Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06073548 |
| Other study ID # |
IC 2022-11 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2023 |
| Est. completion date |
April 1, 2026 |
Study information
| Verified date |
September 2023 |
| Source |
Institut Curie |
| Contact |
Anne BREDART |
| Email |
anne.bredart[@]curie.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The goal of this prospective observational study is to learn about patient quality of life
and experience and medical information needs during uveal melanoma post-treatment
surveillance. Participants have previously undergone treatment for non-metastatic uveal
melanoma and have integrated a oncological and / or ophthalmic surveillance protocol based on
their individual genomic and / or clinical risk of recurrence. The main objectives it aims to
assess are:
- To evaluate the effect of satisfaction with communication with the
oncologist/ophthalmologist during the oncology/ophthalmology surveillance visit 6 months
after the start of surveillance (T1) on the overall level of health status/quality of
life (QoL).
- To explore the impact on psychosocial resources and needs such as fear of recurrence,
anxiety and depression 6 months after the start of surveillance (T1) and 12 months after
the start of surveillance (T2).
- To document patients experience of care and communication during the first 12 months of
surveillance.
Participants will fill in quality of life questionnaires at two timepoints. A sub-sample will
be offered to participate in qualitative research interviews. Researchers will compare data
from patients at low risk of recurrence with those at high risk of recurrence to see if there
are significant differences with regards to quality of life, satisfaction with care and
medical information needs.
Description:
Context and scientific background Uveal melanoma (UM) is the most common malignant ocular
tumour in adults. It is a rare disease with an incidence of four to seven new cases per
million per year in western countries (Mathis, 2018). The diagnosis of uveal melanoma is
usually made when vision problems appear and the disease is still at a localized stage (in
95% of cases). Historically, the standard treatment for uveal melanoma was enucleation.
Today, around 75% of patients can benefit from conservative treatment approaches such as
brachytherapy or proton beam therapy without increasing the risk of metastasis or affecting
survival. The visual prognosis of uveal melanoma depends on the localization of the tumour
and efficacy of the treatment. Vital prognosis depends on the metastatic risk, which is
related to the tumours' size and genomic characteristics (AJCC 7th Edition, 2015).
Up to 50% of patients develop metastases within a median time range of 2 to 3 years (Tuomaala
& Kivelä, 2004). Metastatic progression develops most frequently in the liver (in >80% of
cases). Once the disease spreads to the liver, median survival ranges from 3 to 12 months
(Mariani, 2012) and response to treatment is rare. Estimating metastatic risk allows to
provide personalized surveillance. For high risk patients, current international
recommendations (NICE 2015) advise surveillance with liver CT or MRI (magnetic resonance
imaging) every 6 months for over 10 years. If uveal melanoma metastases are diagnosed early,
surgical liver resection can be considered in 25% of patients (Mariani, 2016). For the
remaining 75%, systemic palliative care is recommended.
Various studies have addressed the effects of localized uveal melanoma and its treatment on
quality of life (QoL). The QoL of patients with uveal melanoma appears to be significantly
lower compared to matched general population (Erim, 2016; Miniati, 2018). Within the two
years after treatment, overall QoL appears to be similar in patients treated by either
enucleation or radiotherapy (Hope-Stone, 2016). Furthermore, no difference has been found
between these treatments regarding specific aspects of QoL such as the ability to drive,
ocular irritation, headaches, concerns regarding body image, and fear of recurrence
(Hope-Stone, 2019). However, 6 months after treatment, functional difficulties are more
important in enucleated patients, whereas difficulties in central and peripheral vision as
well as in reading are higher in patients treated by radiotherapy (Hope-Stone, 2019). A large
prospective study, conducted over a 20 year-period, concluded that overall quality of life
was worse in enucleated patients than in patients treated with radiotherapy. However, this
difference is not attributed to the treatment but to factors predisposing to treatment
choices such as a more severe disease (e.g., larger tumour) (Damato, 2018).
During post-treatment surveillance, important aspects of QoL appear to be altered in patients
treated for uveal melanoma. Depression and QoL levels seem to be worse around three months
post-treatment (Amaro, 2010). Specific problems affecting QoL persist such such as body image
troubles, especially in enucleated patients, as well as psychological adjustment, and social
functioning difficulties, especially when vision problems persist.
As reported by items of the EORTC QLQ-C30 questionnaire, 39% of patients may have significant
vision problems and 33% may report being 'worried about their future health' (Frenkel, 2018).
The latter issue refers to fear of cancer recurrence (FCR) which is defined as the "fear,
worry, or concern relating to the possibility that cancer will come back or progress" (Lebel,
2016). It is characterized by intense worry, intrusive thoughts and difficulty planning the
future. Fear of recurrence (Suchocka-Capuano, 2011; Damato, 2018) has shown to be high and
persists over time. These fears are related to uncertainty regarding future health. They
result in anxiety and depressive symptoms, which significantly affect overall quality
(Hope-Stone, 2015). Risk factors predisposing to distress include tumour stage and time since
the beginning of surveillance. (Klingenstein, 2020) and persistent or emerging post-treatment
symptoms and functional limitations (Brown, 2021). To our knowledge, only one study has
examined unmet needs in patients with non-metastatic uveal melanoma, highlighting significant
unmet medical information and psychological needs within 1 week after diagnosis and 3 months
later (Williamson, 2018).
Prognostication tools based on clinical and genomic factors are available in routine practice
(Cassoux, 2014). These tools may be used in consultation to inform cancer patients about the
estimated risk of recurrence and associated life expectancy. Studies evaluating the
psychosocial impact of communicating genomic test results and informing patients about their
risk of cancer recurrence have been conducted primarily with breast cancer patients to guide
the choice of adjuvant therapy. They suggest that a poor understanding of genomic tests
results leads to increased anxiety (Pellegrini, 2012). Higher levels of anxiety are also
related to lower satisfaction with having this testing done (Tzeng, 2010). Regarding the
utilization of these tests in patients with uveal melanoma, studies from Anglo-Saxon
countries report that many patients want to be informed of the genomic test result indicating
their risk of metastatic recurrence (Beran, 2009; Damato, 2013; Brown, 2020). Risk
estimations are provided in the form of numbers accompanied by graphs or pictograms to help
interpret and understand the information, and thus enable informed decision-making concerning
care and monitoring. However, a significant number of patients also experience regrets about
being informed of their genomic test result and risk of recurrence, regardless of their
personal risk status (Schuermeyer, 2016).
MRI appears to be the most sensitive screening method available for the early detection of
metastases (Piperno-Neumann, 2015). Institut Curie has developed a clinical trial in which
patient surveillance is tailored based on the risk of metastatic recurrence. In this trial,
patients at high risk of recurrence receive liver MRI every 6 months. As for patients at high
risk intense surveillance in terms of frequency and type of medical testing is recommended,
patients may know that they have a higher risk of disease recurrence. However, there is no
scientific data on this. Therefore, it is important to assess how patients with uveal
melanoma at high risk of recurrence perceive the information provided by the oncologist (e.g.
regarding risk of recurrence testing) and to evaluate its impact on quality of life, and more
precisely, fear of recurrence. In general, cancer patients whose information needs are met
have better QoL and lower levels of anxiety and depression (Husson, 2011). Nevertheless, up
to now, we have little knowledge about the relation between information needs and QoL in UM
patients (Lieb, 2020). This study shows that prognostic testing may help to alleviate
distress and promote more realistic risk perception. Furthermore, even less information
exists in French culture, where the communication of precise numeric estimations of
recurrence risk may not be well accepted. Cultural factors affect patients' care needs, their
expectations and expression of wishes, and influence clinicians' attitude in the relationship
and communication with patients. Specifically, Anglo-Saxon cultures tend to value
self-determination and autonomy, which impact the amount, precision and timing process of the
medical information requested or provided in situations of medical uncertainty (Razavi,
2019).
Moreover, most studies on quality of life and psychosocial needs in patients affected with UM
as cited above are conducted in countries with an Anglo-Saxon culture (Schuermeyer, 2016;
Damato, 2018; Hope-Stone, 2019). Studies performed in other countries do not have a
prospective design (Moschos, 2018; Frenkel, 2018) and use heterogeneous quality of life
assessments which make comparisons and synthesis of results difficult (Miniati, 2018). To sum
up, we lack robust, prospective data on needs and satisfaction with type and amount of
information provided and their impact on QoL in French cancer patients with either a
confirmed high risk or low risk of relapse. Advances in prognostication of cancer recurrence
and identification of predictive biomarkers of response to treatment in oncology as well as
the availability of genomic tests in clinical practice (Cassoux, 2014; Piperno-Neumann,
2019), increase the importance to evaluate how French patients perceive medical communication
about the results of these tests and their impact on QoL and fear of metastatic relapse.
A patient-centered approach seems to enhance QoL (Brédart, 2013; Castro, 2016).
Patient-centered care entails attention to the patient's communication needs, personalized
information, emotional support, care coordination and continuity. This kind of approach
promotes patient's ability to remember medical information, understanding of medical
recommendations, and satisfaction with care. Furthermore, it can minimize uncertainty and
distress. In the context of uveal melanoma, patients may expect information regarding their
risk of metastatic recurrence, which enables them to anticipate potential medical and/or
personal consequences (e.g., on medical follow-up, personal life choices). In this context,
some patients may need major attention and emotional support from their physician. A referral
to psychological counselling and further supportive care may also be helpful (Hope-Stone,
2018).
