- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00435474
Malignant Wounds, Wound Treatment, Psycho-Social Support and Relaxation Therapy
Malignant Wounds: A Randomized Clinical Trial Investigating a Complementary Multidimensional Intervention
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Copenhagen, Denmark, 2100
- Rigshospitalet, University hospital of Copenhagen. Oncology department
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Silver product
|
wound treatment (silver product, alginate and foam dressing)
psycho-social support (based on the structure in cognitive therapy)
relaxation therapy
|
Experimental: 2
Honey product
|
psycho-social support (based on the structure in cognitive therapy)
relaxation therapy
wound treatment (honey product, alginate and foam dressing)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Wound size
Time Frame: after four weeks intervention period
|
after four weeks intervention period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Wound odor. Wound infection. Wound exudate. Wound pain. Anxiety and depression. Body-Image.Sexuality.Quality of life.
Time Frame: after the four week intervention period
|
after the four week intervention period
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Lis Adamsen, Professor, Copenhagen University. Faculty of health Sciences, Denmark
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- kf 0102006-5491
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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