International Study to Evaluate Two Programs of Support for Patients With Advanced Cancer and Their Families

The overall aim of this project is to evaluate the effectiveness, cost-effectiveness and mechanisms of action of two psychoeducational interventions (a face-to-face nurse-led intervention called FOCUS+ and an eHealth intervention called iFOCUS) aimed at improving the emotional function and self-efficacy of patients with advanced cancer and their family caregiver. Both interventions are compared to care as usual. Both interventions focus on teaching dyads optimal ways to jointly manage the implications of advanced cancer and responding to their priority concerns and are designed to be tailored to the specific needs and wishes of the patient-caregiver dyads. Tailoring is based on information about the dyad obtained at enrollment (e.g. age, relationship, etc.) and the responses in the intervention sessions. The overarching aim is addressed by five core intervention components: 1. supporting family involvement and improving the dyads mutual communication, 2. supporting outlook (i.e. increasing the dyad's capacity to identify positive or meaningful aspects related to their situation), 3. increasing dyads' coping skills, i.e. their capacity to identify their coping strategies and take action 4. help dyads reduce their uncertainty 5. teaching symptom management and giving them confidence to handle specific tasks and problems Project objectives: 1. To compare 1) the face-to-face FOCUS+ intervention and 2) the iFOCUS web intervention to 3) care as usual in terms of their: * Effect on the emotional function and self-efficacy (primary outcomes), appraisal of illness, uncertainty, hopelessness, coping, dyad communication, quality of life and healthcare resource use of patients with advanced cancer and their family caregivers * Cost-effectiveness * Effects on vulnerable subgroups (particularly women and those of lower socioeconomic status) * Effectiveness in different healthcare systems 2. To evaluate the implementation process of the interventions in terms of the acceptability, feasibility, usefulness as perceived by patients, family caregivers and healthcare staff in each country, and their mechanisms of action. Data will be collected three times from patient-caregiver dyads: 1) baseline measure (t0) after which the dyad will immediately be randomized to one of the study arms, 2) first follow-up at 12 weeks after baseline (t1) and 3) second follow-up at 24 weeks after baseline (t2).

Sex

All

Minimum age

18 Years

PATIENT

Inclusion Criteria:

* Diagnosis of cancer: solid organ (lung, colorectal, breast, prostate and other)
* No longer receives curative treatment (only life-prolonging or palliative treatments)
* Written informed consent
* Lives within feasible distance for intervention nurses to travel

Exclusion Criteria:

* Brain cancer, non-solid cancers
* Prognosis of less than 3 months
* Has no informal caregivers
* \< 18 years old
* Unable to participate in available languages

FAMILY CAREGIVER

Inclusion Criteria:

* Written informed consent
* Primary informal caregiver as determined by the patient
* Lives within feasible distance for intervention nurses to travel

Exclusion Criteria:

* Unable to physically or mentally participate
* Cancer diagnosis in the last 12 months
* \<18 years old
* Unable to participate in available languages

DYAD

Inclusion Criterium:

* Patient and/or family caregivers has access to and is familiar with use of internet

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• BACKGROUNDNorthouse L, Schafenacker A, Barr KL, Katapodi M, Yoon H, Brittain K, Song L, Ronis DL, An L. A tailored Web-based psychoeducational intervention for cancer patients and their family caregivers. Cancer Nurs. 2014 Sep-Oct;37(5):321-30. doi: 10.1097/NCC.0000000000000159. PMID 24945270
• BACKGROUNDNorthouse L, Kershaw T, Mood D, Schafenacker A. Effects of a family intervention on the quality of life of women with recurrent breast cancer and their family caregivers. Psychooncology. 2005 Jun;14(6):478-91. doi: 10.1002/pon.871. PMID 15599947
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• DERIVEDMay P, Smith S, Jallow M, Kalinjuna T, De Vlemnick A, Matthys O, Van Goethem V, Groenvold M, Guerin S, Turola E, Bakker E, Brazil K, Harding R, Northouse L, Hudson P, Cohen J, Normand C; DIAdIC consortium. Assessing the cost-effectiveness of two psychoeducational interventions for people with cancer and their caregivers: An economic evaluation of the multi-country DIAdIC trial. Contemp Clin Trials. 2026 Mar;162:108240. doi: 10.1016/j.cct.2026.108240. Epub 2026 Jan 21. PMID 41577124
• DERIVEDDe Vleminck A, Matthys O, Turola E, Dierickx S, Dombrecht L, Van Goethem V, Deliens L, Lapeire L, Hudson P, Eecloo K, Brazil K, Groenvold M, Di Leo S, van der Heide A, Normand C, Harding R, Pilch M, Northouse L; DIAdIC Team; Cohen J. Impact of a nurse-led and a web-based psychoeducational program for advanced cancer patients and their caregivers: Results of a three-arm randomized controlled trial. Int J Nurs Stud. 2025 Nov;171:105192. doi: 10.1016/j.ijnurstu.2025.105192. Epub 2025 Aug 19.