Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Patients who are identified by the IPHR as study participants will see an attractive link. In the Prefs arm, via question prompt lists, patients will first identify their CRCS preference using previously developed elicitation strategies.

Tailoring will be used to increase salience of information, motivation, communication, and action plans. We envision the Prefs+ arm in its entirety will be 5-7 minutes, but will depend on Phase I formative work. If the patient remains non-adherent, they will receive an e-mail reminder generated by the IPHR (specific text and frequency determined in Phase I). The Prefs content is identical to the preference portion of the Prefs+Barriers arm, which will allow us to assess the incremental benefit of addressing preferences only and the incremental benefit of addressing preferences and barriers.

Patients who are identified by the IPHR as study participants will see an attractive link. In the Prefs+Barriers arm, via question prompt lists, patients will first identify their CRCS preference using previously developed elicitation strategies, and subsequently based on their test preference determine their top 3 test-specific barriers/concerns in "real time".

Tailoring will be used to increase salience of information, motivation, communication, and action plans. We envision the Prefs+Barriers arm in its entirety will be 15-25 minutes, but will depend on Phase I formative work. If the patient remains non-adherent, they will receive an e-mail reminder generated by the IPHR (specific text and frequency determined in Phase I). The Prefs content is identical to the preference portion of the Prefs+Barriers arm, which will allow us to assess the incremental benefit of addressing preferences only and the incremental benefit of addressing preferences and barriers

The IPHR will be programmed so that where the IPHR-CRCS would normally present patients, who based on their demographics and health conditions, with content advising them to seek CRCS and links to third-party sites, they would instead be randomized to receive the usual care (IPHR-CRCS).

MyCRCS+Prefs

Patients who are identified by the IPHR as study participants will see an attractive link. In the Prefs+Barriers arm, via question prompt lists, patients will first identify their CRCS preference using previously developed elicitation strategies, and subsequently based on their test preference determine their top 3-5 test-specific barriers/concerns in "real time".

Tailoring will be used to increase salience of information, motivation, communication, and action plans. We envision the Prefs+Barriers arm in its entirety will be 15-25 minutes, but will depend on Phase I formative work. If the patient remains non-adherent, they will receive an e-mail reminder generated by the IPHR (specific text and frequency determined in Phase I). The Prefs content is identical to the preference portion of the Prefs+Barriers arm, which will allow us to assess the incremental benefit of addressing preferences only and the incremental benefit of addressing preferences and barriers.

MyCRCS+Prefs+Barriers

Resa M Jones, MPH, PhD

This study involves 3 phases that modifies current Interactive Preventative Health Record-Colorectal Cancer Screening (IPHR-CRCS) modules to address each patient's individual colorectal cancer screening (CRCS) knowledge, attitudes, preferences, and test-specific barriers. The study will engage patients, ages 50-75 years who are non-adherent to CRCS, to assess their CRCS test preferences and corresponding test-specific barriers in "real time". Based on patient characteristics (e.g. age, personal and family history, physician CRCS recommendation, CRCS test preferences, top test-specific barriers), tailored messages/videos will appear in the pop-up screens to address/reduce the top patient-reported, test-specific CRCS barriers while incorporating an action plan for CRCS adherence. The investigators hypothesize that modifying the IPHR-CRCS module to address each patient's individual CRCS knowledge, attitudes, preferences, and test-specific barriers will further increase CRCS.

An Interactive Preventive Health Record to Increase Colorectal Cancer Screening

Develop and pretest MyCRCS+, which focuses on integrating patient CRCS preferences and test-specific barriers in an interactive web-based intervention. Answer the question: What intervention content and reminder content, packaging and frequency are acceptable to patients?

Having had ≥1 test (i.e., fecal occult blood test, sigmoidoscopy, colonoscopy and barium enema) within the time frame specified for each procedure will count as adherent CRCS.

The four NCI-recommended CRCS history questions will be included on the self-report surveys. Respondents will identify the last time they had each test (i.e., fecal occult blood test, sigmoidoscopy, colonoscopy and barium enema). Having had ≥1 test within the time frame specified for each procedure will count as adherent CRCS.

We will track participants' use of the intervention and usual care arms to capture number of log-ins, pages viewed, length of view, links clicked. In addition to elucidating patients' uptake of intervention components, these data can indicate engagement for dose-response analyses or be examined as potential mediators. For Phase II, this data will allow us to assess the timing of intervention reminders to make a decision about what frequency is most appropriate so that we can modify before we begin the feasibility study (phase III).

Scales (e.g. Decisional conflict, intentions , self-efficacy, perceived susceptibility, worry, etc.) are included in the patient questionnaire, which have good psychometric properties.

