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

Rigshospitalet, Denmark70 enrolled

Overview

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.

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: 1. wound treatment (silver product, alginate and foam dressing \>\< honey product, alginate and foam dressing) in combination with, 2. psycho-social support (based on the structure in cognitive therapy) and 3. 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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Cancer Malignant Wounds

Interventions

Wound treatmentPROCEDURE

wound treatment (silver product, alginate and foam dressing)

wound treatmentPROCEDURE

wound treatment (honey product, alginate and foam dressing)

psycho-social supportOTHER

psycho-social support (based on the structure in cognitive therapy)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Rigshospitalet, University hospital of Copenhagen. Oncology department

Copenhagen, Denmark

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.

Time frame: after the four week intervention period

Data from ClinicalTrials.gov

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