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

Primary Purpose

Cancer, Malignant Wounds

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Wound treatment
wound treatment
psycho-social support
relaxation therapy
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer focused on measuring Cancer, Malignant wounds, Quality of life, Body-Image, Cancer patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Rigshospitalet, University hospital of Copenhagen. Oncology department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Silver product

Honey product

Outcomes

Primary Outcome Measures

Wound size

Secondary Outcome Measures

Wound odor. Wound infection. Wound exudate. Wound pain. Anxiety and depression. Body-Image.Sexuality.Quality of life.

Full Information

First Posted
February 14, 2007
Last Updated
June 8, 2009
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT00435474
Brief Title
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

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Malignant Wounds
Keywords
Cancer, Malignant wounds, Quality of life, Body-Image, Cancer patients

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Silver product
Arm Title
2
Arm Type
Experimental
Arm Description
Honey product
Intervention Type
Procedure
Intervention Name(s)
Wound treatment
Intervention Description
wound treatment (silver product, alginate and foam dressing)
Intervention Type
Procedure
Intervention Name(s)
wound treatment
Intervention Description
wound treatment (honey product, alginate and foam dressing)
Intervention Type
Other
Intervention Name(s)
psycho-social support
Intervention Description
psycho-social support (based on the structure in cognitive therapy)
Intervention Type
Other
Intervention Name(s)
relaxation therapy
Intervention Description
relaxation therapy
Primary Outcome Measure Information:
Title
Wound size
Time Frame
after four weeks intervention period
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lis Adamsen, Professor
Organizational Affiliation
Copenhagen University. Faculty of health Sciences, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Rigshospitalet, University hospital of Copenhagen. Oncology department
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

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

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