Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals
Phase: NA
Conditions: Other Cancer
Sponsor: Dana-Farber Cancer Institute

Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
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PROTOCOL TITLE: 
Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals  
 
PRINCIPAL INVESTIGATOR: 
Olga Ehrlich 
Phyllis F. Cantor Center for Research in Nursing and Patient Care 
617-582-7847 
olga_ehrlich@dfci.harvard.edu 
VERSION NUMBER: 
1.6 
DATE: 
2-9-22

Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
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Table of Contents 
1.0 
Abbreviations ............................................................................................................................................... 4 
2.0 
Figure 1-Theoretical Framework ................................................................................................................. 5 
3.0 
Objectives* .................................................................................................................................................. 6 
4.0 
Background* ................................................................................................................................................ 6 
4.1 The Prevalence and Problem of Pain ........................................................................................................ 6 
4.2 Cancer Pain Interventions Gaps ................................................................................................................ 6 
4.3 The Gap in Assessing and Managing Pain Clinically Using Cancer Pain Goals ..................................... 7 
4.4 Theoretical Framework and Preliminary Data .......................................................................................... 8 
4.5 Motivational Interviewing to Set Patient-Reported Functional Pain Goals ............................................. 8 
5.0 
Inclusion and Exclusion Criteria* ................................................................................................................ 9 
5.1 Screening Procedures: ............................................................................................................................... 9 
5.2 Sample Inclusion Criteria: ........................................................................................................................ 9 
5.3 Exclusion Criteria: .................................................................................................................................... 9 
5.4 Special populations: .................................................................................................................................. 9 
6.0 
Study-Wide Number of Subjects* ............................................................................................................... 9 
7.0 
Study Timelines* ......................................................................................................................................... 9 
7.1 Participant duration in study: .................................................................................................................... 9 
7.2 Estimated study completion time: ............................................................................................................. 9 
8.0 
Study Endpoints* ....................................................................................................................................... 10 
8.1 Data collection instruments: ................................................................................................................... 10 
To measure the study endpoints outlined in the specific aims, we will use the following instruments: ...... 10 
8.2 Measures: ................................................................................................................................................ 10 
9.0 
Procedures Involved*................................................................................................................................. 11 
9.1 Study design: ........................................................................................................................................... 12 
9.2 Study Procedures: ................................................................................................................................... 12 
9.3 Data to be collected:................................................................................................................................ 14 
9.4 Participant Registration:.......................................................................................................................... 14 
10.0 Data Banking* ........................................................................................................................................... 14 
10.1 Questionnaires....................................................................................................................................... 14 
10.2 Transcripts............................................................................................................................................. 15 
10.3 Accessing .............................................................................................................................................. 15 
11.0 Data Management* and Confidentiality .................................................................................................... 15 
11.1 Analysis: ............................................................................................................................................... 15 
11.2 Training: ................................................................................................................................................ 15 
12.0 Withdrawal of Subjects* ............................................................................................................................ 15 
12.1 Participant withdrawal: ......................................................................................................................... 15 
13.0 Potential Risks to Subjects* ....................................................................................................................... 15 
14.0 Potential Benefits to Subjects* .................................................................................................................. 16 
15.0 Vulnerable Populations* ............................................................................................................................ 16 

Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
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16.0 Sharing of Results with Subjects* ............................................................................................................. 16 
17.0 Setting ........................................................................................................................................................ 16 
18.0 Resources Available................................................................................................................................... 16 
18.1 Research team qualifications: ............................................................................................................... 16 
18.2 Facilities support: .................................................................................................................................. 17 
18.3 Capacity to recruit study sample: .......................................................................................................... 17 
19.0 Prior Approvals .......................................................................................................................................... 17 
20.0 Recruitment Methods ................................................................................................................................. 17 
20.1 Sample: ................................................................................................................................................. 17 
20.2 Eligibility determination: ...................................................................................................................... 17 
20.3 Recruitment methods: ........................................................................................................................... 17 
21.0 Local Number of Subjects ......................................................................................................................... 18 
21.1 Total sample .......................................................................................................................................... 18 
21.2 Sample size calculations: ...................................................................................................................... 18 
22.0 Provisions to Protect the Privacy Interests of Subjects .............................................................................. 18 
22.1 Steps to protect participant privacy: ..................................................................................................... 18 
22.2 Steps to increase sense of ease: ............................................................................................................. 18 
22.3 Identifying potential participants .......................................................................................................... 18 
23.0 Economic Burden to Subjects .................................................................................................................... 18 
24.0 Consent Process ......................................................................................................................................... 18 
24.1 Written and verbal: ............................................................................................................................... 18 
24.2 Waiting period: ..................................................................................................................................... 19 
24.3 Ongoing: ............................................................................................................................................... 19 
24.4 SOP ....................................................................................................................................................... 19 
25.0 Process to Document Consent in Writing .................................................................................................. 19 
26.0 References .................................................................................................................................................. 20 
27.0 Appendices:................................................................................................................................................ 22 
28.0 Appendix A: Eligible Participant Extraction Form ................................................................................... 23 
29.0 Appendix B: Demographic Questionnaire ................................................................................................. 24 
30.0 Appendix C: Pain Self-Efficacy Questionnaire ......................................................................................... 25 
31.0 Appendix D: Barriers Questionnaire II ...................................................................................................... 26 
32.0 Appendix E: Patient Experience Questionnaire ......................................................................................... 32 
33.0 Appendix F: Observed Engagement Table ................................................................................................ 33 
34.0 Appendix G: Intervention Goal Summary ................................................................................................. 34 
35.0 Appendix H: MISHCE ............................................................................................................................... 35 
 
