Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03838861 |
| Other study ID # |
Stinne1977 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2019 |
| Est. completion date |
January 28, 2025 |
Study information
| Verified date |
April 2022 |
| Source |
University of Southern Denmark |
| Contact |
Stinne Holm Bergholdt, PHD |
| Phone |
+45 40849722 |
| Email |
stinne.holm.bergholdt[@]rsyd.dk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This randomized controlled trial is testing the hypothesis that an individually focused and
need-based nurse led follow-up program supported by electronic Patient Reported Outcome
Measures for women with gynecological cancer will improve patient's empowerment, quality of
life and involvement in the follow-up process besides reducing the patient's fear of cancer
recurrence and degree of psychological distress, compared with a doctor led follow-up
program. Further, nurse led follow-up by telephone, may reduce resources of the department as
well as of the patients.
Description:
Background The 2015 release of a new "Follow-up Program for Gynecological Cancers" by the
Danish Health Authority (DHA) marked a break with traditional follow-up. The conclusion,
derived from a Health Technology Assessment report from 2009 assessing the value of follow up
in patients with endometrial and ovarian cancer, was, that regular follow-up visits do not
improve survival and may consume unnecessary resources from both patients and health care
personnel. As a consequence, a need based program was proposed where the follow-up is planned
individually and adjusted according to patient's needs, risks and resources. It was further
emphasized that patient's self-care ability should be supported and that access to specialist
assessment should be easy available.
The new follow-up program was soon implemented in most national gynecological centers without
previous evaluation in a pilot setting and with sparse evidence of benefits and harms.
Further, as the recommendations from the DHA were broad, various forms of the model were
introduced. Optimally, a national common professional agreement to standardize this
transformation should be made. However, there is neither consistency nor sufficient knowledge
about the optimal organizational follow-up model for gynecological cancer patients for this
to be accomplished.
Internationally, various follow-up models for patients with cancer have been tested over the
past decade. In the gynecological setting, evidence of the most optimal organization of
follow-up is sparse. In general, studies suggest that follow-up conducted in a nurse or
general practitioner setting demonstrate similar survival and recurrence detection rates and
similar or slightly better rates of satisfaction and quality of life as compared to follow-up
in a conventional setting.
From previous national studies on survivorship in Danish cancer patients it was learned
learned that involvement of the general practitioners (GPs) in the follow-up process was not
superior, and one in ten cancer patient was not satisfied with the contribution from their GP
during the follow-up. Further, studies have shown that socioeconomic status had a significant
impact on participation in rehabilitation activities of gynecological cancer patients with
cervical and ovarian cancer patients being especially vulnerable. Unmet needs after cancer
was found to be significantly associated with lower quality of life emphasizing the
importance of need assessment. Preliminary data from a local randomized trial of follow up
vs. no follow up in low risk endometrial cancer patients indicate that women report a higher
degree of fear of recurrence after cancer treatment if they receive no follow-up as compared
to a group receiving conventional follow-up. Hence, results obtained from prior studies on
survivorship following gynecological cancer treatment indicate that follow-up to some extent
seems needed and emphasize a need to develop new programs that facilitates self-management
but at the same time embrace those most vulnerable. Question is how the patients needs are
best accommodated with limited resources available. Comprehensive evaluation of effects,
benefits and harms are essential before implementation of new initiatives.
This randomized study suggests a strong focus on promotion of cancer patients' self-care
ability, in this study conceptualized as empowerment. Empowerment has been described as "a
process by which people, organizations, and communities gain mastery over their affairs" and
empowerment processes as "processes in which attempts to gain control, obtain needed
resources, and critically understand one's social environment are fundamental. The process is
empowering if it helps people to develop skills so that they can become independent
problem-solvers and decision-makers". Focus on improvement of patient empowerment may thus
unify the need for patient involvement, promotion of self-care ability and re-allocate
resources to those patients most vulnerable who are often neglected in the follow-up process.
