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

Not Applicable

Completed

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

• Registration Number: ISRCTN13841211
• Lead Sponsor: Camden and Islington NHS Foundation Trust (UK)

Brief Summary

2016 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/26865162 protocol 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35596193/ Qualitative analysis of sessions (added 18/08/2023) 2018 Results article in https://pubmed.ncbi.nlm.nih.gov/30511788/ (added 18/08/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-22
• Study Completion: 2018-01-31
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 42

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).