Cancer, BreastNCT03936075
Guided Imagery & Music in Cancer
A study testing the Guided Imagery and Music method in people with Cancer, Breast and Cancer, Metastatic, run by Aalborg University at 1 site in Greece.
Trial summary
This is an RCT pilot study to explore the potential effects of the Guided Imagery \& Music method for women with breast or gynecologic cancer, during active treatment. The study explores the potential impact in quality of life parameters such as mood, fatigue, and hope. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Cancer, Breast, Cancer, Metastatic, Cancer Ovaries
- What is being tested?
- the Guided Imagery and Music method
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jul 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Speaking Greek
- receiving chemotherapy or radiotherapy treatment for breast or gynecologic cancer
- first occurrence or metastatic
- have an interest in engaging in creative psychotherapies through music
Who cannot join
- women with active psychosis or PTSD symptomatology
- women receiving other psychological support
- women too ill to participate according to doctors' instructions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Guided Imagery & Music in Active Treatment for Gynecologic or Breast Cancer: An RCT Pilot
This is an RCT pilot study to explore the potential effects of the Guided Imagery \& Music method for women with breast or gynecologic cancer, during active treatment. The study explores the potential impact in quality of life parameters such as mood, fatigue, and hope.
Read the detailed description
Guided Imagery and Music is a music-assisted psychotherapy method which has been used as a complementary, supportive psychosocial therapy in cancer care. However, its effects have never been explored during the period of active chemotherapy or radiotherapy treatment in various cancer populations, and especially gynecologic and breast cancer. This pilot study is an effort to explore the feasibility of the method to increase quality of life in this population by possibly reducing side-effects of treatment such as fatigue, improving mood, and building resilience as expressed through levels of hope.
- Being tested
- the Guided Imagery and Music method, standard care and verbal counselling
- Keywords
- receptive music therapy, Guided Imagery & Music (GIM), chemotherapy, radiotherapy, breast cancer, gynecologic cancer
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the Guided Imagery and Music methodBehavioural
Also called receptive music psychotherapy
the method involves listening to the music while describing the experience to the therapist, any visual imagery that is evoked by the music, emotions, body sensations, thoughts or memories. after the music listening session, there is discussion upon making meaning of the experience and finding resources as potential coping skills
standard care and verbal counsellingBehavioural
the participants receive their usual cancer treatment and two individual counselling sessions
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | treatment with the provision of 6 individual sessions of the Guided Imagery and Music method as a psychological supportive intervention, and psychometric questionnaires collection Receives: Behavioral: the Guided Imagery and Music method |
| control | Placebo comparator | standard care treatment with psychometric questionnaires collection and two individual counselling sessions, at baseline (week 1) and at the end (week 6) Receives: Behavioral: standard care and verbal counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Profiles of Mood States (POMS) Brief version (adapted)
Brief version adapted in Greek. A 30-item scale designed to assess six different moods namely tension, anger, vigor, fatigue, depression, confusion. It requires to indicate mood state over the last week, with a single word, each item ranging from 0(not at all) to 4 (extremely). The questionnaire is a sum of its 6 sub scales (each addressing the aforementioned moods), with a total score from 0 to 120. Lower scores indicate better mood states.
Measured: Baseline and up to 12 weeks (post-intervention)
Secondary outcomes (4)
Herth Hope Index
A 12-item Likert-format instrument assessing current levels of hope from 1(strongly disagree) to 4 (strongly agree). It consists of three sub scales, examining interconnectedness, temporality and spirituality, and positiveness or expectancy. A higher score of the sum or the 3 sub scales indicates a higher hope level with scores ranging from 12 to 48.
Measured: Baseline and up to 12 weeks (post-intervention)
Cancer-related Fatigue Scale (CFS)
An instrument consisting of 15 items that assess physical, affective, and cognitive dimensions of fatigue at present moment, with Likert scales ranging from 1 to 5. the physical sub scale consists of 7 items, the affective sub scale consists of 4 items, and the cognitive sub scale consists of 3 items and the total of all 3 sub scales indicate that greater scores correspond to greater fatigue levels.
Measured: Baseline and up to 12 weeks (post-intervention)
Visual Analogue Scale for Hope (VAS-H)
VAS is a single, frequent measurement to address the current levels of hope. Its s based on a 100cm horizontal line from 1cm (hopeless) to 100cm (hopeful)
Measured: obtained 6 times throughout the completion of intervention (up to 12 weeks)
Visual Analogue Scale for Fatigue (VAS-F)
VAS is a single, frequent measurement to address the current levels of fatigue.
