Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Lung Neoplasms

Pain

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

A pilot study to observe satisfaction of analgesia with intercostal catheters after VATS lobectomy.

Pain and satisfaction with pain treatment is investigated in a population after VATS lobectomy.

Inter Costal Catheters for Video-Assisted Thoroscopic (VATS) Lobectomy

Pain Relief After VATS Lobectomy Using Interoperatively Placed Inter Costal Catheters.

Daily presence of, Nausea Dizziness Vomiting Sedation Pruritus

Dept. of thoracic Surgery

Dept. of cardio-thoracic anaesthesia

Dept. Surgical PAthophysiology

all Blegdamsvej 9, 2100-Copenhagen, Denmark

Rigshospitalet, Denmark

MD Kim Wildgaard

Rare Diseases

Behaviors and Mental Disorders

Small Cell Lung Carcinoma

Carcinoma, Non-Small-Cell Lung

Small Cell Lung Cancer

Quality of Life

Individuals who have been diagnosed with lung cancer. Individuals with all stages of lung cancer and individuals who have reached no evidence of disease (NED).

Family and friends who provide care for someone who has been diagnosed with lung cancer

There are no interventions in this study. All participants complete online surveys.

Tracey Grant, MS

Bellinda King-Kallimanis, PhD

Upal Basu Roy, PhD, MPH

LUNGevity Foundation, a non-profit lung cancer organization, wants to learn about living with lung cancer from the point of view of people with lung cancer and their family and friends who provide care. To do this, we have an online study designed to better understand how treatments people living with lung cancer receive impact their quality of life. Participants will complete surveys once a month for 12 months.

What does participation involve?

1. Emailing the study team to learn more and get access to the study website.
2. Once a month for 12 months you will receive a survey by email.
3. Complete these surveys on a smartphone, tablet, or computer at your convenience and receive an e-gift card for your time.

PEER is an international study, that is Institutional Review Board (IRB) approved and General Data Protection Regulation (GDPR) compliant.

The study objective is to collect longitudinal data to facilitate a rigorous understanding of the diagnostic and treatment experiences of people diagnosed with lung cancer and to identify determinants of treatment heterogeneity. Study data will be used to understand the diagnostic and treatment pathways, explore patient-experience data in different domains (financial impact/quality of life/symptoms) and test the hypothesis that different classes of therapies (chemotherapy/ immunotherapy/ targeted therapy/ surgery/ radiation) impact patient experience (eg., physical function).

Study participants will consent and register for the study and complete an initial baseline survey. They will then be followed for 12 months and receive a monthly survey (11 surveys in total) via email. The development of the surveys was guided by input from patients, clinicians, FDA experts, and incorporates questions from existing patient-reported outcomes (PRO) measures.

Summarized study results will also be posted on LUNGevity's website. External researchers will be able to apply to have limited access to de-identified data.

Project PEER: Understanding the Lung Cancer Patient ExperiEnce in the Real-World Setting

Exploratory descriptive analyses to understand the concerns participants who enrolled in 2020 and 2021 experienced with respect to their treatment and COVID-19

Patient-reported treatments will be explored in relation to other clinical data provided (e.g., biomarker presence) and the National Comprehensive Cancer Network (NCCN) guidelines for those clinical characteristics at the time of treatment.

Patterns based on disease staging and treatment class will be explored using the European Organisation for Research and Treatment of Cancer Quality of Life 30-item questionnaire (EORTC QLQ-C30), the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ), and a side effect questionnaire to explore these patient-reported outcomes.

Scores for the EORTC QLQ-C30 are transformed so that for each subscale the range is 0-100. For functioning subscales, higher scores indicate better functioning, and for symptoms higher scores indicate more symptom burden. Scores for the NSCLC-SAQ range from 0-20, with higher scores indicating more severe symptomology.

Test whether different classes of therapies (e.g., chemotherapy/ immunotherapy/ targeted therapy/ surgery/ radiation) impact patient experience (e.g., side effects, functioning). Both within and between patient experiences will be investigated. Results from Project PEER will be compared currently existing clinical trial data.

Amgen

AstraZeneca

Blueprint Medicines Corporation

Boehringer Ingelheim

Bristol-Myers Squibb

Eli Lilly and Company

G1 Therapeutics, Inc.

Genentech, Inc.

Janssen, LP

Jazz Pharmaceuticals

Merck Sharp & Dohme LLC

Novartis

Takeda

LUNGevity Foundation

Anxiety Disorders

Depressive Disorder

Depression

Patients in the intervention group receiving the 8 weeks MSC intervention sessions.

No interventions except conventional care were performed for the control group.

Patients in the intervention group had access to conventional care, in addition to receiving the 8 weeks MSC intervention sessions. The intervention was provided by trained nurses, including one researcher and one MSC therapist. The intervention is mainly out-of-hospital intervention, supplemented by short-term in-hospital intervention. Among them, the first and second weeks of the intervention project in the hospital phase focus on guiding the research subjects to understand the content of mindful self-compassion and emotions, and carry out basic mindful self-compassion training; the content of the 3-8th week of the intervention program outside the hospital, Focus on the maintenance of mindful self-compassion training and the promotion of mindful life. Each face-to-face group contact lasted about 1 hour, depending on the complexity of the patients' problems.

MSC intervention

The incidence and mortality of lung cancer ranks first among cancers in the world, and the five-year survival rate of lung cancer patients is only 15% to 30%. Lung cancer patients bear a great psychological pressure, prone to anger, isolation, anxiety, depression, self-esteem and other psychological problems. The incidence of psychological disorders in lung cancer patients was 24.2 to 73.4%. A diagnosis of cancer not only causes physical and mental pain to the patient, but also has a huge impact on the family and their caregivers. As patients'primary coping resources, caregivers have to bear both physical and mental pressures. Therefore, it is worth to attention the mental health of lung cancer patients and their caregivers.

With the further deepening of self-concept research and the integration of Buddhist thought and psychology, the new concept of 'self-compassion' was proposed and developed. Self-compassion means that individuals treat themselves like their friends, with a friendly and tolerant attitude; maintains an objective and rational attitude towards the individual's own situation at all times; thinks that pain is a common experience shared by others, and everyone should be understood and sympathized. At the same time, self-compassion not only includes acceptance and affirmation of oneself, but also connects oneself with others, advocating that one should sympathize with oneself as sympathizing with others, providing the possibility of emotional connection between patients and their caregivers. Therefore, the study of mindfulness and self-compassion is expected to provide a reference for improving the dyadic mental health of lung cancer patient-caregiver dyads in China.

Mindfulness Self-Compassion (MSC) is a positive psychology intervention method that covers the concept of self-compassion developed by Neff and Germer on the basis of Mindfulness-based Stress Reduction. MSC is a 2.5-hour weekly, 8-week standardized training course. Some studies have shown that MSC can promote the emotional health of cancer patients and buffer their mental symptoms.

To sum up, the current mindfulness self-compassion training program has been applied to some cancer patients, and shows that the intervention has a positive effect, while the research in China has only been initially applied in the student population, and has not been applied in the field of cancer. Therefore, for lung cancer patient-caregiver dyad, the researchers can learn from the experience of mindfulness self-compassion training and develop a dyadic mental health intervention program based on Chinese condition. The current study aims to verify the effect of the dyadic mindfulness self-compassion intervention program for lung cancer patients and their caregivers, and explore its mechanism.

The study was a single blind, follow-up, randomized, controlled trial. Researchers recruited subjects from two general tertiary hospitals in Changsha, Hunan province, China. And the whole trail was on the basis of the CONSORT statements. The two hospitals provided similar conventional care for lung cancer patients. Study procedures were approved by the institutional review boards of all participating centers before data collection began. All patients were screened by researchers for eligibility and then enrolled in the study if eligible and if the provided consent.

Potential eligible participants were identified by researchers according to medical records at the colorectal surgery unit in each hospital. The participants were recruited with informed consent, and researchers explained the study purposes, procedures, benefits, and risks involved orally. The participants were then randomly allocated to the intervention or the control group according to a computer-generated block randomization list. A sequentially numbered and opaque , sealed envelope system was used by a non-investigator. The generated random numbers were put into consecutively numbered and opaque sealed envelopes. When enrolling and randomising a new participant, the enrolling investigators opened the sealed envelope after participant's name was written on next available envelopes; the enrolling investigators were blinded to the trial design and study hypotheses.

The researcher will recruit 74 lung cancer patient-caregiver dyads and randomly divide them into 2 groups: the control group, the dyadic intervention group. Among them, patients in the control group and caregivers received routine psychological care programs; patients in the intervention group had access to conventional care, in addition to receiving the 8-week dyadic MSC intervention sessions. The intervention was provided by trained nurses, including one researcher and one MSC therapist. The researcher was regarded as primary leader of the intervention sessions. The leader informed patients of the schedule for each session using the educational manual'Caring for ourselves, we are together' (developed by psychologists, nursing managers, experienced MSC therapist, oncology Nurse, and researchers).

