Follow-up After Surgery for Colorectal Cancer

Colorectal Cancer Clinical Trial

— FUTURE-primary  

Official title:

Follow-up After Surgery for Colorectal Cancer: the Prospective, Multicentre FUTURE-primary Implementation Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05656326
• Other study ID #: NL77810.078.21
• Status: Recruiting
• Start date: August 23, 2021
• Est. completion date: December 2029

Study information

• Verified date: December 2022
• Source: Erasmus Medical Center
• Contact: Kelly R Voigt, MD
• Phone: +316107042125
• Email: k.voigt[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2029
• Est. primary completion date: December 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Quality of Life

Locations

Country	Name	City	State
Netherlands	Kelly Raquel Voigt	Rotterdam	Zuid Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Successful home-based sampling	Defined as 25% or more of all scheduled or optional CEA assessments actually performed in blood collected by the patients themselves using the self-administered blood-sampling kit	Year 7
Secondary	Quality of life of cancer patients	Measured by the EORTC Core Quality of Life questionnaire (QLQ-C30). All scales and single-item measures range from 0-100 and are calculated using their respective formulas. Higher scores mean a better outcome.	Year 7
Secondary	Health-related quality of life	Measured by the EORTC Quality of Life Questionnaire - Colorectal Cancer Module (EORTC QLQ-CR29). All scales and single-item measures range from 0-100 and are calculated using their respective formulas. Higher scores mean a better outcome.	Year 7
Secondary	Momentary quality of life	Measured by ecological momentary assessment using the Global health status of the EORTC QLQ-C30. The 2 items are scored on a Likert-scale from 1 to 7. Higher scores mean a better outcome.	Year 7
Secondary	Anxiety	Measured by The State-Trait Anxiety Inventory: Six-Item Short-form (STAI-6). The STAI-6 comprises of 6 items, each scored on a Likert-scale from 1-4. The final score ranges from 20-80 and is calculated by adding up the score of all single items (positive items are reverse scored) and multiplying by 20/6. Higher scores mean a better outcome.	Year 7
Secondary	Fear of cancer recurrence	Measured by the Assessment of Survivor Concerns - Cancer Worry subscale (ASC-CW). The total score is calculated by adding up the individual items and ranges from 3-12. Higher scores mean a worse outcome.	Year 7
Secondary	Cost-effectiveness of a patient-led home-based follow-up	The primary effect measure for the economic evaluation will be quality of life, using the The European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L) as a basis for measuring utility. The EQ-5D-5L consists of five levels (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), each scored on a Likert-scale from 1-5 and a visual analogue scale (VAS) scored from 0-100. The total score can be converted into an index value to be used in QALY analysis by ways of an index value calculator taking into account country-specific reference values.	Year 7
Secondary	Relation between coping style and follow-up preferences	Measured by the Threatening Medical Situations Inventory (TMSI). Total monitoring and blunting scores are obtained by summing up the relevant items, ranging from 12-60.	Year 7
Secondary	Satisfaction of the patient-led home-based follow-up	By a two-item questionnaire at the last follow-up. The first question about satisfaction consists of a scale from 1 to 10. Higher score means a better outcome. The second question is an open question whether the patient has ideas to improve the follow-up.	Year 7

External Links

•   Information video FUTURE-primary