A previously validated modality-specific colorectal cancer screening barrier instrument will be used. The FOBT-specific scale includes 19 questions relating to barriers for fecal occult blood test, and the colonoscopy-specific scale includes 21 questions relating barriers to colonoscopy. All items are measured on a 5-point Likert-type scale, with 5 representing greater barrier endorsement. Items are summated to create continuous scale scores (range: FOBT=19-95; colonoscopy=21-105).

Phase III is a feasibility study to determine among other things, implementation in the "real world" setting. The outcomes we propose to measure are defined by the RE-AIM model. Specifically, we selected four essential elements pertaining to the feasibility of fielding MyCRCS+: Reach, Effectiveness, Implementation, and Maintenance.

The patient survey will include key questions related to intervention reach and potential future implementation adaptations addressing patient awareness and perception of the practices' MyCRCS+ integration strategies.Surveys will assess: patients' awareness of MyCRCS+, how they learned about it, what they liked or disliked about how practices promoted and used MyCRCS+; to what extent they used the MyCRCS+, the factors that influenced use, facilitators and barriers to both using and acting on MyCRCS+ recommendations; anxiety and worry; and quality of life (QOL).

National Cancer Institute (NCI)

Virginia Commonwealth University

Temple University

Behaviors and Mental Disorders

Symptoms and General Pathology

Anxiety Disorders

Mental Disorders

Death

Carcinoma

Psychotic Disorders

Adult patients across all phases of advanced disease (UICC stage IV solid tumor or stage III lung or ovarian tumor) from diagnosis to terminal stages

Adult informal caregivers of patients who are diagnosed with stage IV solid tumors or stage III lung or ovarian tumors

In this longitudinal cohort study, patients and caregivers will not receive an intervention. In addition to the outcomes named in the section "Outcome Measures" patients and caregivers will complete self-report questionnaires for

Existential distress (Demoralization Scale-II, Death and Dying Distress Scale, Depressive Experiences Questionnaire, Revised Loss Orientation and Life Engagement in Advanced Cancer Scale, Sense of Dignity Item, Patient Dignity Inventory, Marwit-Meuser Caregiver Grief Inventory, Caregiver Guilt Questionnaire)

Need for and utilization of psychosocial support

Resources (Sources of Meaning and Meaning in Life Questionnaire, Questionnaire on the Defiant Power of the Human Spirit) and

Control variables (Memorial Symptom Assessment Scale, PHQ-9 and GAD-7)

Self-report questionnaires

Sigrun Vehling, PhD

Despite the potential for alleviation of existential distress through psychosocial interventions, existential concerns and their impact on health care outcomes of patients and caregivers have not yet been systematically studied. The aim of this longitudinal cohort study is to investigate the frequency, longitudinal trajectory and predictive impact of existential distress on patient- and caregiver-relevant end-of-life outcomes. Further, it aims to determine the need for and utilization of psychosocial support in patients and caregivers with regard to existential concerns.

Due to medical progress and an aging population, the number of patients and caregivers who face the profound existential challenges of advanced incurable cancer is constantly growing. Clinically significant existential distress may result from a fear of suffering and perceived lack of control, fear and uncertainty about the end of life, feelings of burdensomeness or insufficiency, grief about missed opportunities, and profound loneliness. Such distress may have a unique and independent contribution to health care outcomes at the end of life. Despite an increasing interest in existential and palliative care interventions that discuss such issues openly, a lack of systematic quantitative data on existential distress and specific support needs hampers clinicians to consequently detect and address existential needs. This longitudinal study aims to 1) systematically investigate the frequency, longitudinal trajectory and predictive impact of existential distress on patient- and caregiver-relevant end-of-life outcomes and 2) determine patients' and caregivers' specific need for and utilization of psychosocial support with respect to existential concerns.

Adult patients diagnosed with advanced cancer and caregivers will be consecutively recruited from outpatient and inpatient treatment facilities of the Univer-sity Cancer Center Hamburg and affiliated clinics. Existential distress, end-of-life outcomes, and mental disorders in 1,000 participants (500 patients, 500 care-givers) will be assessed using self-report questionnaires at five points of assessment over a period of 12 months and diagnostic interviews (at baseline, after six months). To determine the prevalence of existential distress, mental disorders and palliative care outcomes descriptive statistics will be calculated. Descriptive analyses will also be used to examine the need for and utilization of psychosocial support. To investigate the predictive impact of existential distress and patient- and caregiver-relevant end-of-life outcomes multiple linear and logistic regression will be conducted. To analyze longitudinal trajectory of existential distress growth mixture models will be used.

Shaping a clear and systematic knowledge about frequent and persistent existential concerns that are most relevant to the risk for unfavorable end-of-life outcomes, results will significantly contribute to the recognition and manage-ment of existential distress and provide a valuable basis for the development of targeted interventions.

