Clinical trial · Interventional
Pilot Study to Test the Feasibility and the Efficacy of the German Language Adapted PRO-SELF© Plus Pain Control Program
Pilot Study to Test the Feasibility and the Efficacy of the German Language Adapted PRO-SELF© Plus Pain Control Program, an Educational Intervention Directed at Patients and Their Family Caregivers to Reduce Cancer Pain and Related Symptoms
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this pilot study is to refine and test an advanced and adapted German version of the PRO-SELF© Plus Pain Control Program (PCP), an educational intervention directed at cancer pain patients and their families to enhance their pain self management abilities, and to calculate effect sizes for the planning of a sufficiently powered randomized controlled trial (RCT).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| German PRO-SELF(c) Plus Pain Control Program (PCP) | Behavioral | — | UNRESOLVED |
| Standard Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- German PRO-SELF(c) Plus PCP
- description
- Group receives 10 weeks German PRO-SELF(c) Plus PCP intervention program
- interventionNames
- Behavioral: German PRO-SELF(c) Plus Pain Control Program (PCP)
- type
- ACTIVE_COMPARATOR
- label
- Standard Care
- description
- control group receives attention control and standard care
- interventionNames
- Behavioral: German PRO-SELF(c) Plus Pain Control Program (PCP)
- Other: Standard Care
Primary outcomes (1)
- measure
- average and worst pain as reported daily by patients on a scale from 0 (no pain) to 10 (worst imaginable pain)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Outpatients * with cancer related pain ≥ 3 on a scale of 0-10 during the last two weeks, * estimated life expectancy of \> 6 months as assessed by the physician, * 18 years of age or older, * able to understand, read and write German, * have access to a telephone, * live in a 1 hour distance around Freiburg or are willing to travel to Freiburg for each visit, agree to participate and give written in-formed consent Exclusion Criteria: * documented previous or current psychiatric disorder or cognitive impairment as assessed by the physician (that is, unable to understand and provide informed consent), * visual or hearing impairment that prevents adequate communication, * a named FC who is not willing to participate in the study
References
Publications (2)
- DERIVEDKoller A, Miaskowski C, De Geest S, Opitz O, Spichiger E. Results of a randomized controlled pilot study of a self-management intervention for cancer pain. Eur J Oncol Nurs. 2013 Jun;17(3):284-91. doi: 10.1016/j.ejon.2012.08.002. Epub 2012 Sep 4. PMID 22959603
- DERIVEDKoller A, Miaskowski C, De Geest S, Opitz O, Spichiger E. Supporting self-management of pain in cancer patients: methods and lessons learned from a randomized controlled pilot study. Eur J Oncol Nurs. 2013 Feb;17(1):1-8. doi: 10.1016/j.ejon.2012.02.006. Epub 2012 Mar 28. PMID 22459260