NCT02713919: PEINCA

Study to Test the Efficacy of the PRO-SELF® Plus Pain Control Program to Reduce Pain in Outpatients With Cancer

Terminated NA Last updated 5 March 2019

What this trial tests

NA trial testing Adapted German PRO-SELF© Plus Pain Control Program in Pain Management in 44 participants. Terminated before completion.

Timeline

22 April 2016

Primary endpoint
20 December 2018

20 December 2018

Quick facts

Lead sponsor	Elisabeth Spichiger
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	44
Start date	22 April 2016
Primary completion	20 December 2018
Estimated completion	20 December 2018
Sites	3 locations across Switzerland

Drugs / interventions tested

• Adapted German PRO-SELF© Plus Pain Control Program

Conditions studied

• Pain Management — all drugs for Pain Management →

Sponsor

Elisabeth Spichiger

Who can join

18 and older, any sex, with Pain Management. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Up to 64% of cancer patients experience pain, and as many as 40% of patients with pain do not receive adequate pain management. And while potential to reduce pain has been shown in several interventions that support patients' self-management, effects have been moderate. Purpose: This multicenter mixed methods study primarily aims to evaluate the efficacy of the adapted German PRO-SELF© Plus Pain Control Program (PCP) on pain intensity, to explore the intervention's effect on associated symptoms and other patient and family caregiver (FC) outcomes, and to explore patients' and FCs' experiences with cancer pain management.

Methods: A nested concurrent mixed methods design will be used for this multi-center study, that is, a randomized controlled trial (RCT) will be combined with a qualitative substudy. Participants will be randomly assigned to a 6-week intervention or usual care group; outcomes will be evaluated at 6 weeks post-randomization. The primary outcome will be pain intensity. A total sample of 210 patients with cancer pain and approximately 105 FCs will be recruited from the oncology outpatient clinics of the University Hospitals Basel, Zurich and Bern. The intervention is designed to implement structured and tailored components (information, skill-building, nurse coaching) and aims at improving patients' pain self-management. Data analysis will follow an intent-to-treat strategy and generalized mixed models will be used. For the qualitative substudy, 60 patients and FCs of both groups will be interviewed. Data will be systematically summarized.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Randomized clinical trial to evaluate a cancer pain self-management intervention for outpatients.
   Valenta S, Miaskowski C, Spirig R, Zaugg K, et al · · 2022 · cited 6× · PMID 35528799 · DOI 10.1016/j.apjon.2021.12.003
2. 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 S, Spirig R, Miaskowski C, Zaugg K, et al · · 2018 · cited 6× · PMID 30559603 · DOI 10.1186/s12912-018-0323-x