Condition category
Cancer
Date applied
05/12/2016
Date assigned
05/12/2016
Last edited
16/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sam Watts

ORCID ID

Contact details

Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
+44 (0)2380 241085
s.watts@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

32108

Study information

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

Acronym

MOVA

Study hypothesis

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

Berkshire Research Ethics Committee, 30/08/2016, ref: 16/SC/0415

Study design

Non-randomised; Interventional; Design type: Treatment, Complementary Therapy, Psychological & Behavioural

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

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 trial start date

01/05/2016

Overall trial end date

09/05/2017

Reason abandoned (if study stopped)

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 30; UK Sample Size: 30

Participant 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

Recruitment start date

09/11/2016

Recruitment end date

01/02/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen Alexandra Hospital
Southwick Hill Road Cosham
Portsmouth
PO6 3LY
United Kingdom

Sponsor information

Organisation

Portsmouth Hospitals NHS Trust

Sponsor details

De La Court House
Queen Alexandra Hospital
Southwick Hill Road
Portsmouth
PO6 3LY
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

09/05/2018

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

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.