Condition category
Cancer
Date applied
23/03/2012
Date assigned
03/04/2012
Last edited
01/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Each year about 2,900 women are diagnosed with gynaecological cancer in Sweden and about 1,000 women die of the diseases. Gynaecological cancer and its treatments are affected by social and cultural values regarding illness, death, sexuality and femininity. Women being treated for these diseases may suffer from many different side-effects, such as varying degrees of altered bowel and bladder function, abdominal pain, bodily changes and problems with sexual function, health and wellbeing. There is a great need for psychosocial support and specialised treatment for women afflicted with gynaecological cancer. These women are subjected to a great deal of social stress. Many women experience fear of recurrence, and need strategies to handle that stress. They must, in addition to the threat of death by the disease, also deal with the loss of female body parts, which often have strong symbolic meanings. For most women of childbearing age their reproductive capacity is lost due to surgery, and the woman goes quickly into menopause. This involves weight gain, hot flashes and an experience of growing old before time. The experiences can be traumatic and affect the woman’s self-concept and identity. She often feels estranged from her body and does not quite know who she is as a woman, and in relationship to others. Self-esteem is also often affected and it is not unusual to experience shame and guilt. Therapy can lead to improved self-esteem and the experience of once again feel like an integrated person. This means greater self-acceptance and having the personal strength to stand up for oneself. Self-image, negative body sensations and sexual difficulties are central issues after completion of treatment, but these are often questions left to "silence". The aim of this study is to evaluate a form of music therapy for women with a history of gynaecological cancer who have completed medical treatment. The music therapy method to be evaluated is based on listening to selected pieces of music, working with art, and talking about the experiences in regards to coping with the illness. In this study we will examine how concerns about recurrence, body experiences, sexual function and existential health are influenced by the music therapy session. We will focus on problems that arise from having been treated for gynaecological cancer.

Who can participate?
Women aged between 18 and 75 who have completed treatment for gynaecological cancer, without recurrence.

What does the study involve?
Participants are randomly allocated to one of two groups. One group attends 12 sessions of individual music therapy. After the individual therapy is completed, the other group are offered six sessions of group therapy with music therapy and expressive arts. Three questionnaires are filled out by the participants before and after treatment, and after three months. The questions cover the following areas: quality of life, fear of recurrence, body image and body experiences, and sexual and existential health.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
Aalborg University, Denmark, the Department of Clinical Cancer Epidemiology, KCE, Department of Oncology-Pathology at Karolinska Institute, the Oncology Clinic at Karolinska University Hospital, and Expressive Arts Stockholm AB, Sweden.

When is the study starting and how long is it expected to run for?
April 2012 to December 2013

Who is funding the study?
Aalborg University (Denmark), Ekhaga Foundation, O-B Jeppson Music Therapy Foundation, and Ax:son Johnson Foundation (Sweden).

Who is the main contact?
Dr Karin Bergmark
Karin.Bergmark@ki.se

Trial website

Contact information

Type

Scientific

Primary contact

Dr Karin Bergmark

ORCID ID

Contact details

Karolinska Institutet
Department of Oncology and Pathology
Karolinska University Hospital
Z5:U1
Stockholm
171 76
Sweden
+46 85 177 5044
Karin.Bergmark@ki.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised controlled trial for women with a history of gynaecological cancer assessing the feasibility, experiences and potential effectiveness of receptive music therapy (KMR) and expressive arts therapy

Acronym

Study hypothesis

Fear of relapse decreases, the body image is better integrated and the existential and sexual health and well-being increases as an effect of short-term music therapy (KMR) for women with a history of gynaecological cancer.

Ethics approval

Ethical Committee, Karolinska Institutet, Stockholm, Sweden, 19/01/2012, ref: 2012/5:1

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Fear of recurrence in gynaecological cancer patients

Intervention

A short-term intervention called KMR will be implemented. KMR (Short Music Journeys) is a receptive form of music therapy that includes the uses of expressive arts techniques (EXA) (especially drawing and writing). This approach will be conducted both in individual therapy and in group therapy.

The KMR method has been developed by Margareta Wärja in collaboration with Swedish psychotherapists from the tradition of The Bonny Method of Guided Imagery and Music (GIM) and the tradition of expressive arts. The theory and approach of KMR is based on humanistic philosophy, existential psychology, psychodynamic theory, attachment theories, phenomenology, and theories of the arts as providers of experiences that create meaning and improve quality of life. Pre-recorded short pieces of music will be used in a psychotherapeutic framework to address issues of existential and sexual health, body image, and fear of recurrence. Visual art techniques will be used to process and work with images and experiences evoked by the music.

