Adaptive and Maladaptive Emotions in Patients With Cancer: Identification of Indicators (EMOCA)

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

Study Overview

• Status: Recruiting
• Conditions: Adaptation, Emotional

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.

• Study Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

• Study Contact: Name: Elise Doppenberg, Msc; Phone Number: +31618148863; Email: g.e.doppenberg@amsterdamumc.nl

Study Locations

• Netherlands
  • Arnhem, Netherlands
    • Recruiting
    • Rijnstate
    • Contact: Elise Doppenberg-Smit; Email: g.e.doppenberg@amsterdamumc.nl
    • Principal Investigator: R.H.T. Koornstra, MD, PhD
  • Den Bosch, Netherlands
    • Recruiting
    • Jeroen Bosch ziekenhuis
    • Contact: Elise Doppenberg; Email: g.e.doppenberg@amsterdamumc.nl
    • Principal Investigator: H. Pruijt, MD, PhD
  • Doetinchem, Netherlands
    • Recruiting
    • Slingeland Ziekenhuis
    • Contact: Elise Doppenberg; Email: g.e.doppenberg@amsterdamumc.nl
    • Principal Investigator: R.A.W. Van de Wetering, MD
  • Nijmegen, Netherlands
    • Recruiting
    • Radboud UMC
    • Contact: Prof. dr. H.M.W. Verheul
    • Principal Investigator: H.M.W. Verheul, MD, PhD
  • Zwolle, Netherlands
    • Recruiting
    • Isala Klinieken Zwolle
    • Contact: Elise Doppenberg-Smit; Email: g.e.doppenberg@amsterdamumc.nl
    • Principal Investigator: J.W.B. de Groot, MD, PhD
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1081 HV
      • Recruiting
      • VU University Medical Center
      • Contact: Elise Doppenberg-Smit, Msc; Phone Number: +31618148863; Email: g.e.doppenberg@amsterdamumc.nl
      • Principal Investigator: Prof. dr. J. Dekker
      • Sub-Investigator: Prof. dr. A.T.F. Beekman
      • Sub-Investigator: M.E. van Linde, MD
      • Sub-Investigator: F. Lamers, PhD
      • Sub-Investigator: G.E. Doppenberg-Smit, Msc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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).

