NCT01220960

Brief Summary

As studies continue to debate the effects of quality of life on survival, increased attention is being focused on investigating complementary alternative therapies to boost overall total health in cancer patients . Art therapy is an interesting growing field, which has shown promise to positively influence quality of life in the pediatric and adult oncology population alike. As there is a paucity of well controlled complete studies in this field, the investigators propose to study the impact of art therapy sessions in women with breast cancer with quantitative and qualitative analysis of emotional health and physical symptoms. The results of the investigators study will have widespread applicability to oncology programs that wish to offer/implement such sessions to their palliative and non-palliative outpatients in an effort to address the important concept of whole person care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Aug 2010

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 14, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

October 25, 2013

Status Verified

October 1, 2013

Enrollment Period

2.3 years

First QC Date

October 9, 2010

Last Update Submit

October 24, 2013

Conditions

Keywords

art therapybreast cancerwomenyoung womenolder womenquality of lifemeaning makingsupport groupart makingart symbols

Outcome Measures

Primary Outcomes (1)

  • Quality of Life (emotional distress, physical symptoms,self-efficacy and well-being)

    To investigate whether the implementation of an 8 week art therapy course in post-operative outpatient breast cancer patients can alleviate/improve 1. Emotional distress as assessed by the Hospital Depression and Anxiety Scale (HADS) (please see below for details) 2. Physical symptoms as assessed by the Edmonton Symptom Assessment Scale (ESAS) 3. Meaning making as assessed by The Generalized Self-Efficacy Scale (GSES) and the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp-12).

    8 weeks

Secondary Outcomes (1)

  • Ability to find and create meaning after the psychosocial impact of a breast cancer diagnosis

    8 weeks

Study Arms (2)

Art Therapy intervention group

EXPERIMENTAL

For participants who will be part of the art therapy intervention, the art therapy group will be a closed group for eight women with breast cancer who are in treatment and recently have had surgery. The group will meet once a week for two hours over a period of 8 weeks, and will focus on exploring the expressive capabilities of art making in a supportive group. This group will be held in the conference room at the Cedars Breast Clinic. Each week will revolve around a theme that pertains to the experience of women living with breast cancer, and will be guided by the women's needs in the group. A broad range of art materials will be made available and various art techniques explored. No art experience is necessary. The intervention group will also need to fill out simple questionnaires before the art therapy groups starts and after the group finishes

Other: art therapy

Control Group

NO INTERVENTION

The group not assigned to the intervention group will be asked to fill out questionnaires at two separate times (before and after the intervention group is run). The Control group will be offered the opportunity to join an open art therapy group upon completing the questionnaires.

Interventions

Art therapy sessions, 2 hours in duration, 1 session/week, 8 continuous weeks of sessions. Each group will be limited to eight women as space is limited.

Art Therapy intervention group

Eligibility Criteria

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

You may qualify if:

  • Any woman 18-years or older
  • Stage I to III breast cancer (first time diagnosis)
  • Minimum of 6 weeks Post Operative status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars Breast Centre\ Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Art Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Katherine L Laux, MA Art Therapy

    Cedars CanSupport

    PRINCIPAL INVESTIGATOR
  • Virginia Lee, PhD

    McGill University Health Centre/Research Institute of the McGill University Health Centre

    PRINCIPAL INVESTIGATOR
  • Sharon Wexler, PhD

    Cedars CanSupport

    PRINCIPAL INVESTIGATOR
  • Monisha Sudarshan, MD

    McGill University Health Centre/Research Institute of the McGill University Health Centre

    PRINCIPAL INVESTIGATOR
  • Sarkis Meterissian, PhD

    MUHC Cedars Breast Centre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Surgery and Oncology Clinic

Study Record Dates

First Submitted

October 9, 2010

First Posted

October 14, 2010

Study Start

August 1, 2010

Primary Completion

December 1, 2012

Study Completion

October 1, 2013

Last Updated

October 25, 2013

Record last verified: 2013-10

Locations