Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

20 in-person or phone qualitative interviews with patients.

four qualitative focus groups of 6-10 women each.

physician qualitative interviews over the telephone.

50 women who will be surveyed before and after their surgical consult

50 women who will be surveyed before and after their surgical consult and will also be sent a web-based decision aid

qualitative data collection

survey

web-based decision aid post-surgical consult

decision aid

Shoshana Rosenberg, ScD

The overall goal of this study is to qualitatively assess the surgical decision-making process from both the patient and physician perspective

1. Conduct short in-person interviews with young women prior to surgery
2. Conduct focus groups with breast cancer survivors about their surgical decision and experience
3. Interview surgical oncologists, plastic surgeons, medical and radiation oncologists about their experiences and how they communicate with breast cancer patients about local therapy decisions
4. To survey women about surgical decision-making prior to and after their consult in conjunction with pilot testing of a web-based decision aid to support high quality surgical decision-making in newly diagnosed young women with breast cancer.

Breast cancer in young women: Breast cancer is the most common cancer diagnosed in women younger than age 40 in the United States, with approximately 14,000 new cases each year. Young women face unique psychosocial challenges, most notably fertility, sexuality, and image concerns and are at a life stage where education, career, and family are important priorities. Concern about these issues may contribute to the greater psychosocial distress seen in younger women at both diagnosis and in follow-up compared with older women. Importantly, these concerns may also influence treatment decisions including receipt of chemotherapy, adherence to endocrine therapy, and surgical decisions. Thus, attending to the unique issues of young women may enhance not only quality of care and quality of life (QOL) but also potentially disease outcomes.

Surgical management of breast cancer: Standard loco-regional management of breast cancer entails partial mastectomy (i.e., breast conserving surgery) followed by radiation or mastectomy with or without radiation. The decision depends on a number of factors including extent of disease, family history, BRCA mutation status, and personal preference. In recent years, an increasing number of women have elected to undergo contralateral prophylactic mastectomy (CPM) in conjunction with surgery of the affected breast (usually choosing bilateral mastectomy), despite a lack of clear evidence for survival benefit from this procedure in the vast majority of women. In weighing the benefits and risks of CPM, one must consider the absolute risk reduction of a new primary breast cancer (usually relatively modest in the average risk survivor), the long and short-term risks of this additional surgery including potential complications (bilateral mastectomy is associated with a greater risk of surgical complications) and the impact on QOL. At the same time, one must consider the competing risk of systemic recurrence of a woman's initial breast cancer. Young women, in particular, have the greatest risk of systemic recurrence and death from their original cancer, lowering the likelihood of benefit of CPM in preventing a new primary breast cancer. However, while CPM rates have increased among all breast cancer patients, increased rates of CPM are particularly pronounced among the youngest women with breast cancer, with several studies identifying young age at diagnosis as one of the strongest determinants of CPM.Physicians and researchers have been observing and discussing this trend for a number of years and yet little has been done to intervene.

The goal of the proposed research is to better understand and improve the surgical decision process in young women with breast cancer. Using qualitative research methods, we will comprehensively assess patient experiences - both patients who have had CPM and patients who did not - as well as physician perspectives regarding this decision. Based on these findings, the investigators will determine how to best improve the quality of the process, e.g., by correcting misperceptions, setting realistic expectations regarding the impact of surgery (including reconstruction) on QOL, improving communication with health care providers, and better management of anxiety surrounding diagnosis. This qualitative research is designed to build on prior quantitative analyses, by gaining an in depth perspective through focus groups and interviews, about certain issues identified as impacting the surgical decision process, including anxiety, fear of recurrence, and patient-physician communication.

Collectively, results from the qualitative assessment will inform a future phase of this research involving the design and subsequent development of a decision aid to help women make informed decisions about their breast cancer surgery.

The goal of this second phase of the research is to survey women about surgical decision-making prior to and after their consult in conjunction with pilot testing of a web-based decision aid to support high quality surgical decision-making in newly diagnosed young women with breast cancer.

Improving Surgical Decision-making in Young Women With Breast Cancer

The goal of the proposed research is to better understand and improve the surgical decision process in young women with breast cancer. Using qualitative research methods, we will comprehensively assess patient experiences - both patients who have had CPM and patients who did not - as well as physician perspectives regarding this decision.

Knowledge will be assessed using selected questions from the Breast Cancer Surgery Decision Quality Instrument (BCS-DQI), an instrument designed to evaluate the quality of breast cancer treatment decisions as well as additional true/false questions related to side effects of radiation.

Decisional conflict will be measured with the SURE scale. The SURE scale is composed of four items from the Decisional Conflict Scale that measure patients' uncertainty about which treatment choice and factors contributing to uncertainty.

Anxiety will be assessed using the PROMIS Emotional Distress - Anxiety - Short Form.

have been adapted from the BCS-DQI. We will ask women to mark on a scale (not important - very important) the importance of several reasons in relation to their decision about surgery as well as concerns (not all concerned-very concerned) about local therapy.

Perception of the decision process will be assessed with an adapted version of the Control Preferences Scale.

Assessment of what patients did and did not like about the DA, ways they think the DA can be improved, and how they felt the DA affected communication with their physician.

National Institutes of Health (NIH)

Agency for Healthcare Research and Quality (AHRQ)

Dana-Farber Cancer Institute

Principal Investigator

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

About 3 weeks after the index LDCT, the study Medical Assistant (MA) will deliver a link to the Patient Voices Video, an educational video about lung cancer screening.

Prior to patient's next LDCT scan is due, MA begins Stepped Reminders intervention:

MA pends LDCT orders to PCP to sign. MA sends reminders to patient when order is placed and follows up by phone if patient has not scheduled LDCT.

See above. Those assigned to the Patient Video and Stepped Reminders will receive both interventions, as described above.

Those assigned to the the Usual Care arm will continue to receive usual lung cancer screening care.

Stepped Reminders, which directly reminds providers to order the next LDCT scan and then reminds patients they are due and prompts them to schedule LDCT with Radiology.

Stepped Reminders

The Patient Voices Video is an educational video about lung cancer screening.

Patient Education

Karen Wernli, PhD

Screening for lung cancer has the potential for a profound public health benefit. Repeat annual screening is necessary for early detection of lung cancer. The investigators will test two interventions which include patient education and reminders to improve adherence to lung cancer screening.

Screening for lung cancer has the potential for a profound public health benefit.

Successful population-based screening requires continuous monitoring to adherence repeat screening in high risk adults to achieve similar results. Repeat annual screening is necessary for early detection of lung cancer. Baseline or first LDCT scans detect prevalent lung cancer, when subsequent screening detects new nodules. However, adherence to screening is low, ranging at 28-38% from centers nationally.

The investigators developed two novel, patient-centered interventions to address patient education and offering reminders for on-time screening. To address these goals, the specific aims are to: 1) Compare effectiveness of two multilevel interventions relative to usual care in improving (a) rates of adherence to lung cancer screening, (b) patient-centered outcomes; and (c) clinic outcomes; and 2) Determine the patient-, clinician-, and system-level factors that influence changes in adherence to inform lung cancer screening programs.

Multilevel Interventions to Increase Adherence to Lung Cancer Screening

Electronic health records will be searched for screening low dose CT (LDCT).

Knowledge of lung cancer screening eligibility, time to return and cost on patient reported outcomes survey.

The Lung Cancer Screening Health Belief Scales: 1) perceived risk of lung cancer (3 items); 2) perceived benefits of lung cancer screening (6 items); (3) perceived barriers to lung cancer screening (17 items); and (4) self-efficacy for lung cancer screening (9 items).

Fred Hutchinson Cancer Center

Hackensack Meridian Health

Kaiser Permanente

Behaviors and Mental Disorders

Quality of Life

Individuals referred for a lung resection via thoracotomy with a primary or secondary diagnosis of lung cancer. Those with a tumor \>7cm will be excluded.

Individuals referred for a lung resection via robotic-assisted thoracic surgery with a primary or secondary diagnosis of lung cancer. Those with a tumor \>7cm will be excluded.

Thoracotomy

Robotic-assisted thoracic surgery

Samantha Harrison

Background Surgery for lung cancer can be performed using open (thoracotomy) or minimally invasive techniques (Video Assisted Thoracic Surgery (VATS)). Despite being associated with fewer postoperative complications (PPCs) VATS is difficult to perform and is only used by 20-44% of thoracic surgeons in the UK. Robotic-Assisted Thoracic Surgery (RATS) maybe a more attractive minimally invasive approach. To date, no studies have explored the impact of RATS on exercise capacity or physical activity and although 1 study has looked at Heath Related Quality of Life (HRQOL) post-RATS compared to an open technique indicators of surgical technique were not controlled for. Furthermore, investigators have little understanding of patients' experience of RATS.

Aims

1. To examine the variability of change in exercise capacity and health-related quality of life (HRQOL) between those who receive thoracotomy V RATS.
2. To compare the difference in post-operative physical activity (step and activity count), across 7 days, in those who receive thoracotomy V RATS.
3. To explore the manner in which patients appraise their experience of undergoing RATS.

Methods:

A mixed-method, multi-center study will be undertaken, utilizing a prospective quasi-experimental study design and an interpretive phenomenological approach. 80 individuals, referred for a lung lobectomy with a primary or secondary diagnosis of lung cancer, will complete outcomes assessed at 4 time-points. The Incremental Shuttle Walk Test (ISWT) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30) and the EORTC Lung Cancer module (EORTC QLQ LC13) will be completed at: baseline, 3-6 days post surgery, 6-weeks post-surgery and at 3-month follow up. Patients will wear an activity monitor immediately post-surgery until 1-week post-discharge. Step and activity counts will be recorded. In-depth interviews will be conducted with up to 15 patients who underwent RATS to explore the manner in which patients appraise their experience of RATS.

Lung cancer is the second most common cause of cancer in the UK and the most common cause of cancer death. Surgery is currently the most effective treatment for curing lung cancer and it can be performed using open (thoracotomy) or minimally invasive techniques (Video Assisted Thoracic Surgery (VATS)). Despite VATS being associated with fewer postoperative complications (PPCs), faster recovery and better survival at 4 years compared to thoracotomy it is only used by 20-44% of thoracic surgeons in the UK and just 5% of surgeons in Europe report using minimally invasive techniques for lung resection. Rigid, restrictive instruments and suboptimal vision means a steep learning curve is necessary to conduct VATS successfully. RATS maybe a more attractive minimally invasive approach as it offers 3DHD vision, a 360 degree view of the chest, and a fully articulated arm. JCUH and the Barts Hospital are two of the few centers in the UK performing RATS.

Research on RATS has been largely limited to single retrospective case series reports focusing on safety (PPCs and mortality) and cost effectiveness outcomes. Little research has been conducted exploring the effect of RATS on patient-centered outcomes that are also important quality measures.

To date, no studies have explored the impact of RATS on exercise capacity, yet investigators know that individuals who undergo a thoracotomy have a 16% reduction in exercise capacity at 6 months follow up. Exercise capacity has been shown to be an important predictor for long-term prognosis and length of stay following thoracic surgery, which can have substantial implications for cost. Furthermore, percentage VO2 max has been shown to be the best predictor of PPCs within 30 days of undergoing a lung resection (predictive value 85.5%), which is an important indicator of patient safety.

Two studies have looked at HRQOL post-RATS and compared it to an open technique. Balduyck and colleagues reported that whilst significant reductions from baseline were seen 1 month post-surgery in those who underwent an open procedure (sternotomy), HRQOL had returned to baseline values by 1 month post-surgery in those who underwent RATS. However, indicators of whether individuals received RATS or an open procedure were not controlled for which is likely to be important as individuals who have large tumors are not eligible to receive RATS. Instead RATS is usually assigned to older, frailer individuals. The second study did conduct between-groups comparisons between those who underwent a robotic lobectomy V those who received an open rib and nerve sparing lobectomy. The mental-component of the SF-12 was significantly higher in the robot group at 3 weeks post-surgery, indicating better mental quality of life, although there were no significant between-group differences detected for the physical-component. By 4 months follow up neither the mental nor the physical HRQOL scores differed between the two groups. The SF-12 in a general measure of health status and to date the impact of open surgery V RATS on disease-specific HRQOL has not been explored.

Physical activity is associated with improved HRQOL in patients with lung cancer and increased survival post-diagnosis of cancer. However, 2 months following a lung resection, performed via a thoracotomy or VATS, physical activity levels were still reduced. Unfortunately comparisons between surgical groups were not possible in this study due to the small number of patients who underwent VATS (14), therefore postoperative physical activity in those who have undergone thoracotomy compared to minimally invasive surgery is still unknown.

