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Efficacy of the cognitive-behavioral online writing therapy Onko-STEP for Cancer patients in young adulthood - a randomized controlled trial

Efficacy of the cognitive-behavioral online writing therapy Onko-STEP for Cancer patients in young adulthood - a randomized controlled trial - Onko-STEP AYA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00023574
Enrollment
172
Registered
2021-02-22
Start date
2022-02-18
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

all tumor entities

Interventions

Group 1: Intervention group - receives Onko-STEP Intervention The intervention contains two modules with five writing tasks each and is accompanied by a trained therapist. The "Looking Back" module fo
t2 - during intervention
t3 - after completion of inter- vention
t4 - follow-up (3 months after t3)). Group 2: Waiting control group - receives information about psycho-oncology services (and after the waiting period, onco-STEP if desired.

Sponsors

Universitätsklinikum LeipzigAbteilung für Medizinische Psychologie und Medizinische Soziologie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 39 Years

Inclusion criteria

Inclusion criteria: Patients aged 18 to 39 years who received a cancer diagnosis (all entities) for the first time in the last 10 years and were not younger than 15 years at the time of diagnosis, - in stable remission for at least 6 months; primary treatments (surgery, chemotherapy, radiotherapy, stem cell transplantation) must have been completed, - current anxiety symptoms (cut-off score > 9 in the Generalized Anxiety Disorder Scale (GAD-7) and cut-off score = 34 in the short form of the Progressive Anxiety Questionnaire (PA-F-KF). - Physically, cognitively, and linguistically (adequate written German language skills) able to participate in the intervention and interview, - Internet access over the period of study participation.

Exclusion criteria

Exclusion criteria: - Evidence of acute suicidality or psychosis, - severe alcohol or drug abuse, - ongoing psychotherapy, - Changes in any psychopharmacotherapy in the period from 6 weeks prior to the initial diagnosis until the end of therapy or the 10-week observation period.

Design outcomes

Primary

MeasureTime frame
Anxiety with Generalized Anxiety Disorder (GAD-7) and progression anxiety with Progression anxiety questionnaire (PA-F), measured before, during, and after the intervention, and catamnesis 3 months after the end of the intervention.

Secondary

MeasureTime frame
Depressivität - Patient Health questionnaire (PHQ-9) Brief Psychiatric Rating Scale Distress-Thermometer Trauma-Screeningquestionnaire (CATS-Kurzversion) Questions on life satisfaction (FLZ-M)

Countries

Germany

Contacts

Public ContactAnnekathrin Sender

Universitätsklinikum Leipzig Abteilung für Medizinische Psychologie und Medizinische Soziologie

annekathrin.sender@medizin.uni-leipzig.de0341/9718804

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026