The above mentioned developments are subject to the I CARE study. We hypothesize that general practitioner (GP) involvement improves both aftercare and preventive care resulting in improved quality of life and patients* satisfaction. Furthermore, a…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcomes include quality of life and patient satisfaction.
Secondary outcome
Secondary outcomes include physical outcomes, psychosocial outcomes, number of
investigations, referrals and related communication between secondary and
primary care, (time of) recurrence detection and protocol adherence, attention
to preventive care, cost effectiveness, and preference of care at the end of
the trial.
Background summary
It is expected that in 2020 more than 17.000 patients with colorectal cancer
will be diagnosed in the Netherlands. To date, after initial treatment patients
are included in a surgeon-led programme with the main focus on recurrence
detection. However, patients often experience multiple physical and
psychosocial problems in this phase. Currently, in secondary care these
problems are not always encountered and only a small number of distressed
patients are identified and supported. Both the Dutch Health Council as the
Dutch Cancer Foundation suggested more generalist care as a solution.
Furthermore, for patients it would be preferable to be able to undergo
rehabilitation as much as possible in their own environment. Evidence shows
that web-based interventions for patient empowerment can improve care. An
important development of these e-health facilities is the OncoKompas which is
an e-health application which facilitates direct-to-user delivery of
individualised healthcare.
Study objective
The above mentioned developments are subject to the I CARE study. We
hypothesize that general practitioner (GP) involvement improves both aftercare
and preventive care resulting in improved quality of life and patients*
satisfaction. Furthermore, a GP-led recurrence detection programme leads to at
least equal detection of recurrences. Also we hypothesize that the
implementation of an e-health application (OncoKompas) to support patients in
managing their own revalidation and aftercare and adapting to a healthier life
leads to more attention for multi-morbidity, preventive care resulting in an
improved quality of life and patients* satisfaction. Finally, we hypothesize
that GPs responsible for the recurrence detection programme will feel more
responsible for aftercare which will enhance revalidation and quality of life.
Study design
The present study proposal consists of a multi-centre 2x2 factorial randomised
controlled trial with a calculated total sample size of 300 patients, based on
the EORTC QLQ-C30. Patients will be randomised in four groups; 1. usual
follow-up visits and aftercare provided in secondary care (surgeon-led), 2.
usual follow-up visits and aftercare provided in secondary care with additional
use of the e-health application OncoKompas, 3. follow-up and aftercare in
primary care (GP-led), and 4. follow-up and aftercare in primary care with
additional use of the e-health application OncoKompas.
Intervention
1. Primary care-led follow-up and aftercare
2. Interactive personal website (OncoKompas)
Study burden and risks
With respect to recurrence detection in both groups (surgeon and GP-led
follow-up) the follow-up schedule is similar and according to the national
guideline which comprise of a clear programme which is convenient to carry out.
Also aftercare is provided according to the same national guideline in both
groups. Furthermore, there is no evidence in which line of care (primary versus
secondary care) aftercare and follow-up should take place.
Furthermore, patients will be appointed to use an interactive website to
empower patients in their revalidation. The use of this website is completely
optional. The questions asked at this website are based on validated quality of
life questionnaires. We have no reasons to think that these questions could
harm the psychological integrity of patients.
The questionnaires sent to patients ion the course of this trial contain
questions on physical, psychosocial wellbeing, sexuality and body image,
healthcare usage. The questionnaire takes about 30-45 minutes.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
•Carcinoma located in the colon and rectosigmoid defined as a tumour located 15
cm above the anal verge by coloscopy or above the sacral promontory as seen
preoperatively
•Stage 1, 2 and 3 carcinoma
•Surgical treatment with curative intent
•Qualified for routine follow-up attendance by surgeon according to the
national guideline.
•Patients with temporary stoma and who received adjuvant chemotherapy are also
eligible.
Exclusion criteria
•Stage IV colorectal tumours
•Hereditary colorectal cancer
•Colorectal cancer in patients with inflammatory bowel disease
•Rectal cancer
•(Sub)total colectomy or proctocolectomy
•History of second primary cancer (except basal cell carcinoma of the skin)
within the last 15 years
•Participation in other (clinical) research, which will affect the outcome
measurements of this trial
•Permanent open wounds after surgery or other conditions where specialised care
is needed
•Any other condition that warrants increased intensity of surveillance with
respect to colon cancer follow-up
•Not able to speak Dutch or English
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 |
|---|---|
| CCMO | NL51026.018.14 |
| OMON | NL-OMON20048 |
| OMON | NL-OMON24929 |