Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

The control group receives standard treatment with 6 months of adjuvant chemotherapy or first -line chemotherapy until operation, other scheduled change in treatment or progression. If the patient has other health problems, those issues will be assessed either by the oncologist or by the general practitioner. Validated quality of life questionnaires will be filled in prior to start, after 2 months and at the end of treatment.

The intervention group also receives standard treatment with 6 months of adjuvant chemotherapy or first -line chemotherapy until operation, other scheduled change of treatment or progression. They will simultaneously receive full geriatric assessement and intervention. The clinical examination includes laboratory parameters, review of medication list, psycho-cognitive assessement, screening for malnutrition and need of physiotherapy, optimizing social support. Validated quality of life questionnaires will be filled in prior to start, after 2 months and at the end of treatment.

The intervention group also receives standard treatment with 6 months of adjuvant chemotherapy or first -line chemotherapy until operation, other scheduled change of treatment or progression. The participants will simultaneously receive full geriatric assessement and intervention. The clinical examination includes laboratory parameters, review of medication list, psycho-cognitive assessement, screening for malnutrition and need of physiotherapy, optimizing social support. Validated quality of life questionnaires will be filled in prior to start, after 2 months and at the end of treatment.

Intervention group

Cecilia M Lund, MD

GERICO is a randomized, controlled prospective trial. The aim is to investigate if frail, elderly patients with stage II-IV colorectal cancer, will profit from full comprehensive geriatric assessment and intervention before and during treatment with chemotherapy.

The hypotheses are: Optimizing the health conditions and functional status of frail elderly patients who suffers from stage II-IV colorectal cancer, with geriatric intervention will lead to a higher grade of completing the planned chemotherapy and at higher dose intensity. This will also result in a higher overall survival and improve quality of life.

Effect of Geriatric Intervention in Frail Elderly Patients Receiving Chemotherapy for Colorectal Cancer

Data will be collected by reviewing patients medical charts

Adverse events will be registered for every cycle of treatment and assessed by an oncologist according to CTC- criteria version 4.0.

Quality of life questionnaires will be filled out by the participants

Danish Cancer Society

University of Copenhagen

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

medical decision based on computerized guideline-based decision support system

Introduction of a computer-based decision support system in the medical decision process

ONCODOC LOGICIEL

Serge UZAN, MD, PhD

The objective of the study is to evaluate how the use of OncoDoc2, a computerized guideline-based decision support system, could improve the compliance of multidisciplinary staff meeting decisions with local clinical practice guidelines in the management of non-metastatic breast cancer.

In France, to promote the quality of cancer care, decisions have currently to be made according to clinical practice guidelines (CPGs) during regularly organized multidisciplinary staff meetings (MSMs). Dissemination of textual CPGs has a poor impact on clinical practice as opposed to the use of clinical decision support systems (CDSSs) known to improve compliance with CPGs. OncoDoc2 is a CDSS providing patient-specific recommendations based on CPGs for non-metastatic female breast cancer management elaborated by the CancerEst INTERMEDICAL collaboration.The main goal of the study is to evaluate the effect of the routine use of OncoDoc2 during MSMs on compliance of MSM decisions with local CPGs. Impact will be measured by the compliance rate of MSM decisions with OncoDoc2 recommendations. The design of the study relies on a cluster randomized controlled trial. Under the assumption of a baseline compliance rate of 70% without intervention, an expected compliance rate of 90% in the intervention group (α = 5%, β = 20%), an inter-cluster variability of 5%, and 59 decisions per center, the required number of centers is 3 in each group, or 177 decisions in each arm. The study will be conducted in cancer care centers (public and private) from Paris area, France.This prospective trial will be conducted in two steps. First, baseline compliance rates will be measured in each center. Then, the 6 centers will be randomized into 2 arms. In the intervention arm, OncoDoc2 will be used during MSMs at decision time. Every case of non-adherence with system recommendations will have to be justified by clinicians. In both arms and after each MSM, MSM decisions will be recorded as well as patient characteristics and OncoDoc2 will be used for each patient case to get system recommendations. In the intervention arm, OncoDoc2 recommendations obtained by MSM will also be recorded, as well as the reason for non following recommendations in case MSM decision does not comply with guidelines.

