Neoplasms

All Conditions

Infections

Symptoms and General Pathology

Rare Diseases

Cholangiocarcinoma

Opisthorchiasis

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Communicable Diseases

Trematode Infections

Helminthiasis

Parasitic Diseases

Bile Duct Cancer

Participants in this arm will not be given the eCHEC program

Participants in this arm will be given the eCHEC program as their intervention

The eCHEC program is the enhanced Community-based Health Education and Communication (CHEC) model to prevent O. viverrini in an effort to decrease cholangiocarcinoma (CCA) in Khon Kaen, Thailand

eCHEC program

Ricardo Angeles, MD, MPH, MHPEd, PhD

Gina Agarwal, MBBS, PhD

Pattapong Kessomboon, MD, PhD

Liver cancer, specifically cholangiocarcinoma (CCA), is very common in different areas in Thailand. Many factors make this cancer more common, such as liver fluke infection, older age, eating raw fish, family history of cancer, alcohol intake, taking certain medicines (praziquantel), low intake of fresh vegetable, and low education. In 2015, researchers from Khon Kaen University developed the Community-based Health Education and Communication (CHEC) program to prevent liver cancer caused by liver flukes in communities of the Khon Kaen province, Thailand.

The main aim of this 5-year research study is to enhance the CHEC program to prevent liver cancer, and test if it is effective in improving the knowledge and behaviours of community residents regarding how to prevent liver cancer. This study will take place in Khon Kaen, Thailand. Other aims are to:

1. Increase understanding in the community that make it difficult to prevent liver cancer, as well as community characteristics that can help prevent liver cancer;
2. Incorporate the program we develop in healthcare to prevent liver cancer in Thailand.

Evaluating a Community-Based Behaviour Change Communication Model to Prevent Cholangiocarcinoma in Khon Kaen, Thailand

Mean difference in the self-reported frequency of intake of raw fish in the intervention group compared to the control group. Self reported, pre- and post- intervention.

Mean difference in the self-reported frequency of intake of fruits and vegetables in the intervention group compared to the control group. Self reported, pre- and post- intervention.

Difference in the proportion of smoking habits in the intervention group compared to the control group. Self reported, pre- and post- intervention.

Mean difference in the intake of alcoholic beverages in the intervention group compared to the control group. Self reported, pre- and post- intervention.

Difference in the proportion of use of the medication praziquantel (prescribed or self-medicated) in the intervention group compared to the control group. Self reported, pre- and post- intervention.

Difference in the proportion of positive stool test of concentration of O. viverrini, pre- and post-intervention.

Difference in the mean concentration of O. viverrini in the stool test, pre- and post-intervention.

Mean difference in the stages of change for risk behaviours in the intervention group compared to the control group. Self reported, pre- and post- intervention.

Mean difference in knowledge score about in knowledge of preventative measures against CCA in the intervention group compared to the control group. Measured in questions included in the community survey.

Cardiobolic measure linked to developing cancer. Change in the mean body mass index calculated from height and weight (self-reported).

Cardiobolic measure linked to developing cancer. Change in the mean waist circumference (measured with measuring tape)

Cardiobolic measure linked to developing cancer. Change in the mean measured blood pressure (automated, validated device)

Mean difference in health literacy knowledge score in the intervention group compared to the control group. Self reported, pre- and post- intervention

Mean difference in quality of life in the intervention group compared to the control group. Self reported, pre- and post- intervention. Using the EuroQol-5 dimension-5 level (EQ-5D-5L) tool

Khon Kaen University

Global Alliance for Chronic Diseases (GACD)

Canadian Institutes of Health Research (CIHR)

McMaster University

Digestive System Diseases

Behaviors and Mental Disorders

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Quality of Life

In the quality of life pathway results of the quality of life (QoL) measure are transferred to a QoL-profile. Three experts with various professional background use the individual patient's QoL-profile and clinical and sociodemographic information in order to generate a QoL-report including therapy recommendation which is sent to the coordinating practitioner. Specific therapeutic options for the treatment of diseased QoL have been identified: pain therapy, psychotherapy, social support, nutrition counseling, stoma care, physiotherapy, fitness. To provide continuous medical education, quality circles for each therapy option haven been founded. Coordinating practitioners receive a list with addresses of all quality circle members.

