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NCT Number: NCT07672314

Bridging the Gap in Psychosocial Care for Cancer Survivors

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.

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Key information

Conditions

Cancer Survivorship Psycho-Oncology Psychological Distress Supportive Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Navigation Call

Behavioral

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

Primary outcomes

  1. Feasibility of the Navigation Call

    Time frame: 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 outcomes

  1. Acceptance of the Navigation Call:

    Time frame: 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

  2. Acceptance of the digital screening in routine care

    Time frame: 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

  3. Prevalence of psychosocial burden - Distress

    Time frame: 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

  4. Prevalence of psychosocial burden - Physical functioning

    Time frame: 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

  5. Prevalence of psychosocial burden - Role functioning

    Time frame: 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

  6. Prevalence of psychosocial burden - Emotional functioning

    Time frame: 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

  7. Prevalence of psychosocial burden - Cognitive functioning

    Time frame: 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

  8. Prevalence of psychosocial burden - Social functioning

    Time frame: 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

  9. Prevalence of psychosocial burden - Global health status / quality of life

    Time frame: 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

  10. Prevalence of psychosocial burden - Fatigue

    Time frame: 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")

  11. Prevalence of psychosocial burden - Sleep problems

    Time frame: 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")

  12. Utilization of psycho-oncological support

    Time frame: 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

  13. Engagement in community-based support programs and barriers to support uptake

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Noa Roemmel

CONTACT

[email protected]

+41 61 55 65325

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Bridging the Gap in Psychosocial Care for Cancer Survivors: Integrating Digital Screening With Navigation Call

Acronym: BRIDGE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 26, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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