Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Patients receive standardized general information about colorectal cancer screening over the telephone.

Patient receive personalized colorectal cancer risk assessment over the telephone by answering the questions as outlined in the National Cancer Institute Colorectal Cancer Risk Assessment Tool (https://ccrisktool.cancer.gov/calculator.html)

Risk Assessment (CCRAT)

Usual Care (UC)

Uri Ladabaum, MD

This study is designed to examine the impact of telephone-based colorectal cancer risk assessment on colorectal screening attitudes and behavior among previously unscreened adults ages 50 to 75.

Colorectal cancer (CRC) remains the 3rd most common cancer in the US. Most CRCs are preventable, but screening participation remains suboptimal. Several factors have been associated with screening compliance, such as perception of CRC risk. Here we study the impact of telephone-based administration of the National Cancer Institute Colorectal Cancer Risk Assessment Tool (CCRAT) compared to usual care.

Usual care of generalized colorectal cancer screening education over telephone versus personalized risk assessment over telephone using National Cancer Institute Colorectal Cancer Risk Assessment Tool (CCRAT)

Does Knowing One's Estimated Colorectal Cancer Risk Influence Screening Behavior?

De-identified IPD will be made available to other researchers through a HIPAA compliant data storage system (Stanford Medicine Box) that is password protected

Differences in perception of one's own risk of colorectal cancer ranging from "very unlikely" (minimum) to "very likely" (maximum), with "very unlikely" representing the most favorable outcome of perceived risk and "very likely" representing the most unfavorable outcome of perceived risk.

Presence of fear of discovering colorectal cancer on performing screening test ranging from "strongly disagree" (minimum) to "strongly agree" (maximum), with "strongly disagree" representing the most favorable outcome of fear and "strongly agree" representing the most unfavorable outcome of fear.

Any CRC screening test completed including stool tests (FOBT (fecal occult blood test), FIT (immunochemical test for fecal blood), stool DNA test), colonoscopy, flexible sigmoidoscopy, double contrast barium enema, CT colonography (virtual colonoscopy)

Differences in progressive behavioral stages of adoption from precontemplation to contemplation to preparation.

Screening completion at 12 months will be compared between the 3 tertiles of CCRAT score in the intervention group to determine whether there is any relationship between absolute CCRAT score and screening completion

Stanford University

Professor of Medicine, Director GI Cancer Prevention Program

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Using focus group methodology, investigators will identify and explore new content topics for inclusion in smoking cessation booklets and gather feedback about the existing Stop Smoking for Good booklets regarding tone and message design. Results will be used to modify and adapt the existing cessation intervention.

The SHI arm will receive the intervention developed in Study I.

The UC arm will receive the existing Clearing the Air smoking-cessation manual.

The newly revised Stop Smoking for Good booklets.

Self-Help (SHI)

The existing Clearing the Air smoking-cessation manual published by the National Cancer Institute (NCI).

Thomas Brandon, Ph.D.

The purpose of this study is to develop and test a self-help smoking cessation treatment for patients receiving a lung cancer screening computed tomography (CT) scan.

Conduct Formative Research (Months 1 - 4): Identification of emergent themes and responses to existing booklets.

Adapt and Refine Booklets (Months 5 - 8): Advanced drafts of booklets.

Final Reactions to Draft Booklets (Months 9 - 12): Series of smoking cessation booklets for spiral computed tomography (CT) patients.

Capitalizing on a Teachable Moment to Promote Smoking Cessation

Complete formative research to adapt and refine the existing Stop Smoking for Good booklets.

Demand will be estimated by noting accrual rates into the study.

Practicality encompasses the degree to which investigators are able to carry out all the piloted elements of the planned randomized control trial (RCT) successfully and efficiently (i.e., recruitment, screening, randomization, and follow-up).

James and Esther King Biomedical Research Program

H. Lee Moffitt Cancer Center and Research Institute

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ovarian Cancer

Ovarian Epithelial Cancer

A health coach will conduct a 15-30 minute telephone counseling session with participants. Prior to the telephone session, participants will receive the same brochure that the TP arm receives. After the phone call, participants will receive a tailored follow-up letter which will include images tailored to the individual's age, self-identified ethnicity, and family composition.

Telephone Counseling & Navigation (TCN)

Participants will be mailed an educational brochure within two weeks of completing the baseline survey that addresses important evidence-based theoretical targets: CGRA guideline (knowledge), threat appraisal (to validate or raise risk perceptions, HBOC seriousness), response efficacy (benefits and expectations about CGRA), self-efficacy messages (CGRA resources, insurance reimbursement, and assistance for those with financial challenges) and possible actions to take (make an appointment and discuss with provider). Both the targeted print and tailored intervention materials were developed using formative community engaged research methods.

Mailed Targeted Print (TP)

A usual care arm is included to assess CGRA uptake in the absence of intervention as well as priming from the surveys for the primary outcome analysis.

Anita Y Kinney, PhD, RN

GRACE is a randomized 3-arm trial to determine the comparative effectiveness of two remote cancer communication interventions: 1) a targeted generic print (TP), or 2) a tailored telephone-based counseling and navigation intervention (TCN).

There is increasing evidence that activated and engaged patients who are equipped with necessary skills and information are more likely to follow through with recommended care and have better health outcomes at reduced costs. Identification of individuals at increased risk of hereditary breast and ovarian cancer (HBOC) is crucial for cancer survivors and their families to benefit from biomedical advances in cancer prevention, early detection, treatment and survivorship. The primary purpose of this study is to assess the feasibility and acceptability of two remote interventions aimed at promoting cancer genetic risk assessment (CGRA) for HBOC. The randomized controlled trial will have 3 arms: usual care (UC) vs. targeted generic print (TP) vs. tailored telephone counseling and navigation intervention (TCN).

Randomization will be single blinded. Research team members who are assessing the outcomes will be blinded to study arm assignment. Research staff who are conducting follow-up interviews will be blinded to group assignment as much as possible. At the beginning of the follow-up interviews, the interviewer will request that the participant does not reveal the study arm they were assigned to.

Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) Project

Comparative Effectiveness of Interventions to Increase Guideline-based Genetic Counseling in Ethnically and Geographically Diverse Cancer Survivors

Questionnaire: Participants will be asked whether they have had CGRA, the provider who conducted the CGRA, and the provider's genetics training. CGRA will be medical record verified delivered by the 6-month follow-up.

Questionnaire: Decisional conflict associated with the CGRA decision will be measured separately with 4 items using the SURE Scale. Range from 0-4, with 0 indicating high decisional conflict.

Questionnaire: One item will measure future intention to get cancer genetic risk assessment. In follow up surveys, this will only be asked if participant does not report uptake of CGRA

Questionnaire: One item will measure future intention to get genetic testing for HBOC. In follow up surveys, this will only be asked if participant does not report uptake of genetic testing

Questionnaire: Participants will be asked if they received the intervention brochure and had telephone coaching. If yes, they will be asked questions regarding their reaction to the intervention.

Questionnaire: Decisional conflict associated with the HBOC gene test decision will be measured separately with 4 items using the SURE SCALE. Sum the four responses. Range from 0-4, with 0 indicating high decisional conflict.

Questionnaire: Decisional satisfaction will be assessed using the Satisfaction with Decision Instrument. Five questions assess their personal satisfaction with their decision and two additional items assess how they feel about their CGRA decision in relation to their family. Satisfaction Score: Range 5-25, with 25 indicating high decisional satisfaction. Family Score: Range 2-10, with 10 indicating high consistency with personal values.

Questionnaire: Five items will ask about regret regarding the decision to have or not have CGRA. Range from 0-100, with 100 indicating high decisional regret.

Questionnaire: Facilitators include but are not limited to: help from family, desire to reduce risk of second cancers, and help/referrals from medical professionals.

Questionnaire: Several items will be used to conduct a cost analysis in terms of costs to participants. These questions were developed for the purpose of this study and include out-of-pocket costs.

Questionnaire: Will assess whether healthcare providers have discussed participant's risk of HBOC and CGRA, and how participants feel discussing genetic testing with health care provider.

Colorado Department of Public Health and Environment

University of New Mexico

Rutgers, The State University of New Jersey

Study Principal Investigator; Associate Director for Cancer Health Equity

Symptoms and General Pathology

Behaviors and Mental Disorders

Prostatic Neoplasms

Fatigue

Urinary Bladder Neoplasms

Thyroid Neoplasms

Thyroid Diseases

Carcinoma, Renal Cell

Sarcoma

Kidney Neoplasms

Colonic Neoplasms

Carcinoma

Rectal Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Urologic Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Kidney Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Connective and Soft Tissue

Quality of Life

Renal Cell Carcinoma

Small Intestine Cancer

Soft Tissue Sarcoma

Herbal and Botanical

All Drugs and Chemicals

Cola

Participants will practice BMT under the instruction of a BMT instructor. There will be 24 sessions. Each session will last 60 minutes and will occur twice a week for 12 weeks. Each session will include both light physical exercise and mind training.

Sessions will be supplemented with home-based practice using an instructional DVD and handouts. Participants will be instructed to practice at least 30 minutes a day (at least 3 days per week) throughout the intervention and post-intervention period.

Body Mind Training (BMT)

Participants will practice BT under the instruction of a BT instructor. There will be 24 sessions. Each session will last 60 minutes and will occur twice a week for 12 weeks. Sessions will be supplemented with home-based practice using an instructional DVD and handouts. Participants will be instructed to practice at least 30 minutes a day (at least 3 days per week) throughout the intervention and post-intervention period.

Body Training (BT):

Participants in the usual care arm will receive care as normal and will not attend classes but will complete the same assessments as participants in the BMT and BT classes.

Michael R. Irwin, MD

Project HERO is a 12-week study of the efficacy of Body Mind Training (BMT) for reducing fatigue in male cancer survivors. This 3-arm randomized clinical trial will examine inflammatory biology and selected gene-expression pathways that are hypothesized to contribute to the intervention's effect.

This study will establish the efficacy of a 12-week Body Mind Training (BMT) for reductions in fatigue (the study's primary outcome). Secondary patient-reported outcomes include quality of life changes (e.g. changes in sleep and perceived psychological distress), changes in the biomarkers of inflammation; including genome wide transcriptional factors, and expression of fatigue-related genes.

There are over 9 million cancer survivors that are 55 years of age or older. Cancer survivors in this age group have unique challenges coping with late and long-term effects of having had a cancer diagnosis and treatment, coupled with age-related declines and comorbidities. This may influence their ability to engage in lifestyle interventions because of slower post-treatment recovery, increased functional limitations, and other quality of life (QOL) impairments. Fatigue is common, under-recognized, undertreated and correlated with impairments in psychological distress, social and functional well-being and health-related QOL in cancer survivors. For male cancer survivors suffering from fatigue, body-mind training (BMT) may be more appealing because it is not overly physically exertive and is safe for people 55 years of age or older.

After obtaining informed consent and baseline assessments, 210 fatigued cancer survivors age 55 years and older will be randomized to the BMT arm or intensity-matched Body Training (BT), or Usual Care (UC) arms. Patient-reported assessments (surveys) will occur at baseline (within 2-weeks pre- intervention), mid-intervention (6 weeks), 1-week post-intervention (13 weeks), and at 3 months and 12 months post-intervention. Phlebotomy is done at baseline, 1 week post intervention (13 weeks), and 3 months and 12 months post intervention. Dietary assessments are done at baseline, and week 13 (1 week post intervention), 3 months and 1 year post-intervention. Physical activity is assessed weekly throughout the intervention. Sleep diaries are collected at all time points.