A mixed methods design with a complex intervention will be applied. Imbedded in the design is a randomised control trial with an individual intervention and a wait-list control group later receiving a group intervention. A qualitative phase of in-depth interviews, literature reviews and a pilot-study has preceded the RCT. Another qualitative phase of interviews and measures will follow after the RCT. Twenty patients will be included in the group receiving individual treatment and forty in the control group. After inclusion, screening, signing of informed consent and base-line measures have been completed; the patient will be randomised to either individual treatment or the wait-list group.

Individual KMR/EXA Therapy (Group A):
The procedure starts with one interview session, followed by twelve weekly therapy sessions each 60 minutes. Four psychotherapists trained in the KMR framework are assigned to the study. They will work from a semi-structured protocol outlining general steps and time posts in the therapy process.

Group Therapy KMR/EXA (Group B):
The procedure starts with one interview session, followed by six weekly group therapy sessions each 120 minutes. Each group consists of five to six members. Two-three therapists trained in the KMR framework are assigned to the study. They will work from a semi-structured protocol outlining general steps and time posts in the group therapy process.

Measurements will be taken pre-, post- and follow-up (after 3 months)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Reduced fear of recurrence
2. Improved sexual health
3. Improved integration of body-image
4. Improved existential health and well-being

The evaluation of these symptoms will be assessed through detailed self-evaluation questionnaires, specifically constructed and validated for this population, and two standardised questionnaires [EORTC QLQ-C30, Montgomery–Åsberg Depression Rating Scale (MADRS)]

Measured at:

Group A, Intervention group (individual treatment):
T0 Screening (0 months)
T1 Baseline (0 months)
T2 End of treatment (C:a 5 months)
T3 Follow-up (C:a 8 months after baseline)

Group B, wait-list group (later group-intervention):
T0 Screening (0 months)
T1 Baseline (0 months)
T2 End of wait-list, before group-intervention (C:a 5 months)
T3 End of treatment (C:a 8 months after baseline)
T4 Follow-up (C:a 11 months after baseline)

Secondary outcome measures

1. Experience and change of quality of life
2. Experiences of cancer treatment
3. Experiences of and change in self-care
4. Experience of information and care from health care personnel
5. Experiences of and changes in body- and self-image, self-esteem and confidence
6. Experiences of and changes in feelings of guilt and shame
7. Experiences of and changes in social interactions and networking
8. Experiences of and changes in practices of cultural events, music and art, and hobbies
9. Experiences of and changes in practices of journal writing and expressive writing
10. Experience of and change in coping strategies
11. Previous experiences of sexual abuse
12. Previous experiences of traumatic life events
13. Experiences of participation in a music therapy study (specific questions in the questionnaire and in qualitative interviews with samples of participants and therapists)
14. Acceptability and feasibility of our methodology (specific questions in the questionnaires and in qualitative interviews with samples of participants)
15. Drop-out analysis:
15.1. Exclusions
15.2. Recruitment rates
15.3. Loss to follow-up
15.4. Drop-outs (group therapy after wait-list)
15.5. Missing data

Measured at:

Group A, Intervention group (individual treatment):
T0 Screening (0 months)
T1 Baseline (0 months)
T2 End of treatment (C:a 5 months)
T3 Follow-up (C:a 8 months after baseline)

Group B, wait-list group (later group-intervention):
T0 Screening (0 months)
T1 Baseline (0 months)
T2 End of wait-list, before group-intervention (C:a 5 months)
T3 End of treatment (C:a 8 months after baseline)
T4 Follow-up (C:a 11 months after baseline)

Overall trial start date

02/04/2012

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women with a history of gynaecological cancer
2. At follow-up at the Department of Gynaecological Oncology, Karolinska University Hospital, Stockholm, Sweden, 3-24 months after primary treatment
3. 18-75 years
4. Fluent in written and spoken Swedish language

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

60

Participant exclusion criteria

1. Relapse
2. High risk of relapse during the study period
3. A history of mental disorder or substance abuse
4. > 75 years

Recruitment start date

02/04/2012

Recruitment end date

31/12/2013

Locations

Countries of recruitment

Sweden

Trial participating centre

Karolinska Institutet
Stockholm
171 76
Sweden

Sponsor information

Organisation

Aalborg University (Denmark)

Sponsor details

c/o Prof Lars Ole Bonde
Faculty of the Humanities
Krogstraede 3
Aalborg Ø
9220
Denmark

Sponsor type

University/education

Website

http://www.mt-phd.aau.dk

Funders

Funder type

University/education

Funder name

Aalborg University, Faculty of the Humanities (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ekhaga Foundation (Sweden) Ref. 2011-66

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

O-B Jeppson Music Therapy Foundation (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ax:son Johnson Foundation (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes