Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Contact information



Primary contact

Dr Marc Serfaty


Contact details

University College London
Department of Mental Health Sciences
Rowland Hill Street
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

The addition of ACT or a Talking Control to treatment as usual for the management of dysfunction in advanced cancer: a feasibility randomised controlled trial



Study hypothesis

To conduct a feasibility randomised controlled trial of the clinical and cost effectiveness of ACT compared to a talking control (TC) or treatment as usual (TAU) in the management of dysfunction in advanced cancer.

1. To test the feasibility of recruitment to/and attrition in people with advanced cancer into a
randomised controlled trial of TAU plus ACT compared to TAU plus TC
2. To explore the feasibility of providing a therapist delivered intervention; individual ACT or TC
3. To assess the usefulness and acceptability of a number of clinical and economic outcomes
4. To determine whether data generated from outcomes in this trial support a larger RCT into the clinical effectiveness of ACT in advanced cancer patients
5. To obtain qualitative data about the experience of receiving ACT and TC

Ethics approval

NRES committee London – Riverside, 04/12/2014, ref: 14/LO/0813

Study design

Randomised; Interventional; Design type: Treatment

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use contact details to request a participant information sheet


Topic: Cancer; Subtopic: All Cancers/Misc Sites; Disease: All


There are two intervention arms:
1. Treatment as usual (TAU) plus acceptance commitment therapy (ACT)
2. TAU plus talking control (TC)
Interventions will be described in detailed manuals to ensure core components are well defined and replicable. For ACT and TC, up to 8 sessions (each 1 hour) will be offered weekly and delivered within 3 months. Sessions will usually take place in a palliative care day therapy unit but the final 3 may occur at home if requested. Both ACT and TC will be delivered by the same therapist to reduce the effects of non-specific factors (e.g. warmth, professionalism).
1. ACT: a contextual behavioural approach which uses a collection of techniques aimed at increasing psychological flexibility to change outcomes. Psychological flexibility is the ability to persist in valued life activities alongside distressing or unwanted private events. There are two main processes
1.1. Mindfulness and acceptance (cognitive fusion and self as context)
1.2. Commitment and behaviour change (being present, defining valued directions and committed action)
We shall follow the work of Hayes et al (1999) and supplement the approach with the manual “"Get out of your mind and into your life"” (Hayes and Smith, 2005). Therapists will be familiar with the skills training manual “"Learning ACT”" by Luoma, Hyes and Walser (2005) and “"ACT made simple”" by Harris (2009). Psychological flexibility mediates outcomes in chronic pain (Wicksell et al, 2010); acceptance, mindfulness and values each mediate outcomes for generalised anxiety.
2. TC: this promotes use of common factors in therapy by encouraging the therapist to be
warm and welcoming, allowing people to ventilate their feelings, feel heard and understood.
It specifically discourages focusing on problem areas and stipulates that problem solving
should not be attempted. The therapist is trained to adhere to guidelines and this approach
has been used previously to control for common factors in therapy.

Intervention type



Drug names

Primary outcome measures

FACT-G: A self-report 5 point Likert type scale, consisting of 27 questions taking 5 minutes to complete. It has four well-being domains (physical, social/family, emotional and activity) summed to a total score. With high internal consistency reliability and validity, it is recommended for assessing health-related quality of life in advanced cancer. A low score suggests poorer function. The mean score in a cancer population is 80.9 (SD 17.0). We shall select those with scores below the mean (pilot predicts 80% of population).

Secondary outcome measures

1. Psychological well-being: (5 minutes) Kessler-10 (K10, a 10-item self-report global measure of "psychological distress" in previous 4 weeks, taking 5 minutes to complete
2. Physical function: (5 minutes). Two minute walking test: the distance walked in 2 minutes (walking continuously, in a controlled space, at own speed, using an aid if necessary). One minute sit to stand test: number of times a person can stand up and sit down from a standardised chair over one minute.
3. Process of ACT: (10 minutes) Acceptance and Action Questionnaire II (AAQII): A 10 item scale measuring experiential avoidance that assesses willingness to accept undesirable thoughts and feelings, whilst acting in congruence with personal values and goals
4. Economic measures: (10 minutes)
4.1. EuroQol (EQ5D): A generic utility measure of quality of life consisting of 5-domains and a visual analogue scale, used in cost-effectiveness analysis
4.2. ICECAP-Supportive care measure: A seven item capability index for older people

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. A clinical diagnosis of advanced cancer defined as disease not amenable to curative treatment, those with metastases at diagnosis, those at first or subsequent extensive recurrence and those receiving palliative treatments
2.Total FACTG score of < 81
3. Agreement to be randomised
4. Sufficient understanding of English to engage in ACT

Participant type


Age group




Target number of participants

Planned Sample Size: 54; UK Sample Size: 54; Description: 27 controls and 27 intervention.

Participant exclusion criteria

1 Clinician estimated survival of less than 4 months
2. Age under 18 years

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Marie Curie Hampstead Hospice
Lyndhurst Gardens
United Kingdom

Trial participating centre

St John's Hospice
60 Grove End Road
United Kingdom

Trial participating centre

St. Joseph's Hospice
Mare St
E8 4SA
United Kingdom

Sponsor information


Camden and Islington NHS Foundation Trust (UK)

Sponsor details

Early Intervention Services
125-133 Camden High Street
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

National Institute for Health Research

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government


United Kingdom

Results and Publications

Publication and dissemination plan

The protocol will be submitted for publication in September 2015. The main analysis will be produced for publication before the end of the trial end date. Additionally, any qualitative data may also be submitted for publication if possible

Intention to publish date


Participant level data

Available on request

Results - basic reporting

Publication summary

2016 protocol in:

Publication citations

Additional files

Editorial Notes

15/02/2016: Publication reference added.