Existential Distress in Patients With Advanced Cancer and Their Caregivers

Existential Distress in Patients With Advanced Cancer and Their Caregivers: A Longitudinal Cohort Study

Will be assessed for patients according to the criteria by Earle et al., 2003: receipt of chemotherapy in the last two weeks of life, emergency hospital admissions or intensive-care treatment during the last month of life. Will be obtained from medical chart reviews for deceased patients.

Will be assessed for patients and caregivers using the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID-5, Beesdo-Baum et al., 2019).

Will be assessed according to International Classification of Diseases (ICD-11) for patients and caregivers using the Adjustment Disorder Module of the CIDI (Composite International Diagnostic Interview, (Perkonigg et al., 2018).

Will be assessed for patients and caregivers using the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID-5, Beesdo-Baum et al., 2019).

Will only be assessed for patients and caregivers who were recruited at location no.4 (Specialized Outpatient Clinic for Autoimmune Liver Disease and for Liver and Bile Duct Tumors, University Medical Center Hamburg-Eppendorf).

Will be assessed for patients using the short form of the Schedule of Attitudes Toward Hastened Death (SAHD-A, Kolva et al., 2017). Items are scored with either being true (1) or false (0). The total score is the number of endorsed items, ranging from 0 to 6, with high scores indicating high levels of desire for hastened death.

Will be assessed for patients and caregivers using the Beck Scale for Suicidal Ideation (BSS, Kliem \& Brähler, 2015). Items are scored from 0 to 2 (e.g., 0 = I have a moderate to strong wish to live, 1 = I have a weak wish to live, 2 = I have no wish to live). The sum score ranges from 0 to 38 for the total scale, with higher scores indicating stronger suicidal tendencies.

Will be assessed for patients and caregivers using the Structured Interview for Psychological Adjustment and Demoralisation (Bobevski \& Kissane, 2019). Participants may answer most of the questions with yes or no.

Will be assessed for caregivers after the patient's death using the Inventory of Complicated Grief (ICG; Lumbeck et al., 2012). Items are scored from 0 (never) to 4 (always). The sum score ranges from 0 to 76, with scores ≥ 25 indicating experiences of complicated grief.

Will be assessed from the caregivers' perspective using a shot version of the Quality of Dying and Death Questionnaire (QODD, Mah et al., 2020). Caregivers indicate how they would rate each experience for the patient on a scale from 0 (terrible experience) to 10 (almost perfect experience). The total score ranges between 0 and 100, with higher scores indicating a better quality of the dying experience.

Universitätsklinikum Hamburg-Eppendorf

Nutritional and Metabolic Diseases

Rare Diseases

Stomach Neoplasms

Weight Loss

Esophageal Neoplasms

Malnutrition

Body Weight

Body Weight Changes

Nutrition Disorders

Stomach Diseases

Head and Neck Neoplasms

Esophageal Diseases

Stomach Cancer

Esophageal Cancer

All Drugs and Chemicals

Gastrointestinal Agents

Hormones

Glucagon

Glucagon-Like Peptide 1

Serial assessment:

Fasting gut hormones, post-prandial gut hormone response to a standardized 400kcal meal

Used to assess post-prandial gut hormone response pre-operatively and at 10 days, 4 weeks, 6 months and 12 months post-operatively.

Standardized 400kcal semi-liquid meal

John V Reynolds, MCh, FRCS

Surgery is the cornerstone of treatment for patients with oesophageal or gastric cancer, but while surgical removal of the tumour (oesophagectomy or gastrectomy) may offer the best chance of cure, these are major operations associated with specific long term complications. Weight loss and poor nutrition are relatively common problems among patients who attain long-term cancer remission and cure after surgery. The mechanisms underlying these problems are not well understood and therefore treatment options are limited.

The investigators research has demonstrated increased levels of chemical messengers (gut hormones) released from the gastrointestinal tract after meals in patients who have previously undergone upper gastrointestinal surgery. These chemical messengers play a role in signalling the feeling of fullness during and after a meal (satiety). Understanding the mechanisms involved in increased gut hormone secretion after these operations may allow us to use certain medications to block gut hormone release and hence reduce satiety allowing patients to eat more, regain weight and prevent nutritional complications after surgery.

Exaggerated post-prandial satiety gut hormone responses following oesophagectomy have, however, only been established cross-sectionally and therefore the time course for development of increased gut hormone secretion is unknown. Data collected from this study will provide important information about optimal timing of therapeutic intervention in this patient group, while offering mechanistic insights with regard to the pathophysiologic process underlying post-operative early satiety.

