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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00435474

Enrollment

Registered

2007-02-15

Start date

2007-04-30

Completion date

2009-05-31

Last updated

2009-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Malignant Wounds

Keywords

Cancer, Malignant wounds, Quality of life, Body-Image, Cancer patients

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.

Interventions

PROCEDUREWound treatment

wound treatment (silver product, alginate and foam dressing)

PROCEDUREwound treatment

wound treatment (honey product, alginate and foam dressing)

OTHERpsycho-social support

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

OTHERrelaxation therapy

relaxation therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Wound size	after four weeks intervention period

Secondary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026