Participants will be instructed not to discuss their arm assignment with study personnel during their assessments; questionnaires will be self-administered, administered in person or by telephone based on participant need and preference. Some investigators, the data manager, biostatisticians, biometric testing and lab technicians will be blinded to intervention allocation. The technicians who analyze biospecimens will be blinded to all other data.

Project HERO: Health Empowerment & Recovery Outcomes

Biobehavioral Effects of Body Mind Training (BMT) for Male Cancer Cancer Survivors With Fatigue (HERO)

Change in fatigue levels over time: measured with 13-item scale assessing the level of fatigue during usual activities over the 7 days prior to the measurement timepoint, with higher scores indicating less fatigue. Administered at several time points to measure the effect the intervention.

Questionnaire: consists of 3 categories related to the risk of having sleep apnea. Patients can be classified into High Risk or Low Risk based on their responses to the individual items and their overall scores in the symptom categories.

Blood samples will be collected at using standardized procedures. The dynamics of inflammation will be measured by using a vertically integrated mechanistic approach and examining upstream signaling pathways and circulating levels. Circulating levels will be assessed by assay of plasma pro- and anti-inflammatory biomarkers; Inflammatory signaling as indexed by activation of key inflammatory transcription factors (e.g., NF-κB) will be measured using intranuclear staining and flow cytometric analyses. Genome-wide transcriptional analyses (all baseline and 13-week biospecimens) will be used to identify the differential regulation of gene expression and the molecular inflammation-related signaling pathways that are plausible candidates driving these changes (e.g., NF-κB).

Specimen collection and analysis to measure mRNA intercorrelations: 1) Inflammation, Vasodilation, and Metabolite Sensing and 2) Energy and Adrenergic Activation.

Questionnaire: Psychological distress (depression and anxiety) is measured using the using the Brief Symptom Inventory-18 instrument. Items are summed to calculate the raw score, range 0-72. Raw scores can be converted to T-scores, based on US population norms. Participants with T-scores that are ≥ 63 are considered a "case," and may need professional help. Somatization Scale: Raw score range 0-24, with 24 indicating high somatization. Depression Scale: Raw score range 0-24, with 24 indicating high depression. Anxiety Scale: Raw score range 0-24, with 24 indicating high anxiety.

Questionnaire: Provides scores for each of the eight health domains and psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores. The raw score of each of the eight SF-36 dimensions was derived by summing the item scores. Subtract the lowest possible raw score from the actual raw score, divide by the possibly raw score range, and multiply by 100 to get the transformed scale. Higher scores indicate better health-related quality of life.

The sleep diary is designed to gather information about daily sleep patterns. Sleep diary is maintained for 7 days prior to each data collection time point.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Does Knowing One's Estimated Colorectal Cancer Risk Influence Screening Behavior?	NCT03819920	Colorectal Canc...	Risk Assessment... Usual Care (UC)	50 Years - 75 Years	Stanford University
Capitalizing on a Teachable Moment to Promote Smoking Cessation	NCT02276664	Smoking Cessati...	Self-Help (SHI) Usual Care (UC)	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) Project	NCT03326713	Breast Cancer Ovarian Cancer	Telephone Couns... Mailed Targeted... Usual Care (UC)	21 Years -	Rutgers, The State University of New Jersey
Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) Project	NCT03326713	Breast Cancer Ovarian Cancer	Telephone Couns... Mailed Targeted... Usual Care (UC)	21 Years -	Rutgers, The State University of New Jersey
Project HERO: Health Empowerment & Recovery Outcomes	NCT03345563	Prostate Cancer Bladder Cancer Kidney Cancer Colon Cancer Rectum Cancer Thyroid Cancer Lung Cancer Small Intestine... Soft Tissue Can...	Body Mind Train... Body Training (... Usual Care (UC)	55 Years -	Rutgers, The State University of New Jersey

Spots Global Cancer Trial Database for usual care (uc)