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Completed

NCT Number: NCT01505972

Time Schedules for Sending Invitations to Colonoscopy Screening

The attendance rate to population based primary screening colonoscopy within NordICC trial (The Nordic-European Initiative on Colorectal Cancer, NCT00883792) in Poland is roughly 33%. The aim of this study is to compare the effect of two different time schedules for sending invitations and reminding letters to a pre-specified colonoscopy appointment. 1,600 screening naive men and women 55 to 64 years of age are randomly assigned in a 1:1 ratio to receive invitation and reminder 6 and 3 weeks (SIX and THREE group) or 4 and 2 weeks (FOUR and TWO group) prior to pre-specified screening colonoscopy appointment date. Outcome measures are participation in screening colonoscopy within 6 months from the date of invitation, response and acceptance rate before sending a reminder. The study is powered to detect 7% difference in participation in screening colonoscopy.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

55 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center of Oncology Institute and the Maria Sklodowska-Curie

Warsaw, W.K.Roentgena, 02-781, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Individuals aged 55-64 years living in Warsaw area randomly drawn from Population Registry and randomized to the screening arm of the NordICC trial.

Exclusion criteria

  • Resident abroad
  • Return of unopened letter of invitation and/or reminder (address unknown)
  • Message from neighbour/family/post office on death of screenee (not updated in Population Registry).

Exclusion criteria

for colonoscopy:

  • Individuals with previous colorectal surgery (resections, enterostomies)
  • Individuals in need of long-lasting attention and nursing services (somatic or psychosocial, mental retardation).
  • On-going cytotoxic treatment or radiotherapy for malignant disease
  • Severe chronic (longer than trial duration) cardiac (NYHA III-IV)or lung disease
  • Lifelong anticoagulant therapy with Warfarin
  • A coronary event requiring hospitalization during the last 3 months
  • A cerebrovascular event during the last 3 months

Treatment and study plan

Six and three time schedule

Other

Invitation letter sent 6 weeks and reminder 3 weeks before a pre-specified screening colonoscopy appointment date.

Four and two time schedule

Other

Invitation letter and reminder sent 4 and 2 weeks before pre-specified screening colonoscopy appointment date.

Primary outcomes

  1. Participation rate

    Time frame: 6 months from the date of sending invitation letter

    Percentage of attenders to screening colonoscopy.

Secondary outcomes

  1. Acceptance rate in SIX &THREE group

    Time frame: 3 weeks from the date of sending invitation letter

    Percentage of invitees who agreed (by phone or letter) to participate in screening colonoscopy before sending a reminder

  2. Acceptance rate in FOUR&TWO group

    Time frame: 2 weeks from the date of sending invitation letter, respectively

    Percentage of invitees who agreed (by phone or letter) to participate in screening colonoscopy before sending a reminder

  3. Response rate in SIX&THREE group

    Time frame: 3 weeks from the date of sending invitation letter

    Percentage of invitees who responded (by phone or letter) before sending a reminder

  4. Response rate in FOUR&TWO group

    Time frame: 2 weeks from the date of sending invitation letter

    Percentage of invitees who responded (by phone or letter) before sending a reminder

Sponsors and collaborators

Lead sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Other

Collaborators

  • National Center for Research and Development, Poland

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 9, 2012
Registry last updated
Jan 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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