PROSPER 

Summary:  

The trial seeks to evaluate the efficacy of an intervention tailored to support adult patients in cancer care awaiting psychological therapy. This intervention consists of a single remote session lasting 60-90 minutes within two weeks of referral to psychology service, followed by personalised automated smart messages designed to enhance motivation and behaviour change.

Patients in cancer care are at a heightened risk of experiencing mental health challenges, including an increased risk of suicide. However, these difficulties often go unnoticed, impacting both their quality of life and the effectiveness of cancer treatment. Currently, the wait time for psychological therapy ranges from four to ten weeks, during which symptoms may exacerbate. Moreover, engaging in therapy poses additional challenges, given patients' numerous commitments, necessitating an effective approach to maximise therapy benefits. Research suggests that a brief preparatory intervention can improve therapy outcomes, particularly when combined with technological support.

This proposed intervention, blending a single preparatory session with smart messaging, offers a cost-effective, easily implementable solution to enhance clinical outcomes and mental well-being among cancer patients. We aim to assess this intervention by comparing two groups of participants: One receiving the Therapy Preparation Intervention (TPI) alongside Treatment As Usual (TAU) and one receiving TAU alone. Participants consenting to take part in the study will be randomly allocated to one group and will be asked to complete five online questionnaires about their mental health and quality of life, each taking 20-30 minutes, over a 24-week period.

The hypotheses of the study are twofold:

Patients receiving both TPI and TAU will experience a greater reduction in depressive symptoms compared to those receiving TAU alone.

Patients receiving both TPI and TAU will exhibit lower dropout rates than those receiving TAU alone.

Non-Commercial Study

Type of Study:  Recruiting

Is this Study Applicable to the RSI Scheme? For the purpose of the RSI scheme this study will count as a Recruiting: Remote Consent study

Practice Activity:  

• Identify participants who meet the study criteria (administering PHQ9)

• Provide a brief introduction to the study 

• Obtain their consent to be contacted by the research team. 

• Refer patients with cancer who are currently experiencing depressive symptoms and are seeking access to psychological treatment to the trial researchers either through a telephone call or via NHS-to-NHS secure email address

• Database Search

• Screening Patient Lists for Eligibility 

• Mailout via SMS

Please note: The research team will then contact the participants to provide more detailed information and consent and recruit participants. 

Optional Pharmacy within GP Practice Activity: NA

Practice Eligibility Criteria: NA

Practice Target:  5 - 10 Participants 

Participant Eligibility Criteria:

Inclusion Criteria: 

• Aged 18 years or older

• Able to engage with psychological therapy sessions conducted in English

• Competent to give informed consent

• Diagnosed with cancer and awaiting psychological therapy with EMCA CPH for symptoms of moderate-to-severe depression during the recruitment period of the study

• A score of 10 or more on PHQ-9

Exclusion Criteria:

•  Immediate risk to self or others

• Currently receiving psychological therapy with another service.

• Unable or unwilling to receive care remotely.

Is this Study Applicable for the Associate PI Scheme?  NA

Resources Provided by the Study Team: NA

Service Support Costs: 

• Opportunistic Approach: £102 fixed fee per practice undertaking the activity. 

• Consent to Contact: £4.33 per patient accepted onto the study.

• For preparation and database search carried out: £26.50 fixed fee per practice undertaking the activity.  

• Screening eligibility check of patients: £62.00 fixed fee per practice undertaking the activity. 

Once Service Support Cost activity has been undertaken, please click here and complete the SSC request to receive payment for activity.  Please do not submit Service Support Costs requests for activities not listed above. If an SSC request has already been requested for completed activity please do not submit a further request. The SSC request form is to be completed for activity taking place after 1st April 2021 only. Please ensure you have claimed all SSC by the end of the current financial year. 

Research Costs: Not applicable for this study 

Excess Treatment Costs: Not applicable for this study 

Contact Details: Clem Boutry  (Clem.Boutry@nottingham.ac.uk)

Is a feasibility database search required before a site can express interest? No