Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Nervous System Diseases

Rare Diseases

Breast Neoplasms

Chronic Pain

Pain

Mastodynia

Breast Diseases

Skin Diseases

Neurologic Manifestations

Chronic Graft Versus Host Disease

This group will receive MBCT for 8 consecutive weeks.

MBCT consists of 8 sessions, incl. 1 whole-day session, weekly meetings of app. 2 hours duration. Daily homework (app. 30-45 min).

Group format (app. 20 persons pr. group). Two trained instructors will manage the groups, both are MSc cand.psych, PhD.

Mindfulness-Based Cognitive Therapy

Waitlist: participants are offered the intervention (MBCT) after the completion of the main study

Waitlist

Maja Johannsen, PhD-fellow, MSc psychology

Robert Zachariae, Professor, MDSci., MSc

A recent epidemiologic survey has indicated that approx. 42% of Danish women treated for breast cancer experience negative sequelae in the form of pain following treatment. Chronic pain is known to be associated with impaired social and emotional functioning, and thus presents a particular concern.

Mindfulness-based intervention is among the complementary, psychological treatments, which cancer patients commonly seek out in relation to the course of their illness. Despite the popularity of mindfulness-based intervention among cancer patients, no studies have so far investigated the effect of mindfulness-based intervention on chronic pain in breast cancer patients. While no studies so far have focused on pain, there is evidence to suggest that mindfulness-based intervention is associated with improved psychosocial adaption to cancer. Furthermore, non-cancer research suggests that mindfulness-based intervention is associated with reduced pain experiences.

The aim of this project is to investigate the effect of Mindfulness-Based Cognitive Therapy (MBCT) on chronic pain in breast cancer patients. Women who have completed their treatment for breast cancer and who experience chronic pain, will be randomized to an intervention group (MBCT) or a treatment-as-usual control group. All participants will be assessed at the same time points, i.e. before the intervention (baseline), and three times after the intervention/control condition, with the last follow-up 6 months after the intervention. In addition, a number of potential moderators and mediators of the outcome will be explored. For example, recent studies indicate that adult attachment style may constitute an important moderator and/or mediator in the development of pain, and preliminary research has suggested that attachment style may moderate the effect of mindfulness-based intervention.

The results will provide valuable new knowledge about the potential of MBCT as a treatment strategy for chronic pain in breast cancer patients, will contribute to the clarification of underlying mechanisms in the experience of and coping with pain, which could help the development of more effective, individualized interventions.

The Effectiveness of Mindfulness on Chronic Pain in Breast Cancer Survivors

A Randomized Controlled Trial of Mindfulness-based Cognitive Therapy (MBCT) on Chronic Pain in Women Treated for Breast Cancer

the Experiences in Close Relationships Short Version

Revised McGill Pain Questionnaire Short Form

VAS: pain interference

Additional items: Pain descriptors

the Hospital Anxiety and Depression Scale

University of Aarhus

Diseases and Abnormalities at or Before Birth

Musculoskeletal Diseases

Heart and Blood Diseases

Behaviors and Mental Disorders

Syndrome

Neurofibromatoses

Neurofibromatosis 1

Neurofibroma

Noonan Syndrome

Costello Syndrome

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Neoplastic Syndromes, Hereditary

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Peripheral Nervous System Diseases

Neuromuscular Diseases

Congenital Abnormalities

Craniofacial Abnormalities

Musculoskeletal Abnormalities

Heart Defects, Congenital

Cardiovascular Abnormalities

Heart Diseases

Connective Tissue Diseases

Abnormalities, Multiple

Quality of Life

Neurofibromatosis

Neurofibromatosis Type 1

Cardiofaciocutaneous Syndrome

Legius Syndrome

Participants will begin their 1-week baseline EMA data collection period and then take part in intervention procedures immediately after enrollment to assess feasibility and acceptability.

Participants will begin their 1-week baseline EMA data collection period immediately after randomization and will begin receiving the 8-week intervention at the end of this week/beginning of the next week (depending on participant schedule).

After an initial 1-week baseline period for EMA data collection and 8 weeks of maintaining their usual routine (wait list period), participants will begin receiving the 8-week intervention.

8 weeks of maintaining usual routine followed by 8-week intervention that emphasizes mindfulness, acceptance, perspective taking, and values-based actions.

8-week intervention that emphasizes mindfulness, acceptance, perspective taking, and values-based actions.

ACT Intervention

Staci M Peron, Ph.D.

Staci Peron, Ph.D.

Background:

RASopathies are a group of genetic diseases that affect a child s development. They cause physical, cognitive, and behavioral symptoms. Caring for a child with a RASopathy can be stressful. Acceptance and Commitment Therapy (ACT) is a therapy that helps people become more aware and accepting of difficult thoughts and feelings. ACT has been found to be helpful for parents with high parenting stress.

Objective:

To find out if Acceptance and Commitment Therapy (ACT) can help caregivers of children with a RASopathy better cope with parenting stress.

Eligibility:

People aged 18 years or older who care for a child (younger than 18 years) with a RASopathy. The child must live with the caregiver at least 50% of the time.

Design:

The study is fully remote. Participants need a mobile device that can play audio and video and connect to the internet. They can borrow an iPod if needed.

Participants will download a free app called MetricWire. They will use this app to watch videos and answer questions.

The first 8 participants will be in a pilot study. They will receive the ACT intervention starting the first week after they begin the study.

After the pilot study, we will start a new phase called the randomized trial. In this phase, participants will have a 50-50 chance of being in the group that will start the intervention right away or the group that will start the intervention after about 2 months.

Participants will fill out surveys on 5 random days each week. These surveys have 7 questions and take about 2 minutes. They will also fill out 3 longer questionnaires: once before ACT begins, once just after the 8-week study period, and once about 3 months later. Questions will cover topics including:

Parenting stress

Life satisfaction

Self-compassion

Uncomfortable feelings and thoughts

Mindfulness

Participants will take part in an 8-week ACT intervention. They will have one 75-minute session with an ACT coach in the first week.

Participants will watch 9- to 17-minute videos each week. The videos talk about how to practice ACT techniques to cope with parenting stress.

Participants will have 20- to 30-minute coaching sessions in weeks 3 and 6. The coach will help them practice exercises and work through any problems.

Background:

* RASopathies are a group of neurodevelopmental genetic conditions caused by mutations affecting components within the RAS-map kinase (RAS-MAPK) cellular signaling pathway.
* Caregivers of children with a RASopathy are faced with numerous challenges related to the physical, cognitive, and behavioral symptoms associated with their child s condition.
* The use of virtual interventions has been increasing over the past decade, which increase accessibility and are especially critical during times of physical distancing, such as due to COVID-19.
* Similarly, Ecological Momentary Assessments (EMA) are being utilized more frequently in order to maximize ecological validity of results and minimize recall bias.
* To our knowledge, no psychological interventions have been investigated targeting parenting stress among caregivers of a child with a RASopathy.

Primary Objectives:

* Internal Pilot Study: To assess the feasibility (e.g., enrollment and attrition) and acceptability (e.g., satisfaction) of an Acceptance and Commitment Therapy (ACT) coping intervention on parenting stress for caregivers of a child with a RASopathy
* Randomized Controlled Trial (RCT): To compare Parental Stress Scale (PSS) changes from baseline to 8 weeks between the Immediate Intervention Arm and the Waitlist Control Arm

Eligibility:

* Caregiver (parent or legal guardian) of a child (\< 18 years) residing with them at least 50% of the time who has a diagnosis of RASopathy syndrome including NF1, Noonan Syndrome, Legius Syndrome, Cardiofaciocutaneous (CFC) syndrome, and Costello Syndrome, or another RASopathy
* Access to necessary resources for participating in a technology-based intervention (i.e., computer, smartphone, internet access) or be willing to use an iPod provided by the study team
* Must score a 15 or higher total score on modified questions from the PSS to indicate at least a moderate level of parenting stress
* Ability to read and speak English

Design:

