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

Phase 3

Completed

• Conditions: Cancer; Malignant Wounds
• Interventions: Procedure: wound treatment; Other: psycho-social support; Other: relaxation therapy

• Registration Number: NCT00435474
• Lead Sponsor: Rigshospitalet, Denmark

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:

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 Timeline

• Study First Submitted: 2007-02-14
• Study First Submitted QC: 2007-02-14
• Study First Posted: 2007-02-15
• Study Start: 2007-04
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-08
• Last Update Posted: 2009-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	relaxation therapy	Honey product
1	wound treatment	Silver product
1	psycho-social support	Silver product
1	relaxation therapy	Silver product
2	wound treatment	Honey product
2	psycho-social support	Honey product

Primary Outcome Measures

Name	Time	Method
Wound size	after four weeks intervention period

Secondary Outcome Measures

Name	Time	Method
Wound odor. Wound infection. Wound exudate. Wound pain. Anxiety and depression. Body-Image.Sexuality.Quality of life.	after the four week intervention period

Trial Locations

Locations (1)

Rigshospitalet, University hospital of Copenhagen. Oncology department; 🇩🇰 Copenhagen, Denmark