Bridging the Gap in Psychosocial Care for Cancer Survivors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Navigation Call
BehavioralSemi-structured psycho-oncological Navigation Call to discuss screening results, identify psychosocial needs and barriers, and facilitate access to supportive care services.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Navigation CallExperimental treatment 1 intervention
Trial outcomes
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
Time frame
During the study intervention period, approximately 3 months after 1. follow-up consultationSecondary outcomes
1
Acceptance of the Navigation Call:
Instrument: Adapted German version of the Theoretical Framework of Acceptability (TFA) questionnaire Items: 8 items Response scale: 5-point Likert scale Score range: 1-5 per item (or corresponding mean score across items) Interpretation: Higher scores indicate greater acceptability of the Navigation Call
Time frame
1 day to 1 week after the Navigation Call2
Acceptance of the digital screening in routine care
Instrument: Adapted German version of the Theoretical Framework of Acceptability (TFA) questionnaire Items: 8 items Response scale: 5-point Likert scale Score range: 1-5 per item (or corresponding mean score across items) Interpretation: Higher scores indicate greater acceptability of the digital screening
Time frame
1 day to 1 week after routine digital screening3
Prevalence of psychosocial burden - Distress
Instrument: Distress Thermometer Score range: 0-10 Interpretation: Higher scores indicate greater distress Threshold for clinically relevant distress: ≥5
Time frame
At study inclusion (first follow-up consultation)4
Prevalence of psychosocial burden - Physical functioning
Instrument: EORTC QLQ-F17 Physical Functioning scale Score range: 0-100 Interpretation: Higher scores indicate better functioning Threshold indicating impairment: \<83
Time frame
At study inclusion (first follow-up consultation)Sponsors and contacts
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Source ClinicalTrials.gov