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

June 8, 2009 updated by: Rigshospitalet, Denmark

Malignant Wounds: A Randomized Clinical Trial Investigating a Complementary Multidimensional Intervention

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.

Study Overview

Status

Completed

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:

  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

Enrollment (Anticipated)

70

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet, University hospital of Copenhagen. Oncology department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Procedure: Wound treatment
wound treatment (silver product, alginate and foam dressing)
Other: psycho-social support
psycho-social support (based on the structure in cognitive therapy)
Other: relaxation therapy
relaxation therapy
Experimental: 2
Honey product
Other: psycho-social support
psycho-social support (based on the structure in cognitive therapy)
Other: relaxation therapy
relaxation therapy
Procedure: wound treatment
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

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Study Chair: Lis Adamsen, Professor, Copenhagen University. Faculty of health Sciences, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

February 14, 2007

First Submitted That Met QC Criteria

February 14, 2007

First Posted (Estimate)

February 15, 2007

Study Record Updates

Last Update Posted (Estimate)

June 9, 2009

Last Update Submitted That Met QC Criteria

June 8, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

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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