* This is an 8-week psychological intervention study that has two phases: the first, an internal pilot study, will enroll an initial, small cohort of caregivers (n = 8), all of whom will participate in the ACT intervention. (COMPLETE)
* Due to the success of the internal pilot study (with specific benchmarks met), the second phase of this study will be an RCT comparing participants who receive the intervention immediately (Immediate Intervention Arm) with those in a control group (Waitlist Control Arm). Participants randomized to the Waitlist Control Arm will cross over to receive the intervention after the waitlist period.
* The intervention for the RCT phase involves a baseline 90-minute coaching session and two follow-up coaching sessions with a therapist over video chat, followed by weekly prerecorded video modules that the participants can view at their convenience over the following 8 weeks.
* Participants will complete measures of parenting stress, mindfulness, psychological flexibility, self-compassion, and perceptions of child well-being at baseline, the 8-week post-intervention assessment, and a 3-month follow-up assessment. Additionally, the study will use EMA whereby questions will be sent electronically at random times and days (once a day at varying times on 5 days a week) during weeks 0-8 (the first week will serve as baseline data for comparison) for the Immediate Intervention Arm and weeks 0-18 for the Waitlist Control Arm using the Catalyst mobile applicatioon by MetricWire software.
* We plan to enroll 8 participants in the internal pilot phase and 56 participants in the RCT phase to account for the potential attrition of two caregivers from the intervention, for a total accrual target of 64 evaluable participants.

Acceptance and Commitment Therapy for Caregivers of Children With a RASopathy: An Internal Pilot Feasibility Study and Follow-up Randomized Controlled Trial

Acceptance and Commitment Therapy for Caregivers of Children With a RASopathy: An Internal Pilot Feasibility Study and Follow-up Phase III Randomized Controlled Trial

.All IPD recorded in the medical record will be shared with intramural investigators upon request.

Feasibility defined by compliance with viewing \>50% of the weekly videos (proposed target rate of 5 out of 8 videos watched; must watch at least 80% of each video), and 70% of participants attending both coaching sessions 2 and 3. Acceptability defined by descriptive data per caregiver reports of satisfaction on the Study Satisfaction survey (mean of questions 1-7 and 9).

RCT: Mean scores on the Parental Stress Scale (PSS) will be compared from pre- to post-intervention (baseline to 8 weeks between the immediate intervention arm and the wait list control arm.

Feasibility defined by compliance with daily surveys (target rate of 30 out of 40 surveys (75%) completed on average by each participant). Acceptability defined by post-intervention participant reports of satisfaction with completing daily EMA ratings on the Study Satisfaction survey.

We will examine pre- to post-intervention changes in scores on measures of psychological flexibility (MPFI-SF), self-compassion (SCS-SF), experiential avoidance (BEAQ), depression (PROMIS Depression 8a) and child affect (PROMIS Positive Affect Scale).

We will look for a significant indirect association between treatment arm assignment and pre- to post-intervention PSS changes via psychological flexibility as measured by the BEAQ.

National Cancer Institute (NCI)

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

COVID-19

Colonic Neoplasms

Pneumonia

Pneumonia, Viral

Communicable Diseases

Respiratory Tract Infections

Virus Diseases

Coronavirus Infections

Coronaviridae Infections

Nidovirales Infections

RNA Virus Infections

Lung Diseases

Respiratory Tract Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Oculocerebral Syndrome With Hypopigmentation

Herbal and Botanical

All Drugs and Chemicals

Cola

Patients aged 45-75 who had their screening or surveillance colonoscopy postponed or delayed due to the COVID pandemic at Massachusetts General Hospital

Karen Sepucha, PhD

The study is a cross-sectional survey study targeting patients aged 45-75 who had their screening or surveillance colonoscopy postponed or delayed due to the COVID pandemic. Study staff will survey a random subsample of patients to assess anxiety, COVID risk tolerance, cancer worry, willingness to screen and barriers to screening colonoscopy, and preference for colonoscopy and alternative colon cancer screening options.

Eligible patients will be sent a survey packet in the mail that will include a cover letter, an information sheet describing the study, an incentive, and the survey. The cover letter will include information for participants to opt-out if they desire. Patients will be asked to complete the survey and return it back to study staff. Consent is implied with return of the survey.

For the study, staff plan to invite 300 patients and expect to receive 195 completed surveys. Analyses will examine whether COVID-19 has changed patients' interest in colon cancer screening and the strength of patients' preferences for colonoscopy and other approaches to colon cancer screening. It will then examine factors associated with positive and negative views on rescheduling colonoscopies such as anxiety, worry, and risk perceptions.

