Clinical trial NCT05656326: Follow-up After Surgery for Colorectal Cancer
Official title: Follow-up After Surgery for Colorectal Cancer: the Prospective, Multicentre FUTURE-primary Implementation Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Colorectal Cancer
Quality of Life
Keywords: Patient-led
Home-based
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Detailed description: As the available literature implies that intensive postoperative surveillance has no impact on (cancer-specific) survival outcomes in patients after curative intent surgery for CRC, critical appraisal of the current follow-up practice and guidelines is needed. Although patients in the referenced randomized controlled trials were included roughly 5 - 15 years ago, treatment for recurrent colorectal cancer has seen little to no change since then. Therefore, efforts to improve the current standard of follow-up in patients with CRC should focus on ameliorating quality of life and cost-effectiveness, rather than survival. It provides an opportunity to support patients emotionally, to evaluate treatment effects and complications, and to inform them on their individual prognosis. This is especially true considering the growing importance of value based healthcare and patient reported outcomes in medicine. The investigators therefore propose a patient-led home-based follow-up approach. This follow-up strategy primarily consists of carcinoembryonic antigen (CEA) level monitoring at home, but additional counselling/diagnostic testing remains possible if desired by patients. In this way the investigators hope to meet the individual needs of patients during follow-up and to improve quality of life outcomes, while achieving equal or greater societal cost-effectiveness.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Successful implementation
timeFrame: Year 7 (after the last follow-up moment of the last included patient)
Secondary outcomes:
measure: Successful home-based sampling
timeFrame: Year 7
measure: Quality of life of cancer patients
timeFrame: Year 7
measure: Health-related quality of life
timeFrame: Year 7
measure: Momentary quality of life
timeFrame: Year 7
measure: Anxiety
timeFrame: Year 7
measure: Fear of cancer recurrence
timeFrame: Year 7
measure: Cost-effectiveness of a patient-led home-based follow-up
timeFrame: Year 7
measure: Relation between coping style and follow-up preferences
timeFrame: Year 7
measure: Satisfaction of the patient-led home-based follow-up
timeFrame: Year 7
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Kelly Raquel Voigt
state: Zuid Holland
Study officials:
affiliation: Erasmus Medical Center
name: Dirk J. Grünhagen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: