NCT03503435

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable quality-of-life

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 19, 2018

Completed
1.2 years until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

June 14, 2022

Status Verified

June 1, 2022

Enrollment Period

6 months

First QC Date

April 11, 2018

Last Update Submit

June 11, 2022

Conditions

Keywords

Art TherapyTotal Laryngectomy

Outcome Measures

Primary Outcomes (1)

  • 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

    10 minutes

Secondary Outcomes (1)

  • The Center for Epidemiological Studies Depression Scale (CESD R-10)

    5 minutes

Other Outcomes (1)

  • Art based intervention questionnaire (ABI)

    10 minutes

Study Arms (1)

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.

Behavioral: Group art therapy

Interventions

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.

Art therapy intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • men or women above the age of 18
  • TL surgery at least one year ago

You may not qualify if:

  • Personality disorders that prevent participation in a group.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • 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.

    PMID: 25619472BACKGROUND
  • 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.

    PMID: 25220842BACKGROUND
  • 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.

    PMID: 16832122BACKGROUND
  • 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.

    PMID: 21298450BACKGROUND
  • 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.

    PMID: 25703153BACKGROUND
  • 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.

    PMID: 17014282BACKGROUND
  • 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;2013(7):CD009441. doi: 10.1002/14651858.CD009441.pub2.

    PMID: 23857592BACKGROUND
  • Malchiodi, C. A. (2003). The art and science of art therapy. Handbook of art therapy, 1-5.

    BACKGROUND
  • 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.

    PMID: 16488349BACKGROUND
  • 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.

    PMID: 20688262BACKGROUND
  • Anand, S.A. & Anand, V.K. (1997). Art therapy with laryngectomy patients. Art Therapy, 14(2), 109-117.

    BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: This is a pre and post design quasi-experimental study looking at changes before and after a supportive care art therapy intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

April 11, 2018

First Posted

April 19, 2018

Study Start

July 1, 2019

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

June 14, 2022

Record last verified: 2022-06