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NCT Number: NCT00435474

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

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.

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Key information

Conditions

Cancer Malignant Wounds Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rigshospitalet, University hospital of Copenhagen. Oncology department

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Wound treatment

Procedure

wound treatment (silver product, alginate and foam dressing)

psycho-social support

Other

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

relaxation therapy

Other

relaxation therapy

Primary outcomes

  1. Wound size

    Time frame: after four weeks intervention period

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 15, 2007
Registry last updated
Jun 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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