Malignant Wounds: A Randomized Clinical Trial Investigating a Complementary Multidimensional Intervention
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- Wound size
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Wound size
Time Frame: after four weeks intervention period
Secondary Outcomes
- Wound odor. Wound infection. Wound exudate. Wound pain. Anxiety and depression. Body-Image.Sexuality.Quality of life.(after the four week intervention period)