The PRoCESS Trial: Pancreatic cancer Relatives Counselling and Education Support Service trial.

INTERVENTION: PRoCESS is a pragmatic trial of a nurse‐led telehealth counselling service for family carers of people diagnosed with pancreatic cancer. The study design is a two‐arm randomised controlled trial in which 200 people who are caring for patients with pancreatic cancer will be randomised in a 1:1 ratio to: A four‐month structured telephone counselling intervention plus a comprehensive information package supplied by PanKind, The Australian Pancreatic Cancer Foundation (Arm 1); or the information package alone (Arm 2). The study duration for each participant will be 6 months of follow‐up. Participants in Arm 1 will be offered ten one‐hour counselling sessions over four months (weekly for 4 weeks, then fortnightly) and then if desired further monthly booster sessions until 30/04/2023 i.e. the end of the study. The mode of delivery will be by video conferencing (zoom, skype or equivalent) or telephone, based on participant preference. With consent, all sessions will be recorded. The intervention is based on a self‐efficacy paradigm and involves assessing needs, delivering intervention components appropriate to those needs, revaluating needs at each session, and providing a care plan or referrals where the nurse’s assessment is that further management may be warranted. The intervention will be delivered by a trained palliative care or oncology nurse and will cover the following components (as required): 1. Psychoeducation about the psychological impact of cancer 2. Coping, problem‐solving and stress management skills 3. Cognitive therapy and challenging unhelpful thoughts 4. Enhancing relationships and support networks 5. Psychoeducation about non‐pharmacological approaches for stress management (mindfulness, exercise, relaxation) 6. Educ CONDITION: Cancer ‐ Pancreatic Cancer;Anxiety;Depression;Fatigue; ; Cancer ; Anxiety ; Depression ; Fatigue Mental Health ‐ Studies of normal psychology, cognitive function and behaviour Public Health ‐ Health service research PRIMARY OUTCOME: Carers anxiety assessed by the HADS‐A mean score; [Time points: Baseline (at enrollment), and follow‐up assessments at 2, 4 and 6 months after baseline. ] ; 1) Asking carers in their baseline questionnaire "Has the person who you care for been referred to or seen a palliative care doctor or nurse? (if yes specify referral date and date first seen)" ; 2) Monthly data collection telephone calls to carers for 6 months after recruitment to ascertain if/when patient has been referred to palliative care. [End of Trial] Number of days patients spent in hospital assessed by: ; 1) Monthly data collection telephone calls to carers for 6 months after recruitment to ascertain number of days patients spent in hospital. ; 2) Linkage to the Queensland Hospital Admitted Patient Data Collection. Note participants not treated in Queensland hospitals and who do not consent to this will be excluded from this component.[End of Trial] Participation rate (%) assessed by comparing participants and eligible non‐participants in terms of demographics and patient clinical characteristics.[End of Trial] Patients number of emergency department presentations assessed by: ; 1) Monthly data collection telephone calls to carers for 6 months after recruitment to ascertain patients’ emergency department presentations, INCLUSION CRITERIA: * Primary carer for a patient who was diagnosed with pancreatic cancer within the last 3 months * Resident in Australia SECONDARY OUTCOME: Carers depression assessed by the HADS‐D mean score[Baseline (at enrollment), and follow‐up assessments at 2, 4 and 6 months after baseline. ] Carers fatigue assessed as the mean score on a 10 point Visual Analogue Scale (VAS) with instructions and response format the same as an item from the Brief Fatigue Inventory.[Baseline (at enrollment), and follow‐up assessments at 2, 4 and 6 months after baseline. ] Carers psychological and emotional unmet needs assessed as a domain score of the SCNS‐P&C [Baseline (at enrollment), and follow‐up assessments at 2, 4 and 6 months after baseline. ] Carers quality of life assessed as the mean score of the CarerQol‐7D[Baseline (at enrollment), and follow‐up assessments at 2, 4 and 6 months after baseline.] Carers quality‐adjusted life years assessed as mean weighted sum cost‐utility score from the CarerQol‐7D[Baseline (at enrollment), and follow‐up assessments at 2, 4 and 6 months after baseline. ] Carers self‐efficacy assessed by a composite of the mean scores of the four separate domains on the Caregiver Inventory: Managing Medical Information; Caring for Care Recipient; Caring for Oneself; and Managing Difficult Interactions/Emotions,[Baseline (at enrollment), and follow‐up assessments at 2, 4 and 6 months after baseline. ] Cost‐effectiveness of the intervention assessed by Incremental cost‐per QALY ratios assessed by carer monthly telephone interview data and linked health services (MBS) or medications (PBS) data and EuroQoL‐5D. [End of Trial] Intervention fidelity (completed sessions/enrolled participants). [End of Trial] Number of days after patients diagnosis to palliative care referral assessed by: ; 2) Linkage to the Queensland Hospital Admitted Patient Data Collection. Note participants not treated in Queensland hospitals and who do not consent to this will be excluded from this component.[End of Trial] Patients overall survival time post diagnosis (all‐cause mortality) as reported by the carer in monthly data collection telephone calls and verified (where possible) with linkage to Qld Hospital Admitted Patient Data Collection. [End of Trial] Patients quality‐adjusted life years as assessed by mean weighted survival time using EuroQoL‐5D (EQ‐5D‐5L) [Baseline (at enrollment), and follow‐up assessments at 2, 4 and 6 months after baseline. ]