Project objectives

The aim of the current investigation was to trial the newly created PCa specific support intervention (entitled PROACTIVE: PROstate Cancer Support Intervention for ACTIVE Surveillance) in a single sample of 10 PCa patients being managed with active surveillance to assess uptake, adherence and efficacy.

Brief summary

The aim of this study was to assess the acceptability and effectiveness of this new PCa specific programme using the following methodology:

Qualitative study

We conducted qualitative interviews with the patients at 2 time points:

1) A focus group interview with the 10 participant making up the group at the end of the final (third) group session. This allowed us to minimise the demands placed upon the patients by interviewing them whilst they are already attending a group session and

2) At 2 month follow up: we conducted brief semi-structured interviews with each of the patients over the phone to further explore if, how and in what context the skills learnt in the intervention still continue to be a part of the participants’ lives. By conducting the interviews over the phone we placed less demand on the participants by reducing the inconvenience associated with attending face to face interviews.

Quantitative study

This study was a secondary study designed to allow us to develop a power calculation for a larger and more definitive clinical trial should that be indicated. Participants completed the HADS, EPIC, SF12 and the CICS before the start of the intervention (baseline) and then at the end of the intervention (6-weeks) and again at 3-months follow up.

The finding suggested that the participants found great benefit in partaking in PROACTIVE. They found the group sessions to be an effective means of receiving the clinical support and information they required in an efficient manner whilst proving them with the means to more effectively manage any distress or anxiety they were experiencing.

The online sessions were also well received and facilitated positive behaviour change relating to diet, exercise, coping and stress management.

Plain English summary

Prostate cancer patients who have localised cancer are often managed with active surveillance (AS). AS involves closely monitoring disease progression but does not involve any invasive treatment. AS often causes high levels of anxiety as men are asked to live with an untreated cancer in their body. This is important as anxiety often causes AS patients to ask for surgery to remove the cancer even though this isn’t the best option clinically, resulting in unpleasant physical side effects.

The aim of this study was to determine the initial feasibility of delivering the PROACTIVE intervention to men on AS within the NHS.

The findings of the study suggest that in its current form, PROACTIVE offers an effective and acceptable form of support that AS patients are willing to recruit into and adhere to.

We now plan to further test the feasibility of PROACTIVE in a larger multi-centre trial.

Dissemination

Published articles

1. Watts, S., Leydon, G., Birch, B., Prescott, P., Lai, L., Powell, C. & Lewith, G. (2013). Depression and anxiety in prostate cancer: a systematic review and meta-analysis of prevalence rates. British Medical Journal Open 2014; 4: e003901. doi:10.1136/ bmjopen-2013-003901.
   http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3963074/
2. Bradbury, K., Watts, S., Arden-Close, E., Yardley, L., & Lewith, G. (2014). Developing Digital Interventions: A Methodological Guide," Evidence-Based Complementary and Alternative Medicine, vol. 2014, Article ID 561320, 7 pages, 2014. doi:10.1155/2014/561320.
   http://www.hindawi.com/journals/ecam/2014/561320/

Planned articles

1. Watts, S., Leydon, G., Lewith, G., Arden-Close, E.J., Richardson, A., Birch, B., Moore, C.M., Ridout, A.J. & Powel, C. (2013). The Prevalence of Depression and Anxiety in Prostate Cancer Patients Undergoing Active Surveillance. (Paper accepted by BMJ Open).
2. Hughes, S., Watts, S., Arden-Close, E., Bradbury, K. & Lewith, G. The development of an integrated self-care programme for managing psychological distress in prostate cancer patients being managed with active surveillance. Paper in preparation.

Public involvement

Throughout the development of this application we have utilised substantial patient involvement (PPI).

Firstly, through our contacts, we invited Mike Hollingsworth (living with prostate cancer) to act as our expert patient, and he agreed to take on this voluntary role. Mike has been involved in the development of the project, its objectives and procedures. He is a full collaborator on the study and participated in guiding all aspects and stages of the intervention design and development, particularly the analysis of data and dissemination of the findings to relevant organisations and charities. In Mike’s second role, he liaised with the Prostate Cancer Support Organisation (PCaSO; Hampshire division) to identify other prostate cancer patients to comment on the design and development of the intervention and allow for any fine tuning. This has resulted in the development of a strong collaborative relationship with PCaSO whose members on AS have had a considerable input into this study. PCaSO also provided us with patients to interview as part of this study.

We have also made contact with the prostate cancer group at the NCRI and are working with their expert patient, Prof Ian Jamieson, who is living with prostate cancer, to ensure that we maximised PPI input in the developmental stage of this investigation. Prof Jamieson will be working, inputting and liaising with our research team throughout the design and piloting of the intervention.

Impact

The intervention developed through this study has subsequently received a 3-year funding grant from Prostate Cancer UK to further test the feasibility of delivering the intervention in the NHS. This study commences in June 2015.

This project was funded by the National Institute for Health Research School for Primary Care Research (project number 193)

Department of Health Disclaimer

The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the NIHR School for Primary Care Research, NIHR, NHS or the Department of Health.