Impact of OncoDoc2 on Guideline Compliance in the Management of Breast Cancer

Impact of the OncoDoc2 Decision Support System on Compliance of Multidisciplinary Staff Meeting Decisions With Clinical Practice Guidelines in the Management of Non-metastatic Breast Cancer.

Assistance Publique - Hôpitaux de Paris

All Drugs and Chemicals

Hormones

Physical activity

Jantine Schuit, PhD

Petra HM Peeters, PhD

Purpose of the SHAPE study is to examine the effects of an 1-year exercise programme on endogenous hormone levels associated with breast cancer among sedentary postmenopausal women and whether a decrease in intra-abdominal fat is associated with a lowering of these hormone levels.

Physical activity has been associated with a decreased risk for breast cancer. The biological mechanism(s) underlying the association between physical activity and breast cancer is not clear. Most prominent hypothesis is that physical activity may protect against breast cancer through reduced lifetime exposure to endogenous hormones. Another hypothesis is that physical activity prevents overweight and abdominal adiposity.

In this intervention study, 189 sedentary postmenopausal women who are aged 50-69 years are randomly allocated to an intervention or a control group. The intervention consists of an 1-year moderate-to-vigorous intensity aerobic and strength training exercise programme. Participants allocated to the control group are requested to retain their habitual exercise pattern. Primary study parameters measured at baseline, at four months and at 12 months are: serum concentrations of endogenous estrogens, endogenous androgens, sex hormone binding globulin and insulin. Other study parameters include: amount of total and abdominal fat, weight, BMI, body fat distribution, physical fitness, blood pressure and lifestyle factors.

This study will contribute to the body of evidence relating physical activity and breast cancer risk and will provide insight into possible mechanisms through which physical activity might be associated with reduced risk of breast cancer in postmenopausal women.

Physical Activity and Breast Cancer Risk in Postmenopausal Women:the SHAPE Study

Physical Activity and Breast Cancer Risk in Postmenopausal Women: the SHAPE Study

National Institute for Public Health and the Environment (RIVM)

Dutch Cancer Society

UMC Utrecht

Symptoms and General Pathology

Fatigue

The intervention group follows a six-month personalized lifestyle program to increase adherence to the World Cancer Research Fund cancer prevention guidelines on healthy nutrition, physical activity and healthy weight.

The wait-list usual care group follows usual care and usual activities. Participants receive a lifestyle program after the intervention period of six months: this includes two personalized behavioural coaching sessions and any material that the intervention group also received.

Participants in the intervention group receive personalized coaching from a lifestyle coach on adhering to the World Cancer Research Fund cancer prevention guidelines. The lifestyle coach is specialized in behaviour change techniques and uses these as the core of the lifestyle coaching. For each participant behavioural determinants will be assessed and targeted with specific applicable behaviour change techniques.

Behaviour change guided lifestyle intervention

The SoFiT study is a randomized controlled trial examining the effects of a behaviour change guided lifestyle intervention on increasing adherence to the World Cancer Research Fund cancer prevention guidelines, compared to the wait-list usual care group, on diminishing cancer-related fatigue in colorectal cancer survivors.

The SoFiT study is a randomized controlled trial examining the effects of a behaviour change guided lifestyle intervention on increasing adherence to the World Cancer Research Fund (WCRF) cancer prevention guidelines, compared to the wait-list usual care group, on diminishing cancer-related fatigue in colorectal cancer survivors.

Colorectal cancer survivors who completed treatment six months to five years ago and who suffer from cancer-related fatigue, are randomized into two parallel groups: an intervention group or the wait-list usual care group. The intervention group follows a six-month personalized lifestyle program, which is guided by behaviour change techniques, to increase adherence to the World Cancer Research Fund cancer prevention guidelines on healthy nutrition, physical activity and healthy weight. Participants are guided by a lifestyle coach specialized in behaviour change. The wait-list usual care group receives a lifestyle program after the intervention period of six months: this includes two personalized behavioural coaching sessions and any material that the intervention group also received.

