NCT06613581

Brief Summary

The primary goal of the patient-led follow-up from home, is the improvement of quality of life and the reduction of stress in patients, while obtaining a more complete picture of their health status. A series of assessments are performed in the home setting:

  • Blood withdrawal for CEA determination
  • Quality of life questionnaires to assess both mental and physical symptoms
  • Vital parameters using a Smart Sensor

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
65mo left

Started Jul 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Jul 2024Sep 2031

Study Start

First participant enrolled

July 18, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 26, 2024

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2031

Last Updated

September 26, 2024

Status Verified

September 1, 2024

Enrollment Period

5.1 years

First QC Date

September 23, 2024

Last Update Submit

September 23, 2024

Conditions

Colorectal Carcinoma (CRC)

Keywords

Colorectal carcinomaHome-based follow-upPatient-ledCapillary blood samplingBiosensorEORTC

Outcome Measures

Primary Outcomes (2)

  • Quality of life

    The primary outcome of this study is to evaluate non-inferiority of the study follow-up with respect to the EQ-5D-5L score at 36 months of follow-up, which starts within 6 months of resection of the primary tumour.

    36 months

  • Number of in hospital visits

    The second primary outcome consists of significantly decreasing the number of in-hospital appointments, by relocating this follow-up care to the home setting. This will be assessed at 36 months postoperatively.

    36 months

Study Arms (1)

Implementation of home-based follow-up

EXPERIMENTAL

All patients within the PROMISE study are included in the 'experimental' arm. The study is set up as an implementation study, meaning that the home-based method of follow-up is applied to all patients in the study.

Other: Home-based follow-up

Interventions

Home-based follow-upOTHER

Follow-up after surgery for colorectal carcinoma, performed from home, within the bounds of the Dutch National guidelines

Implementation of home-based follow-up

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 21 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
  • Access to a smartphone

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
  • Patients with active implantable devices - e.g. pacemaker or implantable defibrillator
  • Inability to complete the questionnaires due to illiteracy and/or insufficient proficiency of the Dutch language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Amphia Hospital

Breda, North Brabant, 4818CK, Netherlands

NOT YET RECRUITING

IJsselland Hospital

Capelle aan den IJssel, South Holland, 2906ZC, Netherlands

NOT YET RECRUITING

Leiden University Medical Center

Leiden, South Holland, 2333ZA, Netherlands

NOT YET RECRUITING

Erasmus Medical Center

Rotterdam, South Holland, 3015GD, Netherlands

RECRUITING

Franciscus Gasthuis and Vlietland

Rotterdam, South Holland, 3045PM, Netherlands

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Dirk J. Grunhagen, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elise M.H.E. van Driel, MD

CONTACT

+310107042125m.h.e.vandriel@erasmusmc.nl

Lissa Wullaert, MD

CONTACT

0031 0107042125l.wullaert@erasmusmc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: All patients included in the study will be followed-up according to the home-based follow-up protocol. The PROMISE study is an implementation study, to further develop and improve home-based follow-up.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Surgical oncologist, MD, PhD

Study Record Dates

First Submitted

September 23, 2024

First Posted

September 26, 2024

Study Start

July 18, 2024

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2031

Last Updated

September 26, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

IPD can be shared, but exclusively upon reasonable request with the affiliated researchers

Locations

NL(5)