Measured: Obtained 6 times throughout the completion of intervention (up to 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start1 Jul 2018
- Primary completion30 Jun 2020
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, BreastStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two randomised groups, one intervention group and one placebo group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Aretaieion University Hospital, SONORA Organisation for Music Therapy and Research
- Responsible party
- Principal investigator, Evangelia Papanikolaou, Aalborg University
- Investigators
- Niels Hannibal, PhD, Study director, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936075
- Sponsor's protocol ID
- 62/19-06-18
- Status last verified
- Jul 2020
- First submitted
- 29 Apr 2019
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Imagery & Music in Active Treatment for Gynecologic or Breast Cancer: An RCT Pilot
- ClinicalTrials.gov ID
- NCT03936075
- Acronym / sponsor ID
- 62/19-06-18
- Keywords
- receptive music therapy, Guided Imagery & Music (GIM), chemotherapy, radiotherapy, breast cancer, gynecologic cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- Aretaieion University Hospital, SONORA Organisation for Music Therapy and Research
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 3 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an RCT pilot study to explore the potential effects of the Guided Imagery \& Music method for women with breast or gynecologic cancer, during active treatment. The study explores the potential impact in quality of life parameters such as mood, fatigue, and hope.
Detailed description
Guided Imagery and Music is a music-assisted psychotherapy method which has been used as a complementary, supportive psychosocial therapy in cancer care. However, its effects have never been explored during the period of active chemotherapy or radiotherapy treatment in various cancer populations, and especially gynecologic and breast cancer. This pilot study is an effort to explore the feasibility of the method to increase quality of life in this population by possibly reducing side-effects of treatment such as fatigue, improving mood, and building resilience as expressed through levels of hope.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- two randomised groups, one intervention group and one placebo group
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Behavioral: the Guided Imagery and Music methodtreatment with the provision of 6 individual sessions of the Guided Imagery and Music method as a psychological supportive intervention, and psychometric questionnaires collection |
| control | Placebo comparator | Behavioral: standard care and verbal counsellingstandard care treatment with psychometric questionnaires collection and two individual counselling sessions, at baseline (week 1) and at the end (week 6) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Speaking Greek
- receiving chemotherapy or radiotherapy treatment for breast or gynecologic cancer
- first occurrence or metastatic
- have an interest in engaging in creative psychotherapies through music
Key exclusion criteria (3 listed)
- women with active psychosis or PTSD symptomatology
- women receiving other psychological support
- women too ill to participate according to doctors' instructions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the Guided Imagery and Music methodAlso: receptive music psychotherapythe method involves listening to the music while describing the experience to the therapist, any visual imagery that is evoked by the music, emotions, body sensations, thoughts or memories. after the music listening session, there is discussion upon making meaning of the experience and finding resources as potential coping skills | Behavioural | intervention |
| standard care and verbal counsellingthe participants receive their usual cancer treatment and two individual counselling sessions | Behavioural | control |
Primary outcome
Profiles of Mood States (POMS) Brief version (adapted)
Time frame: Baseline and up to 12 weeks (post-intervention)
Brief version adapted in Greek. A 30-item scale designed to assess six different moods namely tension, anger, vigor, fatigue, depression, confusion. It requires to indicate mood state over the last week, with a single word, each item ranging from 0(not at all) to 4 (extremely). The questionnaire is a sum of its 6 sub scales (each addressing the aforementioned moods), with a total score from 0 to 120. Lower scores indicate better mood states.
4 secondary outcomes
Herth Hope Index
Time frame: Baseline and up to 12 weeks (post-intervention)
Cancer-related Fatigue Scale (CFS)
Time frame: Baseline and up to 12 weeks (post-intervention)
Visual Analogue Scale for Hope (VAS-H)
Time frame: obtained 6 times throughout the completion of intervention (up to 12 weeks)
Visual Analogue Scale for Fatigue (VAS-F)
Time frame: Obtained 6 times throughout the completion of intervention (up to 12 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels Hannibal, PhD study director
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the Guided Imagery and Music method in people with Cancer, Breast and Cancer, Metastatic, run by Aalborg University at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Profiles of Mood States (POMS) Brief version (adapted) (time frame: Baseline and up to 12 weeks (post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.