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 |
| Secondary identifying numbers | 18493 |
- 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
Contact information
Dr Marc Serfaty
Public
Public
University College London
Department of Mental Health Sciences
Rowland Hill Street
London
NW3 2PF
United Kingdom
Study information
| Study design | Randomized; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a 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 hypothesis | 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 |
| Condition | 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 | 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 study start date | 01/07/2015 |
| Overall study end date | 31/01/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 54; UK Sample Size: 54; Description: 27 controls and 27 intervention. |
| Total final enrolment | 42 |
| 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 exclusion criteria | 1 Clinician estimated survival of less than 4 months 2. Age under 18 years |
| Recruitment start date | 01/09/2015 |
| Recruitment end date | 01/06/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Marie Curie Hampstead Hospice
Lyndhurst Gardens
London
NW3 5NS
United Kingdom
London
NW3 5NS
United Kingdom
St John's Hospice
60 Grove End Road
London
NW8 9NH
United Kingdom
London
NW8 9NH
United Kingdom
St. Joseph's Hospice
Mare St
London
E8 4SA
United Kingdom
London
E8 4SA
United Kingdom
Sponsor information
Camden and Islington NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Early Intervention Services
125-133 Camden High Street
London
NW1 7JR
England
United Kingdom
"ROR" |
https://ror.org/03ekq2173 |
|---|
Funders
Funder type
Government
National Institute for Health Research
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/09/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| 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 |
| Results article | 21/12/2018 | 18/08/2023 | Yes | No |
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.
