Condition category
Cancer
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
02/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Pranathi Ramachandra

ORCID ID

Contact details

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

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

http://www.dh.gov.uk/Home/fs/en

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

  1. 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.

Additional files

Editorial Notes