This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Occupational Therapy Modulates the Pain in Cancer Patient Under Palliative Care

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Barretos Cancer Hospital
ClinicalTrials.gov Identifier:
NCT02102178
First received: March 27, 2014
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Cancer Terminal Disease Pain Other: Tapestry Other: Regular occupation therapy Other: Weaving a scarf on a nail frame Other: Domino game Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Occupational Therapy Modulates the Pain in Cancer Patient Under Palliative

Further study details as provided by Barretos Cancer Hospital:

Primary Outcome Measures:
  • Change in pain intensity [ Time Frame: Before and after occupational therapy intervention every day up to day 10 ]
    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.


Secondary Outcome Measures:
  • Quality of life score [ Time Frame: Baseline and day 10 ]
    Quality of life was evaluated by means of the SF-12 Health Survey, which is a shortened version of the SF-36 Health Survey.

  • Anxiety rate [ Time Frame: Baseline and day 10 ]
    The anxiety symptoms were assessed using the Hospital Anxiety and Depression Scale (HADS).

  • Depression rate [ Time Frame: Baseline and day 10 ]
    The depression symptoms were assessed using the Hospital Anxiety and Depression Scale (HADS)


Enrollment: 58
Study Start Date: July 2007
Study Completion Date: November 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 (Intensive occupational therapy)

All patients received pharmacological treatment for pain in accordance with the World Health Organization (WHO)'s analgesic ladder and occupational therapy follow-up, with guidance regarding activities of daily living (ADLs).

They also carried out therapeutic activities such as embroidery onto gauze (tapestry), weaving a scarf on a nail frame and playing dominos.

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.

Other: 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.
Other Name: Occupational therapy
Other: 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.

Other: 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.
Active Comparator: Group 2 (Regular occupation therapy)
All patients received pharmacological treatment for pain in according to WHO's analgesic ladder and only guidance regarding ADLs from the occupational therapist.
Other: 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.
Other Name: Occupational therapy

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02102178

Sponsors and Collaborators
Barretos Cancer Hospital
Investigators
Principal Investigator: Natasha Takeda, Occupational Therapy Barretos Cancer Hospital
Principal Investigator: Maria Salete A. Nascimento, PhD Barretos Cancer Hospital
  More Information

Publications:
Responsible Party: Barretos Cancer Hospital
ClinicalTrials.gov Identifier: NCT02102178     History of Changes
Other Study ID Numbers: 7683857344959085
Study First Received: March 27, 2014
Last Updated: March 31, 2014

Keywords provided by Barretos Cancer Hospital:
oncological pain
therapeutic activities
occupational therapy.

ClinicalTrials.gov processed this record on August 23, 2017