Art Therapy Intervention for Breast Cancer Patients

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

art therapy

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring art therapy, breast cancer, women, young women, older women, quality of life, meaning making, support group, art making, art symbols

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

Cedars Breast Centre\ Royal Victoria Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Art Therapy intervention group

Control Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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 Emotional distress as assessed by the Hospital Depression and Anxiety Scale (HADS) (please see below for details) Physical symptoms as assessed by the Edmonton Symptom Assessment Scale (ESAS) 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).

Secondary Outcome Measures

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

To investigate qualitatively how group art therapy can address the psychosocial impacts of breast cancer, including the challenges of finding and creating meaning following a recent diagnosis of breast cancer.

Full Information

NCT ID

NCT01220960

First Posted

October 9, 2010

Last Updated

October 24, 2013

Sponsor

Dr. Sarkis Meterissian

Collaborators

The Cedars Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT01220960

Brief Title

Art Therapy Intervention for Breast Cancer Patients

Official Title

A Mixed Methods Approach to Evaluating How Art Therapy Can Benefit Women Recently Diagnosed With Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

August 2010 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dr. Sarkis Meterissian

Collaborators

The Cedars Cancer Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

art therapy, breast cancer, women, young women, older women, quality of life, meaning making, support group, art making, art symbols

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Art Therapy intervention group

Arm Type

Experimental

Arm Description

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

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

art therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

To investigate whether the implementation of an 8 week art therapy course in post-operative outpatient breast cancer patients can alleviate/improve Emotional distress as assessed by the Hospital Depression and Anxiety Scale (HADS) (please see below for details) Physical symptoms as assessed by the Edmonton Symptom Assessment Scale (ESAS) 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).

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

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

Description

To investigate qualitatively how group art therapy can address the psychosocial impacts of breast cancer, including the challenges of finding and creating meaning following a recent diagnosis of breast cancer.

Time Frame

8 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials: