Quality of LifeNCT03503435
The Effect of Art Therapy on Total Laryngectomy Patients
A study testing Group art therapy in people with Quality of Life and Depressive Symptoms, run by University of Haifa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Depressive Symptoms
- What is being tested?
- Group art therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2019to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men or women above the age of 18
- TL surgery at least one year ago
Who cannot join
- Personality disorders that prevent participation in a group.
About this study
Official title: The Effect of Art Therapy on Psychological and Physiological Health in Total Laryngectomy Patients
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.
Read the 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.
- Conditions
- Quality of Life, Depressive Symptoms
- Being tested
- Group art therapy
- Keywords
- Art Therapy, Total Laryngectomy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group art therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Art therapy intervention | Other | 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. Receives: Behavioral: Group art therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 minutes
Secondary outcomes (1)
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study startJul 2019 (estimated)
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Why it stopped: Due to COVID-19 we are not able to recruit in the foreseeable future
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Collaborators
- Carmel Medical Center
- Responsible party
- Principal investigator, Johanna Czamanski-Cohen, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503435
- Sponsor's protocol ID
- TL-Art
- Status last verified
- Jun 2022
- First submitted
- 11 Apr 2018
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25619472Ferlay 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.
PubMed 25220842American 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.
PubMed 16832122Dooks 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.
PubMed 21298450Perry 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.
PubMed 25703153Hagedoorn 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.
PubMed 17014282Semple 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;2013(7):CD009441. doi: 10.1002/14651858.CD009441.pub2.
PubMed 23857592Malchiodi, C. A. (2003). The art and science of art therapy. Handbook of art therapy, 1-5.
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.
PubMed 16488349Geue 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.
PubMed 20688262Anand, S.A. & Anand, V.K. (1997). Art therapy with laryngectomy patients. Art Therapy, 14(2), 109-117.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Art Therapy on Psychological and Physiological Health in Total Laryngectomy Patients
- ClinicalTrials.gov ID
- NCT03503435
- Acronym / sponsor ID
- TL-Art
- Conditions
- Quality of Life, Depressive Symptoms
- Keywords
- Art Therapy, Total Laryngectomy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to COVID-19 we are not able to recruit in the foreseeable future
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Collaborators
- Carmel Medical Center
- Study start
- Jul 2019 (estimated)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 19 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pre and post design quasi-experimental study looking at changes before and after a supportive care art therapy intervention.
| Arm | Type | Receives |
|---|---|---|
| Art therapy intervention | Other | Behavioral: Group art therapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- men or women above the age of 18
- TL surgery at least one year ago
Key exclusion criteria (1 listed)
- Personality disorders that prevent participation in a group.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group art therapyParticipants 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. | Behavioural | Art therapy intervention |
Primary outcome
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
1 secondary outcome
The Center for Epidemiological Studies Depression Scale (CESD R-10)
Time frame: 5 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Background: PubMed 25619472Pereira 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.
- Background: PubMed 25220842Ferlay 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.
- Background: PubMed 16832122American 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.
- Background: PubMed 21298450Dooks 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.
- Background: PubMed 25703153Perry 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.
- Background: PubMed 17014282Hagedoorn 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.
- Background: PubMed 23857592Semple 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;2013(7):CD009441. doi: 10.1002/14651858.CD009441.pub2.
- BackgroundMalchiodi, C. A. (2003). The art and science of art therapy. Handbook of art therapy, 1-5.
- Background: PubMed 16488349Nainis 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.
- Background: PubMed 20688262Geue 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.
- BackgroundAnand, S.A. & Anand, V.K. (1997). Art therapy with laryngectomy patients. Art Therapy, 14(2), 109-117.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Group art therapy in people with Quality of Life and Depressive Symptoms, run by University of Haifa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The functional assessment of cancer therapy questionnaire (FACT H-N) (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03503435, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.