Follow-up After Surgery for Colorectal Cancer

NCT05656326 | Active Not Recruiting

• 1 other identifier: NL77810.078.21
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The currently developed implementation study aims to evaluate if a patient-led home-based follow-up approach is successful, improves quality of life, reduces anxiety and lessens fear of cancer recurrence during the years after surgical treatment of colorectal cancer (CRC).

Conditions

Colorectal Cancer; Quality of Life

Keywords

Patient-led; Home-based

Outcome Measures

Primary Outcomes (1)

• Successful implementation

  Patient-led follow-up will be considered successful if the used optional follow up rate is below 75%.

  Year 7 (after the last follow-up moment of the last included patient)

Secondary Outcomes (9)

• Successful home-based sampling

  Year 7

• Quality of life of cancer patients

  Year 7

• Health-related quality of life

  Year 7

• Momentary quality of life

  Year 7

• Anxiety

  Year 7

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are 18 years or older who received curative intent surgical treatment for CRC, and who (will) undergo postoperative surveillance are eligible. Patients can be included up to 6 months after surgery.

You may qualify if:

• Histologically confirmed colorectal adenocarcinoma without distant metastasis and treated with curative intent surgical resection less than 6 months ago
• Scheduled or currently undergoing postoperative surveillance according to national guidelines
• Written informed consent by the patient

You may not qualify if:

• Patients with a severely complicated postoperative course, needing in hospital follow-up longer than 6 months postoperatively
• Patients enrolled in other studies that require strict adherence to any specific follow-up practice with regular imaging - yearly or more frequent - of the abdomen and/or thorax
• Patients with comorbidity or other malignancy that requires imaging of the abdomen and/or thorax every year or more frequent
• Inability to complete the questionnaires due to illiteracy and/or insufficient proficiency of the Dutch language

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Kelly Raquel Voigt

Rotterdam, South Holland, 3015 GD, Netherlands

Location

Related Publications (1)

• Voigt KR, Wullaert L, Hoppener DJ, Schreinemakers JMJ, Doornebosch PG, Verseveld M, Peeters K, Verhoef C, Husson O, Grunhagen D. Patient-led home-based follow-up after surgery for colorectal cancer: the protocol of the prospective, multicentre FUTURE-primary implementation study. BMJ Open. 2023 Oct 12;13(10):e074089. doi: 10.1136/bmjopen-2023-074089.

  PMID: 37827744 DERIVED

Related Links

• Information video FUTURE-primary

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Dirk J. Grünhagen, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 19, 2022
• Study Start: August 23, 2021
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)