Further, by empowering patients to master the consequences of their cancer disease, they may
have fewer unmet needs, which may altogether improve quality of life and reduce fear of
recurrence.
Use of electronic Patient Reported Outcome Measures (ePROMs) in the follow-up process has in
selected populations shown to improve quality of life, reduce emergency room visits and
hospitalizations, and improve quality-adjusted survival. Therefore ePROMs are suggested as
important elements of future follow-up programs for cancer patients.
By combining nurse-led, needs based and individually planned follow-up, support of patient
empowerment to self-manage with use of ePROMS to provide a safe and efficient follow-up
program, the extended model of follow-up of the present study may improve patient outcomes
and reduce economic as well as human resourses.
Study design Randomized, controlled study. Patients and health care professionals are not
blinded, but randomization will be carried out centrally and the allocation sequence is
computer-generated with varying block size and is kept unknown for all investigators. In
addition, the patient's randomization status will be blinded during data processing and
analysis.
The study will be developed, implemented and results will be published in accordance with the
CONSORT statement.
Participants and Setting Women with cervical or endometrial cancer who are surgically treated
at the Department of Gynecology at Odense University Hospital (OUH) are invited to
participate. Women referred to oncological treatment post operative, who do not speak or read
Danish, or where consent is unethical, i.e. caused by dementia, are not eligible. Patients
will be recruited from 2019-2021.
The project is carried out by project nurses and doctors of the Department of Gynecology at
OUH, where inclusion of patients and follow-up are conducted. The department operates 350-400
gynecological cancer patients annually, of which 50-70 with cervical cancer and 160-180 with
endometrial cancer. Overall, about 60% (126-150 patients per year) will meet the inclusion
criteria.
Patients, who do not wish to participate or for other reasons are not included, are referred
to the doctor led follow-up program, which was implemented as the new standard during the
autumn of 2017.
The project group consists of clinicians and researchers from the Department of Gynecology at
OUH and Clinical Institute, Research Unit for General Practice, and Department of Psychology
at University of Southern Denmark. In addition, patient representatives from the Danish
"Patient Association of Women with Gynecological Cancer" are invited to give feedback on the
proposed intervention, the questionnaires and all patient materials. In addition they will be
asked to participate in the interpretation of the study results.
Odense Patient data Explorative Network (OPEN) which is a non-profit research infrastructure
of OUH and University of Southern Denmark, contribute to the management of the questionnaires
and data collection by using the Research Electronic Data Capture (REDCap) technology.
Further, OPEN provides data management assistance and statistical support.
Study plan In the present study an innovative model is tested where specialized nurses handle
the follow-up of endometrial and cervical cancer patients in the intervention group. The
model is based on telephone consultations and developed to ensure timely identification of
alarm symptoms and potential needs and support of the patient's empowerment to manage life
after cancer.
Until the intervention baseline at 4 months post operative, all patients receive the same
follow-up. Hence, before randomization, all patients are offered a follow-up consultation
with a nurse 4 weeks post operative, where a need assessment is conducted using the
"Preparatory Form for the patient" as described by the Region of Southern Denmark in their
"Guide to need assessment of patients with cancer". Further, a disease specific list of alarm
symptoms prepared by working groups of the Danish Gynecological Cancer Group (DGCG) is
reviewed with the patient. The patient is carefully instructed to be aware of and contact the
department in case of symptoms from the list as they may indicate recurrence, and that access
to clinical examination is available and provided when needed.
All patients are eventually offered a follow-up consultation with a doctor 4 months post
operative, where a clinical assessment is performed and the Preparatory Form and symptom list
are reviewed as part of the needs assessment. If the patient meets the inclusion criteria,
she is asked to participate in the study and is randomized if consent is obtained. The
randomization status is immediately revealed. For control group patients a new appointment
with the doctor is arranged if needed, and for patients in the intervention group a telephone
follow-up with the attending nurse is arranged.
