Influencing factors on somatic and psychological well-being in the long-term course in patients with breast cancer after surgical treatment: a prospective observational study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00034875

Enrollment

200

Registered

2024-09-13

Start date

2024-10-09

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

C50 D05

Interventions

Group 1: Breast cancer patients at a German university hospital who are undergoing surgical treatment are to be questioned. The study comprises a total of five survey points (preoperative, postoperati

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: German-speaking, adults, existing legal capacity, no mental impairments

Exclusion criteria

Exclusion criteria: Minors, men, lack of legal capacity, insufficient knowledge of German

Design outcomes

Primary

Measure	Time frame
• Pain: oBrief Pain Inventory (BPI) oNeuropathic pain (Douleur neuopathique, DN4) •Influencing factors on pain: oPain catastrophization (Pain Catastrophizing Scale, PCS) oPain expectation (item from the German pain questionnaire) •Sleep: o Insomnia Severity Index, ISI oQuality of sleep, subjective sleep duration (Pittsburg Sleep Quality Index, PSQI) oSleep log o Dysfunctional Beliefs and Attitudes about Sleep scale (DBAS-16) •Demoralization: oDS-II Munster •Depression: oPatient Health Questionnaire, depression module (PHQ-9) •Hopelessness: oBeck Hopelessness Scale	—

Measure

Time frame

• Pain: oBrief Pain Inventory (BPI) oNeuropathic pain (Douleur neuopathique, DN4) •Influencing factors on pain: oPain catastrophization (Pain Catastrophizing Scale, PCS) oPain expectation (item from the German pain questionnaire) •Sleep: o Insomnia Severity Index, ISI oQuality of sleep, subjective sleep duration (Pittsburg Sleep Quality Index, PSQI) oSleep log o Dysfunctional Beliefs and Attitudes about Sleep scale (DBAS-16) •Demoralization: oDS-II Munster •Depression: oPatient Health Questionnaire, depression module (PHQ-9) •Hopelessness: oBeck Hopelessness Scale

—

Secondary

Measure	Time frame
• Anxiety: o General Anxiety Disorder Scale-7 (GAD-7) • Suicidality: o Beck Scale for Suicide Ideation • Quality of life: o EORTC QLQ (QLQ-BR23)	—

Countries

Germany

Contacts

Public ContactMarkus Ramm

Klinik für Psychosomatische Medizin und Psychotherapie

markus.ramm@ukmuenster.de02518353415

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 27, 2026