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

NCT02713919 | Terminated DMC

• 1 other identifier: Multicenter PEINCA
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Pain Management

Keywords

Cancer; Outpatients; Family Caregivers

Outcome Measures

Primary Outcomes (1)

• Change in average and worst pain intensity

  Measurement of Change in pain intensity using a numeric rating scale, 0-10,with 0 = no pain, 10 = worst imaginable pain

  daily during weeks 0 - 6

Study Arms (2)

Intervention Group

EXPERIMENTAL

Adapted German PRO-SELF© Plus Pain Control Program

Behavioral: Adapted German PRO-SELF© Plus Pain Control Program

Control Group

NO INTERVENTION

No intervention

Interventions

Adapted German PRO-SELF© Plus Pain Control Program BEHAVIORAL

Two in-home visits (60 minutes) with at least weekly follow-up (visit or telephone call according to algorithm): Structured and tailored components; review of pain diary with participant, provision of information on pain medication, nurse coaching regarding pain self-management, detailed side-effect management plan, if distressing side-effects arise, re-evaluation together with participant at each subsequent visit.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• \- 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

You may not qualify if:

• 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).
• years of age or older
• being able to understand, speak and write German; and
• willingness to participate in all intervention sessions
• hearing impairment that precludes understanding telephone conversation

Sponsors & Collaborators

• Elisabeth Spichiger: lead
• University Hospital, Zürich: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator
• University Hospital, Basel, Switzerland: collaborator

Study Sites (3)

University Hospital Basel

Basel, 4031, Switzerland

Location

Inselspital Bern University Hospital

Bern, 3010, Switzerland

Location

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (2)

• Valenta 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 DERIVED

• Valenta 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 DERIVED

MeSH Terms

Conditions

Agnosia; Neoplasms

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elisabeth Spichiger, PhD

  University Basel, Medical Faculty, Institute of Nursing Science

  PRINCIPAL INVESTIGATOR

• Horst Rettke, PhD

  University Hospital Zurich, Center Clinical Nursing Science

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: March 21, 2016
• Study Start: April 22, 2016
• Primary Completion: December 20, 2018
• Study Completion: December 20, 2018
• Last Updated: March 5, 2019

Record last verified: 2019-03

Locations

CH (3)