CancerNCT02756780
Tenovus Cancer Choirs Study: the Benefits of Singing for Those Affected by Cancer
A study testing Tenovus Cancer Choir in people with Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
'Sing With Us' choirs are an initiative established in Wales by Tenovus Cancer Care to provide social support and improve mental wellbeing amongst those affected by cancer, whether patients, carers or staff. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Tenovus Cancer Choir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2016to Apr 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- COHORT A: (i) Patients with stage I-III breast cancer up to 24 months post diagnosis
- (ii) Patients with diagnosed prostate cancer on active surveillance
- (iii) Patients with colorectal cancer stages I-III up to 24 months post diagnosis
- COHORT B: (i) Members of staff at a hospital
- (ii) People who care for somebody with cancer, whether formally or informally
- (iii) People who have lost a family member or somebody they cared for to cancer in the last 3 years
Show all 20Show fewer
- COHORT C: anybody who is affected by cancer and has joined the choir
- General exclusion Criteria:
- Participants aged under the age of 18
- Level of English insufficient to provide informed consent or complete the psychological questionnaires
- Refusal to participate
- Already engaged in a weekly group choir
- Started a formal course of psychological therapy in the past 1 month or scheduled to start in the next 12 weeks
- Started any new medication for anxiety or depression in the last month
- Additional exclusion criteria for cohort A:
- Currently having chemotherapy or radiotherapy or less than 90 days since last session
- Scheduled for surgery in the next 12 weeks or less than 90 days post surgery
- Have a current diagnosis of an additional immune condition e.g. lupus
- Currently being treated with steroids or immunosuppressive medication
- Participants who are pregnant
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Marsden Hospital NHS Foundation Trust
London/Surrey
Theresa Wiseman, PhD
Theresa Wiseman, PhD
About this study
Official title: Tenovus Cancer Choirs: the Effect of Choir Singing on Psychological and Immune Responses of Cancer Patients, Staff and Carers
'Sing With Us' choirs are an initiative established in Wales by Tenovus Cancer Care to provide social support and improve mental wellbeing amongst those affected by cancer, whether patients, carers or staff. Research has already demonstrated that these choirs can reduce depression and anxiety amongst participants and improve social support networks and quality of life as well as preliminary evidence that they can reduce levels of stress hormones and improve immune function. The aim of this study is to establish more about the psychological benefits of regular choir singing and explore whether the biological changes noted in pilot studies can be sustained over time. This could identify whether choirs have the potential to optimise health in people affected by cancer, helping to put patients in the best position to receive treatment or maintain remission and supporting those who care for someone with cancer, whether professionally or informally.
Read the detailed description
There is growing evidence that psychosocial interventions from mindfulness to yoga to the arts can reduce symptoms of depression and anxiety, increase social support networks, improve quality of life and raise perceptions of care in people affected by cancer 1,2. These positive states have, in turn, been linked with optimised immune responses including reduced stress hormones and enhanced cellular activity 1,3,4. However, despite growing numbers of music interventions for cancer care, there is little research into their psychobiological impact.
'Sing With Us' choirs are an initiative established in Wales by Tenovus Cancer Care to provide social support and improve mental wellbeing amongst those affected by cancer, whether patients, carers or staff. Research has already demonstrated that these choirs can reduce depression and anxiety amongst participants and improve social support networks and quality of life as well as preliminary evidence that they can reduce levels of stress hormones and enhance immune activity 5,6. The aim of this study is to establish more about the psychological benefits of regular choir singing and explore whether the biological changes noted in pilot studies can be sustained over time. This could identify whether choirs have the potential to optimise health in people affected by cancer, helping to put patients in the best position to receive treatment or maintain re mission and supporting those who care for someone with cancer, whether professionally or informally.