Longitudinal Assessment of Gut Hormone Secretion Following Upper Gastrointestinal Surgery for Cancer

University College Dublin

University of Dublin, Trinity College

St. James's Hospital, Ireland

Surgical Research Fellow

Age-eligible adults in the intervention communities will be exposed to the shared decision-making intervention when they are seen in the primary care clinics (N=all patients 50-75 years seen during the study period who are non-adherent to CRCS recommendation). Additionally, among patients with primary care visits scheduled one week or more before the visit, they will be randomized to receive either a mailed decision aid booklet or an informational flyer on shared decision making and CRCS prior to the visit. Patients with primary care visits scheduled less than one week prior to the visit will not be mailed materials in advance. The effect of the pre-visit materials on referral to SDM session and CRCS adherence between these groups will be compared. They will also be exposed to shared decision-making tools and resources available through the community-wide intervention activities.

Shared Decision Making for Colorectal Cancer Screening

The purpose of this study is to increase colorectal cancer screening by implementing a community-wide shared decision-making (SDM) intervention, which embeds shared decision making within clinical practice and also uses an extensive community engagement campaign. The investigators hypothesize that colorectal cancer screening adherence will be higher in the intervention group (participating communities) compared to the usual care control group (non-participating comparison communities).

Clinical practice: All patients 50-75 years seen in the participating primary care clinics during the study period who are non-adherent to CRCS recommendation. This sample is anticipated to be N\~50,000 patients.

Community engagement: Includes mailed questionnaires to age-eligible adults residing in intervention and comparison (control) communities (N=2150).

Colorectal Cancer Screening With Improved Shared Decision Making

Colorectal Cancer Screening With Improved Shared Decision Making (CRCS-WISDM)

Colorectal cancer screening adherence will be defined as having screening according to the recommendations of the United States Preventive Services Task Force. Participants will be classified as screened per recommendations if they have had fecal occult blood testing in the last year, flexible sigmoidoscopy in the last five years, or colonoscopy in the last ten years. Participants will be classified as non-adherent if they have not had any of the modalities within the recommended timeframe.

A previously validated decisional conflict scale, will be used, which includes 16 items all measured on a 5-point Likert-type scale. (e.g. difficulty in decision making, certainty with a decision, demonstrated feeling of understanding about risks and benefits of a decision, and satisfaction with a decision). Responses will be coded so that higher responses represent greater decisional conflict.

A previously validated modality-specific colorectal cancer screening barrier instrument will be used. The FOBT-specific scale includes 19 questions relating to barriers for fecal occult blood test and the colonoscopy-specific scale includes 21 questions relating barriers to colonoscopy. All items are measured on a 5-point Likert-type scale, with 5 representing greater barrier endorsement.

Colorectal cancer-related confusion will be measured using 9 items which will be coded on a scale from 1 to 5 where 5 represents greater confusion endorsement.

Patients will answer multiple questions relating to their experience with the implementation of shared decision-making and their interactions with clinical staff. Items will be measured on Likert-like scales and will be coded so that higher scale numbers reflect more endorsement of positive opinions and experiences.

Providers and staff will answer multiple questions relating to their experience with the implementation of shared decision-making with their patients in clinical practice. Items will be measured on Likert-like scales and will be coded so that higher scale numbers reflect more endorsement of positive opinions and experiences.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Interactive Preventive Health Record to Increase Colorectal Cancer Screening	NCT01885351	Colorectal Canc...	MyCRCS+Prefs MyCRCS+Prefs+Ba...	50 Years - 75 Years	Temple University
An Interactive Preventive Health Record to Increase Colorectal Cancer Screening	NCT01885351	Colorectal Canc...	MyCRCS+Prefs MyCRCS+Prefs+Ba...	50 Years - 75 Years	Temple University
Existential Distress in Patients With Advanced Cancer and Their Caregivers	NCT04600206	Neoplasms Malig... Carcinoma Palliative Care	Self-report que...	18 Years -	Universitätsklinikum Hamburg-Eppendorf
Longitudinal Assessment of Gut Hormone Secretion Following Upper Gastrointestinal Surgery for Cancer	NCT02385630	Esophageal Neop... Stomach Neoplas... Weight Loss Malnutrition	Standardized 40...	18 Years -	St. James's Hospital, Ireland
Existential Distress in Patients With Advanced Cancer and Their Caregivers	NCT04600206	Neoplasms Malig... Carcinoma Palliative Care	Self-report que...	18 Years -	Universitätsklinikum Hamburg-Eppendorf
Colorectal Cancer Screening With Improved Shared Decision Making	NCT01519999	Colorectal Canc... Shared Decision...	Shared Decision...	50 Years - 75 Years	Virginia Commonwealth University

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