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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00435474
• Other study ID #: kf 0102006-5491
• Status: Completed
• Phase: Phase 3
• First received: February 14, 2007
• Last updated: June 8, 2009
• Start date: April 2007
• Est. completion date: May 2009

Study information

• Verified date: June 2009
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer
• Malignant Wounds

Intervention

Procedure:
• Wound treatment
wound treatment (silver product, alginate and foam dressing)
• wound treatment
wound treatment (honey product, alginate and foam dressing)

Other:
• psycho-social support
psycho-social support (based on the structure in cognitive therapy)
• relaxation therapy
relaxation therapy

Locations

Country	Name	City	State
Denmark	Rigshospitalet, University hospital of Copenhagen. Oncology department	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound size		after four weeks intervention period	No
Secondary	Wound odor. Wound infection. Wound exudate. Wound pain. Anxiety and depression. Body-Image.Sexuality.Quality of life.		after the four week intervention period	No