NCT02680236

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 11, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

May 1, 2018

Status Verified

April 1, 2018

Enrollment Period

3.8 years

First QC Date

January 5, 2016

Last Update Submit

April 30, 2018

Conditions

Keywords

PainCancerChemotherapyAnxietyDepressionIsolation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Percentage of patient showing change in Brief Pain Inventory pain severity score

    From baseline to end of the study (approx six months)

Study Arms (1)

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.

Other: Art Therapy Group

Interventions

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.

Breast Cancer Patients

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with breast cancer as assessed by the RM pain team.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

PainNeoplasmsAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Clare Shaw, BSc,RD,PhD

    Royal Marsden NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amyn A Lalji, BSc, MA

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2016

First Posted

February 11, 2016

Study Start

June 1, 2015

Primary Completion

March 1, 2019

Study Completion

August 1, 2019

Last Updated

May 1, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations