Clinical trial NCT05062447: Adaptive and Maladaptive Emotions in Patients With Cancer: Identification of Indicators
Official title: Adaptive and Maladaptive Emotions in Patients With Cancer: Identification of Indicators
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Adaptation, Emotional
Keywords: cancer
patients
emotions
psychosocial
care
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
First posted: 2021-09-30
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with solid malignancy, either (i) non-metastatic disease or (ii) metastatic disease, except for patients with a (indication of) brain tumor or -metastases. In each stratum (non-metastatic or metastatic disease), 40 patients with adaptive emotions and 40 patients with maladaptive emotions are recruited from the outpatient clinics at the Departments of Medical Oncology at seven major hospitals (160 patients in total). Patients are stratified by sex (female/male) and age (18-40; 40-70 and \> 70 years old).

Brief summary: Primary Objective: To identify indicators distinguishing between adaptive and maladaptive emotions in patients with cancer.

Detailed description: Background of the study:

The occurrence of cancer constitutes a major stressor, leading to a wide range of emotions. Patients need support from relatives, friends and caregivers to deal with these emotions. Some patients need professional mental health care, in addition to support. Unfortunately, an accurate instrument to identify patients in need of professional mental health care is not available. This leads to important mismatches in the provision of care.

In the field of oncology, the concept of 'distress' is used to refer to emotions associated with cancer. Measurement instruments (e.g. Distress Thermometer) are used to identify patients with clinically relevant distress. This approach results in major inconsistencies.While approximately one in three patients scores above the cut-off for distress, only about one in ten patients accepts mental healthcare, while it is unclear how many need mental health care.

In the field of mental health, it is generally acknowledged that a distinction needs to be made between normal and adaptive emotions versus maladaptive and psychopathological emotions in response to a potentially traumatic event such as cancer. The concept of distress fails to make this distinction. Some patients scoring above the cut-off for distress may indeed experience maladaptive emotions. Other patients scoring above the cut-off may actually experience adaptive emotions, which facilitate coping with cancer. Therefore, in order to provide appropriate care, identification of indicators distinguishing between adaptive and maladaptive emotions in patients with cancer is an urgent research priority.

Objective of the study:

To identify indicators that distinguish between adaptive and maladaptive emotions in patients with cancer, derived from recent innovative developments in the field of mental health.

Study design:

Patients are categorized as having 'adaptive emotions' or 'maladaptive emotions', using a reference standard: (a) a diagnostic mental health interview and questionnaires, or (b) patient's subjective need for professional mental health care. In all patients, emotional symptoms, cancer-treatment related symptoms and activities are assessed during a period of two weeks via mobile phone. Assessments of patients takes place twice; at 3 and 6 months after the start of chemo-or immunotherapy.

Eligibility criteria: Inclusion Criteria:

* diagnosis of a solid malignancy cancer, (i) non-metastatic disease or (ii) metastatic disease;
* between 3 and 7 months after start of treatment with (neo)adjuvant or 1st line chemotherapy or with (neo)adjuvant or 1st line immunotherapy;
* life expectancy of more than 3 months.

Exclusion Criteria:

* age \< 18;
* insufficient command of the Dutch language;
* severe psychopathology, other than mood or anxiety disorder (e.g. lifetime history of bipolar disorder, schizophrenia, MDD (Major Depressive Disorder) with psychotic features, schizoaffective disorders);
* severe cognitive impairments (e.g. dementia);
* patients with a (indication of) brain tumor or -metastases;
* a history of severe drug or alcohol abuse within past 6 months;
* not competent in the use of a mobile phone
* no informed consent.

Primary outcomes:
measure: Emotional symptoms
timeFrame: During two weeks, once as soon as possible after inclusion and once three months later
measure: Cancer-treatment-related symptoms
timeFrame: During two weeks, once as soon as possible after inclusion and once three months after first assessment
measure: Activities related to the pursuit of life goals
timeFrame: During two weeks, once as soon as possible after inclusion and once three months after first assessment
measure: Specific signs and symptoms as identified by oncologists and nurses
timeFrame: Once as soon as possible after inclusion in the study and once three months after first assessment
measure: Life goals
timeFrame: Once as soon as possible after inclusion in the study and once three months after first assessment
measure: Diagnostic mental health interview
timeFrame: Once as soon as possible after inclusion in the study and once three months after first assessment
measure: The need for professional mental health care
timeFrame: Once as soon as possible after inclusion in the study and once three months after first assessment
measure: Threatening experiences
timeFrame: Once as soon as possible after inclusion in the study and once three months after first assessment
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: Once as soon as possible after inclusion in the study and once three months after first assessment
measure: Mastery
timeFrame: Once as soon as possible after inclusion in the study and once three months after first assessment
measure: Emotional reactivity in daily life
timeFrame: Once as soon as possible after inclusion in the study and once three months after first assessment
measure: Social and instrumental support
timeFrame: Once as soon as possible after inclusion in the study and once three months after first assessment
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
state: Noord-Holland
city: Arnhem
country: Netherlands
facility: Rijnstate
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Doetinchem
country: Netherlands
facility: Slingeland Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Radboud UMC
city: Zwolle
country: Netherlands
facility: Isala Klinieken Zwolle
Study officials:
affiliation: VUmc
name: Prof. dr. J. Dekker
role: PRINCIPAL_INVESTIGATOR
References: