Document is current

Article History

Received: 30 March 2024

Accepted: 16 April 2024

First Online: 18 April 2024

Declarations

:

: The project is being conducted in accordance with the Helsinki Declaration (World Medical Association, 2008) and has been approved by the Swedish Ethical Review Authority (Dnr 2020–04650/2022-06520-02/2023-02005-02). Written informed consent to participate will be obtained from all participants. All research data will be coded and stored on encrypted and secured servers at Uppsala University. Personal data will be stored and secured in a separate database (also on a server at Uppsala University), which is compliant with the European Union General Data Protection Regulation (GDPR, 2016/679).

: N/A for this study protocol.

: The authors declare no competing interests.

: Changes in the protocol will be reported to clinicaltrials.gov and to the authority for research ethics that has vetted the study.

: There is no planned interim analysis or external monitoring of this RCT, since as this is a low-risk intervention directed toward informal caregivers (ICs) of patients with cancer, and not toward patients.

: An expert group of ICs each with experience of being an IC to an individual treated for HNC has been involved in developing the intervention and in planning the study’s procedures. The group will also be asked to take part in interpreting the study results. In addition, one member of the research team has experience of being an IC to an individual treated for HNC.

: The results will be presented at national and international conferences, in meetings with clinicians, and to patient organizations including families and friends, and will be published in open-access peer-reviewed journals. The Vancouver authorship guidelines will be employed for all publications emanating from the RCT.