The MSC techniques include body scanning, breathing meditation, sitting meditation, walking meditation, loving-kindness practice, and self-compassion writing expression. Intensive training once a week, 1 hour each time, encourage students to use 15-20 minutes a day to learn these skills, the total training time per week is 2.5 hours. The intervention is mainly out-of-hospital intervention, supplemented by short-term in-hospital intervention (1-2 weeks, adjusted according to the patient's hospital stay). The in-hospital stage focuses on guiding the research subjects to understand the content of mindful self-compassion and emotions, and conduct basic mindful self-compassion training; the outside of the hospital focuses on the maintenance of mindful self-compassion training and the promotion of mindful life.

Data were collected by a research assistant who was blind to the study design and allocation of participants. At baseline, before randomization, sociodemographic and clinical characteristics were collected from medical records and personal interviews. The two groups of participants completed surveys after each follow-up via face to face interviews at baseline (T0) and immediately after intervention (T1). The next two evaluations were performed at 1-month (T2) and 3-months (T3) after intervention via telephone contact.

Patients in the intervention group had access to conventional care, in addition to receiving the follow-up MSC intervention sessions. The intervention was provided by trained nurses, including one researcher and one MSC therapist. The researcher was regarded as primary leader of the intervention sessions. The leader informed patients of the schedule for each session using the educational manual 'Caring for ourselves, we are together' (developed by psychologists, nursing managers, experienced oncology nurses, and researchers).

No interventions were performed for the control group participants during the study. However, these patients received conventional care in the oncology departments according to the two hospitals' similar nursing guidelines.

Potential eligible participants were identified by researchers according to medical records at the oncology departments in each hospital. They were recruited with informed consent, and researchers explained the study purposes, procedures, benefits, and risks involved orally. The participants were then randomly allocated to the intervention or the control group according to a computer-generated block randomization list. The generated random numbers were put into consecutively numbered and opaque sealed envelopes. When enrolling and randomising a new participant, the enrolling investigators opened the sealed envelope after participant's name was written on next available envelopes. A sequentially numbered and opaque , sealed envelope system was used by a non-investigator. Additionally, all data collection was conducted by another research assistant who was blind to the study design and allocation of participants.

Effects of MSC Intervention on the Dyadic Mental Health of Lung Cancer Patients and Their Caregivers

Effects of Mindfulness Self-Compassion Intervention on the Dyadic Mental Health of Lung Cancer Patients and Their Caregivers: a Randomized Controlled Trial

The process of data collection cost a lot of human and material resources, some of the data was privacy information of participants, and so on. Considering this, it is improper to share these data.

Patient Health Questionnaire 2-item Depression Screen (PHQ-2) is used to initially screen the high-risk groups of depression. The score of each item ranges from "0 means no at all" to "3 points means almost every day". The total score is equal to the sum of the items is 6 points, and 3 points or more can be considered as depressed. . PHQ-2 has good reliability and validity in the screening of depression in patients with cardiovascular diseases. Cronbach's α coefficient is 0.809, and the test-retest reliability coefficient is 0.882.

Generalized Anxiety Disorder-7 (GAD-7) is used to screen for Generalized Anxiety. There are 7 items in total. It is scored from 0 (never) to 3 (almost every day). , The higher the score, the more serious the anxiety. According to Spitzer's assessment of GAD-7 scale, 5 is divided into the cut-off value of symptom-positive samples.

The Self-compassion Scale has good adaptability in both healthy people and patients with chronic diseases. The scale contains 6 subscales of self-tolerance, self-criticism, universal humanity, loneliness, mindfulness and over-identification, with a total of 26 items. Each item uses a Likert 5-level score, ranging from "never" to "always". The score is 1 to 5, and the total score is 26 to 130. The three dimensions of self-criticism, loneliness, and over-identification use the reverse scoring method. The Cronbach coefficient of the scale is 0.84, and the test-retest reliability is 0.89.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Inter Costal Catheters for Video-Assisted Thoroscopic (VATS) Lobectomy	NCT01213654	Lung Cancer Pat...		18 Years -	Rigshospitalet, Denmark
Project PEER: Understanding the Lung Cancer Patient ExperiEnce in the Real-World Setting	NCT05826756	Lung Cancer Pat... Caregivers	There are no in...	18 Years -	LUNGevity Foundation
Effects of MSC Intervention on the Dyadic Mental Health of Lung Cancer Patients and Their Caregivers	NCT04795700	Depression, Anx...	MSC interventio...	18 Years -	Central South University
Inter Costal Catheters for Video-Assisted Thoroscopic (VATS) Lobectomy	NCT01213654	Lung Cancer Pat...		18 Years -	Rigshospitalet, Denmark

Spots Global Cancer Trial Database for lung cancer patients