The Effect of Art Therapy on Total Laryngectomy Patients
Primary Purpose
Quality of Life, Depressive Symptoms
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Group art therapy
Sponsored by

About this trial
This is an interventional supportive care trial for Quality of Life focused on measuring Art Therapy, Total Laryngectomy
Eligibility Criteria
Inclusion Criteria:
- men or women above the age of 18
- TL surgery at least one year ago
Exclusion Criteria:
- Personality disorders that prevent participation in a group.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Art therapy intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
The functional assessment of cancer therapy questionnaire (FACT H-N)
39 items asking questions about physical, emotional, social and functional well being in the past 7 days
Secondary Outcome Measures
The Center for Epidemiological Studies Depression Scale (CESD R-10)
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.
Full Information
NCT ID
NCT03503435
First Posted
April 11, 2018
Last Updated
June 11, 2022
Sponsor
University of Haifa
Collaborators
Carmel Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03503435
Brief Title
The Effect of Art Therapy on Total Laryngectomy Patients
Official Title
The Effect of Art Therapy on Psychological and Physiological Health in Total Laryngectomy Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Due to COVID-19 we are not able to recruit in the foreseeable future
Study Start Date
July 2019 (Anticipated)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
January 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Haifa
Collaborators
Carmel Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Total laryngectomy (TL) patients suffer from a myriad of psychological and physiological difficulties following surgery. One of their main difficulties in communication due to problems in speaking. Art therapy offers an alternative means of communication via visual art making and has been shown to reduce psychological distress in cancer patients. Thus the goal of our study is to examine the effect of participating in a group art therapy session on the psychological and physical well being of TL patients. Our design is a quasi-experimental qualitative study with a pre-post design, collecting data with validated questionnaires and self-reports of the participants.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life, Depressive Symptoms
Keywords
Art Therapy, Total Laryngectomy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Art therapy intervention
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group art therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
The functional assessment of cancer therapy questionnaire (FACT H-N)
Description
39 items asking questions about physical, emotional, social and functional well being in the past 7 days
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
The Center for Epidemiological Studies Depression Scale (CESD R-10)
Description
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.
Time Frame
5 minutes
Other Pre-specified Outcome Measures:
Title
Art based intervention questionnaire (ABI)
Description
41 item questionnaire assessing an individuals experience an art based intervention
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
men or women above the age of 18
TL surgery at least one year ago
Exclusion Criteria:
Personality disorders that prevent participation in a group.
12. IPD Sharing Statement
Citations:
PubMed Identifier
25619472
Citation
Pereira da Silva A, Feliciano T, Vaz Freitas S, Esteves S, Almeida E Sousa C. Quality of life in patients submitted to total laryngectomy. J Voice. 2015 May;29(3):382-8. doi: 10.1016/j.jvoice.2014.09.002. Epub 2015 Jan 22.
Results Reference
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PubMed Identifier
25220842
Citation
Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
Results Reference
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PubMed Identifier
16832122
Citation
American Society of Clinical Oncology; Pfister DG, Laurie SA, Weinstein GS, Mendenhall WM, Adelstein DJ, Ang KK, Clayman GL, Fisher SG, Forastiere AA, Harrison LB, Lefebvre JL, Leupold N, List MA, O'Malley BO, Patel S, Posner MR, Schwartz MA, Wolf GT. American Society of Clinical Oncology clinical practice guideline for the use of larynx-preservation strategies in the treatment of laryngeal cancer. J Clin Oncol. 2006 Aug 1;24(22):3693-704. doi: 10.1200/JCO.2006.07.4559. Epub 2006 Jul 10.
Results Reference
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PubMed Identifier
21298450
Citation
Dooks P, McQuestion M, Goldstein D, Molassiotis A. Experiences of patients with laryngectomies as they reintegrate into their community. Support Care Cancer. 2012 Mar;20(3):489-98. doi: 10.1007/s00520-011-1101-4. Epub 2011 Feb 6.
Results Reference
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PubMed Identifier
25703153
Citation
Perry A, Casey E, Cotton S. Quality of life after total laryngectomy: functioning, psychological well-being and self-efficacy. Int J Lang Commun Disord. 2015 Jul;50(4):467-75. doi: 10.1111/1460-6984.12148. Epub 2015 Feb 19.
Results Reference
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PubMed Identifier
17014282
Citation
Hagedoorn M, Molleman E. Facial disfigurement in patients with head and neck cancer: the role of social self-efficacy. Health Psychol. 2006 Sep;25(5):643-7. doi: 10.1037/0278-6133.25.5.643.
Results Reference
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PubMed Identifier
23857592
Citation
Semple C, Parahoo K, Norman A, McCaughan E, Humphris G, Mills M. Psychosocial interventions for patients with head and neck cancer. Cochrane Database Syst Rev. 2013 Jul 16;(7):CD009441. doi: 10.1002/14651858.CD009441.pub2.
Results Reference
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Citation
Malchiodi, C. A. (2003). The art and science of art therapy. Handbook of art therapy, 1-5.
Results Reference
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PubMed Identifier
16488349
Citation
Nainis N, Paice JA, Ratner J, Wirth JH, Lai J, Shott S. Relieving symptoms in cancer: innovative use of art therapy. J Pain Symptom Manage. 2006 Feb;31(2):162-9. doi: 10.1016/j.jpainsymman.2005.07.006.
Results Reference
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PubMed Identifier
20688262
Citation
Geue K, Goetze H, Buttstaedt M, Kleinert E, Richter D, Singer S. An overview of art therapy interventions for cancer patients and the results of research. Complement Ther Med. 2010 Jun-Aug;18(3-4):160-70. doi: 10.1016/j.ctim.2010.04.001. Epub 2010 May 15.
Results Reference
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Citation
Anand, S.A. & Anand, V.K. (1997). Art therapy with laryngectomy patients. Art Therapy, 14(2), 109-117.
Results Reference
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The Effect of Art Therapy on Total Laryngectomy Patients
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