The study is a cross-sectional survey study targeting patients aged 45-75 who had their screening or surveillance colonoscopy postponed or delayed due to the COVID pandemic. Staff will survey a random subsample of patients to assess anxiety, COVID risk tolerance, cancer worry, willingness to screen and barriers to screening colonoscopy, and preference for colonoscopy and alternative colon cancer screening options.

Study staff will work with the gastroenterology department to identify patients whose colonoscopy has been delayed due to COVID-19 and who meet the eligibility criteria. A random sample of about 300 eligible patients will be selected for the survey study.

Eligible patients will be sent a survey packet in the mail that will include a cover letter, an information sheet describing the study, an incentive, and the survey. The cover letter will include information for participants to opt-out if they desire. Patients will be asked to complete the survey and return it back to study staff. Patients will also be able to complete the survey online via a RedCap link. Consent is implied with return of the completed survey. Staff will make up to three reminder phone calls and will send a reminder packet to non responders.

The study staff will invite 300 patients and expect to receive about 195 completed surveys.

Analyses will first examine whether there are differences between responders and non responders. Then, the analysis will examine descriptive statistics exploring patients' interest in colon cancer screening, strength of preference for switching to stool based testing or postponing colonoscopy for a year. The analyses will explore patients' perspective towards colonoscopy in the coming months and factors associated with positive or negative perceptions of colonoscopy such as anxiety, cancer worry, COVID worry and risk perceptions. The relationships between these factors will be examined using chi-square analysis (for categorical data) and correlations (for continuous data). Models will be used to explore factors associated with different preferences for screening.

Patients' Preferences About Rescheduling Colonoscopies Delayed Due to COVID-19: Cross Sectional Study

To promote research replicability, transparency and future use of the data, de-identified data sets of the patient survey data will be created and will be available, by request, to outside researchers.

After the main manuscripts have been published, de-identified data sets will also be deposited in an open access service such as, ICPSR (https://www.icpsr.umich.edu/icpsrweb/). Before a dataset is made available for access, ICPSR completes a detailed review of all datasets to assess disclosure risk. If necessary, ICPSR modifies data to reduce disclosure risk or limits access to datasets for which modifying the data would substantially limit their utility or the risk of disclosure remains high. No information that contains identifiers or that could be used to link an individual to the data will be included in the de-identified data set.

Item with 5-point response assessing whether COVID-19 has increased, decreased or not changed interest in colon cancer screening

Item with 5-point response (definitely want to definitely do not want) measuring interest in having a stool test for colon cancer

Item with 5-point response (definitely want to definitely do not want) measuring interest in postponing colonoscopy for one year

Item with 5 point response (extremely worried to not at all worried) assessing worry about the delay of the colonoscopy on their colon cancer risk

Item with 5-point response (very high to very low) assessing patients' perception about risk of getting COVID-19 from having a colonoscopy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effectiveness of Mindfulness on Chronic Pain in Breast Cancer Survivors	NCT01674881	Breast Cancer Chronic Pain	Mindfulness-Bas... Waitlist	18 Years -	University of Aarhus
Acceptance and Commitment Therapy for Caregivers of Children With a RASopathy: An Internal Pilot Feasibility Study and Follow-up Randomized Controlled Trial	NCT05361811	Neurofibromatos... Noonan Syndrome Legius Syndrome Cardiofaciocuta... Costello Syndro...	Waitlist ACT Interventio...	18 Years -	National Institutes of Health Clinical Center (CC)
Acceptance and Commitment Therapy for Caregivers of Children With a RASopathy: An Internal Pilot Feasibility Study and Follow-up Randomized Controlled Trial	NCT05361811	Neurofibromatos... Noonan Syndrome Legius Syndrome Cardiofaciocuta... Costello Syndro...	Waitlist ACT Interventio...	18 Years -	National Institutes of Health Clinical Center (CC)
Patients' Preferences About Rescheduling Colonoscopies Delayed Due to COVID-19: Cross Sectional Study	NCT04432870	Colon Cancer		45 Years - 75 Years	Massachusetts General Hospital
The Effectiveness of Mindfulness on Chronic Pain in Breast Cancer Survivors	NCT01674881	Breast Cancer Chronic Pain	Mindfulness-Bas... Waitlist	18 Years -	University of Aarhus

Spots Global Cancer Trial Database for waitlist

Every month we try and update this database with for waitlist cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for waitlist

Every month we try and update this database with for waitlist cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for waitlist cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.