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

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.

Sex

All

Minimum age

18 Years

Patient Inclusion Criteria:

* any type of cancer pain, including bone metastasis, somatic or visceral pain, with repeated pain ≥ 3 on a 0-10 Numeric Rating Scale (NRS) during the last week
* estimated life expectancy of \> 6 months as assessed by the physician
* 18 years of age or older
* being able to understand, read and write German
* access to a telephone
* living within one hour's driving distance of a participating site

Adapted inclusion criterion (from 01 Sept 2016 on)

\- any type of cancer pain, including bone metastasis, somatic or visceral pain, with repeated pain ≥ 3 on a 0-10 Numeric Rating Scale (NRS) during the last week

Patient Exclusion Criteria:

* cognitive dysfunction (as assessed by the physician) that would preclude full participation
* hearing impairment that precludes telephone conversations
* solely neuropathic pain (as assessed by the physician)
* participation in another clinical trial that requires extended hospitalizations (\> 2 weeks)
* participation in another clinical trial that could exert an influence on the study intervention's effectiveness
* Family caregiver (FC) involved in pain management who declines to participate in the intervention (FCs are not required to participate in the study as participants).

FC Inclusion Criteria:

* 18 years of age or older
* being able to understand, speak and write German; and
* willingness to participate in all intervention sessions

FC Exclusion Criterion:

* hearing impairment that precludes understanding telephone conversation

• DERIVEDValenta S, Miaskowski C, Spirig R, Zaugg K, Denhaerynck K, Rettke H, Spichiger E. Randomized clinical trial to evaluate a cancer pain self-management intervention for outpatients. Asia Pac J Oncol Nurs. 2022 Jan 21;9(1):39-47. doi: 10.1016/j.apjon.2021.12.003. eCollection 2022 Jan. PMID 35528799
• DERIVEDValenta S, Spirig R, Miaskowski C, Zaugg K, Spichiger E. 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 Nurs. 2018 Dec 12;17:54. doi: 10.1186/s12912-018-0323-x. eCollection 2018. PMID 30559603