Both groups participate in measurements at baseline, three months, at the end of the intervention (six months) and at follow-up (twelve months). The follow-up timepoint is included to study long-term behavioural lifestyle change. The primary outcome is the change in cancer-related fatigue, as measured by the FACIT-Fatigue questionnaire, between the intervention and wait-list usual care group from baseline till six months.

Secondary outcomes include cancer-related fatigue (at other timepoints), skeletal muscle fat infiltration and cross-sectional area, gut microbiota composition, health-related quality of life, physical performance, sleep quality and duration, depression and anxiety, behavioural determinants and adherence to the WCRF guidelines by assessing habitual dietary intake, physical activity level, height, weight, waist circumference and BMI. Other outcomes of interest include, blood pressure, chrono-nutrition, colorectal cancer related complaints, hemoglobin blood levels, self-reported weight (at three months) and cost-effectiveness evaluation. Moreover, the following data will be collected to characterize the population: sociodemographic information (age, sex, marital status, education, smoking) and clinical parameters (time since diagnosis, current and received treatment, comorbidities, medicine and supplement use).

Randomized controlled trial with two parallel arms: intervention and control.

The nature of the intervention does not allow for blinding of the participants or researchers. The baseline measurements are however blinded as both the participant and the researchers do not yet know in which group the participant will be classified. Randomization is done directly after the baseline measurements. After data collection, the database will be coded by an independent researcher to ensure that data analysis is conducted in a blinded way.

Study on Fatigue in Colorectal Cancer Survivors, a Lifestyle Intervention

Blood pressure is measured using a sphygmomanometer. Both diastolic and systolic blood pressure are measured.

Heart rate is measured using a sphygmomanometer.

Chrono-nutrition, the timing of dietary intake, is measured with the "Chromes vragenlijst patiënten eetpatronen". This is a Dutch questionnaire containing 26 items that assess meal regularity (8-items), meal frequency (7-items), and meal clock time (11-items).

Measuring colorectal cancer specific problems is done using the additional concerns (i.e. subscale) of the Functional Assessment of Cancer Therapy - Colorectal (FACT-C). This questionnaire contains 9 items and scores are ranging from 0-28 points.

Finger prick blood sampling is used for assessing haemoglobin status as an indicator for anaemia.

Sociodemographic information is collected using standardized questionnaires.

Clinical parameters such as time since diagnosis, current and received treatment, comorbidities and medicine use, are collected either via standardized questionnaires or from medical records (part of informed consent).

Cancer-related fatigue is assessed with the FACIT-Fatigue Scale, a 13 item questionnaire with scores ranging from 0-52. A score below 34 indicates fatigue. The minimal clinically important difference is reported to be 3.0 for this scale.

Echo intensity of the skeletal muscle rectus femoris, lateral gastrocnemius and biceps brachialis is measured using a portable ultrasound machine.

Faecal samples are collected and the microbiota composition in this will be analyzed. The investigators will use 16S rRNA sequencing data for the taxonomic characterization of the gut microbiota. Eventually shotgun sequencing may also be done.

Health-related quality of life is measured with the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire, which contains the following domains of well-being: physical, social/family, emotional and functional. The 27-item questionnaire has scores ranging from 0 to 108.

This test indicates cardiovascular fitness by heart rate measurement for one minute after the completion of three minutes of stepping.

This test indicates lower extremity skeletal muscle strength. The time necessary to achieve the standing position on the 5th repetition is measured.

This test measures balance for three different standing positions. Each position has to be maintained for 10 seconds in order to pass the test.

This test measures lower extremity and lower back flexibility. Participants sit on a chair and bend forward and reach for their toes. The distance between the hand and toes is measured.

This test uses a hand dynamometer to measure strength.

