Malignant Wounds, Wound Treatment, Psycho-Social Support and Relaxation Therapy
NCT ID: NCT00435474
Last Updated: 2009-06-09
Study Results
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Basic Information
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COMPLETED
PHASE3
70 participants
INTERVENTIONAL
2007-04-30
2009-05-31
Brief Summary
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Detailed Description
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1. wound treatment (silver product, alginate and foam dressing \>\< honey product, alginate and foam dressing) in combination with,
2. psycho-social support (based on the structure in cognitive therapy) and
3. relaxation therapy.
Furthermore to investigate coping strategies, body image, stigma and quality of life in cancer patients with malignant wounds.
Design: A hypothesis testing prospective randomized clinical intervention study (n=70) and an explorative qualitative interview study
Method: Digital photographing, measurement of wound size with Quantify-Image-One, wound morphology registration (the extent of malodour, infection, seepage, bleeding, pain, the healing process), grafting, VAS-score, quality of life questionnaire (EORTC-QLQ-C30, DLQI), Hospital Anxiety and Depression Scale (HAD), Mental Adjustment to Cancer (MAC), interview.
Patients will fill out a diary focusing on wound related problems.
Perspectives: The results will determine whether the honey treatment is an improvement, and whether the silver treatment has statistical and clinical significance.
The qualitative study will contribute new knowledge about conditions of life for cancer patients with cancer wounds, their feelings and impositions.
In spite of proving positive effect, the project will contribute with new required knowledge on treatment and support for cancer patients suffering from malignant wounds.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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1
Silver product
Wound treatment
wound treatment (silver product, alginate and foam dressing)
psycho-social support
psycho-social support (based on the structure in cognitive therapy)
relaxation therapy
relaxation therapy
2
Honey product
wound treatment
wound treatment (honey product, alginate and foam dressing)
psycho-social support
psycho-social support (based on the structure in cognitive therapy)
relaxation therapy
relaxation therapy
Interventions
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Wound treatment
wound treatment (silver product, alginate and foam dressing)
wound treatment
wound treatment (honey product, alginate and foam dressing)
psycho-social support
psycho-social support (based on the structure in cognitive therapy)
relaxation therapy
relaxation therapy
Eligibility Criteria
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Inclusion Criteria
* Cancer wound \>2 cm.
* Receiving antineoplasm treatment.
* \> 18 years.
* Receiving antineoplasm treatment in out-patient clinic.
* Read, speak and write Danish.
Exclusion Criteria
* Life expectancy \> 3 month.
* Not psychotic.
18 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Principal Investigators
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Lis Adamsen, Professor
Role: STUDY_CHAIR
Copenhagen University. Faculty of health Sciences, Denmark
Locations
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Rigshospitalet, University hospital of Copenhagen. Oncology department
Copenhagen, , Denmark
Countries
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Other Identifiers
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kf 0102006-5491
Identifier Type: -
Identifier Source: org_study_id
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