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

Rigshospitalet

Status and phase: Completed; Phase 3

Conditions: Cancer; Malignant Wounds

Treatments: Other: relaxation therapy; Other: psycho-social support; Procedure: wound treatment; Procedure: Wound treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT00435474

kf 0102006-5491

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

1

Active Comparator group

Description:

Silver product

Treatment:

Procedure: Wound treatment

Other: relaxation therapy

Other: psycho-social support

2

Experimental group

Description:

Honey product

Treatment:

Procedure: wound treatment

Other: relaxation therapy

Other: psycho-social support