Clinical trial NCT00435474: Malignant Wounds, Wound Treatment, Psycho-Social Support and Relaxation Therapy
Official title: Malignant Wounds: A Randomized Clinical Trial Investigating a Complementary Multidimensional Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer
Malignant Wounds
Keywords: Cancer
Malignant wounds
Quality of life
Body-Image
Cancer patients
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2007-02-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Wound size
timeFrame: after four weeks intervention period
Secondary outcomes:
measure: Wound odor. Wound infection. Wound exudate. Wound pain. Anxiety and depression. Body-Image.Sexuality.Quality of life.
timeFrame: after the four week intervention period
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, University hospital of Copenhagen. Oncology department
Study officials:
affiliation: Copenhagen University. Faculty of health Sciences, Denmark
name: Lis Adamsen, Professor
role: STUDY_CHAIR
References: