Malignant Wounds, Wound Treatment, Psycho-Social Support and Relaxation Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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: wound treatment (silver product, alginate and foam dressing >< honey product, alginate and foam dressing) in combination with, psycho-social support (based on the structure in cognitive therapy) and 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.

Official Title
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Malignant Wounds: A Randomized Clinical Trial Investigating a Complementary Multidimensional Intervention

Conditions
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Cancer, Malignant Wounds

Intervention / Treatment
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* Procedure: Wound treatment
* Procedure: wound treatment
* Other: psycho-social support
* Other: relaxation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cancer with evidence of disease. Cancer wound >2 cm. Receiving antineoplasm treatment. > 18 years. Receiving antineoplasm treatment in out-patient clinic. Read, speak and write Danish. Exclusion Criteria: No radiation therapy the last 6 month (on the wound). Life expectancy > 3 month. Not psychotic.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Silver product | Procedure: Wound treatment<br>* wound treatment (silver product, alginate and foam dressing)<br>Other: psycho-social support<br>* psycho-social support (based on the structure in cognitive therapy)<br>Other: relaxation therapy<br>* relaxation therapy<br>|
| Experimental: 2<br>Honey product | Procedure: wound treatment<br>* wound treatment (honey product, alginate and foam dressing)<br>Other: psycho-social support<br>* psycho-social support (based on the structure in cognitive therapy)<br>Other: relaxation therapy<br>* relaxation therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound size |  | after four weeks intervention period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound odor. Wound infection. Wound exudate. Wound pain. Anxiety and depression. Body-Image.Sexuality.Quality of life. |  | after the four week intervention period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Malignant wounds, Quality of life, Body-Image, Cancer patients