Breast CancerNCT01220960
Art Therapy Intervention for Breast Cancer Patients
A study testing art therapy in people with Breast Cancer, run by Dr. Sarkis Meterissian at 1 site in Canada.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- art therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2010to Oct 2013
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any woman 18-years or older
- Stage I to III breast cancer (first time diagnosis)
- Minimum of 6 weeks Post Operative status
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Cedars Breast Centre\ Royal Victoria Hospital
Montreal, Quebec, H3A 1A1
About this study
Official title: A Mixed Methods Approach to Evaluating How Art Therapy Can Benefit Women Recently Diagnosed With Breast Cancer
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.
- Conditions
- Breast Cancer
- Being tested
- art therapy
- Keywords
- art therapy, breast cancer, women, young women, older women, quality of life, meaning making, support group, art making, art symbols
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
art therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 weeks
Secondary outcomes (1)
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2012
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Sarkis Meterissian
- Sponsor type
- University, hospital or other
- Collaborators
- The Cedars Cancer Institute
- Responsible party
- Sponsor-investigator, Dr. Sarkis Meterissian, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Katherine L Laux, MA Art Therapy, Principal investigator, Cedars CanSupportVirginia Lee, PhD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreSharon Wexler, PhD, Principal investigator, Cedars CanSupportMonisha Sudarshan, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreSarkis Meterissian, PhD, Study director, MUHC Cedars Breast Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01220960
- Sponsor's protocol ID
- 10-049-PSY
- Status last verified
- Oct 2013
- First submitted
- 9 Oct 2010
- Last updated
- 25 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mixed Methods Approach to Evaluating How Art Therapy Can Benefit Women Recently Diagnosed With Breast Cancer
- ClinicalTrials.gov ID
- NCT01220960
- Acronym / sponsor ID
- 10-049-PSY
- Conditions
- Breast Cancer
- Keywords
- art therapy, breast cancer, women, young women, older women, quality of life, meaning making, support group
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Dr. Sarkis MeterissianUniversity, hospital or other
- Collaborators
- The Cedars Cancer Institute
- Study start
- Aug 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 14 Oct 2010 (estimated)
- 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Art Therapy intervention group | Experimental | Other: art therapyFor 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 |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any woman 18-years or older
- Stage I to III breast cancer (first time diagnosis)
- Minimum of 6 weeks Post Operative status
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| art therapyArt 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. | Other | Art Therapy intervention group |
Primary outcome
Quality of Life (emotional distress, physical symptoms,self-efficacy and well-being)
Time frame: 8 weeks
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).
1 secondary outcome
Ability to find and create meaning after the psychosocial impact of a breast cancer diagnosis
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2013.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Katherine L Laux, MA Art Therapy principal investigator
Cedars CanSupport
Virginia Lee, PhD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Sharon Wexler, PhD principal investigator
Cedars CanSupport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing art therapy in people with Breast Cancer, run by Dr. Sarkis Meterissian at 1 site in Canada.
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 3 inclusion and 0 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: finished, as of the sponsor's last update on 25 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quality of Life (emotional distress, physical symptoms,self-efficacy and well-being) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Oct 2013.