Clinical Commissioning Group (CCG) outcome indicator set 2015/16 includes enhancing quality of life and ensuring patients have a positive experience of care (NHS England, 2015). To date, no qualitative research exploring the patients' experience of RATS has been conducted and investigators have little understanding of patients' experience of thoracic surgery in general. Interestingly, a very recent study exploring preoperative nurses work experience with robotics found that feelings of uncertainty and concerns about safety were common due to a lack of education about the robot system. It is likely, these feelings of unease are translated to patients during their preoperative consultation leading to heightened anxiety. Furthermore, if nurses do not feel they have sufficient information about the robot system they are unlikely to be educating patients fully about their procedure. A study exploring the appraisals of patients' experience of RATS is important to identify ways in which both pre and postoperative care can be improved.

It would seem literature is scare exploring the impact of RATS on outcomes that are likely to be meaningful to patients. Therefore the overall aim of this study is to examine the impact of RATS compared to thoracotomy on patient-centered outcomes and to explore the individuals' experience of undergoing RATS.

Research strategy

Study design

A mixed-method, multi-center study will be undertaken, utilizing a prospective quasi-experimental study design and an interpretive phenomenological approach.

Inclusion/exclusion criteria

Individuals referred for a lung resection with a primary or secondary diagnosis of lung cancer will be eligible, although those with a tumor \>7cm will be excluded. Individuals referred for a lung resection via thoracotomy will be recruited from James Cook University Hospital (JCUH), Middlesbrough and those referred for RATS will be recruited from JCUH or St Bartholomew's hospital, London (Barts).

Recruitment

Once a referral for a lung resection via thoracotomy or RATS is received a cover letter and information sheet, containing details of the study, will be mailed to patients along with their clinic appointment letter. Interested patients will be encouraged to contact a member of the research team, by telephone or email, to discuss the study in more detail. When patients attend their preoperative clinic a member of the clinical team will request permission for a member of the research team to approach them about participation in the study. If individuals would like to participate in the study informed consent will be obtained.

Surgical care

Prior to surgery all patients receive standard physiotherapy consisting of breathing exercises and advice on activities postoperatively.

Three cardiothoracic surgeons, 2 at JCUH and 1 at Barts, will perform lung resections.

Consistent with usual care at JCUH and Barts all individuals will be transferred to sitting at the bedside as soon as possible post-surgery and will be required to walk 150m before being discharged home. At JCUH patients are also required to complete a flight of stairs and cycle for five minutes (with no resistance).

Data collection

Demographic and anthropometric information will be collected at baseline at the preoperative clinic visit including; age, sex, BMI, lung function (forced expiratory volume in one second (FEV1) and forced vital capacity (FVC)), smoking history, comorbidities, cancer stage and grade. Details of the operation (i.e. technique, time, surgeon, post-operative pain management) will be documented. Length of stay, readmissions and PPCs will be recorded at 3 months follow-up. The same criteria will be used to define a PPC as applied by Brocki et al. PPCs will be classified as minor (a score of 1), medium (a score of two) or severe (a score of three). A PPC will be defined as clinically relevant if two or more items are graded as a minor complication (score of 1) or one item is graded as a medium or severe complication (scores ≥2).

Quantitative phase

Outcomes will be assessed at 4 time-points; at baseline in the preoperative clinic (1 day to 2 weeks prior to surgery), day 3 post-surgery, at the follow up postoperative clinic visit (within 6 weeks post-surgery) and at an additional hospital visit which will take place at 3 months. The time taken to complete each assessment will be recorded, we estimate no more than 2 hours will be required to complete the outcome variables (ISWT, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30) and the EORTC Lung Cancer module (EORTC QLQ LC13)). Individuals will also be requested to wear an activity monitor Actigraph G3TX (Actigraph) immediately post-surgery until 1-week post-discharge. Data will be stored on the cardiothoracic database at JCUH or Barts and on an IBM SPSS statistics database at Teesside University.

Qualitative phase

An interpretive phenomenological approach (IPA) will be applied to the collection and analysis of the qualitative data. IPA aims to understand the lived experience of participants in response to a specific event (i.e. undergoing surgery). Analysis examines in detail how an event is experienced and what meaning is ascribed to that event.

