PainNCT02680236
Art Therapy for Pain Relief in Breast Cancer Patients
An observational study of Pain, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Art therapy offers benefits and support for a range of psychological symptoms caused by cancer and its treatments, for example anxiety, stress, depression, sleeplessness, identity or end of life concerns. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- Art Therapy Group
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2015to Aug 2019
- Phase
- Observational
- 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 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patient with breast cancer as assessed by the RM pain team.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ
Amyn Lalji, BSc, MA, 02073528171 ext. 8105, amyn.lalji@rmh.nhs.uk
Samantha Chilvers, 02073528171 ext. 2811, samantha.chilvers@rmh.nhs.uk
About this study
Official title: Can Art Therapy Improve Breast Cancer Patients' Perception of Persistent Post Treatment Pain and Functioning? A Mixed Methods Pilot Study
Art therapy offers benefits and support for a range of psychological symptoms caused by cancer and its treatments, for example anxiety, stress, depression, sleeplessness, identity or end of life concerns. Persistent post treatment pain that adversely affects quality of life may be experienced by up to 50% of breast cancer patients. Factors such as depression, fear, anxiety or lack of sleep are shown to increase pain and suffering in people with cancer. A multitreatment approach treatment of cancer pain is therefore recommended. Art therapy offers an opportunity to communicate the experience of suffering in a non verbal mode and can be offered in addition to other treatment for pain. 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.
Read the 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.
- Conditions
- Pain
- Being tested
- Art Therapy Group
- Keywords
- Pain, Cancer, Chemotherapy, Anxiety, Depression, Isolation
- Medical subject headings
- Pain, Neoplasms, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art Therapy GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Art Therapy Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patient showing change in Brief Pain Inventory pain interference score
The percentage of patients who will demonstrate a 2 point change in Brief Pain Inventory pain interference score from baseline to end of study.
Measured: From baseline to end of the study (approx six months)
Secondary outcomes (1)
Percentage of patient showing change in Brief Pain Inventory pain severity score
The percentage of patients who will demonstrate a 2 point change in Brief Pain Inventory pain severity score from baseline to end of study.
Measured: From baseline to end of the study (approx six months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2016 (estimated)
- Study startJun 2015
- Primary completionMar 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clare Shaw, BSc,RD,PhD, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680236
- Sponsor's protocol ID
- CCR 4218
- Status last verified
- Apr 2018
- First submitted
- 5 Jan 2016
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Art Therapy Improve Breast Cancer Patients' Perception of Persistent Post Treatment Pain and Functioning? A Mixed Methods Pilot Study
- ClinicalTrials.gov ID
- NCT02680236
- Acronym / sponsor ID
- CCR 4218
- Conditions
- Pain
- Keywords
- Pain, Cancer, Chemotherapy, Anxiety, Depression, Isolation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 11 Feb 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 offers benefits and support for a range of psychological symptoms caused by cancer and its treatments, for example anxiety, stress, depression, sleeplessness, identity or end of life concerns. Persistent post treatment pain that adversely affects quality of life may be experienced by up to 50% of breast cancer patients. Factors such as depression, fear, anxiety or lack of sleep are shown to increase pain and suffering in people with cancer. A multitreatment approach treatment of cancer pain is therefore recommended. Art therapy offers an opportunity to communicate the experience of suffering in a non verbal mode and can be offered in addition to other treatment for pain. 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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Patients | – | Other: Art Therapy GroupThis 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with breast cancer as assessed by the RM pain team.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 Therapy GroupPatients 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. | Other | Breast Cancer Patients |
Primary outcome
Percentage of patient showing change in Brief Pain Inventory pain interference score
Time frame: From baseline to end of the study (approx six months)
The percentage of patients who will demonstrate a 2 point change in Brief Pain Inventory pain interference score from baseline to end of study.
1 secondary outcome
Percentage of patient showing change in Brief Pain Inventory pain severity score
Time frame: From baseline to end of the study (approx six months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
- 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.
Clare Shaw, BSc,RD,PhD principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
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 7 inclusion and 8 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 1 May 2018. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amyn A Lalji, BSc, MA (020 7811 8105, amyn.lalji@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patient showing change in Brief Pain Inventory pain interference score (time frame: From baseline to end of the study (approx six months)). 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 1 May 2018.