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Adaptive emotions, non-metastatic disease; Participants who are categorized as having 'adaptive emotions' and have a non-metastatic disease
Adaptive emotions, metastatic disease; Participants who are categorized as having 'adaptive emotions' and have a metastatic disease
maladaptive emotions, non-metastatic disease; Participants who are categorized as having 'maladaptive emotions' and have a non-metastatic disease
maladaptive emotions, metastatic disease; Participants who are categorized as having 'maladaptive emotions' and have a metastatic disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotional symptoms	Prompted by Ecological Momentary Assessment (EMA), patients rate the following 15 mood states on a 7-point scale ranging from 1 'not at all' to 7 'very' (in the present study, we use 'emotional symptoms' to refer to these mood states). Emotional symptoms with a negative valence: feeling agitated, upset, irritated, listless/apathetic, down, nervous, bored, anxious, and worried. Emotional symptoms with a positive valence: satisfied, relaxed, cheerful, energetic, enthusiastic and calm. These items have been derived from the The Netherlands Study of Depression and Anxiety (NESDA) EMA diary-protocol, have sufficient with-in person variability and have been extensively used in previous studies.	During two weeks, once as soon as possible after inclusion and once three months later
Cancer-treatment-related symptoms	Prompted by Ecological Momentary Assessment, patients rate the following six symptoms related to cancer-treatment on a 7-point scale ranging from 1 'not at all' to 7 'very': feeling tired, difficulty concentrating, nauseousness, loss of appetite, pain, and shortness of breath. These symptoms have been derived from the European Organisation For Research And Treatment Of Cancer (EORTC) item bank.	During two weeks, once as soon as possible after inclusion and once three months after first assessment
Activities related to the pursuit of life goals	Prompted by Ecological Momentary Assessment, patients indicate whether they have been involved in the following five categories of activities: (a) work/study, (b) health-related activities (we will differentiate between activities focused on disease and treatment and activities focused on improving/maintaining physical fitness, and building or maintaining a healthy lifestyle), (c) social activities with relatives or friends, (d) intellectual and religious/spiritual activities, and (e) leisure/pleasure related activities.This question covers activities in the interval since the last assessment. The list of activities corresponds to the list of life goals (see below). Patients indicate in which activities they were involved. Combined with the patient's rating of the personal relevance of life goals (see below), this results in a rating of the involvement in specific activities related to the pursuit of personally relevant life goals.	During two weeks, once as soon as possible after inclusion and once three months after first assessment
Specific signs and symptoms as identified by oncologists and nurses	In a qualitative study prior to this study, we have developed a checklist of potential signs and symptoms (e.g. a specific observation by an oncologist and nurse, such as crying or nervousness) which lead oncologists and nurses to suspect the need for professional mental health care among their patients. This checklist will be filled in by an oncologist and a nurse.	Once as soon as possible after inclusion in the study and once three months after first assessment
Life goals	Patients are interviewed about their life goals. In the interview, they are presented with an empirically-derived list of potential life goals, in five categories: (a) achievement or work/study related goals, (b) health-related goals (we will differentiate between goals focused on disease and treatment and goals focused on improving/maintaining physical fitness, and building or maintaining a healthy lifestyle), (c) social goals, (d) psychological goals that focus on inner psychological states, and (e) leisure/pleasure related goals (cheerfulness/fun). Subsequently, patients assess to what extent they are striving to attain these goals, on a 5-point Likert scale raging from 1 'not at all' to 5 'very' (i.e. they rate the personal relevance of these life goals). The scores are used to weigh the five categories of activities (see above).	Once as soon as possible after inclusion in the study and once three months after first assessment
Diagnostic mental health interview	The Composite International Diagnostic Interview (CIDI) (version 2.1) is a comprehensive, fully-structured interview for the assessment of lifetime and current (1 month recency) mental disorders, used to assess the presence of depression and anxiety disorder. In addition, we use the Four-dimensional symptom questionnaire (4DSQ) (Vier Dimensionele Klachten Lijst (4DKL) to assess adjustment disorder, with patients scoring > 20 on Distress and without a depressive or anxiety disorder on the CIDI categorized as having an adjustment disorder. The interview is conducted in person by a well-trained researcher. Maladaptive emotions are rated as present if the patient scores positive on major depressive disorder, an anxiety disorder (panic disorder, agoraphobia without panic, specific phobia, social phobia, generalized anxiety disorder, and posttraumatic stress disorder) or adjustment disorder.	Once as soon as possible after inclusion in the study and once three months after first assessment
The need for professional mental health care	The Distress Thermometer is a single item self-report measure of distress. Patients are asked to rate their overall distress on a visual scale from 0 (no distress) to 10 (extreme distress). The Problem List identifies problems in five domains: the practical, social, cognitive-emotional, spiritual/religious and physical domain. Patients indicate whether in the last three months they experienced a problem in these domains, using a five-point scale (ranging from 1 'no problem at all' to 5 'very much a problem'). For every domain in which patients report at least one problem, we ask whether they (a) received a referral for the problem, (b) did not receive a referral, but would have preferred a referral for the problem, (c) did not want or receive a referral for the problem, but would be willing to consider a referral in the future, or (d) did not want or receive a referral, neither in the present nor the future.	Once as soon as possible after inclusion in the study and once three months after first assessment
Threatening experiences	The List of Threatening Experiences is a brief life events questionnaire, assessing the occurrence of 12 events (never, past year, life time)	Once as soon as possible after inclusion in the study and once three months after first assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh Sleep Quality Index	Pittsburgh Sleep Quality Index is a 19 item self-report questionnaire assessing sleep quality and quantity. There are 7 component scores: subjective sleep quality, sleep latency, duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction	Once as soon as possible after inclusion in the study and once three months after first assessment
Mastery	Mastery is the feeling to which a person perceives himself or herself to be in control of events and ongoing situations. The 5-item abbreviated mastery scale will be used. A 5-point Likert scale is used to rate each item (e.g. 0 = strongly disagree, 4 = strongly agree).	Once as soon as possible after inclusion in the study and once three months after first assessment
Emotional reactivity in daily life	Participants are asked whether they agree, disagree or are unsure about 3 statements concerning emotional reactivity in daily life (e.g. "Sometimes my feelings are strong, but they don't get in the way of day to day life), and how often (always, often, sometimes, rarely, never) 2 situations concerning emotional reactivity in daily life occur (e.g. How often do you find that your emotions are very unstable, or swing from one extreme to another in a way you sometimes find hard to control?).	Once as soon as possible after inclusion in the study and once three months after first assessment
Social and instrumental support	The Close Person Inventory is a 14 item self-report questionnaire that will be used to measure social support received from the individual reported as being closest to the participant during the previous 12-month period. A 5-point Likert scale is used to measure how often they experience 3 components of social support: confiding/emotional, practical and negative social support (0 = never, 4 = very often).	Once as soon as possible after inclusion in the study and once three months after first assessment

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc
• Collaborators: Dutch Cancer Society
• Investigators: Principal Investigator: Prof. dr. J. Dekker, VUMC

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2021
• Primary Completion (Anticipated): March 31, 2024
• Study Completion (Anticipated): March 31, 2024

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: September 20, 2021
• First Posted (Actual): September 30, 2021

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: patients; cancer; psychosocial; care; emotions
• Other Study ID Numbers: NL72824.029.20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No