SURECAN: Survivors rehabilitation evaluation after cancer

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2019
INTERVENTION: 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). Acceptance and Commitment Therapy (ACT) puts patients’ views about what they value most in their lives at the heart of the therapy, to improve their quality of life. ACT helps patients to accept what they cannot change and commit themselves to goals they are able and want to achieve, based on their own values. If physical activity and work support are deemed important by the patient the relevant support will be integrated into the therapy (ACT+). Number of sessions The intervention will take the form of up to eight sessions at weekly or fortnightly intervals using different modalities of delivery to suit individual needs: face‐to‐face sessions, over the phone or skype. The first session will be conducted face‐to‐face with the therapist. The intervention will be introduced and participants will be provided with the ACT+ participant handbook. Therapy will be delivered by therapists trained in the approach i.e. ACT. They could be situated in Improving Access to Psychological Therapies (IAPT), specialist services, cancer psychological services, or cancer charities. Duration of sessions Each session will take around one hour to complete and will include further exercises to be completed at home in time for the next session. Scheduling of sessions All sessions should be scheduled and take place within a 14 ‐ 20 week period starting from when a participant is allocated to the therapist (i.e. from randomisation). Control (usual aftercare) All participants in the study will receive usual aftercare provided by the NHS or support services. Participants randomised to the usual aftercare arm will receive a Macmillan Cancer Sup CONDITION: Mental health, quality of life in cancer survivors ; Mental and Behavioural Disorders ; Mental health, quality of life in cancer survivors PRIMARY OUTCOME: ; 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 OUTCOME: ; 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; 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)
Epistemonikos ID: 40a7be1e3e30ee362100980555efa9912232dd76
First added on: Aug 24, 2024