PEPSIN
Research type
Research Study
Full title
Psychobiological effects of personalised supportive interventions: a feasibility study
IRAS ID
221083
Contact name
Kevin Davies
Contact email
Sponsor organisation
Brighton & Sussex Medical School
Duration of Study in the UK
0 years, 9 months, 1 days
Research summary
There is evidence that breast cancer patients experience increased stress associated with treatment-related physical changes, such as removal or changes to the breast, hair loss, skin reactions or changes in weight. Alleviating stress is an important part of survivorship planning and care. Some of the more traditional stress reduction techniques include cognitive behavioural therapy, yoga and mindfulness. More novel interventions designed to address particular problems that patients face might also play a role but have received limited evaluation. In particular we will examine two supportive interventions; a make-up and skincare workshop and a specialised exercise programme.
This pilot study will examine the feasibility and acceptability of measuring biological and psychological stress in women with breast cancer participating in individualised treatments. The study will explore the usefulness of the measures used in this study and the feasibility of including them in a larger study. Recruitment will focus on women with early stage disease who have completed surgical treatment. Eligible participants will be approached by specialist nurses in breast cancer clinics at the same time as they are given information about either the make-up/skincare or exercise programme.
Forty participants will be asked to complete questionnaires targeting areas of quality of life (QoL), perceived stress, body image and self-esteem. These will be taken prior to and following the intervention and then at 6 and 12 weeks later. Additionally, participants can opt to provide saliva and hair samples at baseline, 6 and 12 weeks follow up. The time points will allow us to assess whether there are psychobiological changes associated with attendance, whether or not these changes are durable over time, and relate to psychosocial outcomes. At the end of study we will conduct telephone interviews with participants to discuss their experiences of taking part e.g. collecting biological samples, and recommendations for future studies.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
17/SC/0170
Date of REC Opinion
3 Apr 2017
REC opinion
Favourable Opinion