Breast CancerPhase 1NCT04427215
Complementary and Alternative Medicine on Mental Health in Breast Cancer Patients
A Phase 1 study testing Complementary and alternative medicines in people with Breast Cancer, run by Klaipėda University at 1 site in Lithuania.
Trial summary
During cancer treatment, several patient experience substantial psychological distress, mainly depression and anxiety, which can persist over years after completion of treatment. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Complementary and alternative medicines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Jul 2020to 30 Oct 2021
- Phase
- Phase 1
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult woman with breast cancer diagnoses and their primary family caregiver
Who cannot join
- Insufficient physical capacity
- Severe mental disorder
- Inability ti give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Complementary and Alternative Medicine on Mental Health in Breast Cancer Patients and Their Family Caregivers
During cancer treatment, several patient experience substantial psychological distress, mainly depression and anxiety, which can persist over years after completion of treatment.
Complementary and alternative medicine (CAM) has been in use among cancer patients for a long time and several types of CAM that are practiced in various parts of the world.
Read more
However, the effectiveness of different CAM therapies on mental health is still limited.
Therefore, the investigators want to assess the effectiveness of complementary and alternative medicine (CAM) (Dance/movement therapy, Art Therapy, Music Therapy, Bibliotherapy and Physical Activity) on mental health of cancer patients as well as their caregiver
Read the detailed description
During cancer treatment, several patient experience substantial psychological distress, mainly depression and anxiety, which can persist over years after completion of treatment. These psychological impairments can aggravate symptom burden and can seriously affect health-related quality of life. Likewise, the diagnosis of cancer has not only a significant impact on the affected patients, but also on their families, and may cause emotional responses of shock, doubt, anxiety, and depression.
Complementary and alternative medicine (CAM) has been in use among cancer patients for a long time and several types of CAM that are practiced in various parts of the world. In the general among Lithuanian adult population, the use of CAM begins to seem common and the country claim for guidelines researches and to test the effectiveness of this practice to support the use of some CAM therapies on mental health of patients as well as their families.
In the St. Francis Oncology Center in Klaipeda some CAM have been applied aimed to increase the recovery and quality of life in the patients and their families. The effectiveness of different CAM therapies (Dance/movement therapy, Art Therapy, Music Therapy, Bibliotherapy and Physical Activity ) on mental health and recovery of cancer patients as well as on caregiving experiences and mental health of partners of cancer patients, it will be of great value to improve and provide a more effective service and the quality of caring in this patient as well as the continuing work of the Francis Oncology Center in Klaipeda and partners, with more higher scientific excellence and quality .
Objectives
- To assess the effectiveness of complementary and alternative medicine (CAM) (Dance/movement therapy, Art Therapy, Music Therapy, Bibliotherapy and Physical Activity) on mental health of cancer patients as well as their caregiver.
- Conditions
- Breast Cancer
- Being tested
- Complementary and alternative medicines
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complementary and alternative medicinesOther
Five types of Complementary and alternative medicines (Music Therapy, Art Therapy, Dance-Movement Therapy, Bibliotherapy, Physical Activity) will be applied twice a week.
| Study group | Role | What they receive |
|---|---|---|
| A - Music Therapy | Experimental | Two section a week of music therapy Receives: Other: Complementary and alternative medicines |
| B - Art Therapy | Experimental | Two section a week of Art therapy Receives: Other: Complementary and alternative medicines |
| C - Dance-Movement Therapy | Experimental | Two section a week of Dance-Movement Therapy Receives: Other: Complementary and alternative medicines |
| D - Bibliotherapy | Experimental | Two section a week of Bibliotherapy Receives: Other: Complementary and alternative medicines |
| E - Physical Activity | Experimental | Two section a week of systematized physical activity Receives: Other: Complementary and alternative medicines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental Health
Questionnaire to assess mental health
Measured: Mental health (score)changes over 4 weeks intervention
Quality of Life
Questionnaire to assess quality of life
Measured: Quality of life changes (score) over 4 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Jul 2020 (estimated)
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 5 intervention groups (music therapy, art therapy, dance-movement therapy, physical activity, bibliotherapy) and 1 control group.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klaipėda University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health of The Republic of Lithuania
- Responsible party
- Principal investigator, Cesar Agostinis-Sobrinho, Klaipėda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427215
- Sponsor's protocol ID
- S-169
- Status last verified
- Jun 2020
- First submitted
- 2 Jun 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Complementary and Alternative Medicine on Mental Health in Breast Cancer Patients and Their Family Caregivers
- ClinicalTrials.gov ID
- NCT04427215
- Acronym / sponsor ID
- S-169
- Conditions
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Klaipėda UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health of The Republic of Lithuania
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 11 Jun 2020 (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.
During cancer treatment, several patient experience substantial psychological distress, mainly depression and anxiety, which can persist over years after completion of treatment.
Complementary and alternative medicine (CAM) has been in use among cancer patients for a long time and several types of CAM that are practiced in various parts of the world.
However, the effectiveness of different CAM therapies on mental health is still limited.
Therefore, the investigators want to assess the effectiveness of complementary and alternative medicine (CAM) (Dance/movement therapy, Art Therapy, Music Therapy, Bibliotherapy and Physical Activity) on mental health of cancer patients as well as their caregiver
Detailed description
During cancer treatment, several patient experience substantial psychological distress, mainly depression and anxiety, which can persist over years after completion of treatment. These psychological impairments can aggravate symptom burden and can seriously affect health-related quality of life. Likewise, the diagnosis of cancer has not only a significant impact on the affected patients, but also on their families, and may cause emotional responses of shock, doubt, anxiety, and depression.
Complementary and alternative medicine (CAM) has been in use among cancer patients for a long time and several types of CAM that are practiced in various parts of the world. In the general among Lithuanian adult population, the use of CAM begins to seem common and the country claim for guidelines researches and to test the effectiveness of this practice to support the use of some CAM therapies on mental health of patients as well as their families.
In the St. Francis Oncology Center in Klaipeda some CAM have been applied aimed to increase the recovery and quality of life in the patients and their families. The effectiveness of different CAM therapies (Dance/movement therapy, Art Therapy, Music Therapy, Bibliotherapy and Physical Activity ) on mental health and recovery of cancer patients as well as on caregiving experiences and mental health of partners of cancer patients, it will be of great value to improve and provide a more effective service and the quality of caring in this patient as well as the continuing work of the Francis Oncology Center in Klaipeda and partners, with more higher scientific excellence and quality .
Objectives
- To assess the effectiveness of complementary and alternative medicine (CAM) (Dance/movement therapy, Art Therapy, Music Therapy, Bibliotherapy and Physical Activity) on mental health of cancer patients as well as their caregiver.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- 5 intervention groups (music therapy, art therapy, dance-movement therapy, physical activity, bibliotherapy) and 1 control group.
| Arm | Type | Receives |
|---|---|---|
| A - Music Therapy | Experimental | Other: Complementary and alternative medicinesTwo section a week of music therapy |
| B - Art Therapy | Experimental | Other: Complementary and alternative medicinesTwo section a week of Art therapy |
| C - Dance-Movement Therapy | Experimental | Other: Complementary and alternative medicinesTwo section a week of Dance-Movement Therapy |
| D - Bibliotherapy | Experimental | Other: Complementary and alternative medicinesTwo section a week of Bibliotherapy |
| E - Physical Activity | Experimental | Other: Complementary and alternative medicinesTwo section a week of systematized physical activity |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult woman with breast cancer diagnoses and their primary family caregiver
Key exclusion criteria (3 listed)
- Insufficient physical capacity
- Severe mental disorder
- Inability ti give informed consent
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 |
|---|---|---|
| Complementary and alternative medicinesFive types of Complementary and alternative medicines (Music Therapy, Art Therapy, Dance-Movement Therapy, Bibliotherapy, Physical Activity) will be applied twice a week. | Other | A - Music Therapy, B - Art Therapy, C - Dance-Movement Therapy, D - Bibliotherapy, E - Physical Activity |
Primary outcome
Mental Health
Time frame: Mental health (score)changes over 4 weeks intervention
Questionnaire to assess mental health
Quality of Life
Time frame: Quality of life changes (score) over 4 weeks intervention
Questionnaire to assess quality of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Project blog at university levelLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Complementary and alternative medicines in people with Breast Cancer, run by Klaipėda University at 1 site in Lithuania.
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 1 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 11 Jun 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 Lithuania. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mental Health (time frame: Mental health (score)changes over 4 weeks intervention). The study lists 2 primary outcomes in all. 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 11 Jun 2020.