Breast CancerNCT02982421
The Effect of Art Therapy on Physical and Psychological Symptoms of Breast Cancer Survivors
A study testing Group art therapy in people with Breast Cancer, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Art Therapy is a health profession in which art making is utilized as a means of expression and communication within a therapeutic and supportive relationship [1]. Art therapy has been shown to reduce psychological (anxiety, negative mood) and physical (pain, fatigue) symptoms which accompany many breast cancer… 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?
- Group art therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2016to Jun 2017
- 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
- Adult women (over age 18), breast cancer survivors without evidence of active illness, hebrew speaking and receiving preventative hormonal therapy for at least 6 months (steady state), receiving care at the survivor's clinic of Davidoff Medical Center
Who cannot join
- A psychiatric diagnosis requiring medication, functional difficulties that affect the ability to handle art supplies, non-hebrew speaking, unwilling to answer the research questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Group Art Therapy on Physical and Psychological Symptoms of Breast Cancer Survivors Receiving Hormonal Therapy
Art Therapy is a health profession in which art making is utilized as a means of expression and communication within a therapeutic and supportive relationship [1]. Art therapy has been shown to reduce psychological (anxiety, negative mood) and physical (pain, fatigue) symptoms which accompany many breast cancer patients and survivors [2-7]. Qualitative studies provide an initial understanding of the mechanisms through which art therapy facilitates symptom reduction [8]. Breast cancer patients have reported that art therapy provided them with access to emotional material otherwise inaccessible [9]. The goal of this study is to examine the effect of art making within a therapeutic framework on emotional awareness and acceptance.
- Conditions
- Breast Cancer
- Being tested
- Group art therapy, Control
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group art therapyBehavioural
Participants will engage in an art therapy group tailored at emotion expression related to the experience of breast cancer survivorship.
ControlBehavioural
Participants will receive Psychoeducational material in the form of a lecture and will engage in the coloring of mandalas.
| Study group | Role | What they receive |
|---|---|---|
| Research | Experimental | Group Art Therapy Receives: Behavioral: Group art therapy |
| Control | Sham comparator | Participants will receive Psychoeducational material in the form of a lecture and will engage in the coloring of mandalas. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life: The FACT-B (Hahn et al, 2015)
36 item scale
Measured: Change from study start to end of intervention (8 weeks)
Secondary outcomes (7)
The levels of Emotional Awareness Scale (LEAS; Lane et al, 1990)
20 item scale
Measured: Change from study start to end of intervention (8 weeks)
Acceptance of Emotion Scale (AE; Weihs et al, 2008)
13 item scale
Measured: Change from study start to end of intervention (8 weeks)
Emotional Approach Coping scales (Stanton et al., 2000)
36 item scale
Measured: Change from study start to end of intervention (8 weeks)
The Mindful Attention Awareness Scale (MAAS)(Carlson & Brown, 2005).
15 item scale
Measured: Change from study start to end of intervention (8 weeks)
Center for Epidemiologic Studies Depression Scale (CES-D) (Cohen, 1997)
20 item scale
Measured: Change from study start to end of intervention (8 weeks)
The Generalized Anxiety Disorder scale (GAD-7) (Spitzer, Kroenke, Williams, & Löwe, 2006)
7 item scale
Measured: Change from study start to end of intervention (8 weeks)
The Breast Cancer Prevention Trial (BCPT) Symptom Scales (Stanton et al., 2005)
23 item scale
Measured: Change from study start to end of intervention (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionMay 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rinat Yerushalmi, MD, Study director, Oncology Department, RMCTal Granot, MA, RN, Study director, Davidoff Cancer Center, RMCNoga Sela, BA, RN, Study chair, Oncology, RMCSylvia Drier, MA, RN, Study director, Davidoff Cancer Center, RMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982421
- Sponsor's protocol ID
- 0304-16-RMC
- Status last verified
- Jul 2016
- First submitted
- 24 Jul 2016
- Last updated
- 5 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Uttley L, Stevenson M, Scope A, Rawdin A, Sutton A. The clinical and cost effectiveness of group art therapy for people with non-psychotic mental health disorders: a systematic review and cost-effectiveness analysis. BMC Psychiatry. 2015 Jul 7;15:151. doi: 10.1186/s12888-015-0528-4.
PubMed 26149275Archer S, Buxton S, Sheffield D. The effect of creative psychological interventions on psychological outcomes for adult cancer patients: a systematic review of randomised controlled trials. Psychooncology. 2015 Jan;24(1):1-10. doi: 10.1002/pon.3607. Epub 2014 Jun 21.
PubMed 24953449Monti DA, Peterson C, Kunkel EJ, Hauck WW, Pequignot E, Rhodes L, Brainard GC. A randomized, controlled trial of mindfulness-based art therapy (MBAT) for women with cancer. Psychooncology. 2006 May;15(5):363-73. doi: 10.1002/pon.988.
PubMed 16288447Nainis 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 16488349Oster I, Svensk AC, Magnusson E, Thyme KE, Sjodin M, Astrom S, Lindh J. Art therapy improves coping resources: a randomized, controlled study among women with breast cancer. Palliat Support Care. 2006 Mar;4(1):57-64. doi: 10.1017/s147895150606007x.
PubMed 16889324Svensk AC, Oster I, Thyme KE, Magnusson E, Sjodin M, Eisemann M, Astrom S, Lindh J. Art therapy improves experienced quality of life among women undergoing treatment for breast cancer: a randomized controlled study. Eur J Cancer Care (Engl). 2009 Jan;18(1):69-77. doi: 10.1111/j.1365-2354.2008.00952.x.
PubMed 19473224Thyme KE, Sundin EC, Wiberg B, Oster I, Astrom S, Lindh J. Individual brief art therapy can be helpful for women with breast cancer: a randomized controlled clinical study. Palliat Support Care. 2009 Mar;7(1):87-95. doi: 10.1017/S147895150900011X.
PubMed 19619378Boehm K, Cramer H, Staroszynski T, Ostermann T. Arts therapies for anxiety, depression, and quality of life in breast cancer patients: a systematic review and meta-analysis. Evid Based Complement Alternat Med. 2014;2014:103297. doi: 10.1155/2014/103297. Epub 2014 Feb 26.
PubMed 24817896Collie K, Bottorff JL, Long BC. A narrative view of art therapy and art making by women with breast cancer. J Health Psychol. 2006 Sep;11(5):761-75. doi: 10.1177/1359105306066632.
PubMed 16908471
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Group Art Therapy on Physical and Psychological Symptoms of Breast Cancer Survivors Receiving Hormonal Therapy
- ClinicalTrials.gov ID
- NCT02982421
- Acronym / sponsor ID
- 0304-16-RMC
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 5 Dec 2016 (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.
Art Therapy is a health profession in which art making is utilized as a means of expression and communication within a therapeutic and supportive relationship [1]. Art therapy has been shown to reduce psychological (anxiety, negative mood) and physical (pain, fatigue) symptoms which accompany many breast cancer patients and survivors [2-7]. Qualitative studies provide an initial understanding of the mechanisms through which art therapy facilitates symptom reduction [8]. Breast cancer patients have reported that art therapy provided them with access to emotional material otherwise inaccessible [9]. The goal of this study is to examine the effect of art making within a therapeutic framework on emotional awareness and acceptance.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Research | Experimental | Behavioral: Group art therapyGroup Art Therapy |
| Control | Sham comparator | Behavioral: ControlParticipants will receive Psychoeducational material in the form of a lecture and will engage in the coloring of mandalas. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult women (over age 18), breast cancer survivors without evidence of active illness, hebrew speaking and receiving preventative hormonal therapy for at least 6 months (steady state), receiving care at the survivor's clinic of Davidoff Medical Center
Key exclusion criteria (1 listed)
- A psychiatric diagnosis requiring medication, functional difficulties that affect the ability to handle art supplies, non-hebrew speaking, unwilling to answer the research questionnaires
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 engage in an art therapy group tailored at emotion expression related to the experience of breast cancer survivorship. | Behavioural | Research |
| ControlParticipants will receive Psychoeducational material in the form of a lecture and will engage in the coloring of mandalas. | Behavioural | Control |
Primary outcome
Quality of Life: The FACT-B (Hahn et al, 2015)
Time frame: Change from study start to end of intervention (8 weeks)
36 item scale
7 secondary outcomes
The levels of Emotional Awareness Scale (LEAS; Lane et al, 1990)
Time frame: Change from study start to end of intervention (8 weeks)
Acceptance of Emotion Scale (AE; Weihs et al, 2008)
Time frame: Change from study start to end of intervention (8 weeks)
Emotional Approach Coping scales (Stanton et al., 2000)
Time frame: Change from study start to end of intervention (8 weeks)
The Mindful Attention Awareness Scale (MAAS)(Carlson & Brown, 2005).
Time frame: Change from study start to end of intervention (8 weeks)
Center for Epidemiologic Studies Depression Scale (CES-D) (Cohen, 1997)
Time frame: Change from study start to end of intervention (8 weeks)
The Generalized Anxiety Disorder scale (GAD-7) (Spitzer, Kroenke, Williams, & Löwe, 2006)
Time frame: Change from study start to end of intervention (8 weeks)
The Breast Cancer Prevention Trial (BCPT) Symptom Scales (Stanton et al., 2005)
Time frame: Change from study start to end of intervention (8 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2016.
- Background: PubMed 26149275Uttley L, Stevenson M, Scope A, Rawdin A, Sutton A. The clinical and cost effectiveness of group art therapy for people with non-psychotic mental health disorders: a systematic review and cost-effectiveness analysis. BMC Psychiatry. 2015 Jul 7;15:151. doi: 10.1186/s12888-015-0528-4.
- Background: PubMed 24953449Archer S, Buxton S, Sheffield D. The effect of creative psychological interventions on psychological outcomes for adult cancer patients: a systematic review of randomised controlled trials. Psychooncology. 2015 Jan;24(1):1-10. doi: 10.1002/pon.3607. Epub 2014 Jun 21.
- Background: PubMed 16288447Monti DA, Peterson C, Kunkel EJ, Hauck WW, Pequignot E, Rhodes L, Brainard GC. A randomized, controlled trial of mindfulness-based art therapy (MBAT) for women with cancer. Psychooncology. 2006 May;15(5):363-73. doi: 10.1002/pon.988.
- 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 16889324Oster I, Svensk AC, Magnusson E, Thyme KE, Sjodin M, Astrom S, Lindh J. Art therapy improves coping resources: a randomized, controlled study among women with breast cancer. Palliat Support Care. 2006 Mar;4(1):57-64. doi: 10.1017/s147895150606007x.
- Background: PubMed 19473224Svensk AC, Oster I, Thyme KE, Magnusson E, Sjodin M, Eisemann M, Astrom S, Lindh J. Art therapy improves experienced quality of life among women undergoing treatment for breast cancer: a randomized controlled study. Eur J Cancer Care (Engl). 2009 Jan;18(1):69-77. doi: 10.1111/j.1365-2354.2008.00952.x.
- Background: PubMed 19619378Thyme KE, Sundin EC, Wiberg B, Oster I, Astrom S, Lindh J. Individual brief art therapy can be helpful for women with breast cancer: a randomized controlled clinical study. Palliat Support Care. 2009 Mar;7(1):87-95. doi: 10.1017/S147895150900011X.
- Background: PubMed 24817896Boehm K, Cramer H, Staroszynski T, Ostermann T. Arts therapies for anxiety, depression, and quality of life in breast cancer patients: a systematic review and meta-analysis. Evid Based Complement Alternat Med. 2014;2014:103297. doi: 10.1155/2014/103297. Epub 2014 Feb 26.
- Background: PubMed 16908471Collie K, Bottorff JL, Long BC. A narrative view of art therapy and art making by women with breast cancer. J Health Psychol. 2006 Sep;11(5):761-75. doi: 10.1177/1359105306066632.
- Individual participant dataSharing planned: No
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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.
Rinat Yerushalmi, MD study director
Oncology Department, RMC
Tal Granot, MA, RN study director
Davidoff Cancer Center, RMC
Noga Sela, BA, RN study chair
Oncology, RMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group art therapy in people with Breast Cancer, run by Rabin Medical Center at 1 site in Israel.
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 1 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: status not confirmed, as of the sponsor's last update on 5 Dec 2016. 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 Israel. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johanna Czamanski-Cohen, PhD (+972532775350, joczamanski@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life: The FACT-B (Hahn et al, 2015) (time frame: Change from study start to end of intervention (8 weeks)). 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 NCT02982421, which also lists 9 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 5 Dec 2016.