An informal interview schedule consisting of open-ended questions will be developed in conjunction with members of the cardiothoracic team. The questions will be developed to stimulate narratives focusing on the experience of undergoing RATS whilst also permitting other topics, important to the individuals, to be discussed.

In-depth interviews will be conducted on up to 15 patients who underwent RATS. The interviews will be conducted at patient's homes one week following hospital discharge (at the same time the activity monitor is collected). Interviews will be largely patient led, allowing individuals to tell their own story in their own words and at their own pace.

Sample Size and Analysis Plan

Quantitative phase

The primary endpoint is exercise capacity measured by the ISWT (m) completed at patients' 6-week postoperative clinic. Based on the minimal clinically important difference (MCID) (48m) for the ISWT (Singh et al 2008), the between-subjects variability in the measure, and the variability in the change scores (the 7-week reliability). A conventional estimation with 90% power and 2 p=0.05 returned a required sample size of 80 patients, 40 per group. This is based on an ANCOVA analysis model, where invetigators look at the differences in the change in ISWT between groups, adjusted for any imbalance between groups in ISWT performance at baseline

Qualitative phase

Analysis will involve conducting a close line-by-line analysis on each original transcript to explore the claims and understandings of the participants. A second researcher will review the original transcripts before the 'emerging themes' are agreed. Once agreed, 2 researchers will transfer the 'emerging themes' across the entire data set, thereafter referring to them as 'master themes' The final master themes will be presented to a third researcher and agreed. Thematic mapping will be used to develop the relationship between themes. Finally, the findings will be translated into a narrative account with verbatim extracts (quotes) to provide a means of validation.

Exploring Robotic-assisted Thoracic Surgery for Lung Cancer

Exploring Robotic-assisted Thoracic Surgery for Lung Cancer: Does Robotic-assisted Thoracic Surgery Result in Improved Functional Outcomes Compared to Thoracotomy and How do Patients Appraise the Experience of Undergoing RATS

Number of times readmitted to hospital following discharge

Based on criteria applied by Brocki et al. Classified as minor, medium or severe

Actigraph G3TX. Activity counts will be recorded.

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30)

European Organization for Reseach and Treatment of Cancer Quality of Life - Lung Cancer module (EORTC QLQ LC13)

South Tees Hospitals NHS Foundation Trust

Barts & The London NHS Trust

Teesside University

Reader in research

Rare Diseases

Oculocerebral Syndrome With Hypopigmentation

It will include subjects with Refractory Diffuse Large B-cell Lymphoma and Multiple Myeloma, Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) and/or who participated in a CAR-T clinical trial or autologous treatment. Subjects will undergo a telephonic interview for up to 90 minutes.

It will Include subjects with NSCLC on second or later-line therapy or soft-tissue sarcoma on second or later line therapy. Subjects will undergo a telephonic interview for up to 90 minutes.

It will include oncologists using TCR therapies, CAR-T or participating in CAR-T or TCR therapy clinical trials. Oncologists will undergo a telephonic interview for up to 60 minutes.

It will include oncologists from community clinics who evaluate, prescribe, treat, and actively interact with subjects with NSCLC or soft tissue sarcoma, who have used immuno-oncology (IO) therapies. Oncologists will undergo a telephonic interview for up to 60 minutes.

Subjects with cancer and Oncologists will undergo a semi-structured one-to-one telephonic interview for up to 90 and 60 minutes respectively.

Telephonic interview

GSK Clinical Trials

Gene and cell therapies have a real value potential (example: potential long-term effect, curative potential, and single administration) but also drawbacks (example: treatment perceived as complex and risky generating fear and anxiety in subjects and their family; high cost) that require significant educational efforts and planning for optimal market access. It is therefore important to understand subject and physician perceptions of T-Cell Receptor (TCR) therapies. The aim of this study is to collect qualitative data from a small but diverse sample of oncologists and subjects in the United States to gather qualitative evidence for a preliminary understanding about their perceptions of T-cell therapies in the treatment of cancer. This cross-sectional study will involve up to 20 adult subjects with cancer and up to 20 oncologists/hematologist-oncologists in the United States. Eligible subjects will be scheduled for a telephone interview lasting approximately 60-90 minutes. Eligible oncologists will be scheduled for a telephone interview lasting approximately 60 minutes.

Searching social media is another way of understanding the perceptions of prescribers and consumers of CGT, in addition to interviews being conducted under the original protocol. The results of a feasibility assessment suggested that it would be helpful to explore social media to add to the findings from the interviews. This social media study(SMS) is being conducted as a pilot study to hone methods for future explorations of social media. The pilot study will investigate and describe initial themes emerging from existing discussions related to CGT. Findings from this work will help GlaxoSmithKline to plan future work in the social media landscape.

Perceptions of Cell and Gene Therapies (CGT) for the Treatment of Cancer

Understanding Patients and Prescriber Perceptions of Cell and Gene Therapy (CGT) in Oncology

Telephonic interview will be conducted to assess preliminary understanding about subjects perceptions of CGT, especially TCR and CAR T-Cell therapies in the treatment of cancer.

Telephonic interview will be conducted to assess preliminary understanding about physicians perceptions of CGT, especially TCR and CAR T-Cell therapies in the treatment of cancer.

GlaxoSmithKline

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Patients at St. Jude Children's Research Hospital between the ages of 7 and 11 years who have a working diagnosis or initial diagnosis of a bone or soft tissue sarcoma.

Interventions: two unstructured life-story interview sessions, observations, and guided activities.

Each participant will complete two interview sessions with the primary investigator. Each interview will be conducted in a private, quiet room. Parents may choose to remain with the child during the interview if they would like, but only the responses of the child will be analyzed. Each interview session will last no more than one hour; if the child is not able to respond to each of the primary interview questions during this time, a second follow-up session will be scheduled so that the remainder of the questions can be answered. All interviews will be audio-recorded and transcribed.

Interview

Observations help to give insights about interpersonal interactions, actions, non-verbal cues, and the activities and function of areas within the hospital. Three kinds of observation will be used: participant observation, non-participant observation, and guided activities. These observations will be conducted to learn more about the hospital environment as it intersects with the learning experiences of the participants.

Observations

This study will use three different types of arts and play-based activities to give participants a variety of ways to express their thoughts and perceptions of what it is like to learn about their cancer diagnosis and treatment.

The first activity will be a guided medical play opportunity that prompts the child to use actual medical equipment while taking care of a doll.

For the second activity, the child will be given a digital camera to use and a prompt that asks them to photograph things and individuals in the hospital that have helped them to learn about their diagnosis and treatment.

The third activity will be an open-ended art prompt in which the child will create an artistic representation of what it means to have cancer and get treatment.

Guided Activities

Jessika Boles, MEd

Thousands of children are diagnosed with cancer each year, many of whom will achieve long term survival due to advances in treatments and technologies. However, when a child is first diagnosed, they are confronted with a wealth of new and unfamiliar medical information that they must integrate in order to understand their diagnosis and treatment plan. Little is yet known about how children with cancer experience learning about their diagnosis and treatment in the hospital setting, or the individuals and materials that may help to facilitate the child's developing understanding. This information could help to identify or guide educational and supportive child life interventions to help children with cancer better understand their illness and its treatment.

This observational study will collect data about how children currently learn about their cancer diagnosis and treatment in the hospital setting. The interventions used do not seek to change the health outcomes of the participants in this study. The observational data collected may serve to improve how future patients learn about their cancer-related diagnosis.

This is a longitudinal qualitative case study, and no randomized interventions will be used. Instead, participants will complete two interview sessions, three guided activities, and observations with the primary investigator to explore their experiences of learning about their diagnosis and treatment in the hospital setting.

PRIMARY OBJECTIVE:

* The primary objective of this qualitative case study is to describe the ways in which children with cancer learn about their cancer diagnosis and treatment in the hospital setting.

A Qualitative Case Study of the Experiences of Children With Cancer as They Learn About Their Diagnosis and Treatment

Data will be collected during individual interviews, guided activity sessions, and observations of participant clinic appointments, inpatient admissions, and other medical events. Because there are no hypotheses to be tested or evaluated, and because this is a qualitative study, no statistical analyses will be used. Instead, coding and categorizing techniques will be used as are common in multiple case study designs. Data analysis in this study will occur constantly and simultaneously alongside data collection and interpretation. Data sources will be analyzed between and within participants using multiple case study analysis. Contextualizing analysis will be used to construct a thematic analysis.