Sleep quality is measured with the Pittsburgh Sleep Quality Index (PSQI), a 19-item questionnaire with scores ranging from 0-21. A score above 5 indicates bad sleep quality.

The Consensus sleep diary morning (CSD), a 15-item diary, is used for measuring other sleep outcomes such as sleep onset latency and sleep duration.

Depression is measured using the 8-item Patient Healthcare Questionnaire (PHQ-8). It contains 8 items, and scores range from 0-24, with higher scores indicating a higher chance of depression.

Anxiety is measured using the 7-item Generalized Anxiety Disorder (GAD-7). The GAD-7 contains 7 items, its scores range from 0-21, with higher scores indicating a higher chance of anxiety.

Identified behavioural determinants through focus groups and a systematic review, are assessed using a self-reported questionnaire with questions based on previous reported questions on different determinants. These were adapted to reflect the WCRF guidelines. Higher scores for each of the determinants (scale 1-7) indicate better results.

Nutritional intake is measured using a semi-quantitative Food Frequency Questionnaire (FFQ). Scores are calculated using the Dutch National Food Consumption tables. In addition, the validated questionnaire Eetscore is used, which contains a short online questionnaire (10-15 minutes) that serves as an indicator to assess diet quality, based on the Dutch Healthy Diet index 2015 (DHD15-index). Scores range from 0-160, with higher scores indicating better diet quality.

Nutritional intake is also measured using the validated questionnaire Eetscore, which uses a short online questionnaire (10-15 minutes) that serves as an indicator to assess diet quality, based on the Dutch Healthy Diet index 2015 (DHD15-index). Scores range from 0-160, with higher scores indicating better diet quality.

Physical activity is measured using the Short QUestionnaire to ASsess Health-enhancing physical activity (SQUASH). The questions in the SQUASH are pre-structured in commuting, leisure time, household and work/school activities. Scores will be assigned to the different reported activities base on intensities in MET and translated to minutes of physical activity.

Physical activity is also measured using ActivPalTM Micro3, an accelerometer measuring sedentary behaviour and physical activity. The ActivPalTM is worn for 9 days.

Height (in cm) is measured with a stadiometer.

Weight (in kg) is measured with a calibrated scale.

Waist circumference (in cm) is measured using tape measures.

The cost-effectiveness of the intervention is evaluated using a questionnaire that includes items on for example costs that the participant has made in order to follow the lifestyle program.

World Cancer Research Fund International

Gelderse Vallei Hospital

Flevoziekenhuis

Slingeland Hospital

Rijnstate Hospital

Het Prospectief Landelijk CRC cohort (PLCRC)

Deventer Ziekenhuis

Wageningen University

Dr.Ir.

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

Resa M Jones, MPH, PhD

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
Effect of Geriatric Intervention in Frail Elderly Patients Receiving Chemotherapy for Colorectal Cancer	NCT02748811	Colorectal Neop...	Intervention gr...	70 Years -	University of Copenhagen
Impact of OncoDoc2 on Guideline Compliance in the Management of Breast Cancer	NCT00728442	Breast Cancer	ONCODOC LOGICIE...	-	Assistance Publique - Hôpitaux de Paris
Physical Activity and Breast Cancer Risk in Postmenopausal Women:the SHAPE Study	NCT00359060	Breast Cancer	Physical activi...	50 Years - 69 Years	UMC Utrecht
Study on Fatigue in Colorectal Cancer Survivors, a Lifestyle Intervention	NCT05390398	Colorectal Canc... Cancer-related ... Colon Cancer Rectal Cancer	Behaviour chang...	18 Years -	Wageningen University
Study on Fatigue in Colorectal Cancer Survivors, a Lifestyle Intervention	NCT05390398	Colorectal Canc... Cancer-related ... Colon Cancer Rectal Cancer	Behaviour chang...	18 Years -	Wageningen University
Impact of OncoDoc2 on Guideline Compliance in the Management of Breast Cancer	NCT00728442	Breast Cancer	ONCODOC LOGICIE...	-	Assistance Publique - Hôpitaux de Paris
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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