Mental health, quality of life in cancer survivors Mental and Behavioural Disorders Mental health, quality of life in cancer survivors
Conditions
Interventions
Patients will be randomised with an allocation ratio 1:1 to enhanced Acceptance and Commitment Therapy (plus) added to usual aftercare (intervention), versus usual aftercare only (control).
Acceptan
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 28/11/2023: 1. Within 24 months of having completed cancer treatment, (or about to complete) with curative intent for breast cancer, lower gastro-intestinal cancer, urological cancer, a haematological cancer, head and neck cancer, and any other common cancer with good survival 2. Aged 18 years or over 3. Participant’s GP practice falls within a participating IAPT service catchment, or if other psychological service provider, participant resides within their catchment area 4. Ability to give informed consent 5. Sufficient fluency in spoken English to be able to participate in a talking-based therapy delivered in English 6. With a score of 78 or less on the Functional Assessment of Cancer Therapy – General (FACT-G) _____ Previous inclusion criteria: 1. Within 24 months of having completed cancer treatment, (or about to complete) with curative intent for breast cancer, colorectal cancer, prostate cancer, a haematological cancer, head and neck cancer, and any other common cancer with good survival 2. Aged 18 years or over 3. Participant’s GP practice falls within a participating IAPT service catchment, or if other psychological service provider, participant resides within their catchment area 4. Ability to give informed consent 5. Sufficient fluency in spoken English to be able to participate in a talking-based therapy delivered in English 6. With a score of 78 or less on the Functional Assessment of Cancer Therapy – General (FACT-G)
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 28/11/2023: 1. Will not have not completed their cancer treatment by the commencement of the trial (excepting those receiving long-term, ongoing maintenance treatment e.g. androgen suppression therapy in urological cancer) 2. Receiving palliative or terminal care 3. Currently receiving another psychological intervention (NB participants taking antidepressants or anxiolytic drugs remain eligible) 4. Other serious co-morbid condition which would make it difficult for the participant to receive a talking-based one-to one intervention 5. Require urgent psychiatric or clinical psychology assessment _____ Previous exclusion criteria: 1. Will not have not completed their cancer treatment by the commencement of the trial (excepting those receiving long-term, ongoing maintenance treatment e.g. androgen suppression therapy in prostate cancer) 2. Receiving palliative or terminal care 3. Currently receiving another psychological intervention (NB participants taking antidepressants or anxiolytic drugs remain eligible) 4. Other serious co-morbid condition which would make it difficult for the participant to receive a talking-based one-to one intervention 5. Require urgent psychiatric or clinical psychology assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Functional Assessment of Cancer Therapy: General scale (FACT-G) at 12 months 2. Primary health economics outcome: Quality-adjusted life-years based on EQ5D5L and net monetary benefit at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Self-reported by patient response to questionnaires: 1. Quality of life measured using Functional Assessment of Cancer Therapy: General scale (FACT-G) at screening, baseline, 7 weeks, 16 weeks, 52 weeks, 2 years 2. Health economics measured using the Client Service Receipt Inventory (CSRI) at baseline, 16 weeks, 52 weeks, 2 years 3. Fear of cancer recurrence measured using the Fear of Cancer Recurrence (FCR4) at baseline, 7 weeks, 16 weeks, 52 weeks, 2 years 4. Depression and anxiety measured using the Hospital Anxiety and Depression Scale (HADS) at baseline, 7 weeks, 16 weeks, 52 weeks, 2 years 5. Fatigue measured using the Chalder Fatigue Scale (CFS) at baseline, 7 weeks, 16 weeks, 52 weeks, 2 years 6. Impact of cancer on QoL measured using the Impact Of Cancer scale (IOC) at baseline, 7 weeks, 16 weeks, 52 weeks, 2 years 7. Psychological flexibility measured using the Acceptance and Action Questionnaire (AAQ-II) at baseline, 7 weeks, 16 weeks, 52 weeks, 2 years 8. Values measured using the Valuing Questionnaire (VQ) at baseline, 7 weeks, 16 weeks, 52 weeks, 2 years 9. Goal-directed behaviour measured using the Committed Action Questionnaire (CAQ) at baseline, 7 weeks, 16 weeks, 52 weeks, 2 years 10. Beliefs about emotions measured using Beliefs about Emotions Scale (BES) at baseline, 7 weeks, 16 weeks, 52 weeks, 2 years | — |
Countries
England, United Kingdom
Contacts
Public ContactImran Khan
Outcome results
None listed