Testing a pain self-management intervention by exploring reduction of analgesics' side effects in cancer outpatients and the involvement of family caregivers: a study protocol (PEINCA-FAM).

Valenta, Sabine; Spirig, Rebecca; Miaskowski, Christine; Zaugg, Kathrin; Spichiger, Elisabeth (2018). Testing a pain self-management intervention by exploring reduction of analgesics' side effects in cancer outpatients and the involvement of family caregivers: a study protocol (PEINCA-FAM). BMC nursing, 17(54), p. 54. BioMed Central 10.1186/s12912-018-0323-x

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Pain is one of cancer patients' most frequent and distressing symptoms; however, analgesics' side effects often increase symptom burden. Further, with the home rapidly becoming the primary cancer care setting, family caregivers (FCs) commonly play central roles in patients' pain self-management, but with little or no preparation. One US-tested intervention, the PRO-SELF© Plus Pain Control Program (PCP), designed to support cancer outpatients and their FCs in pain self-management, is currently being tested in the Swiss multi-centre PEINCA study. The current PEINCA-FAM study is a sub-study of PEINCA. The aims of PEINCA-FAM are: a) to test the efficacy of the adapted German PRO-SELF © Plus PCP to reduce side effects of analgesics; b) to enhance patients'/FCs' knowledge regarding cancer pain; and c) to explore FCs' involvement in patients' pain self-management.


This mixed methods project combines a multi-centre randomized controlled clinical trial with qualitative data collection techniques and includes 210 patients recruited from three oncology outpatient clinics. FCs involved in patients' pain self-management are also invited to participate. After baseline evaluation, eligible participants are randomized to a 6-week intervention group and a control group. Both groups complete a daily pain and symptom diary. Intervention group patients/FCs receive the weekly psychoeducational PRO-SELF© Plus PCP interventions; control group patients receive usual care. After completing the six-week study procedures, a subsample of 7-10 patients/FCs per group and hospital ( = 42-60) will be interviewed regarding their pain management experiences. Data collection will take place from April 2016 until December 2018. An intent-to-treat analysis and generalized linear mixed models will be applied. Qualitative data will be analysed by using interpretive description. Quantitative and qualitative results will be combined within a mixed method matrix.


In clinical practice, specially trained oncology nurses in outpatient clinics could apply the intervention to reduce side effects and to enhance patients'/FCs' self-efficacy and pain management knowledge.

Trial registration

The PEINCA study is registered in the Clinical Trials.gov site (code: NCT02713919, 08 March 2016).

Item Type:

Journal Article (Original Article)


04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Clinic of Radiation Oncology

UniBE Contributor:

Zaugg, Kathrin


600 Technology > 610 Medicine & health




BioMed Central




Beatrice Scheidegger

Date Deposited:

04 Feb 2019 13:07

Last Modified:

05 Dec 2022 15:23

Publisher DOI:


PubMed ID:


Uncontrolled Keywords:

Adverse effects Caregivers Health behaviour Health knowledge, attitudes, practice Neoplasms Pain management Patient education Randomized controlled trial Self-care





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