CancerPhase 2NCT02102178
Occupational Therapy Modulates the Pain in Cancer Patient Under Palliative Care
A Phase 2 study testing Tapestry, Regular occupation therapy and Weaving a scarf on a nail frame in people with Cancer and Terminal Disease, run by Barretos Cancer Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Terminal Disease, Pain
- What is being tested?
- Tapestry, Regular occupation therapy and Weaving a scarf on a nail frame
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Nov 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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.
Who cannot join
- 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)
About this study
Official title: Occupational Therapy Modulates the Pain in Cancer Patient Under Palliative
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.
Read the 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.
- Conditions
- Cancer, Terminal Disease, Pain
- Being tested
- Tapestry, Regular occupation therapy, Weaving a scarf on a nail frame, Domino game
- Keywords
- oncological pain, therapeutic activities, occupational therapy.
- Medical subject headings
- Neoplasms, Pain, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TapestryOther
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 therapyOther
Also called Occupational 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 frameOther
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 gameOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Intensive occupational therapy) | Experimental | 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. Receives: Other: Tapestry; Other: Regular occupation therapy; Other: Weaving a scarf on a nail frame; Other: Domino game |
| Group 2 (Regular occupation therapy) | Active comparator | All patients received pharmacological treatment for pain in according to WHO's analgesic ladder and only guidance regarding ADLs from the occupational therapist. Receives: Other: Regular occupation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and after occupational therapy intervention every day up to day 10
Secondary outcomes (3)
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.
Measured: Baseline and day 10
Anxiety rate
The anxiety symptoms were assessed using the Hospital Anxiety and Depression Scale (HADS).
Measured: Baseline and day 10
Depression rate
The depression symptoms were assessed using the Hospital Anxiety and Depression Scale (HADS)
Measured: Baseline and day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startJul 2007
- Primary completionJul 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barretos Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natasha Takeda, Occupational Therapy, Principal investigator, Barretos Cancer HospitalMaria Salete A. Nascimento, PhD, Principal investigator, Barretos Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102178
- Sponsor's protocol ID
- 7683857344959085
- Status last verified
- Mar 2014
- First submitted
- 27 Mar 2014
- Last updated
- 2 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20875180Sviden 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.
PubMed 20875178Halkett 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.
PubMed 20868419Meredith 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.
PubMed 20854596Kumano 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.
PubMed 20841957Kuhara 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.
PubMed 20000010
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupational Therapy Modulates the Pain in Cancer Patient Under Palliative
- ClinicalTrials.gov ID
- NCT02102178
- Acronym / sponsor ID
- 7683857344959085
- Conditions
- Cancer, Terminal Disease, Pain
- Keywords
- oncological pain, therapeutic activities, occupational therapy.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Barretos Cancer HospitalUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 2 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Intensive occupational therapy) | Experimental | Other: Tapestry, Other: Regular occupation therapy, Other: Weaving a scarf on a nail frame, Other: Domino gameAll 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. |
| Group 2 (Regular occupation therapy) | Active comparator | Other: Regular occupation therapyAll patients received pharmacological treatment for pain in according to WHO's analgesic ladder and only guidance regarding ADLs from the occupational therapist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- > 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%
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TapestryA 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 | Group 1 (Intensive occupational therapy) |
| Regular occupation therapyAlso: Occupational therapyAll 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 | Group 1 (Intensive occupational therapy), Group 2 (Regular occupation therapy) |
| Weaving a scarf on a nail frameWeaving 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 | Group 1 (Intensive occupational therapy) |
| Domino gameEach 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. | Other | Group 1 (Intensive occupational therapy) |
Primary outcome
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.
3 secondary outcomes
Quality of life score
Time frame: Baseline and day 10
Anxiety rate
Time frame: Baseline and day 10
Depression rate
Time frame: Baseline and day 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2014.
- Background: PubMed 20875180Kasven-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.
- Background: PubMed 20875178Sviden 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.
- Background: PubMed 20868419Halkett 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.
- Background: PubMed 20854596Meredith 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.
- Background: PubMed 20841957Kumano 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.
- Background: PubMed 20000010Kuhara 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natasha Takeda, Occupational Therapy principal investigator
Barretos Cancer Hospital
Maria Salete A. Nascimento, PhD principal investigator
Barretos Cancer Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tapestry, Regular occupation therapy and Weaving a scarf on a nail frame in people with Cancer and Terminal Disease, run by Barretos Cancer Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity (time frame: Before and after occupational therapy intervention every day up to day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02102178, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2014.