In control group QoL is also measured but the coordinating practitioner neither receives a QoL-profile nor a QoL-report.

Quality of life measurement, diagnosis and tailored therapy (pain therapy, psychotherapy, social support, nutrition, stoma care, physiotherapy, fitness)

quality of life pathway

placebo control

Monika Klinkhammer-Schalke, MD, Ass. Prof.

Michael Koller, Ph.D., Prof.

Wilfried Lorenz, MD, Prof. Ɨ

Ferdinand Hofstädter, MD, Prof.

Jeremy C Wyatt, MD, Prof.

The purpose of the study is to determine whether a quality of life pathway with defined diagnostic and therapeutic options improves quality of life in colorectal cancer patients during follow-up.

There is a growing interest in using quality of life (QoL) data not only as relevant endpoint in clinical trials on cancer patients, but also in routine practice in order to improve patients' health during treatment. The investigators designed, implemented and evaluated an integrated quality of life diagnosis and therapy pathway (QoL pathway) for breast cancer patients (Klinkhammer-Schalke et al, 2008; 2012), guided by the UK Medical Research Council framework for developing and testing complex interventions. It could be demonstrated in a routine setting that breast cancer patients showed a benefit from tailored QoL diagnosis and therapy (Klinkhammer-Schalke et al, 2012).

But there is also requirement for managing QoL deficits of patients with other cancers and to replicate findings of the previous trial. To achieve this aim, the QoL pathway has been modified for colorectal cancer patients. The Tumor Center Regensburg provides the infrastructure of the present project (quality circles, project groups).

This is a two-arm randomised clinical trial with one intervention group and one control group. Patients' QoL is assessed with the EORTC QLQ-C30 and QLQ-CR29 at 0, 3, 6, 12, and 18 months after surgery.

In intervention group results of the QoL-measure are transferred to a QoL-profile including 13 dimensions on scales of 0-100 (cutoff for "diseased QoL \<50). Three experts with varying professional background use the individual patient's QoL-profile and clinical and sociodemographic information in order to generate a QoL-report including therapy recommendation which is sent to the coordinating practitioner. Specific therapeutic options for the treatment of diseased QoL have been identified: pain therapy, psychotherapy, social support, nutrition counseling, stoma care, physiotherapy, fitness. To provide continuous medical education, quality circles for each therapy option have been founded. Coordinating practitioners receive a list with addresses of all quality circle members.

In control group QoL is also measured but the coordinating practitioner neither receives a QoL-profile nor a QoL-report.

The investigators expect that patients in the intervention group will experience a lower number of QoL-deficits (QoL \< 50 points) in the first year after surgery compared with patients in the control group

Direct Improvement of Quality of Life Using a Tailored Pathway With Quality of Life Diagnosis and Therapy: Randomised Trial in Colorectal Cancer Patients

Direct Improvement of Quality of Life Using a Tailored Pathway With Quality of Life Diagnosis and Therapy: Protocol of a Randomised Clinical Trial in Colorectal Cancer Patients

German Federal Ministry of Education and Research

Tumor Center Regensburg

PD Dr.med. Monika Klinkhammer-Schalke

This group is composed of health mediators, the people living in informal housing they support and stakeholders. The ECEMSo intervention will be implemented in this group

This group is composed of health mediators, the people living in informal housing they support and stakeholders. The ECEMSo intervention will not be implemented in this group.

This group is composed of health workers, social workers, the people living in informal housing they support and stakeholders. The ECEMSo intervention will be implemented in this group.

The ECEMSo intervention involves knowledge mobilization to facilitate the structuring of health mediation throughout French territory, and the development of a co-designed effective action plan to facilitate cancer screening uptake by people living in informal housing.

