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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13841211

Enrollment

Registered

2015-07-22

Start date

2015-09-01

Completion date

Unknown

Last updated

2023-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Cancer

Interventions

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 cor

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

England, United Kingdom

Contacts

Public ContactMarc Serfaty

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 2, 2026