The addition of ACT or a talking control to treatment as usual for the management of dysfunction in advanced cancer

ISRCTN	ISRCTN13841211
DOI	https://doi.org/10.1186/ISRCTN13841211
Protocol serial number	18493
Sponsor	Camden and Islington NHS Foundation Trust (UK)
Funder	National Institute for Health Research

Submission date: 22/07/2015
Registration date: 22/07/2015
Last edited: 18/08/2023

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

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-comparing-2-talking-therapies-for-people-having-treatment-for-cancer-symptoms-canact

Contact information

Dr Marc Serfaty
Public

University College London
Department of Mental Health Sciences
Rowland Hill Street
London
NW3 2PF
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomized; Interventional; Design type: Treatment
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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 acronym	CanACT
Study objectives	Aim: 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. Objectives: 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(s)	NRES committee London – Riverside, 04/12/2014, ref: 14/LO/0813
Health condition(s) or problem(s) studied	Topic: Cancer; Subtopic: All Cancers/Misc Sites; Disease: All
Intervention	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	Other
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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
Completion date	31/01/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	54
Total final enrolment	42
Key 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
Key exclusion criteria	1 Clinician estimated survival of less than 4 months 2. Age under 18 years
Date of first enrolment	01/09/2015
Date of final enrolment	01/06/2016

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

Marie Curie Hampstead Hospice

Lyndhurst Gardens
London
NW3 5NS
United Kingdom

St John's Hospice

60 Grove End Road
London
NW8 9NH
United Kingdom

St. Joseph's Hospice

Mare St
London
E8 4SA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		21/12/2018	18/08/2023	Yes	No
Protocol article	protocol	11/02/2016		Yes	No
HRA research summary			28/06/2023	No	No
Other publications	Qualitative analysis of sessions	20/05/2022	18/08/2023	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

18/08/2023: Publication references and total final enrolment added.
11/12/2018: No publications found, verifying study status with principal investigator.
15/02/2016: Publication reference added.