Pain ManagementPEINCANCT02713919
Study to Test the Efficacy of the PRO-SELF® Plus Pain Control Program to Reduce Pain in Outpatients With Cancer
A study of Pain Management, run by Elisabeth Spichiger at 3 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 22 Apr 2016to 20 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
University Hospital Basel
Basel, 4031
Inselspital Bern University Hospital
Bern, 3010
University Hospital Zurich
Zurich, 8091
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain Management
- Being tested
- Adapted German PRO-SELF© Plus Pain Control Program
- Keywords
- Cancer, Outpatients, Family Caregivers
- Medical subject headings
- Agnosia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted German PRO-SELF© Plus Pain Control ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Adapted German PRO-SELF© Plus Pain Control Program Receives: Behavioral: Adapted German PRO-SELF© Plus Pain Control Program |
| Control Group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: daily during weeks 0 - 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study start22 Apr 2016
- Primary completion20 Dec 2018
- Study completion20 Dec 2018
Why it stopped: insufficient enrollment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elisabeth Spichiger
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Zürich, Insel Gruppe AG, University Hospital Bern, University Hospital, Basel, Switzerland
- Responsible party
- Sponsor-investigator, Elisabeth Spichiger, University Hospital, Basel, Switzerland
- Investigators
- Elisabeth Spichiger, PhD, Principal investigator, University Basel, Medical Faculty, Institute of Nursing ScienceHorst Rettke, PhD, Study director, University Hospital Zurich, Center Clinical Nursing Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713919
- Sponsor's protocol ID
- Multicenter PEINCA
- Acronym
- PEINCA
- Status last verified
- Mar 2019
- First submitted
- 8 Mar 2016
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35528799Valenta 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.
PubMed 30559603
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02713919
- Acronym / sponsor ID
- PEINCA / Multicenter PEINCA
- Conditions
- Pain Management
- Keywords
- Cancer, Outpatients, Family Caregivers
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient enrollment rate
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Elisabeth SpichigerUniversity, hospital or other
- Collaborators
- University Hospital, Zürich, Insel Gruppe AG, University Hospital Bern, University Hospital, Basel, Switzerland
- Study start
- 22 Apr 2016 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 21 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Adapted German PRO-SELF© Plus Pain Control ProgramAdapted German PRO-SELF© Plus Pain Control Program |
| Control Group | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted German PRO-SELF© Plus Pain Control ProgramTwo 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. | Behavioural | Intervention Group |
Primary outcome
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
Results and safety
The study was stopped early (reason given: insufficient enrollment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Derived from this study: PubMed 35528799Valenta 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.
- Derived from this study: PubMed 30559603Valenta 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.
Related trials for Pain Management
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
RecruitingPhase 3
A Study to Learn About Study Medicine Called Berobenatide in Adults With Knee Pain and Overweight or Obesity (VESPER-OA 1)
Obesity, Overweight
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Spichiger, PhD principal investigator
University Basel, Medical Faculty, Institute of Nursing Science
Horst Rettke, PhD study director
University Hospital Zurich, Center Clinical Nursing Science
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Pain Management, run by Elisabeth Spichiger at 3 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: insufficient enrollment rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in average and worst pain intensity (time frame: daily during weeks 0 - 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02713919, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.