Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02680236
Other study ID # CCR 4218
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 2015
Est. completion date August 2019

Study information

Verified date April 2018
Source Royal Marsden NHS Foundation Trust
Contact Amyn A Lalji, BSc, MA
Phone 020 7811 8105
Email amyn.lalji@rmh.nhs.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date August 2019
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Art Therapy Group
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.

Locations

Country Name City State
United Kingdom The Royal Marsden NHS Foundation Trust London

Sponsors (1)

Lead Sponsor Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. From baseline to end of the study (approx six months)
Secondary 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. From baseline to end of the study (approx six months)
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Completed NCT04748367 - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care N/A
Terminated NCT04356352 - Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain Phase 2/Phase 3
Completed NCT05057988 - Virtual Empowered Relief for Chronic Pain N/A
Completed NCT04466111 - Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
Recruiting NCT06206252 - Can Medical Cannabis Affect Opioid Use?
Completed NCT05868122 - A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy Phase 3
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Enrolling by invitation NCT06087432 - Is PNF Application Effective on Temporomandibular Dysfunction N/A
Completed NCT05508594 - Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001 Phase 2/Phase 3
Recruiting NCT03646955 - Partial Breast Versus no Irradiation for Women With Early Breast Cancer N/A
Active, not recruiting NCT03472300 - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Completed NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Completed NCT02913027 - Can We Improve the Comfort of Pelvic Exams? N/A
Terminated NCT02181387 - Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor? Phase 4
Recruiting NCT06032559 - Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment Phase 3
Active, not recruiting NCT03613155 - Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care