PEF-Adjuvant – Shared Decision-Making for Adjuvant Systemic Therapy in Melanoma: A Multicentre, Prospective, Cluster-Randomised Implementation Study Using a Stepped-Wedge Design

PEF-Adjuvant – Shared Decision-Making for Adjuvant Systemic Therapy in Melanoma: A Multicentre, Prospective, Cluster-Randomised Implementation Study Using a Stepped-Wedge Design - PEF-Adjuvant

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00038387

Enrollment

294

Registered

2026-02-09

Start date

2026-03-31

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C43

Interventions

Group 1: Control group Patients with melanoma in stages IIB/C and III, after surgical removal of the primary tumor and any affected lymph nodes, who face a decision for or against adjuvant systemic th

physicians trained in shared decision-making (participatory decision-making).

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with melanoma in stages IIB/C or III, after surgical removal of the primary tumor and any affected lymph nodes, who are eligible for adjuvant systemic therapy.

Exclusion criteria

Exclusion criteria: Not legally competent; patients who, due to physical or mental impairments or insufficient German language skills, are unable to use the PtDA and/or complete the questionnaires.

Design outcomes

Primary

Measure	Time frame
Decisional Conflict Assessment following the physician–patient consultation using the Decisional Conflict Scale	—

Secondary

Measure	Time frame
Shared decision making: Patient´s perspective (PEF-FB-9, collaboRATE, PICS), physician´s perspective (PEF-FB-9-Doc); decisional regret (DRS); Adjuvant systemic therapy uptake; depressivity (PHQ-9); fear of progression (PA-F12) ; well-being (WHO-5; VAS); preferred and perceived involvement in decision-making (Degener Skala: CPS/PPS); evaluation of the PtDA (intervention group only): preparation for decision-making (PrePDM), knowledge, acceptance, and comprehensibility	—

Measure

Time frame

Shared decision making: Patient´s perspective (PEF-FB-9, collaboRATE, PICS), physician´s perspective (PEF-FB-9-Doc); decisional regret (DRS); Adjuvant systemic therapy uptake; depressivity (PHQ-9); fear of progression (PA-F12) ; well-being (WHO-5; VAS); preferred and perceived involvement in decision-making (Degener Skala: CPS/PPS); evaluation of the PtDA (intervention group only): preparation for decision-making (PrePDM), knowledge, acceptance, and comprehensibility

—

Countries

Germany

Contacts

Public ContactChristiane Bieber

Universitätsklinikum Heidelberg, Klinik für Allgemeine Innere Medizin und Psychosomatik, Zentrum für Psychosoziale Medizin

PEF-adjuvant.nct@med.uni-heidelberg.de+49 6221 56 8652

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026