Malignant Wounds, Wound Treatment, Psycho-Social Support and Relaxation Therapy
Primary Purpose
Cancer, Malignant Wounds
Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Wound treatment
wound treatment
psycho-social support
relaxation therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer focused on measuring Cancer, Malignant wounds, Quality of life, Body-Image, Cancer patients
Eligibility Criteria
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.
Sites / Locations
- Rigshospitalet, University hospital of Copenhagen. Oncology department
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Silver product
Honey product
Outcomes
Primary Outcome Measures
Wound size
Secondary Outcome Measures
Wound odor. Wound infection. Wound exudate. Wound pain. Anxiety and depression. Body-Image.Sexuality.Quality of life.
Full Information
NCT ID
NCT00435474
First Posted
February 14, 2007
Last Updated
June 8, 2009
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT00435474
Brief Title
Malignant Wounds, Wound Treatment, Psycho-Social Support and Relaxation Therapy
Official Title
Malignant Wounds: A Randomized Clinical Trial Investigating a Complementary Multidimensional Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Malignant Wounds
Keywords
Cancer, Malignant wounds, Quality of life, Body-Image, Cancer patients
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Silver product
Arm Title
2
Arm Type
Experimental
Arm Description
Honey product
Intervention Type
Procedure
Intervention Name(s)
Wound treatment
Intervention Description
wound treatment (silver product, alginate and foam dressing)
Intervention Type
Procedure
Intervention Name(s)
wound treatment
Intervention Description
wound treatment (honey product, alginate and foam dressing)
Intervention Type
Other
Intervention Name(s)
psycho-social support
Intervention Description
psycho-social support (based on the structure in cognitive therapy)
Intervention Type
Other
Intervention Name(s)
relaxation therapy
Intervention Description
relaxation therapy
Primary Outcome Measure Information:
Title
Wound size
Time Frame
after four weeks intervention period
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lis Adamsen, Professor
Organizational Affiliation
Copenhagen University. Faculty of health Sciences, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Rigshospitalet, University hospital of Copenhagen. Oncology department
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
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Malignant Wounds, Wound Treatment, Psycho-Social Support and Relaxation Therapy
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