Occupational Therapy Modulates the Pain in Cancer Patient Under Palliative Care

Pain Clinical Trial

Official title:

Occupational Therapy Modulates the Pain in Cancer Patient Under Palliative

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02102178
• Other study ID #: 7683857344959085
• Status: Completed
• Phase: Phase 2
• First received: March 27, 2014
• Last updated: March 31, 2014
• Start date: July 2007
• Est. completion date: November 2008

Study information

• Verified date: March 2014
• Source: Barretos Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: November 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer
• Pain
• Terminal Disease

Intervention

Other:
• Tapestry
A gauze screen, wool thread appropriate for tapestry and a large needle were used. The entire screen was filled with a striped pattern made of embroidered half-stitches in the individuals' preferred colors. To fill the screen with half-stitches, the needle was always worked in diagonal movements, point to point. The stitches were started keeping a distance of three points from the four edges.
• Regular occupation therapy
All the patients were followed up daily for 10 days by a single occupational therapist for around 30 minutes, during which they received guidance regarding how best to perform their ADLs, i.e. how to position themselves when sitting down and standing up, dressing and undressing, feeding themselves, performing personal hygiene and undertaking leisure activities, with the aim of protecting their joints, reducing the pain and expending less energy.
• Weaving a scarf on a nail frame
Weaving a scarf on a nail frame: this activity used a rectangular wooden frame (30 cm x 10 cm), with an empty space in the middle and nails distributed at 1 cm intervals along all sides, together with a crochet needle and wool thread. Procedure: The thread was measured out on the frame and all the fringes were cut to the same length. After this, each thread was knotted, leaving a loop that was placed over each nail. A wool thread was tied to the nail at the corner and a zigzag pattern was woven between alternate nails. On the return, the zigzag weave went via the nails that had initially been missed out. Using the crochet needle, the loop of the fringe was pulled across on top of the zigzag. The scarf went on coming out from under the frame. The zigzag sequence and the needle movement were repeated until the scarf reached the desired length.
• Domino game
Each player received seven dominos and kept them concealed from the adversaries' eyes. The player with the double-six (domino with the number six at both ends) started the game. If this domino had not been dealt out to any player, the one with the highest double domino started. Following on from this first player, in clockwise direction, each subsequent player placed one domino at one of the ends of the chain that was formed as the dominos were played. If a player did not have a domino that could be played, he would go to the pile and keep on picking up dominos until getting one that would fit. If no such domino existed, the player would then pass his turn on to the next player. The first player to get rid of all his dominos was the winner. If the game became "blocked", i.e. there was no longer any possibility of adding dominos to the chain, the points in each player's hand were counted and the winner was the one with the lowest number of points in his hand.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Barretos Cancer Hospital

References & Publications (6)

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. — View 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. — View 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. Japanese. — View 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. Japanese. — View 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. — View Citation

Svidén 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain intensity	The pain intensity was assessed every day before and after each intervention by means of the 10 cm VAS. The McGill pain questionnaire was used on the first and last (tenth) day of the study.	Before and after occupational therapy intervention every day up to day 10	Yes
Secondary	Quality of life score	Quality of life was evaluated by means of the SF-12 Health Survey, which is a shortened version of the SF-36 Health Survey.	Baseline and day 10	No
Secondary	Anxiety rate	The anxiety symptoms were assessed using the Hospital Anxiety and Depression Scale (HADS).	Baseline and day 10	No
Secondary	Depression rate	The depression symptoms were assessed using the Hospital Anxiety and Depression Scale (HADS)	Baseline and day 10	No