NCT00435474

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_3 cancer

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_3 cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

June 9, 2009

Status Verified

June 1, 2009

Enrollment Period

2.1 years

First QC Date

February 14, 2007

Last Update Submit

June 8, 2009

Conditions

CancerMalignant Wounds

Keywords

CancerMalignant woundsQuality of lifeBody-ImageCancer patients

Outcome Measures

Primary Outcomes (1)

  • Wound size

    after four weeks intervention period

Secondary Outcomes (1)

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

    after the four week intervention period

Study Arms (2)

1

ACTIVE COMPARATOR

Silver product

Procedure: Wound treatmentOther: psycho-social supportOther: relaxation therapy

2

EXPERIMENTAL

Honey product

Procedure: wound treatmentOther: psycho-social supportOther: relaxation therapy

Interventions

wound treatmentPROCEDURE

wound treatment (silver product, alginate and foam dressing)

1
psycho-social supportOTHER

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

12
relaxation therapyOTHER

relaxation therapy

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • No radiation therapy the last 6 month (on the wound).
  • Life expectancy \> 3 month.
  • Not psychotic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet, University hospital of Copenhagen. Oncology department

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Relaxation Therapy

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Lis Adamsen, Professor

    Copenhagen University. Faculty of health Sciences, Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 14, 2007

First Posted

February 15, 2007

Study Start

April 1, 2007

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

June 9, 2009

Record last verified: 2009-06

Locations

DK(1)