The action plan will, consider territorial specificities at the regional level. The ECEMSo project team will organize a seminar and three workshops. The aim of the seminar and workshops is to mobilize knowledge to facilitate i) the structuring of health mediation in the regions, and ii) the development of an action plan with health mediators and other stakeholders to foster organized cancer screenings uptake by underserved people. This action plan must match with the needs of people living in informal housing, and must be coordinated, suitable and feasible to implement, in terms of knowledge about people living in informal housing specificities and specific local collaborations

Knowledge mobilization to facilitate the structuring of health mediation

Judith Martin-Fernandez, PhD

Garance Perret

The investigators are conducting a longitudinal mixed-method intervention study with a multi-center, multi-case explanatory sequential design. The ECEMSo study aims to identify the impact of health mediation on fostering healthcare utilization, in particular organized cancer screening uptake, by underserved populations living in informal housing in France.

Health mediation may foster underserved populations' healthcare utilization. No study to date has demonstrated its effectiveness in an experimental context. The ECEMSo case study aims to identify the impact of health mediation on fostering healthcare utilization - in particular organized cancer screening uptake - by underserved populations living in informal housing in France.

Grounded in a theory-based framework, the ECEMSo case study is a longitudinal mixed-method intervention study with a multi-center, multi-case explanatory sequential design. The study population comprises various participant profiles including health mediators, health workers, social workers, people living in informal housing whom these professionals support, and other stakeholders concerned with underserved populations' health issues. Participants will be recruited in several French regions and divided into three mixed participant profile groups. In group 1, health mediation and the ECEMSo intervention will be implemented. This intervention comprises knowledge mobilization to facilitate the structuring of health mediation throughout France, and the development of an action plan to facilitate cancer screening uptake by people living in informal housing. In group 2, only health mediation will be implemented (i.e., no ECEMSo intervention). In group 3, neither health mediation nor the ECEMSo intervention will be implemented, but health and social workers will implement other health system navigation interventions.

Quantitative and qualitative data will be collected by interviewers through face-to-face questionnaires, interviews, observations, focus groups, and tracking tables of health mediation activities over six months. Data collection will be based on the health mediation conceptual framework.

longitudinal mixed-method intervention study with a multi-center, multi-case explanatory sequential design

Study of the Conditions of the Effects of Health Mediation on Underserved Population

Study of the Conditions of the Effects of Health Mediation on Underserved Populations' Healthcare Utilization

The difference in healthcare utilization by PLIH between groups 2 and group 3

The difference in organized cancer screening uptake (breast cancer, colorectal cancer, cervical cancer) between PLIH in group 1 and PLIH in group 2

The difference in organized cancer screening uptake (at 2 years since diagnosis for breast cancer and colorectal cancer, at 3 years since diagnosis for cervical cancer) between PLIH in group 1 and people living in informal housing in group 3

University Hospital, Bordeaux

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Patients who are not fully continent 6-weeks post-surgery (i.e., do not use pads in 24 hours) are randomized into the intervention or control group. In the intervention group, when the respective questionnaire thresholds are exceeded in the ePROM survey, an alarm is triggered at the treating prostate cancer center and contact is made by the center, as well as subsequent actions, if necessary.

Patients who are not fully continent 6-weeks post-surgery (i.e., do not use pads in 24 hours) are randomized into the intervention or control group. In the control group, ePROMs will be collected 24 and 52 weeks after radical prostatectomy, but without triggering an alarm with subsequent measures - the control group will therefore receive treatment according to the current clinical routine.

In patients who are fully continent 6-weeks post-surgery (i.e., do not use pads in 24 hours), ePROMs are collected at 24 and 52 weeks, but no alarms or further actions are derived from them. Thus, treatment is provided according to routine clinical practice. Patients are not randomized.

The intervention has several elements:

1. Regular symptom monitoring via ePROMs
2. Alarm when defined thresholds of EPIC-26 or PHQ-4 are reached or exceeded, 3.) In case of alarm, standardized telephone contact by a study nurse at the treating center with the offer to coordinate a urological consultation at the center, 4.) if requested by the patient: a urological consultation at the treating prostate cancer center by urologists trained in the PRO-P study,

4) content of the consultation: if necessary, the guideline-compliant initiation of further diagnostics and therapy including in this context necessary follow-up contacts and 5) postal communication of the ePROM results in case of an alarm as well as postal dispatch of a report of the findings in case of a urological consultation at the treating prostate cancer center to the practicing, treating urologist.

complex intervention

current clinical practice

Dominik Fugmann, MD

Johanna Droop, PhD

Philipp Krausewitz, MD

Michael C Truß, MD

Rouvier Al-Monajjed, MD

Rein-Jüri Palisaar, MD

Meike Mohr

Philipp Papavassilis, MD

Peter Albers, MD

André Karger, MD

The study investigates the influence of structured follow-up using ePROMS in the 1st year after prostatectomy on the postoperative course. It will be examined whether this intervention leads to early detection of postoperative symptoms and whether the subsequent initiation of further measures lead to an improvement of incontinence, symptom burden, quality of life and patient competence.

PRO-P is planned as a multicenter, prospective, and two-arm randomized control group study in which ePROMs will be performed in a standardized fashion once before and six times (intervention group) or three times (control group) after primary prostatectomy in patients with PCa. PROMs are collected either web-based or through a dedicated app and entered by the patient using either a mobile device or computer. Patients are invited to enter ePROMS into the app or web tool through email and app-driven push messages. Patients who are incontinent (at least one pad in 24 hours) at the 6-week postoperative survey are randomized into two groups: The intervention group and the control group. In the intervention group, when the respective questionnaire cut-off values are exceeded in the ePROM survey, an alarm is triggered at the treating prostate cancer center and contact is made by the center as well as subsequent measures, if necessary. This is done at 6 weeks postoperatively and at 12, 18, 24, 36 and 52 weeks postoperatively. In the control group, ePROMs are recorded 24 and 52 weeks after radical prostatectomy, but without triggering an alarm with subsequent measures - the control group thus receives treatment in accordance with the current clinical routine. The mechanisms of action of the intervention will be investigated within the framework of a qualitative process evaluation. Characteristics on the patient level (e.g., treatment-related attitudes, comorbidity, social support), on the practitioner level (e.g., communication skills), on the organizational level, and the interactions between the levels (e.g., patient-doctor relationship) will be explored. The goal is to develop an intervention model, or to describe the effective elements of the intervention.

Intention-to-treat principle, comparison (regarding superiority) of primary endpoint using mixed linear model for repeated measures: dependent variable: primary endpoint, influencing factors: Indicator for intervention/control group, time, group\*time, center, tumor stage, and age group; downstream sequential-rejection testing of equality of expected values in the individual strata via appropriate contrasts; control of multiple error for at least one false rejection (final test principle); supplementary: mixed linear models with additional independent variables; sensitivity analyses on the influence of missing values (multiple imputation); subgroup analyses according to center, stage, and age group

Influence of Electronic Patient Reported Outcomes (ePROMs) in Surgical Therapy for Prostate Cancer on Postoperative Outcome

The Expanded Prostate Cancer Index Short Form (EPIC-26) is a questionnaire that assesses symptoms and functions of people with prostate cancer in 5 domains. A total of 100 points can be achieved for each domain, with a higher score indicating better function. The urinary incontinence domain consists of four items. To calculate the primary endpoint, the difference between the scores on the urinary incontinence scale of the EPIC-26 is taken at 52 and 6 weeks. Changes regarding urinary incontinence (Minimally Important Difference (MID) \>= 9) at 52 weeks postoperatively compared with 6 weeks postoperatively are considered.

Similar to the primary endpoint, changes at 52 weeks postoperatively compared with 6 weeks postoperatively are considered for the changes in in sexual function according to EPIC-26 (MID \>= 10).

Similar to the primary endpoint, changes at 52 weeks postoperatively compared with 6 weeks postoperatively are considered for the changes in irritative/obstructive an gastrointestinal symptoms according to EPIC-26 (MID \>= 7).

