Positive Psychology Interventions in Patients with Advanced Cancer
| ISRCTN | ISRCTN73517077 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73517077 |
| Protocol serial number | N0544187603 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funder | Cambridge Consortium - Addenbrooke's (UK), Own Account NHS R&D Support Funding |
- 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
Scientific
Palliative Care Team
Box 193
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Well being |
| Key secondary outcome measure(s) |
Quality of life, functioning. |
| Completion date | 01/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 20 |
| 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
- United Kingdom
- England
Study participating centre
Palliative Care Team
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
