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

March 4, 2019 updated by: Elisabeth Spichiger

Mixed Methods Study to Test the Efficacy of the Adapted German PRO-SELF® Plus Pain Control Program, an Intervention Directed at Outpatients With Cancer and Their Family Caregivers to Reduce Pain and Related Symptoms

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Background: Between 33% and 64% of cancer patients experience pain; however, despite effective treatment options, 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 of cancer pain, effects to date have been moderate. However, in a recent randomized controlled trial (RCT), Miaskowski's PRO-SELF© Pain Control Program (PCP) showed statistically and clinically significant pain reduction. This intervention was subsequently adapted for a second trial as PRO SELF© Plus PCP. The planned multi-center mixed methods study is based on this earlier work. In our previous pilot study, the PRO-SELF© Plus PCP was translated and adapted for a German speaking population. The feasibility of the intervention and study procedures was established and the intervention enhanced based on the pilot study's implications.

Purpose: This multi-center mixed methods study aims (1) to evaluate the efficacy of the adapted German PRO-SELF© Plus PCP, designed to improve outpatients' and their family caregivers' (FCs) management of pain on pain intensity; (2) to explore the intervention's effect on associated symptoms and other patient and FC outcomes; (3) to explore patients' and FCs' experiences with cancer pain management in both the intervention group and the usual care group; and (4) to interpret quantitative and qualitative findings and eventually synthesize them. To our knowledge, this will be the first evaluation of an intervention to support pain self-management in German speaking outpatients with cancer related pain and their FCs.

Methods: A nested concurrent mixed methods design will be used for this multi-center study, that is, an RCT will be combined with a qualitative substudy. Participants will complete a baseline evaluation, after which they will be randomly assigned to a 6-week intervention or usual care group. Blinding of data collectors is not feasible. Participants in both groups will complete a daily pain and symptom diary; other outcomes will be evaluated at 6 weeks post-randomization. The primary outcome of this study will be average and worst 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) of the German PRO-SELF© Plus PCP. Participants will receive weekly in-home or telephone visits. Data analysis will follow an intent-to-treat strategy and generalized mixed models will be used. Average per-patient costs for the intervention will be calculated. For the qualitative substudy, approximately 7-10 patients and FCs per group and site will be interviewed regarding their experiences with pain management and intervention. Interpretive description will be used, including stepwise, systematic and iterative processing of data, leading to a meaningful description and interpretation.

Significance: The planned RCT will test the efficacy of the adapted German PRO-SELF© Plus PCP, with findings from the qualitative substudy providing additional insights. Qualitative results will support the interpretation of quantitative results and vice versa. If efficacious in decreasing average and worst pain in patients with cancer by improving patients' and FCs' pain self-management, the adapted German PRO-SELF© Plus PCP could be adapted to and implemented in clinical practice. Specially trained oncology nurses in outpatient clinics and home care organizations could apply the intervention as needed.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • University Hospital Basel
      • Bern, Switzerland, 3010
        • Inselspital Bern University Hospital
      • Zurich, Switzerland, 8091
        • University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention Group
Adapted German PRO-SELF© Plus Pain Control Program
Behavioral: Adapted German PRO-SELF© Plus Pain Control Program
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.
NO_INTERVENTION: Control Group
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in average and worst pain intensity
Time Frame: daily during weeks 0 - 6
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elisabeth Spichiger

Collaborators

University Hospital Inselspital, Berne
University Hospital, Basel, Switzerland
University Hospital, Zürich

Investigators

  • Principal Investigator: Elisabeth Spichiger, PhD, University Basel, Medical Faculty, Institute of Nursing Science
  • Study Director: Horst Rettke, PhD, University Hospital Zurich, Center Clinical Nursing Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 22, 2016

Primary Completion (ACTUAL)

December 20, 2018

Study Completion (ACTUAL)

December 20, 2018

Study Registration Dates

First Submitted

March 8, 2016

First Submitted That Met QC Criteria

March 18, 2016

First Posted (ESTIMATE)

March 21, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 5, 2019

Last Update Submitted That Met QC Criteria

March 4, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Multicenter PEINCA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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