As part of this project, and in addition to the choirs already run by Tenovus Cancer Care, Tenovus will fund two choirs, one at each of the Royal Marsden sites. These will run on a weekly basis for 18 months and will consist of a session lasting 1 hour led by a professional choir leader who is a member of the Tenovus Cancer Care staff. The choirs will be open to anybody affected by cancer at the Royal Marsden Hospital or in the local area. However, there will be three cohorts of patients involved in the research running alongside the choir: cohorts A and B involving active recruitment of participants and Cohort C in which people who join the choir of their own volition but are not eligible for the first 3 cohorts will be invited to participate:
Cohort A: breast, prostate and colorectal cancer patients will be invited to join the study for a period of 12 weeks. If they are able to make the dates and times of the choir sessions they will become part of the experimental group. If they are unable to make the dates and times or live too far away but fulfil all the same criteria (including expressing an interest in singing) they will become part of the control group. Data collection for all participants will include (a) completing psychological scales which will be available in hard copy or as online versions; (b) providing saliva samples before 4 choir rehearsals: week 1, week 6 and week 12 with a three month follow-up (week 24). Experimental participants will be expected to attend as many of the first 12 choir sessions in the time period as possible but will then select whether they continue involvement in the choir for the following 12 weeks.
Cohort B: hospital staff, carers of somebody affected by cancer and bereaved carers will be invited to join the study for a period of 12 weeks. Recruitment and participation for this Cohort (including the presence of a control group) will be as in Cohort A except there will be no biological component. Participants will merely complete the online psychological questionnaires.
Cohort C: all other participants who decide to join the choirs (whether patients, carers or staff) will be invited to take part in the psychological part of the study, completing the anonymous questionnaires at weeks 0, 6, 12 and 24. This will be an uncontrolled Cohort. But it may identify additional participant groups for whom the choirs provide support.
- Conditions
- Cancer
- Being tested
- Tenovus Cancer Choir
- Keywords
- Remission, Carer, Psychological, Bereaved, Cancer, Breast, Prostate, Colorectal, Music
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenovus Cancer ChoirOther
Choir sessions will take place at both of the Royal Marsden Hospital sites on a weekly basis. Sessions typically consist of learning popular songs with messages of support. Songs are learnt without sheet music, using specially created backing tracks. These are also made available to participants at home so they can continue singing away from the sessions. No singing experience is required and the main aim of the sessions is enjoyment and meeting other people. Sessions will take place in the early evening so that participants have the option of staying to socialise afterwards.
| Study group | Role | What they receive |
|---|---|---|
| Tenovus Cancer Choir | Experimental | Participants will be asked to attend 12 weeks of weekly choir rehearsals lasting approximately 1 hour. Following the first 12 weeks, participants will no longer be asked to attend rehearsals, but are welcome to do so. Whether or not they do and how many they attend will be measured as an outcome variable to assess whether initial 3-month involvement leads to long-term engagement. Receives: Other: Tenovus Cancer Choir |
| Control (no choir) Group | No intervention | If eligible participants are unable to make the dates and times or live too far away but fulfil all the same criteria (including expressing an interest in singing) they will become part of the control group. This will involve the same data collection as the Cancer Choir Group but participants will not sing in a weekly choir. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety & Depression
Hospital Anxiety and Depression Scale (HADS)
Measured: Change in anxiety and depression level at weeks 6, 12 and 24 compared to baseline
Secondary outcomes (7)
Social Support
Social Provisions Scale (SPS)
Measured: Change in social provision level at weeks 6, 12 and 24 compared to baseline
Wellbeing
Warwick-Edinburgh Short Questionnaire (WEMWBS)
Measured: Change in wellbeing level at weeks 6, 12 and 24 compared to baseline
Self-efficacy
General Self-Efficacy scale short form (GSE-6)
Measured: Change in self-efficacy level at weeks 6, 12 and 24 compared to baseline
Self-esteem
Sing Item Self-Esteem Scale
Measured: Change in self-esteem level at weeks 6, 12 and 24 compared to baseline
General Health
Short Form 12 Health Survey (SF12)
Measured: Change in general health level at weeks 6, 12 and 24 compared to baseline
Stress hormones
Salivary cortisol levels
Measured: Change in stress hormone levels at weeks 6, 12 and 24 compared to baseline
Immune proteins
Saliva cytokines, chemokines and receptors
Measured: Change in immune protein levels at weeks 6, 12 and 24 compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2017 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- London Cancer Alliance, Royal College of Music, Tenovus Cancer Care
- Responsible party
- Sponsor
- Investigators
- Theresa Wiseman, PhD, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756780
- Sponsor's protocol ID
- SWU2016
- Status last verified
- Apr 2016
- First submitted
- 28 Apr 2016
- Last updated
- 29 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Fancourt D, Finn S, Warran K, Wiseman T. Group singing in bereavement: effects on mental health, self-efficacy, self-esteem and well-being. BMJ Support Palliat Care. 2022 Oct;12(e4):e607-e615. doi: 10.1136/bmjspcare-2018-001642. Epub 2019 Jun 26.
PubMed 31243022
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tenovus Cancer Choirs: the Effect of Choir Singing on Psychological and Immune Responses of Cancer Patients, Staff and Carers
- ClinicalTrials.gov ID
- NCT02756780
- Acronym / sponsor ID
- SWU2016
- Conditions
- Cancer
- Keywords
- Remission, Carer, Psychological, Bereaved, Cancer, Breast, Prostate, Colorectal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- London Cancer Alliance, Royal College of Music, Tenovus Cancer Care
- Study start
- Apr 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 29 Apr 2016 (estimated)
- 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.
'Sing With Us' choirs are an initiative established in Wales by Tenovus Cancer Care to provide social support and improve mental wellbeing amongst those affected by cancer, whether patients, carers or staff. Research has already demonstrated that these choirs can reduce depression and anxiety amongst participants and improve social support networks and quality of life as well as preliminary evidence that they can reduce levels of stress hormones and improve immune function. The aim of this study is to establish more about the psychological benefits of regular choir singing and explore whether the biological changes noted in pilot studies can be sustained over time. This could identify whether choirs have the potential to optimise health in people affected by cancer, helping to put patients in the best position to receive treatment or maintain remission and supporting those who care for someone with cancer, whether professionally or informally.
Detailed description
There is growing evidence that psychosocial interventions from mindfulness to yoga to the arts can reduce symptoms of depression and anxiety, increase social support networks, improve quality of life and raise perceptions of care in people affected by cancer 1,2. These positive states have, in turn, been linked with optimised immune responses including reduced stress hormones and enhanced cellular activity 1,3,4. However, despite growing numbers of music interventions for cancer care, there is little research into their psychobiological impact.
'Sing With Us' choirs are an initiative established in Wales by Tenovus Cancer Care to provide social support and improve mental wellbeing amongst those affected by cancer, whether patients, carers or staff. Research has already demonstrated that these choirs can reduce depression and anxiety amongst participants and improve social support networks and quality of life as well as preliminary evidence that they can reduce levels of stress hormones and enhance immune activity 5,6. The aim of this study is to establish more about the psychological benefits of regular choir singing and explore whether the biological changes noted in pilot studies can be sustained over time. This could identify whether choirs have the potential to optimise health in people affected by cancer, helping to put patients in the best position to receive treatment or maintain re mission and supporting those who care for someone with cancer, whether professionally or informally.
As part of this project, and in addition to the choirs already run by Tenovus Cancer Care, Tenovus will fund two choirs, one at each of the Royal Marsden sites. These will run on a weekly basis for 18 months and will consist of a session lasting 1 hour led by a professional choir leader who is a member of the Tenovus Cancer Care staff. The choirs will be open to anybody affected by cancer at the Royal Marsden Hospital or in the local area. However, there will be three cohorts of patients involved in the research running alongside the choir: cohorts A and B involving active recruitment of participants and Cohort C in which people who join the choir of their own volition but are not eligible for the first 3 cohorts will be invited to participate:
Cohort A: breast, prostate and colorectal cancer patients will be invited to join the study for a period of 12 weeks. If they are able to make the dates and times of the choir sessions they will become part of the experimental group. If they are unable to make the dates and times or live too far away but fulfil all the same criteria (including expressing an interest in singing) they will become part of the control group. Data collection for all participants will include (a) completing psychological scales which will be available in hard copy or as online versions; (b) providing saliva samples before 4 choir rehearsals: week 1, week 6 and week 12 with a three month follow-up (week 24). Experimental participants will be expected to attend as many of the first 12 choir sessions in the time period as possible but will then select whether they continue involvement in the choir for the following 12 weeks.
