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Colorectal CancerFUTURE-primaryNCT05656326

Follow-up After Surgery for Colorectal Cancer

An observational study of Colorectal Cancer and Quality of Life, run by Erasmus Medical Center at 1 site in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer, Quality of Life
How many people
200 participants
Where
1 siteNetherlands
Study dates
23 Aug 2021to Dec 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Kelly Raquel Voigt

    Rotterdam, South Holland, 3015 GD

Other trials in Netherlands

About this study

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

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).

Read the 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.

Keywords
Patient-led, Home-based
Medical subject headings
Colorectal Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Successful implementation

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

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

Secondary outcomes (9)

  1. 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

    Measured: Year 7

  2. 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.

    Measured: Year 7

  3. 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.

    Measured: Year 7

  4. 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.

    Measured: Year 7

  5. 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.

    Measured: Year 7

  6. 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.

    Measured: Year 7

  7. 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.

    Measured: Year 7

  8. 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.

    Measured: Year 7

  9. 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.

    Measured: Year 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2022
  2. Study start23 Aug 2021
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05656326
Sponsor's protocol ID
NL77810.078.21
Acronym
FUTURE-primary
Status last verified
Sep 2024
First submitted
2 Dec 2022
Last updated
25 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37827744

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer and Quality of Life, run by Erasmus Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful implementation (time frame: Year 7 (after the last follow-up moment of the last included patient)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05656326, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.

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