St. Jude Children's Research Hospital

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Stool samples will be tested with the qualitative fecal immunochemical test (qFIT), and will be stratified for colonoscopy as follows:

\>200 ng/dL - colonoscopy with one month 100-200 ng/dL - colonoscopy as per waiting list \<100 ng/dL - no colonoscopy

Cost analysis, anxiety scores and patient satisfaction scores will be calculated for all patients.

Stool samples will be tested with the quantitative fecal immunochemical test (FIT), and will be scheduled for colonoscopy as follows:

Positive - colonoscopy as per waiting list Negative - no colonoscopy

Cost analysis, anxiety scores and patient satisfaction scores will be calculated for all patients.

This test measures the amount of blood within the submitted stool specimen

Qualitative fecal immunochemical test

This test detects presence or absence of blood within a submitted stool specimen.

Quantitative fecal immunochemical test

Patients with positive tests will be subjected to colonoscopy to determine presence or absence of advanced colorectal neoplasms.

Colonoscopy

Data on direct and indirect costs to patient and institution will be collected at each patient visit related to screening.

Cost analysis

Hospital Anxiety and Depression Scale (HADS) questionnaire

Anxiety scores

A 5-point patient satisfaction score will be documented at each patient visit related to screening.

Patient satisfaction scores

April C Roslani, MBBCh

The main aim of this study is to determine whether there is a difference in time to diagnosis of advanced colorectal neoplasms using quantitative Fecal Immunochemical Tests (FIT) to prioritize referral for colonoscopy (intervention) compared to usual care (qualitative FIT and appointment-based referral).

It is hypothesized that quantitative FIT will enable faster detection of advanced neoplasms compared to qualitative FIT.

Quantitative Versus Qualitative Fecal Immunochemical Tests (FIT) to Prioritize Urgency of Colonoscopy Referral

Evaluating the Effectiveness of Screening Strategies Using Quantitative Versus Qualitative Fecal Immunochemical Test (FIT) to Prioritize Urgency of Colonoscopy Referral - a Randomized Controlled Trial Protocol

Measured as number of days from the time of enrolment until histological diagnosis of a colorectal neoplasm

Total costs incurred as a result of the screening process

As measured by the Hospital Anxiety and Depression Scale (HADS)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Improving Surgical Decision-making in Young Women With Breast Cancer	NCT02644382	Breast Cancer	qualitative dat... survey decision aid	18 Years - 80 Years	Dana-Farber Cancer Institute
Multilevel Interventions to Increase Adherence to Lung Cancer Screening	NCT05747443	Lung Cancer Lung Cancer Scr...	Stepped Reminde... Patient Educati...	50 Years - 78 Years	Kaiser Permanente
Exploring Robotic-assisted Thoracic Surgery for Lung Cancer	NCT03658083	Lung Cancer Thoracic Cancer Surgery	Thoracotomy Robotic-assiste...	-	Teesside University
Exploring Robotic-assisted Thoracic Surgery for Lung Cancer	NCT03658083	Lung Cancer Thoracic Cancer Surgery	Thoracotomy Robotic-assiste...	-	Teesside University
Perceptions of Cell and Gene Therapies (CGT) for the Treatment of Cancer	NCT03336567	Neoplasms	Telephonic inte...	18 Years -	GlaxoSmithKline
A Qualitative Case Study of the Experiences of Children With Cancer as They Learn About Their Diagnosis and Treatment	NCT02041689	Sarcoma	Interview Observations Guided Activiti...	7 Years - 11 Years	St. Jude Children's Research Hospital
A Qualitative Case Study of the Experiences of Children With Cancer as They Learn About Their Diagnosis and Treatment	NCT02041689	Sarcoma	Interview Observations Guided Activiti...	7 Years - 11 Years	St. Jude Children's Research Hospital
Quantitative Versus Qualitative Fecal Immunochemical Tests (FIT) to Prioritize Urgency of Colonoscopy Referral	NCT02037646	Colorectal Canc...	Qualitative fec... Quantitative fe... Colonoscopy Cost analysis Anxiety scores Patient satisfa...	50 Years -	University of Malaya

Spots Global Cancer Trial Database for qualitative

Every month we try and update this database with for qualitative 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 qualitative

Every month we try and update this database with for qualitative 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 qualitative 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.