Colon Cancer Clinical Trial
Official title:
Can a Multimodal Approach Using SMS Reminders and an Opt-out Mailed FIT Kits Improve Participation in Colorectal Cancer Screening? A Single Center Randomized Controlled Trial
NCT number | NCT03479645 |
Other study ID # | 828624 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 23, 2018 |
Est. completion date | June 16, 2018 |
Verified date | July 2019 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This pilot study is a 2-armed randomized controlled trial assessing the impact of a multimodal approach on colorectal cancer screening participation rates in a Federally Qualified Health Center. The trial will test serial text message reminders and opt-out mailed fecal immunochemistry test (FIT) home kits against a simple reminder text message control. Patients aged 50-74 years, who are registered at a Family Practice and Counselling Network (FPCN) clinic and are overdue for colorectal cancer screening will be recruited. The primary outcome is the rate of FIT kits being returned at 12 weeks.
Status | Completed |
Enrollment | 440 |
Est. completion date | June 16, 2018 |
Est. primary completion date | June 16, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 74 Years |
Eligibility |
Inclusion Criteria: 1. aged 50-74 2. at least 1 clinic visit to the FPCN within the previous 12 months 3. due or overdue for colorectal screening 4. Asymptomatic for bowel cancer 5. mobile phone number available Exclusion Criteria: 1. Has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, and FOBT/FIT within twelve months of the chart review (We will exclude patients who self-report undergoing any of the above procedures) 2. Has a history of CRC 3. Has a history of other GI cancer 4. Has history of confirmed Inflammatory Bowel Disease (IBD) (e.g. Crohns disease, ulcerative colitis) Irritable bowel syndrome does not exclude patients. 5. Has history of colitis other than Crohns disease or ulcerative colitis 6. Has had a colectomy 7. Has been diagnosed with Lynch Syndrome (i.e. HNPCC) 8. Has been diagnosed with Familial Adenomatous Polyposis (FAP) 9. Has metastatic (Stage IV) blood or solid tumor cancer 10. Has end stage renal disease 11. Has dementia 12. Has liver cirrhosis 13. Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study. |
Country | Name | City | State |
---|---|---|---|
United States | Family Practice and Councelling Network | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
Clegg LX, Li FP, Hankey BF, Chu K, Edwards BK. Cancer survival among US whites and minorities: a SEER (Surveillance, Epidemiology, and End Results) Program population-based study. Arch Intern Med. 2002 Sep 23;162(17):1985-93. — View Citation
Halpern MT, Ward EM, Pavluck AL, Schrag NM, Bian J, Chen AY. Association of insurance status and ethnicity with cancer stage at diagnosis for 12 cancer sites: a retrospective analysis. Lancet Oncol. 2008 Mar;9(3):222-31. doi: 10.1016/S1470-2045(08)70032-9. Epub 2008 Feb 20. — View Citation
Hardcastle JD, Chamberlain JO, Robinson MH, Moss SM, Amar SS, Balfour TW, James PD, Mangham CM. Randomised controlled trial of faecal-occult-blood screening for colorectal cancer. Lancet. 1996 Nov 30;348(9040):1472-7. — View Citation
Institute NC. Caner trends progress reprot; Colorectal Screening. https://progressreport.cancer.gov/detection/colorectal_cancer
Power E, Miles A, von Wagner C, Robb K, Wardle J. Uptake of colorectal cancer screening: system, provider and individual factors and strategies to improve participation. Future Oncol. 2009 Nov;5(9):1371-88. doi: 10.2217/fon.09.134. Review. — View Citation
von Wagner C, Baio G, Raine R, Snowball J, Morris S, Atkin W, Obichere A, Handley G, Logan RF, Rainbow S, Smith S, Halloran S, Wardle J. Inequalities in participation in an organized national colorectal cancer screening programme: results from the first 2.6 million invitations in England. Int J Epidemiol. 2011 Jun;40(3):712-8. doi: 10.1093/ije/dyr008. Epub 2011 Feb 17. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Colorectal screening rate | The rate patients with who completed colorectal screening within the trial period | 12 weeks | |
Secondary | Per Protocol analysis: Colorectal screening rate | The rate of FIT kit return by trial arm in individuals who received at least the first text message, who did not self-report being up to date with colorectal cancer screening. | 12 weeks | |
Secondary | FIT kit return rate | The rate of FIT kit return by trial arm | 12 weeks | |
Secondary | Per protocol analysis: FIT kit return rate | The rate of FIT kit return by trial arm, in participants who received at least the first text message, who did not self-report being up to date with colorectal cancer screening. | 12 weeks | |
Secondary | colonoscopy completion rate | The rate of colonoscopy within the trial period by trial arm | 12 weeks | |
Secondary | Per protocol analysis: colonoscopy completion rate | The rate of colonoscopy within the trial period by trial arm, in participants who received at least the first text message, who did not self-report being up to date with colorectal cancer screening. | 12 weeks | |
Secondary | Colorectal screening return rate by gender | Uptake of screening and FIT return by gender | 12 weeks | |
Secondary | FIT return rate by gender | Uptake of screening and FIT return by gender | 12 weeks | |
Secondary | Colorectal screening rate by insurance status | Uptake of screening by insurance status | 12 weeks | |
Secondary | FIT kit return rate by insurance status | FIT return by insurance status | 12 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05551052 -
CRC Detection Reliable Assessment With Blood
|
||
Completed |
NCT03457454 -
Reducing Rural Colon Cancer Disparities
|
||
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04088955 -
A Digimed Oncology PharmacoTherapy Registry
|
||
Recruiting |
NCT06010862 -
Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors
|
Phase 1 | |
Terminated |
NCT01347645 -
Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT03390907 -
Hybrid APC Assisted EMR for Large Colon Polyps
|
N/A | |
Recruiting |
NCT03175224 -
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
|
Phase 2 | |
Completed |
NCT04079478 -
The AID Study: Artificial Intelligence for Colorectal Adenoma Detection
|
||
Active, not recruiting |
NCT04057274 -
Acute Effect of modeRate-intensity aerOBIc Exercise on Colon Cancer Cell Growth
|
N/A | |
Recruiting |
NCT03190941 -
Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT05147545 -
Impact of Exercise and Hyperlipidic Meal on Free Circulating DNA in Patients With Metastatic Colonic Cancer and Healthy Subjects
|
N/A | |
Recruiting |
NCT05026268 -
The Laparoscopic Right Colectomy With Intracoroporeal Anastomosis
|
N/A | |
Not yet recruiting |
NCT03277235 -
Effect of a Resilience Model-Based Care Plan in Newly Diagnosed Colorectal Cancer Patients
|
N/A | |
Active, not recruiting |
NCT02959541 -
PK/PD Investigation of Calciumfolinat in Blood, Tumor and Adjacent Mucosa in Patient With Colon Cancer
|
N/A | |
Active, not recruiting |
NCT02730702 -
Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure
|
||
Completed |
NCT02810652 -
Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection
|
N/A | |
Recruiting |
NCT02577627 -
Multi-Indication, Retrospective Oncological Study to Validate the Accuracy in Predicting TTP by PrediCare in Patients Under SOC
|
N/A | |
Terminated |
NCT02628535 -
Safety Study of MGD009 in B7-H3-expressing Tumors
|
Phase 1 | |
Recruiting |
NCT02526836 -
Complete Mesocolic Excision With Central Vessel Ligation Compared With Conventional Surgery for Colon Cancer
|
Phase 2/Phase 3 |