investigators will obtain informed consent from all participants. Upon inclusion in the study, participants will start getting a text message every day for 12 consecutive weeks. The texts will contain links to a digital platform on which participants will complete an exercise in either self-reflection or guided mindfulness meditation.

The psychological training program is based on 12 modules with evidence-based treatments in other medical contexts and age groups. The practices are based on acceptance, commitment, re-appraisal, meaning and purpose, expressive writing, narrative processes, mindfulness, compassion, equanimity, and gratitude. The combination of practices and the implementation in pediatric oncology has not been studied earlier.

The cancer patients will be recruited during the first month after diagnosis, meet with an instructor during 2-4 start-up meetings, and thereafter practice on their own or with participating family members.

The pediatric patients with chronic diseases will be recruited during a follow-up visit to an out-patient clinic and meet with an instructor during 2-4 start-up meetings, and thereafter practice on their own or together with participating family members.

Investigators will address the primary research question of the feasibility of the intervention by investigating participant activity data, written evaluations of the experience of participation, and through phone interviews of participants.

Secondary research questions, such as preliminary data on changes in mental health and psychological distress, will be investigated with self-report questionnaires.

Interventional group of cancer patients, and observational group of pediatric patients with other chronic conditions.

Collection of data and analysis will be made by researcher with limited knowledge of participant status.

Cultivating Resilience in Oncology Practice

Cultivating Resilience in Oncology Practice: A Feasibility Study of Pediatric Patients

Study data will be made available upon reasonable request from other researchers.

14 items. Score (min-max): 0-70. A high score indicates mental well-being.

25 items. Score (min-max): 0-25. A high score indicates psychiatric difficulties.

25 items. Score (min-max): 0-25. A high score indicate psychiatric difficulties.

25 items. Score (min-max): 0-75. A high score indicates symptoms of anxiety and depression.

10 items. Score (min-max): 10-50. A high score indicates a high level of usability.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Developing and Implementing E-psychotherapy Program for Mental Health Challenges in Oncology and Palliative Care	NCT04664270	Mental Health I... Depression Anxiety Palliative Care Oncology	e-CBT	18 Years - 55 Years	Queen's University
Previvors Recharge: A Resilience Program for Cancer Previvors	NCT06378749	Hereditary Canc... Mental Health I...	PreCharge	18 Years -	Pro-Change Behavior Systems
Developing and Implementing E-psychotherapy Program for Mental Health Challenges in Oncology and Palliative Care	NCT04664270	Mental Health I... Depression Anxiety Palliative Care Oncology	e-CBT	18 Years - 55 Years	Queen's University
AIMS Medical Outcomes Study	NCT04512755	Mental Health I... PTSD Pain Chronic Pain Chronic Disease		-	Advanced Integrative Medical Science Institute
Chilean Maternal & Infant Cohort Study II (CHiMINCs-II)	NCT03920098	Breast Density Body Compositio... Nutritional Sta... Mental Health I...	Nutrition and m...	18 Years - 50 Years	Instituto de Nutrición y Tecnología de los Alimentos
Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) Multi-Site RCT	NCT05442957	Head and Neck C... Body Image Dist... Body Image Survivorship Psychosocial Im... Mental Health I...	BRIGHT Attention Contr...	18 Years -	Medical University of South Carolina
Previvors Recharge: A Resilience Program for Cancer Previvors	NCT06378749	Hereditary Canc... Mental Health I...	PreCharge	18 Years -	Pro-Change Behavior Systems
AIMS Medical Outcomes Study	NCT04512755	Mental Health I... PTSD Pain Chronic Pain Chronic Disease		-	Advanced Integrative Medical Science Institute
Evaluating Personalized Therapeutics Clinic (PTC) on Drug-Drug Interactions and Drug-Gene Interactions	NCT05166694	Cancer Advanced Cancer Advanced Solid ... Mental Health I... Behavior Disord...	Drug-Drug Inter... Drug-Gene Inter... Standard of Car...	18 Years -	University of Chicago
Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) Multi-Site RCT	NCT05442957	Head and Neck C... Body Image Dist... Body Image Survivorship Psychosocial Im... Mental Health I...	BRIGHT Attention Contr...	18 Years -	Medical University of South Carolina
Cultivating Resilience in Oncology Practice	NCT04902313	Childhood Cance... Depressive Symp... Anxiety Disorde... Mental Health I...	Awareness and i...	10 Years - 18 Years	Linkoeping University

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