Similar to the primary endpoint, changes at 52 weeks postoperatively compared with 6 weeks postoperatively are considered for the changes an gastrointestinal symptoms according to EPIC-26 (MID \>= 5).

Similar to the primary endpoint, changes at 52 weeks postoperatively compared with 6 weeks postoperatively are considered for the changes in vitality/ hormonal function according to EPIC-26 (MID \>= 4).

The European Quality of Life Five-Dimensions Questionnaire (EQ-5D-5L) measures health-related quality of life on five scales: 1. mobility, 2. ability to care for oneself, 3. activities of daily living, 4. pain/physical discomfort, and 5. anxiety/dejection, each of which is represented by a question that provides five response options for grading symptoms. In addition, a question on self-assessment of health status is asked on a visual analog scale from 0 to 100, where 100 is the best imaginable health.

The Patient Health Questionnaire-4 (PHQ-4) measures depressiveness and generalized anxiety on two subscales with two items each. For each question, scores from 0 to 3 can be achieved, so that a cumulative score of 12 points can be reached, whereby a higher score indicates a more pronounced symptomatology. The cut-off value for depressivity is defined for the subscales of the PHQ-4 is definied by \>= 3 points, the respective attainment of which (independent of the preoperative value) triggers an alarm at each survey time point.

The Patient Enablement Instrument (PEI) measures patient empowerment through six questions; a validated German translation with a modified question sequence and Likert scale is used. Overall, the sum score ranges from 6 to 30 points, with a higher score corresponding to greater patient empowerment.

semi-structured interviews with patients, urologists, psychooncologists, study nurses (N=10-15); data from Module 1 will be evaluated qualitatively using content analysis; criteria are based on the feasibility criteria for evaluating the acceptance and feasibility of the intervention and the study procedures

sequential semi-structured interviews with patients and relatives from the intervention and control groups in the main study (N=30-40); data from module 2 will be evaluated by contrastive thematic coding; in addition to possible differences between the intervention and control groups, intraindividual changes are also evaluated by contrastive coding of the data material at several time points

Semi-structured interviews with urologists, psychooncologists, study nurses in the main study (N=10-15); focus group discussion with study participants; analysis of implementation factors is guided by the Consolidated Framework for Advancing Implementation Science (CFIR); data from module 3 on implementation are evaluated qualitatively by content analysis

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluating a Community-Based Behaviour Change Communication Model to Prevent Cholangiocarcinoma in Khon Kaen, Thailand	NCT05321992	Cholangiocarcin... Liver Fluke-Rel... Opisthorchiasis	eCHEC program	20 Years -	McMaster University
Direct Improvement of Quality of Life Using a Tailored Pathway With Quality of Life Diagnosis and Therapy: Randomised Trial in Colorectal Cancer Patients	NCT02321813	Quality of Life Colorectal Neop...	quality of life... placebo control	18 Years -	Tumor Center Regensburg
Direct Improvement of Quality of Life Using a Tailored Pathway With Quality of Life Diagnosis and Therapy: Randomised Trial in Colorectal Cancer Patients	NCT02321813	Quality of Life Colorectal Neop...	quality of life... placebo control	18 Years -	Tumor Center Regensburg
Evaluating a Community-Based Behaviour Change Communication Model to Prevent Cholangiocarcinoma in Khon Kaen, Thailand	NCT05321992	Cholangiocarcin... Liver Fluke-Rel... Opisthorchiasis	eCHEC program	20 Years -	McMaster University
Study of the Conditions of the Effects of Health Mediation on Underserved Population	NCT06180746	Mediation	Knowledge mobil...	18 Years - 99 Years	University Hospital, Bordeaux
Influence of Electronic Patient Reported Outcomes (ePROMs) in Surgical Therapy for Prostate Cancer on Postoperative Outcome	NCT05644821	Prostate Cancer	complex interve... current clinica...	18 Years -	Heinrich-Heine University, Duesseldorf

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