Cohort B: hospital staff, carers of somebody affected by cancer and bereaved carers will be invited to join the study for a period of 12 weeks. Recruitment and participation for this Cohort (including the presence of a control group) will be as in Cohort A except there will be no biological component. Participants will merely complete the online psychological questionnaires.
Cohort C: all other participants who decide to join the choirs (whether patients, carers or staff) will be invited to take part in the psychological part of the study, completing the anonymous questionnaires at weeks 0, 6, 12 and 24. This will be an uncontrolled Cohort. But it may identify additional participant groups for whom the choirs provide support.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tenovus Cancer Choir | Experimental | Other: Tenovus Cancer ChoirParticipants will be asked to attend 12 weeks of weekly choir rehearsals lasting approximately 1 hour. Following the first 12 weeks, participants will no longer be asked to attend rehearsals, but are welcome to do so. Whether or not they do and how many they attend will be measured as an outcome variable to assess whether initial 3-month involvement leads to long-term engagement. |
| Control (no choir) Group | No intervention | –If eligible participants are unable to make the dates and times or live too far away but fulfil all the same criteria (including expressing an interest in singing) they will become part of the control group. This will involve the same data collection as the Cancer Choir Group but participants will not sing in a weekly choir. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- COHORT A: (i) Patients with stage I-III breast cancer up to 24 months post diagnosis
- (ii) Patients with diagnosed prostate cancer on active surveillance
- (iii) Patients with colorectal cancer stages I-III up to 24 months post diagnosis
- COHORT B: (i) Members of staff at a hospital
- (ii) People who care for somebody with cancer, whether formally or informally
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Tenovus Cancer ChoirChoir sessions will take place at both of the Royal Marsden Hospital sites on a weekly basis. Sessions typically consist of learning popular songs with messages of support. Songs are learnt without sheet music, using specially created backing tracks. These are also made available to participants at home so they can continue singing away from the sessions. No singing experience is required and the main aim of the sessions is enjoyment and meeting other people. Sessions will take place in the early evening so that participants have the option of staying to socialise afterwards. | Other | Tenovus Cancer Choir |
Primary outcome
Anxiety & Depression
Time frame: Change in anxiety and depression level at weeks 6, 12 and 24 compared to baseline
Hospital Anxiety and Depression Scale (HADS)
7 secondary outcomes
Social Support
Time frame: Change in social provision level at weeks 6, 12 and 24 compared to baseline
Wellbeing
Time frame: Change in wellbeing level at weeks 6, 12 and 24 compared to baseline
Self-efficacy
Time frame: Change in self-efficacy level at weeks 6, 12 and 24 compared to baseline
Self-esteem
Time frame: Change in self-esteem level at weeks 6, 12 and 24 compared to baseline
General Health
Time frame: Change in general health level at weeks 6, 12 and 24 compared to baseline
Stress hormones
Time frame: Change in stress hormone levels at weeks 6, 12 and 24 compared to baseline
Immune proteins
Time frame: Change in immune protein levels at weeks 6, 12 and 24 compared to baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2016.
- Derived from this study: PubMed 31243022Fancourt D, Finn S, Warran K, Wiseman T. Group singing in bereavement: effects on mental health, self-efficacy, self-esteem and well-being. BMJ Support Palliat Care. 2022 Oct;12(e4):e607-e615. doi: 10.1136/bmjspcare-2018-001642. Epub 2019 Jun 26.
- 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.
Theresa Wiseman, PhD principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tenovus Cancer Choir in people with Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
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 20 inclusion and 0 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 29 Apr 2016. 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 United Kingdom. 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.
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?
Contact Daisy Fancourt, PhD (07958 065 563, d.fancourt@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety & Depression (time frame: Change in anxiety and depression level at weeks 6, 12 and 24 compared to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02756780, which also lists 1 linked publication.
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 29 Apr 2016.