Primary Objective: 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…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study is a successful implementation of
patient-led home based follow-up in patients under surveillance for CRC.
Patient-led follow-up will be considered successful if the used optional follow
up rate is below 75%. The rationale being that if more than 75% of the optional
follow up moments are used, the added value of providing patients with a say in
the frequency of their postoperative surveillance is minimal, as most will opt
for the maximum frequency anyway.
Secondary outcome
Secondary endpoints of the study will be:
* Successful implementation of home-based sampling by the patients themselves,
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.
* Quality of life: measured by the QLQ-C30 43,44 (Appendix D)
* Health-related quality of life and the QLQ-CR29 45 (Appendix E)
* Momentary quality of life: measured by ecological momentary assessment using
the Global health status of the EORTC QLQ-C30 (Appendix F)
* Anxiety: measured by The State-Trait Anxiety Inventory: Six-Item Short-form
(STAI-6) 46,47 (Appendix G)
* Fear of cancer recurrence: measured by the Assessment of Survivor Concerns -
Cancer Worry subscale (ASC-CW) 48 (Appendix H)
* Cost-effectiveness: incremental costs and effectiveness will be determined:
• Utility measure: EQ-5D-5L questionnaire 49 (Appendix I)
• Intramural costs: assessed by review of patient records
• Extramural costs: assessed by a selection of relevant questions from the
Medical Consumption Questionnaire (iMCQ) form the institute of Medical
Technology Assessment.50 (Appendix J)
o Questions 14, 15 and 18 - 31 are omitted from the original questionnaire.
* Survival: both overall and cancer-specific, calculated from the date of
surgical resection to the date of death or last follow-up.
* Relation between coping style and follow-up preferences: measured by the
Threatening Medical Situations Inventory (TMSI) (Appendix K)
* Satisfaction of the patient-led home-based follow-up by a two-item
questionnaire at the last follow-up (Appendix L)
Background summary
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.
We therefore propose a patient-led home-based follow-up approach. This
follow-up strategy primarily consists of CEA level monitoring at home, but
additional counselling/diagnostic testing remains possible if desired by
patients. In this way we 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.
The currently developed implementation study aims to evaluate if such 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 CRC.
Study objective
Primary Objective:
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 Objective(s):
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 through use of a fingerprick lancet or TAP-II device.
• 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
Study design
The FUTURE-primary trial is a multicentre prospective regional implementation
study of a patient-led home-based follow-up approach after curative treatment
for CRC. Follow-up will be carried out for up to five years after surgery.
Follow-up will be performed in accordance with the current Dutch national
guidelines. Blood sampling will in principle be performed at home, while the
actual CEA measurements will be centralized and interpretation of the results
will be done by the treating physician in the participating centre (the centre
where the initial treatment was performed). Blood sampling is planned every six
months during the first two years after inclusion and yearly thereafter. One
year after surgery medical imaging (according to local practices) and clinical
evaluation will be scheduled. In hospital evaluation will only be performed in
case of abnormal CEA values or if desired by the patient (in case of normal CEA
levels). Subsequent use of medical imaging is used according to national
guidelines and local practices. The frequency of patient-initiated CEA
measurements and in-hospital evaluations cannot exceed the maximum amount of
the current Dutch national guidelines unless clinically indicated (e.g. CEA
increase or symptoms). The Dutch national guidelines advise CEA measurements
every three months during the first two years and every six months thereafter.
The desired frequency can be changed by the patient at any time.
Study burden and risks
We hypothesize that a patient-led home-based follow-up can be implemented
successfully. In addition, we hypothesize that such an approach improves
quality of life outcomes and reduces anxiety and fear of cancer recurrence when
compared with the contemporary in-hospital approach. These hypotheses were
substantiated by way of systematic patient-interviews. We also expect the home
based approach to achieve an equal or greater cost-effectiveness.
This study will provide valuable insights in the questions surrounding
follow-up, mainly whether current follow-up practices based on frequent
hospital visitations can be replaced by a more modern, home based follow-up
with an emphasis on shared-decision making. Therefore, our aim is to identify
an optimal, patient-tailored way of monitoring patients after surgical
treatment of CRC. An individualized home based surveillance approach fits well
in the current era of value based healthcare and patient reported outcomes. The
results of this study will be used to create evidence based guidelines for
long-term surveillance of these patients and could potentially lead to similar
studies and approaches in other suitable patient populations.
Dr.Molewaterplein 40
Rotterdam 3015 GD
NL
Dr.Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
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
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCTnummervolgt |
| CCMO | NL77810.078.21 |