NCT02756780

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
420

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 29, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

April 29, 2016

Status Verified

April 1, 2016

Enrollment Period

1.7 years

First QC Date

April 28, 2016

Last Update Submit

April 28, 2016

Conditions

Keywords

RemissionCarerPsychologicalBereavedCancerBreastProstateColorectalMusic

Outcome Measures

Primary Outcomes (1)

  • Anxiety & Depression

    Hospital Anxiety and Depression Scale (HADS)

    Change in anxiety and depression level at weeks 6, 12 and 24 compared to baseline

Secondary Outcomes (7)

  • Social Support

    Change in social provision level at weeks 6, 12 and 24 compared to baseline

  • Wellbeing

    Change in wellbeing level at weeks 6, 12 and 24 compared to baseline

  • Self-efficacy

    Change in self-efficacy level at weeks 6, 12 and 24 compared to baseline

  • Self-esteem

    Change in self-esteem level at weeks 6, 12 and 24 compared to baseline

  • General Health

    Change in general health level at weeks 6, 12 and 24 compared to baseline

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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.

Tenovus Cancer Choir

Eligibility Criteria

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

You may qualify if:

  • 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
  • COHORT C: anybody who is affected by cancer and has joined the choir

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Marsden Hospital NHS Foundation Trust

London/Surrey, United Kingdom

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Theresa Wiseman, PhD

    Royal Marsden NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daisy Fancourt, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2016

First Posted

April 29, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2017

Study Completion

April 1, 2018

Last Updated

April 29, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations