The Effect of Art Therapy on Total Laryngectomy Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03503435|
Recruitment Status : Withdrawn (Due to COVID-19 we are not able to recruit in the foreseeable future)
First Posted : April 19, 2018
Last Update Posted : September 29, 2021
|Condition or disease||Intervention/treatment||Phase|
|Quality of Life Depressive Symptoms||Behavioral: Group art therapy||Not Applicable|
Laryngeal carcinoma (LC) is a cancer that is originated in the larynx which is responsible for three vital functions: the correct passage of air while breathing, closing off the airway during swallowing and voice production. An estimation of around 160,000 new cases of LC are reported worldwide annually, with male predominance. In Israel there are around 200 new cases of LC annually. There are more men than women with the condition and more Arab and Russian immigrants than native Jewish. Laryngeal Cancer can be treated with a combination of surgery, radiotherapy and chemotherapy. The surgical treatment for advanced LC is total laryngectomy (TL). Patients report difficulties adjusting to their stoma, communicating, coughing and eating in public, as well as shame associated with their changed appearance. Many patients state that trying to live the way they did before surgery is frustrating, yet some find hope in striving to get better and "getting back on track". Many patients state they benefited from speaking to other patients about these topics. Psychological well-being is also highly associated with social quality of life.
Laryngectomy patients suffer from dramatic disfigurement. They have a stoma - opening of the trachea at their necks - at a visible location. Patients surveyed at different stages of disease for dissatisfaction with body image and its relation to health related quality of life (HRQOL) reported that they were frequently concerned and dissatisfied with their changed appearance. Dissatisfaction also predicted lesser improvement in HRQOL, recovery and function. Observed disfigurement and dissatisfaction with appearance was shown to be moderated by the sense of social self-efficacy.
A Cochrane review of psychological interventions (C.B.T., dynamic, psycho-education and group interventions) performed with the HNC population showed ambiguous results as to the effects of interventions on improving QOL. This could be due to the difficulty of conducting verbal psychosocial interventions with a population suffering with speech impairments. Art therapy is a means with which patients can express themselves in a non-verbal way, experience creativity, address psychological and social issues, battle addictions and immerse themselves in a feeling of flow. The use of art materials is a sensorial activity that can engage the body in a relatively effortless yet meaningful way.
Studies examining the efficacy of art therapy with cancer patients, demonstrate the decrease of depressive symptoms anxiety and fatigue, moving patient's attention away from worry and pain, improving QOL, and coping capabilities. To the best of our knowledge, there has only been one published study of art therapy with laryngectomy patients. In this article, the art therapist worked with three laryngectomy patients, describing it as an ideal therapy for people with diminished communication capabilities as it provides for a safe arena for them to practice growing communication skills.
Thus, the aim of our study is to examine the psychological changes of post-laryngectomy patients following group art therapy. In order to obtain our study objectives, we propose to conduct a pilot study with Laryngectomy patients at Carmel Medical Center, Haifa, Israel. Our design is a quasi-experimental qualitative study with a pre-post design, collecting data with validated questionnaires and self-reports of the participants.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a pre and post design quasi-experimental study looking at changes before and after a supportive care art therapy intervention.|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Effect of Art Therapy on Psychological and Physiological Health in Total Laryngectomy Patients|
|Estimated Study Start Date :||July 2019|
|Estimated Primary Completion Date :||January 1, 2020|
|Actual Study Completion Date :||January 1, 2020|
Art therapy intervention
Participants will then take part in six-weeks of group art therapy with a goal of increasing self-awareness and expression. During the intervention sessions, participants will have access to a wide range of materials conventionally used in art therapy excluding materials that may be abrasive or powdery and unsuitable around people wearing a stoma.
Behavioral: Group art therapy
Participants will undergo 6 weeks of group art therapy in which they will learn tools to cope with a variety of cognitive, emotional and social aspects of life after TL.
- The functional assessment of cancer therapy questionnaire (FACT H-N) [ Time Frame: 10 minutes ]39 items asking questions about physical, emotional, social and functional well being in the past 7 days
- The Center for Epidemiological Studies Depression Scale (CESD R-10) [ Time Frame: 5 minutes ]This scale is a self-report measure of depression. The total score is calculated by finding the sum of 10 items. Scores range from 0-40. A score equal to or above 16 indicates a person at risk for clinical depression.
- Art based intervention questionnaire (ABI) [ Time Frame: 10 minutes ]41 item questionnaire assessing an individuals experience an art based intervention