Cancer Survivorship, Psychological Distress, Psycho-Oncology, Supportive Care
Conditions
Keywords
Cancer survivors, Survivorship care, Digital screening, Psycho-oncology, Psychosocial distress, Patient-reported outcomes (PROs), Navigation Call, Feasibility study, Acceptability
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.
Detailed description
Cancer survivors frequently experience persistent psychosocial distress, including anxiety, fatigue, fear of recurrence, and reduced quality of life after completion of active treatment. Although routine distress screening is widely recommended, screening results alone often fail to translate into the utilization of psychosocial support services due to motivational, informational, and organizational barriers. This single-centre prospective feasibility study evaluates a combined intervention consisting of routine digital patient-reported outcome screening and a structured psycho-oncological Navigation Call conducted shortly after follow-up consultation. The Navigation Call aims to discuss screening results, identify unmet psychosocial needs, address barriers to care, and facilitate referral to appropriate support services. The study primarily assesses the feasibility and acceptability of this intervention while also exploring psychosocial burden, support utilization, and reasons for accepting or declining psychosocial care.
Interventions
BEHAVIORALNavigation Call
Semi-structured psycho-oncological Navigation Call to discuss screening results, identify psychosocial needs and barriers, and facilitate access to supportive care services.
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the Navigation Call | During the study intervention period, approximately 3 months after 1. follow-up consultation | Assessment: Proportion of included participants who complete the Navigation Call Scale: Dichotomous outcome (completed yes/no) Interpretation: Higher proportion indicates greater feasibility |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptance of the Navigation Call: | 1 day to 1 week after 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 |
| Acceptance of the digital screening in routine care | 1 day to 1 week after routine digital screening | 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 |
| Prevalence of psychosocial burden - Distress | At study inclusion (first follow-up consultation) | Instrument: Distress Thermometer Score range: 0-10 Interpretation: Higher scores indicate greater distress Threshold for clinically relevant distress: ≥5 |
| Prevalence of psychosocial burden - Physical functioning | At study inclusion (first follow-up consultation) | Instrument: EORTC QLQ-F17 Physical Functioning scale Score range: 0-100 Interpretation: Higher scores indicate better functioning Threshold indicating impairment: \<83 |
| Prevalence of psychosocial burden - Role functioning | At study inclusion (first follow-up consultation) | Instrument: EORTC QLQ-F17 Role Functioning scale Score range: 0-100 Interpretation: Higher scores indicate better functioning Threshold indicating impairment: \<58 |
| Prevalence of psychosocial burden - Emotional functioning | At study inclusion (first follow-up consultation) | Instrument: EORTC QLQ-F17 Emotional Functioning scale Score range: 0-100 Interpretation: Higher scores indicate better functioning Threshold indicating impairment: \<70 |
| Prevalence of psychosocial burden - Cognitive functioning | At study inclusion (first follow-up consultation) | Instrument: EORTC QLQ-F17 Cognitive Functioning scale Score range: 0-100 Interpretation: Higher scores indicate better functioning Threshold indicating impairment: \<75 |
| Prevalence of psychosocial burden - Social functioning | At study inclusion (first follow-up consultation) | Instrument: EORTC QLQ-F17 Social Functioning scale Score range: 0-100 Interpretation: Higher scores indicate better functioning Threshold indicating impairment: \<58 |
| Prevalence of psychosocial burden - Global health status / quality of life | At study inclusion (first follow-up consultation) | Instrument: EORTC QLQ-F17 Global Health Status / QoL scale Score range: 0-100 Interpretation: Higher scores indicate better global quality of life Threshold indicating impairment: \<66.1 |
| Prevalence of psychosocial burden - Fatigue | At study inclusion (first follow-up consultation) | symptom-specific screening single items are collected using the standard EORTC 4-point response format: Response options: 1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much Score range: 1-4 Interpretation: Higher scores indicate greater symptom burden Threshold indicating clinically relevant symptoms: responses of 3 ("Quite a bit") or 4 ("Very much") |
| Prevalence of psychosocial burden - Sleep problems | At study inclusion (first follow-up consultation) | symptom-specific screening single items are collected using the standard EORTC 4-point response format: Response options: 1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much Score range: 1-4 Interpretation: Higher scores indicate greater symptom burden Threshold indicating clinically relevant symptoms: responses of 3 ("Quite a bit") or 4 ("Very much") |
| Utilization of psycho-oncological support | Within 4 months after screening | Outcome measure: New engagement with in-house psycho-oncology services following screening Scale: Dichotomous outcome (yes/no) Interpretation: Higher proportions indicate greater uptake of psycho-oncological support |
| Engagement in community-based support programs and barriers to support uptake | During the Navigation Call | Outcome measure: Use of community-based support services and reported barriers/facilitators Assessment method: Qualitative data collected during the Navigation Call and documented in structured field notes or call transcripts |
Countries
Switzerland
Contacts
CONTACTNoa Roemmel
STUDY_CHAIRDiana Zwahlen,, Dr. phil.
University Hospital of Basel
Outcome results
None listed