Mapping Emotional Dynamics During Corticosteroid Treatment

Study Overview
=================
Brief Summary
-----------------
Rationale: Synthetic glucocorticoids can result in neuropsychiatric adverse effects in a minority of patients. Although, not all patients experience severe adverse effects, more subtle emotional disturbances are often experienced. With a variation on ecological momentary assessment (EMA), with a daily assessment, the investigators will collect the patient's emotional symptoms in real time and in the patients natural environment during corticosteroid treatment. With dynamic time warping (DTW) analysis the investigators aim to analyse the temporal dynamics of different emotional states and visualize these emotional dynamics over time. The patient and dermatologist will receive the idiographic results as a feedback form, which may give insights into temporal (and possibly causal) central emotions, which may help to overcome mood disturbances. Objective: Mapping emotional dynamics with DTW analysis in six mycosis fungoides or Sezary syndrome patients treated with systemic corticosteroids. Study design: Case series report study. Study population: Six patients with cutaneous T-cell lymphoma (type mycosis fungoides and/or Sezary syndrome). Main study parameters/endpoints: An idiographic DTW analysis of emotional dynamics during and after corticosteroid treatment in six mycosis fungoides and/or Sezary syndrome patients. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are no additional risks associated with study participation. The patients who will participate in this case series study need to complete a 5-minute survey daily using a m-Path smartphone app during corticosteroid treatment. The data analysis may increase the insight into centrality measures of emotions and the emotional clusters for the individual patient.

Official Title
-----------------
Mapping Emotional Dynamics in Cutaneous T-cell Lymphoma (Type Mycosis Fungoides and/or Sezary Syndrome) Patients During Treatment With Corticosteroids: a Case Series Study

Conditions
-----------------
Emotions, Corticosteroids

Intervention / Treatment
-----------------
* Other: Short daily questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mycosis fungoides and/or Sezary syndrome patients Corticosteroid treatment Exclusion Criteria: N/A
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 6 Mycosis fungoides patients and/or Sezary syndrome patients.<br>The patients will be treated according to standard regular care, which is a corticosteroid treatment regime. | Other: Short daily questionnaire<br>* This study includes 1 survey that needs to be filled out by the patient on his/her phone daily during the course of corticosteroid treatment. The investigators will start the survey few days before the corticosteroid treatment and it will continue till the end of the treatment regime. The treatment regime is regular care and patient specific, but will approximately have a duration of 40 days. In case of prolonged treatment with steroids it is decided to have a limit for our study: either until 7 days after the end of corticosteroid treatment or a maximum of 60 days.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mapping emotional dynamics with DTW analysis in mycosis fungoides and/or Sezary syndrome patients treated with corticosteroids. | A dynamic time warping (DTW) analysis on the data. | Short daily questionnaire for +- 1 month |