Positive Psychology Interventions in Patients with Advanced Cancer

ISRCTN	ISRCTN73517077
DOI	https://doi.org/10.1186/ISRCTN73517077
Secondary identifying numbers	N0544187603

Submission date: 28/09/2007
Registration date: 28/09/2007
Last edited: 02/08/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Pranathi Ramachandra
Scientific

Palliative Care Team
Box 193
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
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
Study objectives	To see if simple positive psychology interventions will improve well being and quality of life in persons with advanced cancer.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cancer: Breast & prostate
Intervention	Theoretical framework: psychological interventions have been known to improve quality of life, functioning, well being and immunity in early stage cancer. Similar studies are needed in late stage cancer. Purpose of the study: to see if simple, easy to use, cost effective strategies of positive psychology can be used to improve quality of life in people with advanced cancer. Study design: pilot study for a Randomised Control trial. Methodological evaluation study. Methodology: patients attending the oncology clinic at Addenbrookes Hospital will be invited to participate in the trial. An initial screening will be conducted and suitable candidates will be recruited after obtaining written consent when they come to attend their oncology clinic appointment. This is expected to take 15-30 minutes. If they agree to take part, they will be randomly allocated into one of two groups: 1. Fast-track group who will start immediately 2. A delayed start group who will start 6 weeks later The fast track group will be interviewed on the same day and asked to fill some baseline questionnaires. They will also be given written information about positive psychology methods and also verbal explanation. They will be given diary sheets to be filled out on a daily basis and tapes or CDs to listen to for their relaxation/meditation exercises. This can be done in 30-45 minutes. They will then be contacted on phone 1, 2 and 4 weeks after the first meeting in order to clarify any doubts they may have and also to encourage them to complete their daily tasks. Each phone conversation is not expected to last more than 10 minutes. After this, there will be no further phone contact. Face to face interviews will take place at 6, 12, and 18 weeks after the initial interview. Each is expected to last 30 minutes and will coincide with clinic appointments. Patients will be asked some questions and requested to fill out questionnaires at these meetings. The delayed start group will undergo an identical process, after a lag of 6 weeks.
Intervention type	Other
Primary outcome measure	Well being
Secondary outcome measures	Quality of life, functioning.
Overall study start date	01/08/2006
Completion date	01/08/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Minimum of 10 in each group
Key inclusion criteria	1. Age above 18 (age of consent) 2. Women with advanced breast cancer (study involves cancer patients and breast cancer is one of the commonest forms of cancer in women) 3. Men with advanced prostate cancer (study involves cancer patients and prostate cancer is one of the commonest forms of cancer in men)
Key exclusion criteria	1. Significant psychological distress - it is not ethical to include them as they may benefit from treatment with medication. 2. Current treatment with medication for psychological distress, unless they have been stable on them for more than a year - inclusion of such people will confound the results of the study as it would be difficult to say whether improvement is due to medication or the intervention. 3. Those who are unable to understand, read or write in English - a currently all the material is only available in English. 4. Those who have severe memory impairment - as they may not be able to learn and use the strategies.
Date of first enrolment	01/08/2006
Date of final enrolment	01/08/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Palliative Care Team

Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Cambridge Consortium - Addenbrooke's (UK), Own Account NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
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?
Results article	results	01/12/2009		Yes	No