Malignant Wounds, Wound Treatment, Psycho-Social Support and Relaxation Therapy
Study Details
Study Description
Brief Summary
The purpose of this study is to investigate whether treatment for cancer patients with malignant wounds can improve (wound healing/wound size, odor, infection, seepage, pain) through comparing the effects of two multidimensional interventions including wound treatment, psycho-social support and relaxation therapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Objective: To investigate whether treatment for cancer patients with malignant wounds can improve (wound healing/wound size, odor, infection, seepage, pain) through comparing the effects of two multidimensional interventions:
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wound treatment (silver product, alginate and foam dressing >< honey product, alginate and foam dressing) in combination with,
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psycho-social support (based on the structure in cognitive therapy) and
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 1 Silver product |
Procedure: Wound treatment
wound treatment (silver product, alginate and foam dressing)
Other: psycho-social support
psycho-social support (based on the structure in cognitive therapy)
Other: relaxation therapy
relaxation therapy
|
| Experimental: 2 Honey product |
Procedure: wound treatment
wound treatment (honey product, alginate and foam dressing)
Other: psycho-social support
psycho-social support (based on the structure in cognitive therapy)
Other: relaxation therapy
relaxation therapy
|
Outcome Measures
Primary Outcome Measures
- Wound size [after four weeks intervention period]
Secondary Outcome Measures
- Wound odor. Wound infection. Wound exudate. Wound pain. Anxiety and depression. Body-Image.Sexuality.Quality of life. [after the four week intervention period]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Cancer with evidence of disease.
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Cancer wound >2 cm.
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Receiving antineoplasm treatment.
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18 years.
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Receiving antineoplasm treatment in out-patient clinic.
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Read, speak and write Danish.
Exclusion Criteria:
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No radiation therapy the last 6 month (on the wound).
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Life expectancy > 3 month.
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Not psychotic.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rigshospitalet, University hospital of Copenhagen. Oncology department | Copenhagen | Denmark | 2100 |
Sponsors and Collaborators
- Rigshospitalet, Denmark
Investigators
- Study Chair: Lis Adamsen, Professor, Copenhagen University. Faculty of health Sciences, Denmark
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- kf 0102006-5491