Clinical trial NCT02102178: Occupational Therapy Modulates the Pain in Cancer Patient Under Palliative Care
Official title: Occupational Therapy Modulates the Pain in Cancer Patient Under Palliative
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer
Terminal Disease
Pain
Keywords: oncological pain
therapeutic activities
occupational therapy.
Lead sponsor: Barretos Cancer Hospital
Sponsor class: OTHER
First posted: 2014-04-02
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Pain is one of the most incapacitating symptoms because it is a complex experience that includes sensory and emotional perceptions, in which sensory, affective, cognitive, behavioral, cultural and social characteristics interact. Around 79% of advanced cancer cases present pain.

There is evidence that non-pharmacological therapeutic activities are useful for controlling oncological pain and other symptoms resulting from such diseases.

This study evaluated the results relating to pain modulation and improvement of emotional symptoms and quality of life, from an occupational therapy program applied to oncological patients who were receiving palliative care.

Detailed description: Occupational therapy provides a variety of practical and psychosocial interventions to enable individuals to adapt to the difficulties that result from advanced disease. In this form of therapy, the use of certain manual play activities are highlighted as a working tool, with the aim of intervening in relation to the limitations and/or physical and psychological diseases. Such interventions may transform some of these patients' interests in life, facilitate the development of undiscovered talents and skills and allow them to discover their artistic, artisanal or physical potentials.

The role and interventions of occupational therapy within palliative care are wide-ranging and challenging, with a vocation to help individuals to value the remainder of their lives and live for the present moment in the best way possible, through providing options for them to keep themselves in a physical and emotional condition that allows them to carry out activities that would be gratifying and stimulating. The effects from this will assist them in preparing for the end of life with more dignity and respect.

The relevance of occupational therapy interventions in relation to oncology and, in particular, palliative care has been little studied. However, it is known that this may contribute towards improving the quality of life in interpersonal relationships and diminishing pain and distress, through providing guidance regarding activities of daily living and through the use of therapeutic activities, especially in relation to hospitalization processes.

Eligibility criteria: Inclusion Criteria:

* \> 18 years old
* advanced neoplasia without therapeutic possibilities for cure
* intensity of pain greater than or equal to 5 on the 10-centimeter VAS.
* expected to live for more than three months,
* Karnofsky Performance Status (KPS) of between 40 and 70%
* Patients not candidate to palliative and antalgic chemotherapy and/or radiotherapy.
* Patients or their legal representatives must be able to read, understand and provide written informed consent to participate in the study.

Exclusion Criteria:

* Presence of aphasia and/or severe visual disturbances;
* Patients admitted to hospital for pain control in situations considered to be pain emergencies such as bone fracture, infection, medullary compression or metastasis in the central nervous system
* Patients with poor cognitive capacity (unable to understand the research questionnaires)

Primary outcomes:
measure: Change in pain intensity
timeFrame: Before and after occupational therapy intervention every day up to day 10
Secondary outcomes:
measure: Quality of life score
timeFrame: Baseline and day 10
measure: Anxiety rate
timeFrame: Baseline and day 10
measure: Depression rate
timeFrame: Baseline and day 10
Other outcomes:
Locations:
Study officials:
affiliation: Barretos Cancer Hospital
name: Natasha Takeda, Occupational Therapy
role: PRINCIPAL_INVESTIGATOR
affiliation: Barretos Cancer Hospital
name: Maria Salete A. Nascimento, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kasven-Gonzalez N, Souverain R, Miale S. Improving quality of life through rehabilitation in palliative care: case report. Palliat Support Care. 2010 Sep;8(3):359-69. doi: 10.1017/S1478951510000167.
citation: Sviden GA, Tham K, Borell L. Involvement in everyday life for people with a life threatening illness. Palliat Support Care. 2010 Sep;8(3):345-52. doi: 10.1017/S1478951510000143.
citation: Halkett GK, Ciccarelli M, Keesing S, Aoun S. Occupational therapy in palliative care: is it under-utilised in Western Australia? Aust Occup Ther J. 2010 Oct;57(5):301-9. doi: 10.1111/j.1440-1630.2009.00843.x.
citation: Meredith PJ. Has undergraduate education prepared occupational therapy students for possible practice in palliative care? Aust Occup Ther J. 2010 Aug;57(4):224-32. doi: 10.1111/j.1440-1630.2009.00836.x.
citation: Kumano K, Matsuda N, Matsumoto H, Noguchi A, Tada Y, Koezuka M, Sano K, Kasamatu Y. [The role of occupational therapist in Palliative Care Team]. Gan To Kagaku Ryoho. 2010 Sep;37(9):1825-7. No abstract available. Japanese.
citation: Kuhara S, Kakou H, Tokuo M, Nogami M, Takemura J, Hachisuka K. [Palliative rehabilitation of two patients with terminal stage cancer: a visit to patient's home and the provision of advice by a nurse and rehabilitation staff members before discharge--from physical therapist's perspective]. J UOEH. 2009 Dec 1;31(4):359-64. doi: 10.7888/juoeh.31.359. Japanese.