- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02680236
Art Therapy for Pain Relief in Breast Cancer Patients
Can Art Therapy Improve Breast Cancer Patients' Perception of Persistent Post Treatment Pain and Functioning? A Mixed Methods Pilot Study
Study Overview
Detailed Description
Art therapy is a type of psychotherapy that uses making art and creative processes to allow patients to express feelings that may be difficult to put into words. It has been available at The Royal Marsden NHS Foundation Trust since 1988. Patients are referred for a range of issues that include isolation, anxiety, depression, identity or end of life issues. Research has shown art therapy to offer significant improvements in these areas. There is much anecdotal evidence within art therapy of it's effectiveness for physical pain, but little research in this area. Pain itself is acknowledged as a complex phenomena that demands a multifocused approach to treatment. The British Pain Society's guidelines recommend a combined approach to treatment that includes psychological and complementary therapies, but although music therapy is cited, art therapy is not. This study proposes to broaden the research base into art therapy's effectiveness as an additional intervention to support patients managing physical pain, and thus be able to be offered as additional support to the interventions currently on offer.
Art therapy would, in practice be able to be offered concurrently to all other treatments for pain, and at at any point in the treatment journey. However for the purpose of this study, in order to understand art therapy's potential effectiveness, it is useful to narrow the focus of the research. It is reported that up to 50% of breast cancer patients suffer from chronic post treatment pain, that is, for an extended period of time after all treatment for cancer and despite being optimally treated already for their pain. In consultation with the Pain Team at the RM it was decided that breast cancer patients were a suitable cohort for this study.
As this is the first study at the RM looking into art therapy and physical pain, it was decided that a mixed method study would produce the most valuable data. Narrative data from interviews will allow a greater understanding of participants experience of art therapy, and how it might be effective for pain. Numerical data will give information on the extent of how effective for pain art therapy might be. The sample size is small (20 participants) in order to allow for in depth analysis of the narrative data. Previous research studies looking at art therapy in oncology have offered between a single, to eight, one hour individual art therapy sessions. Art therapy research in oncology that included pain as a criteria for study, has offered a single, hour long session and examined data on its impact on pain collected immediately after the art therapy session. As this study proposes to explore art therapy as an intervention that may offer benefits for pain that develop over time, four, hour long individual art therapy sessions have been decided on. This allows for an understanding of whether art therapy may have any effect on pain beyond an immediate lessening during an art therapy session.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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London, United Kingdom, SW3 6JJ
- Recruiting
- The Royal Marsden NHS Foundation Trust
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Contact:
- Amyn Lalji, BSc, MA
- Phone Number: 8105 02073528171
- Email: amyn.lalji@rmh.nhs.uk
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Contact:
- Samantha Chilvers
- Phone Number: 2811 02073528171
- Email: samantha.chilvers@rmh.nhs.uk
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Principal Investigator:
- Clare Shaw, BSc,RD,PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- reporting pain of longer than three months duration post chemotherapy, surgical or radiation treatment
- aged 18 years or older
- with more than two months predicted life expectancy
- who has English fluency
- who has capacity to consent
- wishing to access art therapy
- who is assessed by the pain team as stable on their current medication
Exclusion Criteria:
- who is less than three months post their chemotherapy or radiation treatment, or who receives new chemotherapy or radiation treatment during the study.
- who has had pain reduction surgery less than three months before the study, or receives it during the study period
- who has had any change in medication for pain control less than two weeks prior to the study, or during the study period
- who scores less than moderate pain (less than 4 on a scale of 1 -10) in a verbal self-reported measure of their worst pain felt, for the preceding two weeks before the study period
- who intends to access art therapy outside the sessions offered within the study, for the duration of the study
- who receives other psychological therapies from another practitioner during the study period
- who receives physiotherapy for problems related to their breast cancer treatment during the study period
- who receives massage or reflexology treatments from the complementary therapy team during the study period
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Breast Cancer Patients
This pilot study proposes to explore the effect of art therapy on breast cancer patients' perception of pain, and its impact on daily functioning by offering four sessions of individual art therapy, spaced between one to three weeks apart. The study will be open to breast cancer patients over the age of 18, who have been assessed by the Royal Marsden (RM) Pain Team, and who report having persistent post treatment pain of at least moderate intensity for the preceding two weeks despite having been optimally treated for their pain already, and who fulfil the inclusion criteria. |
Patients fulfilling the inclusion criteria will be made an appointment with the art therapist for the Initial Assessment session. They will be given the following Reflect Interview session Final interview session An analgesic use form will be given to the patient to take home to note their actual analgesic use At the end of each of these art therapy sessions, patients will be given a Brief Pain Inventory form (BPI) with a stamped addressed envelope. This is to be completed twenty four hours after the appointment and returned by post. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Percentage of patient showing change in Brief Pain Inventory pain interference score
Time Frame: From baseline to end of the study (approx six months)
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The percentage of patients who will demonstrate a 2 point change in Brief Pain Inventory pain interference score from baseline to end of study.
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From baseline to end of the study (approx six months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of patient showing change in Brief Pain Inventory pain severity score
Time Frame: From baseline to end of the study (approx six months)
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The percentage of patients who will demonstrate a 2 point change in Brief Pain Inventory pain severity score from baseline to end of study.
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From baseline to end of the study (approx six months)
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Collaborators and Investigators
Investigators
- Principal Investigator: Clare Shaw, BSc,RD,PhD, Royal Marsden NHS Foundation Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CCR 4218
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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