Mindfulness in ovarian cancer
| ISRCTN | ISRCTN95243663 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95243663 |
| Secondary identifying numbers | 32108 |
- Submission date
- 05/12/2016
- Registration date
- 05/12/2016
- Last edited
- 16/01/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Ovarian cancer is a common form of cancer that often returns after treatment.Having cancer return can be traumatizing, causing mental distress. Mindfulness is a technique that aims patients live life in a present moment and could help patients with recurrent ovarian cancer. The aim of this study is to explore the feasibility of delivering a 6-week mindfulness based group support intervention to a cohort of ovarian cancer patients who have experienced disease recurrence.
Who can participate?
Woman aged 18 and older who have a confirmed ovarian cancer.
.
What does the study involve?
All participants receive a 6-week mindfulness-based intervention comprising a total of 8.5 contact hours. The programme has been specifically adapted and modified for cancer patients based around extensive qualitative research to ensure its applicability and acceptability and in this capacity it has been successfully trialled in a population of stage 4 breast cancer patients.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Queen Alexandra Hospital (UK)
When is the study starting and how long is it expected to run for?
May 2016 to May 2017
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Sam Watts (Scientific)
s.watts@soton.ac.uk
Contact information
Scientific
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
| Phone | +44 (0)2380 241085 |
|---|---|
| s.watts@soton.ac.uk |
Study information
| Study design | Non-randomised; Interventional; Design type: Treatment, Complementary Therapy, Psychological & Behavioural |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A six-week programme of group mindfulness sessions to improve mental health and wellbeing in patients with recurrent ovarian cancer: a feasibility study |
| Study acronym | MOVA |
| Study objectives | The aim of this study is to explore the feasibility of delivering a 6-week mindfulness based group support intervention to a cohort of ovarian cancer patients who have experienced disease recurrence. |
| Ethics approval(s) | Berkshire Research Ethics Committee, 30/08/2016, ref: 16/SC/0415 |
| Health condition(s) or problem(s) studied | Specialty: Cancer, Primary sub-specialty: Gynaecological Cancers; UKCRC code/ Disease: Cancer/ Malignant neoplasms of female genital organs |
| Intervention | All participants receive a 6-week mindfulness-based intervention comprising a total of 8.5 contact hours. The intervention has been specifically adapted and modified for cancer patients based around extensive qualitative research to ensure its applicability and acceptability and in this capacity it has been successfully trialled in a population of stage 4 breast cancer patients. |
| Intervention type | Other |
| Primary outcome measure | Feasibility outcomes: 1. Recruitment rate 2. Response rates 3. Number of patients completing the intervention 4. Number of patients completing the 6 month follow-up 5. Qualitative assessment of the intervention 6. Quantitative data analysis |
| Secondary outcome measures | 1. Anxiety 2. Depression 3. Quality of life 4. Diurnal cortisol variations |
| Overall study start date | 01/05/2016 |
| Completion date | 09/05/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | Planned Sample Size: 30; UK Sample Size: 30 |
| Key inclusion criteria | 1. Any confirmed recurrence of OvCa at any stage 2. Aged 18 years and above 3. Willing to participate and provide informed consent 4. Fluent English (questionnaires validated and interviews conducted in English) |
| Key exclusion criteria | 1. Additional cancer diagnoses 2. Any significant mental illness (i.e. overt psychosis, history of suicidal ideation) but not to include clinical depression and/or anxiety 3. Receiving any other psychological therapy |
| Date of first enrolment | 09/11/2016 |
| Date of final enrolment | 01/02/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Cosham
Portsmouth
PO6 3LY
United Kingdom
Sponsor information
Hospital/treatment centre
De La Court House
Queen Alexandra Hospital
Southwick Hill Road
Portsmouth
PO6 3LY
England
United Kingdom
"ROR" |
https://ror.org/009fk3b63 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 09/05/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
16/01/2018: The plain English summary has been added.
18/10/2017: Internal review.
16/10/2017: Internal review.
15/09/2017: Internal review.
06/06/2017: Internal review.
