NCT07672314

Brief Summary

The study aims to assess the feasibility and acceptability of the implementation of a routine digital psychosocial screening combined with a psycho-oncological Navigation Call for cancer survivors after completion of primary treatment with the goal to improve identification of psychosocial needs and facilitate access to supportive care.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
21mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Jul 2026May 2028

First Submitted

Initial submission to the registry

June 17, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 26, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

June 29, 2026

Status Verified

June 1, 2026

Enrollment Period

1.8 years

First QC Date

June 17, 2026

Last Update Submit

June 26, 2026

Conditions

Keywords

Cancer survivorsSurvivorship careDigital screeningPsycho-oncologyPsychosocial distressPatient-reported outcomes (PROs)Navigation CallFeasibility studyAcceptability

Outcome Measures

Primary Outcomes (1)

  • Feasibility of the Navigation Call

    Assessment: Proportion of included participants who complete the Navigation Call Scale: Dichotomous outcome (completed yes/no) Interpretation: Higher proportion indicates greater feasibility

    During the study intervention period, approximately 3 months after 1. follow-up consultation

Secondary Outcomes (13)

  • Acceptance of the Navigation Call:

    1 day to 1 week after the Navigation Call

  • Acceptance of the digital screening in routine care

    1 day to 1 week after routine digital screening

  • Prevalence of psychosocial burden - Distress

    At study inclusion (first follow-up consultation)

  • Prevalence of psychosocial burden - Physical functioning

    At study inclusion (first follow-up consultation)

  • Prevalence of psychosocial burden - Role functioning

    At study inclusion (first follow-up consultation)

  • +8 more secondary outcomes

Study Arms (1)

Navigation Call

EXPERIMENTAL

Routine digital psychosocial screening plus a semi-structured psycho-oncological Navigation Call conducted 7-14 days after follow-up. The call focuses on discussion of screening results, identification of psychosocial needs and barriers, and facilitation of access to supportive care services.

Behavioral: Navigation Call

Interventions

Navigation CallBEHAVIORAL

Semi-structured psycho-oncological Navigation Call to discuss screening results, identify psychosocial needs and barriers, and facilitate access to supportive care services.

Navigation Call

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged ≥18 years
  • Under oncological care at the USB for ≥9 months
  • Completion of primary cancer treatment (see definition below)
  • Attendance at routine oncological follow-up at USB
  • Ability to provide written informed consent

You may not qualify if:

  • Primary brain tumors
  • Severe cognitive impairment
  • Acute psychiatric symptoms that may impair the participant's ability to provide informed consent or comply with study procedures
  • Insufficient German language skills

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

Study Officials

  • Diana Zwahlen,, Dr. phil.

    University Hospital of Basel

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Random invitation single-arm trial (RISAT) in which eligible patients are randomly invited to receive a psycho-oncological Navigation Call in addition to routine care, while non-invited patients receive routine follow-up care only. Randomization applies to the invitation to the intervention rather than treatment allocation, and any comparison with non-invited patients is exploratory.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2026

First Posted

June 26, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

June 29, 2026

Record last verified: 2026-06

Locations