CanTalk : A trial into the benefits of a talking therapy called cognitive behaviour therapy for the treatment of depression in adults with advanced cancer to see whether the intervention is better than treatment as usual

CanTalk: The clinical and cost effecttiveness of cognitive behaviour therapy (CBT) plus treatment as usual for the treatment of depression in advanced cancer: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN07622709

Enrollment

240

Registered

2011-07-20

Start date

2012-09-19

Completion date

Unknown

Last updated

2019-10-29

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

Conditions

Cancer and major depression Cancer Cancer

Interventions

Intervention group (treatment as usual + CBT) and Control (treatment as usual), 120 patients in each group Intervention: The availability of trained psychologists to d

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. A diagnosis of cancer not amenable to curative treatment (this includes patients initially diagnosed with metastatic disease, those at first or subsequent incurable recurrence and who may be receiving palliative treatments including non-curative radiotherapy, chemotherapy, biological therapy or surgery) verified by contacting general practitioners (GPs) or oncologist. 2. A clinical diagnosis of depression through clinical interview on the Mini-International Neuropsychiatric Interview (MINI) (Sheenan et al, 1998) 3. Agreement to be randomised 4. Sufficient understanding of English to be able to engage in CBT 5. The patient is eligible for Improving Access to Psychological Therapies (IAPT) - either they or their GP is in an appropriate catchment area 6. Agreement for GP to be involved so that referral to IAPT can take place through GP

Exclusion criteria

Exclusion criteria: 1. Clinician estimated survival of less than 4 months (verified by contacting patients' oncologists/GP) 2. Suicidal intent; scoring 3 on question 9 of the Beck Depression Inventory (BDI)-II 3. Currently receiving or having received a psychological intervention recommended by Niational Institute for Health and Clinical Excellence (NICE) aimed at treating depression (e.g. Interpersonal Psychotherapy, CBT etc) in the last 2 months 4. Suspected alcohol dependence using the Alcohol Use disorders Identification Test (AUDIT; Saunders et al, 1993)

Design outcomes

Primary

Measure	Time frame
1. The Beck Depression Inventory-II (BDI-II; Beck and Steer, 1996): This is a 21 item self report measure with a maximum score of 63 indicating severe depressive symptoms. It contains few items measuring affective-somatic symptoms, with 15 of the 21 items assessing negative cognitions, a target of cognitive interventions. Its psychometric properties are similar to the BDI (Beck et al, 1961), the most widely used self report instrument for measuring depressive symptoms and which has also been used in trials of psychotherapy for patients with advanced cancer (McLean et al 2008; Savard et al, 2006; Laidlaw et al, 2005). 1.1. We elected not to use the Profile of Mood States (McNair, 1992) which is often used to measure mood in psychological treatments in advanced cancer (Akechi et al 2009) and metastatic breast cancer (Edwards et al, 2009), because it is less sensitive and precise in assessing depressive symptoms and cognitive change when compared to measures solely designed for those purposes (Nezu et al, 2000). The BDI-II also has a number of cognitive elements which are particularly useful for measuring change with CBT. Other rating scales for depression have fewer cognitive elements and scales such as the PHQ-9 have not been used in this sample population and so it would not be possible to generate a suitable power analysis. Measured at baseline, 6 weeks, 12 weeks (end of intervention), 18 weeks and 24 week follow up	—

Measure

Time frame

1. The Beck Depression Inventory-II (BDI-II; Beck and Steer, 1996): This is a 21 item self report measure with a maximum score of 63 indicating severe depressive symptoms. It contains few items measuring affective-somatic symptoms, with 15 of the 21 items assessing negative cognitions, a target of cognitive interventions. Its psychometric properties are similar to the BDI (Beck et al, 1961), the most widely used self report instrument for measuring depressive symptoms and which has also been used in trials of psychotherapy for patients with advanced cancer (McLean et al 2008; Savard et al, 2006; Laidlaw et al, 2005). 1.1. We elected not to use the Profile of Mood States (McNair, 1992) which is often used to measure mood in psychological treatments in advanced cancer (Akechi et al 2009) and metastatic breast cancer (Edwards et al, 2009), because it is less sensitive and precise in assessing depressive symptoms and cognitive change when compared to measures solely designed for those purposes (Nezu et al, 2000). The BDI-II also has a number of cognitive elements which are particularly useful for measuring change with CBT. Other rating scales for depression have fewer cognitive elements and scales such as the PHQ-9 have not been used in this sample population and so it would not be possible to generate a suitable power analysis. Measured at baseline, 6 weeks, 12 weeks (end of intervention), 18 weeks and 24 week follow up

—

Secondary

Measure	Time frame
1. Patient Health Questionnaire (PHQ9; Kroenke et al, 2002) screens for depression and is used by IAPT therapists and in primary care. It is a valid measure of severity of depression in primary care and has the advantage that it can be administered over the telephone. Measured at baseline, 12 weeks and 24 weeks follow up. 2. EuroQol (EQ5D; Brooks, 1996; EuroQol Group, 1990) A generic utility measure of quality of life consisting of 5-domains and a visual analogue scale. It will be used in cost-effectiveness analysis. Measured at baseline, 12 weeks and 24 weeks follow up. 3. Satisfaction with care using methods using a visual analogue scale (scored 0 to 10 towards higher satisfaction). Measured at 12 weeks 4. Eastern Cooperative Oncology Group-Performance Status (ECOG-PS; Oken et al, 1982): is a scale to measure physical functioning based on five levels: 0, asymptomatic normal activity; 1, symptomatic but fully ambulatory; 2, symptomatic and in bed less than 50% of time; 3, symptomatic and in bed more than 50% of time; 4, 100% restricted to bed. Measured at baseline, 12 weeks and 24 weeks follow up. 5. Measures of service utilisation: The Client Service Receipt Inventory (CSRI; Beecham and Knapp, 1992). We shall use a short modified version of this measure of service use which collects data directly from patients and their GP. Measured at baseline, 12 weeks and 24 weeks follow up.	—

Measure

Time frame

1. Patient Health Questionnaire (PHQ9; Kroenke et al, 2002) screens for depression and is used by IAPT therapists and in primary care. It is a valid measure of severity of depression in primary care and has the advantage that it can be administered over the telephone. Measured at baseline, 12 weeks and 24 weeks follow up. 2. EuroQol (EQ5D; Brooks, 1996; EuroQol Group, 1990) A generic utility measure of quality of life consisting of 5-domains and a visual analogue scale. It will be used in cost-effectiveness analysis. Measured at baseline, 12 weeks and 24 weeks follow up. 3. Satisfaction with care using methods using a visual analogue scale (scored 0 to 10 towards higher satisfaction). Measured at 12 weeks 4. Eastern Cooperative Oncology Group-Performance Status (ECOG-PS; Oken et al, 1982): is a scale to measure physical functioning based on five levels: 0, asymptomatic normal activity; 1, symptomatic but fully ambulatory; 2, symptomatic and in bed less than 50% of time; 3, symptomatic and in bed more than 50% of time; 4, 100% restricted to bed. Measured at baseline, 12 weeks and 24 weeks follow up. 5. Measures of service utilisation: The Client Service Receipt Inventory (CSRI; Beecham and Knapp, 1992). We shall use a short modified version of this measure of service use which collects data directly from patients and their GP. Measured at baseline, 12 weeks and 24 weeks follow up.

—

Countries

United Kingdom

Outcome results

None listed

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