The primary objective of this trial is to evaluate quality of life outcomes in patients with CRLM during a patient-controlled follow-up approach. Secondary objectives are to evaluate anxiety, fear of cancer recurrence, survival, and the cost-…
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Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of this trial is the quality of life. The effect of
follow-up on health related quality of life will be assessed by the validated
European Organisation for Research and Treatment of Cancer core quality of life
questionnaire (EORTC QLQ-C30).
Secondary outcome
In addition to evaluating the quality of life using a retrospective
questionnaire, ecological momentary assessment will also be performed. The
momentary quality of life is considered one of the secondary endpoints and will
be evaluated every 10 days for the entire duration of the study by requesting
patients to complete the Life Evaluation Index (LEI) from the larger Gallup
Healthways Well-Being Index (GHWBI) on their smartphone (or computer if
desired).
The other secondary outcomes are anxiety (measured by the State-Trait Anxiety
Inventory: six-item short-form (STAI-6)), fear of cancer recurrence (measured
by the cancer-worry subscale of the assessment of survivor concerns (ASC-CW)),
survival, and cost-effectiveness. Cost-effectiveness will be evaluated by
calculating the incremental cost-effectiveness (C/E) ratios, using the EQ-5D-5L
questionnaire as a utility measure and by assessing the intramural costs
directly associated with the follow-up after resection of CRLM(assessed by
review of medical records) and extramural costs (assessed by a selection of
relevant questions from the Medical Consumption Questionnaire (iMCQ) form the
institute of Medical Technology Assessment).
All of the retrospective questionnaires, with the exception of the ASC-CW, will
be completed at baseline and every 6 months thereafter until the end of the
study (3 years after inclusion). The ASC-CW scale will be completed once at 12
months following inclusion and in case of no disease recurrence. This is due to
the concern that the nature of the questions of the ASC-CW might directly
affect the measurement of itself and/or other questionnaires when completed
frequently. The ecological momentary assessment of momentary quality of life
will be performed for the entire duration of the study.
Since up to 70% of recurrences after curative treatment of CRLM present within
2 years, the expected effect of the intervention is greatest in this
time-window. Therefore, analyses of the primary and secondary endpoints will
be performed 18 months after inclusion of the last patient (roughly 2 years
after curative treatment of CRLM) and after completion of the study (3 years
after inclusion of the last patient). The study will be seen as successful if
quality of life measured at 18 months is non-inferior compared to reference
values.
Background summary
To date no evidence-based surveillance protocol after resection of colorectal
liver metastasis (CRLM) has been developed, mostly due to the lack of
prospectively gathered data. The traditional follow-up approach in most
hospitals consists of regular clinical evaluation, carcinoembryonic antigen
(CEA) monitoring and thoracoabdominal CT-scans. However, current literature
indicates that follow-up could mainly be based on CEA monitoring and that other
diagnostic modalities have little additional value, with regards to survival
outcomes.
As frequent multimodality surveillance does not seem to result in better
survival outcomes, improvement of follow-up should focus on optimizing
patients* quality of life, rather than survival. A patient-controlled follow-up
scheme, mainly consisting of CEA level monitoring at home, might be feasible
and beneficial from both a patient and societal perspective. In view of the
increasing importance of value based healthcare and patient reported outcomes,
evaluation of such a surveillance programme is needed.
The current prospective study aims to evaluate a patient-controlled
surveillance strategy. We hypothesize that a patient-controlled follow-up
results in improved quality of life outcomes after treatment of CRLM.
Study objective
The primary objective of this trial is to evaluate quality of life outcomes in
patients with CRLM during a patient-controlled follow-up approach. Secondary
objectives are to evaluate anxiety, fear of cancer recurrence, survival, and
the cost-effectiveness of this follow-up approach.
Study design
A multicentre prospective cohort study.
Intervention
Patients will enrol in a patient-controlled surveillance strategy. In this
follow-up approach blood sampling will be performed at home by the patients
themselves using a self-administered blood-sampling kit. Serum CEA monitoring
will be performed every 3 months during the first 2 years of follow-up after
inclusion and every 6 months thereafter. Further clinical evaluation with use
of subsequent medical imaging at the discretion of the specialist will be
performed in case of symptoms, CEA levels above 5 µg/L or a two-fold increase
in serum CEA compared to the first postoperative CEA, or two consecutive
increases in serum CEA. Patients will have one planned in hospital evaluation
with medical imaging (CT and/or MRI) 1 year (12 months) after inclusion. In
case of normal CEA values, patients decide themselves whether in hospital
evaluation is desired.
Study burden and risks
We hypothesize that a patient-controlled follow-up at home improves quality of
life outcomes and reduces anxiety and fear of cancer recurrence. These
hypotheses were substantiated by way of systematic patient-interviews. We also
expect the patient-controlled approach to achieve an equal or greater
cost-effectiveness. No differences in survival outcomes are expected based on
our extensive review of currently available literature.
This study will provide valuable insights in the questions currently
surrounding follow-up, mainly whether current follow-up practices based on
frequent hospital visitations and medical imaging can be replaced by a more
modern, patient centred follow-up schedule performed mainly, if desired, at
home. Therefore, our aim is to identify an optimal way of monitoring patients
after resection of CRLM. An individualized surveillance approach fits well with
the current era of value based healthcare and patient reported outcomes. The
results of this trial will be used to create evidence based guidelines for
long-term surveillance of these patients.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- Patients with CRLM treated with curative intent
- Age >= 18 years
- ECOG performance status <= 2
- Histologically confirmed and previously resected primary colorectal carcinoma
- Disease-free at three to six months after CRLM treatment (assessed by medical
imaging)
- Disease-free at three to six months after treatment for colorectal metastases
and a history of CRLM (assessed by medical imaging)
Exclusion criteria
- Metastatic extrahepatic disease (EHD) precluding curative treatment of CRLM
- Patients with confirmed hereditary CRC
- 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 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| Other | NTR7278 |
| CCMO | NL66210.078.18 |