In uveal melanoma, the information of high metastatic recurrence risk is generally
communicated by an oncologist to whom the patient is referred and who implement a first
oncology surveillance visit (~ 2 months post-treatment). This patient generally does not see
his/her hospital ophthalmologist anymore. In contrast, UM patients at low risk of recurrence
continue to be follow-up by this specialist in collaboration with an extra-hospital
ophthalmologist. Patients' QoL and fear of recurrence may be affected by their satisfaction
with the interactions with clinicians and cancer care services. For UM patients these aspects
are thus relevant in terms of patient-reported outcomes. Studies with breast cancer patients
have shown that sharing emotions with physicians can reduce fear of recurrence after
radiation therapy. It reflects the effect of communication processes on this aspect of QoL
(Humphris, 2019). To our knowledge, the association between the patients' satisfaction with
information and their QoL and fear of recurrence has never been explored in the context of
non-metastatic uveal melanoma at either high or low recurrence risk.
Methodology This is a single-centre, prospective observational study, which combines a
quantitative and qualitative research approach. This mixed method design will enable to
explore the relationships between patients' experience of communication with the oncologist,
and quality of life, and fear of recurrence.
At six months (+/- one month) after the end of treatment (T1), patients will be invited to
participate in the study. They will be invited to complete a set of questionnaires, including
the EORTC QLQ-C30, EORTC QLQ-OPT30 quality of life questionnaires and the FCRI Fear of cancer
recurrence inventory. Patients will be invited to complete some of these measures again at
T2, i.e. 12 months (+/- one month) post-treatment. Clinical data will be collected at T1 by
the researcher.
A complementary sequential qualitative study will be conducted involving a random sub-sample
of the study population after completion of questionnaires. A purposive sampling will target
an equivalent number of patients per UM treatment (enucleation vs radiotherapy only) and
surveillance modality (MRI for high risk vs CT scan only for low risk).
An interview guide will be developed to explore: how oncologist- or ophthalmologist-patient
interactions potentially relate to fear of recurrence and quality of life during the first
6-month of follow-up; how oncologist or ophthalmologist-patient interactions can minimize the
effect of factors such as physical symptoms and functional limitations which are likely risk
factors for persistent fear of recurrence (Brown, 2021); what about the more intensive
follow-up of uveal melanoma at high risk of recurrence, the information given and their
impact on fear of recurrence and quality of life? Data are collected using psychometrically
validated questionnaires, items adapted from the literature and from the medical records for
age, gender and clinical information.
The EORTC QLQ-C30 (30 items) (Aaronson, 1993) is used to assess functioning difficulties,
symptoms and general aspects of quality of life.
The EORTC QLQ-OPT30 module (30 items) (Brandberg, 2004) will be used to measure aspects of
quality of life specific to ocular cancers and their treatments (e.g., ocular irritation or
difficulties with daily activities).
For both the QLQ-C30 and QLQ-OPT30, a score from one to 100 is calculated on each scale. A
high score for a functional scale or the global health status/QoL denotes high/healthy level
of functioning and high QoL, while high score on symptom scales denotes high level of
symptomatology/problem.
The FCRI (42 items) (Simard, 2009) measures fear of cancer recurrence in seven factors:
Triggers, Severity, Psychological Distress, Coping Strategies, Functioning impairments,
Insight, and Reassurance. The total score ranges from 0 to 168. A higher score indicates a
higher level of fear of recurrence. A cut-off score of 13 on the FCRI Severity Subscale was
found to be associated with optimal sensitivity and specificity for detection of clinical
levels of FCR.
Anxiety and depression are assessed by the HADS (14 items) (Zigmond & Snaith, 1983; VF Razavi
et al., 1990). This questionnaire includes 14 items whose answers are scored 0 to 3 Higher
scores indicate higher levels of anxiety and/or depression.
The EORTC QLQ-INFO25 (25 items) (Arraras et al., 2010) is used to assess the perception of
information about the disease and treatment. It is composed of 4 multi-item scales
(information about disease, medical tests, treatment and other services) and eight single
items. Response to each item are scored from 1 to 4. The sum of scores by dimension is
transformed into a score from 0 to 100 scale. A high score on a given subscale indicates a
higher amount of received information or of higher levels of satisfaction. Among single
items, one addresses the wish to receive additional information and another the wish to
receive less information, with response options yes versus no.
Multi-item subscales of the EORTC PATSAT-C33 (27 items) (Brédart, 2018) are used to assess
technical skills, information exchange and interactions with physicians; and services and
organisation of care in terms of coordination of care and interactions with all care
professionals. In this project we will also use a single item assessing overall quality of
care.
The multi-item scales or single items are scored in a similar way: (1) the scores of the
individual items in a scale are first summed up and then, for multi-item scales, divided by
the number of items in the scale; (2) these single item/scale scores are then transformed in
order to obtain a score range from 0 to 100, with a higher score representing a higher level
of satisfaction with care/perceived quality of care.
Data collected from clinicians: Perception of the surveillance consultation as well as
satisfaction with the consultation are assessed by a 6-items questionnaire similar to the
questionnaire addressed to patients.
