Clinical trial NCT03082911: A Telephone Intervention to Improve Participation in a Screening Program.
Official title: Effectiveness of a Brief Telephone Intervention to Improve Participation in a Colorectal Cancer Screening Program: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Colorectal Neoplasms
Keywords: screening
early detection
participation
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2017-03-17
Enrollment: 432
Sex: ALL
Minimum age (years): 49
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Objective: To assess the effectiveness of a brief telephone intervention added to an post invitation letter in the participation rate to a colorectal cancer screening program.

Methods: Randomized controlled trial. This study is framed inside the colorectal cancer screening program of Catalonia, concretely in the region of Vallès Occidental. This program is directed to men and women from 50 to 69 years. The screening test used is the fecal immunological test (FIT) that is offered every 2 years. If the screening test is positive, a colonoscopy with sedation is offered as a diagnostic test.


Eligibility criteria: Inclusion Criteria:

* Women and men from 50 to 69 years living in the selected territories (Terrassa C, Terrassa A, Cerdanyola del Vallès 1) that will be invited for the first time in the Colorectal cancer screening program.

Exclusion Criteria:

* The same as those used in the population program:

  1. History of colorectal cancer;
  2. History of inflammatory bowel disease;
  3. history of colorectal adenomas;
  4. family history of polyposis syndromes or hereditary nonpolyposis colorectal cancer;
  5. family history of colorectal cancer if: two first grade relatives affected or only one fist grade relative affected diagnosed before the age of 60;
  6. terminal illness or severe disability which contraindicates the study of the colon. People is excluded temporally if:

     * 1) they have a colonoscopy performed in the last 5 years;
     * 2) present digestive signs or symptoms (rectal bleeding, change in bowel habits, abdominal pain, weight loss with fatigue and anorexia, abdominal mass);
     * 3) they express the will to be out of the Program.

Primary outcomes:
measure: Participation
timeFrame: 6 months
Secondary outcomes:
measure: Knowledge of the program
timeFrame: 1 day at the time of intervention administration
measure: Comprehension of the information received
timeFrame: 1 day at the time of intervention administration
measure: Help to decide about participation
timeFrame: 1 day at the time of intervention administration
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Corporació Sanitària Parc Taulí
state: Barcelona
Study officials:
References:
citation: Selva A, Tora N, Pascual E, Espinas JA, Bare M. Effectiveness of a brief phone intervention to increase participation in a population-based colorectal cancer screening programme: a randomized controlled trial. Colorectal Dis. 2019 Oct;21(10):1120-1129. doi: 10.1111/codi.14707. Epub 2019 Jun 17.