Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0544187603
Study information
Scientific title
Acronym
Study hypothesis
To see if simple positive psychology interventions will improve well being and quality of life in persons with advanced cancer.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
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
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
Phase
Not Specified
Drug names
Primary outcome measures
Well being
Secondary outcome measures
Quality of life, functioning.
Overall trial start date
01/08/2006
Overall trial end date
01/08/2007
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Minimum of 10 in each group
Participant 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.
Recruitment start date
01/08/2006
Recruitment end date
01/08/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Palliative Care Team
Cambridge
CB2 2QQ
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Cambridge Consortium - Addenbrooke's (UK), Own Account NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19180530
Publication citations
-
Results
Ramachandra P, Booth S, Pieters T, Vrotsou K, Huppert FA, A brief self-administered psychological intervention to improve well-being in patients with cancer: results from a feasibility study., Psychooncology, 2009, 18, 12, 1323-1326, doi: 10.1002/pon.1516.