Follow-up after surgery for colorectal cancer: the FUTURE-primary implementation study

Follow-up after surgery for colorectal cancer: the prospective, multicentre FUTURE-primary implementation study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON27170

Enrollment

200

Registered

2021-10-28

Start date

2021-08-23

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer Quality of life Shared decision making Follow-up Cost-effectiveness

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: • Age = 18 years • 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

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

Design outcomes

Primary

Measure	Time frame
The primary objective of this study is to implement a patient-led home-based follow-up approach in patients treated surgically for CRC. A successful implementation of the patient-led aspect is defined as 75% or less of optional follow-up moments (i.e. CEA measurements) utilized.	—

Secondary

Measure	Time frame
The secondary objectives of this study are: • To measure successful implementation of out of hospital CEA measurement A successful implementation of the home-based aspect is defined as 25% or more of all CEA measurements actually being performed at home by the patients themselves. • To compare the quality of life with an in-hospital standard of care related cohort • To compare anxiety • To compare the fear of cancer • To compare overall and cancer-specific survival • To determine and compare the cost-effectiveness of follow-up • To predict follow-up preferences based on patients’ coping style • To measure patient satisfaction at the end of the follow-up period	—

Measure

Time frame

The secondary objectives of this study are: • To measure successful implementation of out of hospital CEA measurement A successful implementation of the home-based aspect is defined as 25% or more of all CEA measurements actually being performed at home by the patients themselves. • To compare the quality of life with an in-hospital standard of care related cohort • To compare anxiety • To compare the fear of cancer • To compare overall and cancer-specific survival • To determine and compare the cost-effectiveness of follow-up • To predict follow-up preferences based on patients’ coping style • To measure patient satisfaction at the end of the follow-up period

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Contacts

Public ContactKelly Voigt

Erasmus MC

k.voigt@erasmusmc.nl0107042125

Outcome results