 
 

Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
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1.0 
Abbreviations 
MI 
motivational interviewing 
IRB 
institutional review board 
PPG 
personal pain goal 
FPG 
functional pain goal 
BQII 
Barriers Questionnaire II 
PSEQ 
Pain Self-Efficacy Questionnaire 
MISHCE 
Motivational Interviewing Skills in Health Care Encounters  
PEQ 
Patient Experience Questionnaire  
OET 
Observed Engagement Table 
 
 
Study Schema 
 
  
 
 
 
 
 
 
 
 
 
DFCI Recruitment Sample: 
Patients referred to Ambulatory 
Palliative Care Program for pain 
consultation 
Recruitment & Data Collection 
 
Data Analysis 
 
Study Ends 
Month 1 – 9 
 
 
 
 
Month 11 – 12  
 
Month 12 

Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
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2.0 
Figure 1-Theoretical Framework 
 
Cancer Pain Social Processes Theoretical Framework (Ehrlich & Walker, 2018) 
 
 
 
 
 
 

Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
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3.0 
Objectives* 
Purpose: To evaluate the acceptability and feasibility of using a cognitive behavioral intervention called 
motivational interviewing (MI) to help persons with pain from cancer set goals for managing their pain and 
improving pain control. Using MI, in our study the researcher will guide patients in goals-focused discussion of 
their cancer pain. At this time, there are no tested methods that clinicians can use for helping patients set these 
kinds of functional cancer pain goals (FPGs), despite the importance goal-setting in planning and managing 
healthcare behavior interventions. The study aims are: 
Aim one: Evaluate the feasibility of motivational interviewing with regard to a) completion rate of a baseline 
and at least one follow-up study visit; b) the number of completed sessions; and c) patient acceptability of 
nurse-led motivational interviewing to set FPGs in the ambulatory palliative care setting. 
Aim two: Explore relationships between patient-reported pain self-efficacy, attitudinal barriers to pain, and 
observed engagement in a motivational interviewing intervention focused on FPGs. 
4.0 
Background* 
4.1 The Prevalence and Problem of Pain  
Despite decades of research about cancer pain treatment, patients with advanced cancers have rates as high as 
64% of moderate-to-severe pain (van den Beuken-van Everdingen, 2016).1 In a 1998 seminal study, Turk et al. 
found that for persons with cancer pain, greater levels of anxiety were significantly correlated with lower levels 
of activity.2 Although the fear of cancer pain is referenced in research papers making the case for improved pain 
control,3,4,5 only one study has measured its prevalence.6 LeMay et al. in a descriptive cross-sectional study 
measured fear of cancer pain prevalence and reported that patients with advanced cancers feared pain. Patient-
reported fear of pain and pain severity were both significantly correlated with reduced self-reported functional 
capacity (B 0.19 p<.001, B 2.68 p<.001, respectively).6 Yet, it is unknown if fear contributes to worse pain, or if 
having had pain generates fear of pain. Attitudinal barriers patients reported, such as fear of addiction to 
opioids, also have been identified and positively correlated with pain severity ratings.7,8 An intervention which 
reduced patient barriers and increased patient feelings of power to control pain led to greater functional 
capacity.9 In a review of 74 longitudinal cancer pain intervention studies, Sauzet et al. reported the problematic 
finding that a lack of statistical outcomes reporting prevented definitive conclusions between interventions and 
sustained effects from being made.10 In our grounded theory study exploring social processes related to end-
stage cancer pain management, when talking about times of good pain control respondents spoke of the 
importance of functional capacity by describing their activities.11 We ascribed this activity talk to the social 
processes concept of ‘goals’, one of six fundamental pain management components. However, these 
participants who alluded to functional pain goals through indirect talk were not discussing or setting functional 
pain goals (FPGs) during routine pain management visits.11 While goal-setting may seem like a logical step in a 
symptom management intervention, studies about goal-setting for managing pain have been limited to setting 
personal pain goals (PPGs), the numeric rating at which pain is considered tolerable,12,13 and have not resulted 
in significant patient-reported pain reductions13 or have not tested the effect of setting goals as an element of 
intervention.14 To date, there are no clear guidelines about how or when to assess cancer pain goals, and 
whether establishing patient-reported functional pain goals can contribute to reduction of moderate-to-severe 
pain. More research is needed to understand how patients’ FPGs can be assessed, discussed, and implemented 
in managing cancer pain. 
4.2 Cancer Pain Interventions Gaps  
Societal guidelines exist for cancer pain treatment, including acute, chronic, and breakthrough types,15,16 and 
researchers have identified barriers at the patient, caregiver, and clinician levels. Several systematic reviews of 
the literature on educational interventions for cancer pain self-management have concluded that across studies, 

Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
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generalizations about which types of interventions are effective cannot be made due to heterogeneity of 
interventions and mixed results reported within types of interventions delivered.17,18,19 For the most recent of 
these reviews, in 31% of the 26 randomized control trials (RCTs) included (dating from 1995 to 2017), authors 
reported significant differences in pain reduction for intervention and control groups in studies using combined 
video or written materials with in-person coaching.19 All but one of the included studies also measured and 
reported improved pain knowledge or barriers. However, because of the overall heterogeneity of interventions 
and outcomes measures, unclear reporting of study methods, and variations in intervention timing, the review 
authors were unable to make recommendations for effective cancer pain educational interventions.19 Another 
under-reported outcome in the review was testing of patient self-efficacy.19 Two cited studies reported on self-
efficacy.18,20 Kravitz et al. studied general patient self-efficacy.20 Koller et al. used a nurse coaching 
intervention to increase knowledge and reduce pain intensity with significant positive changes in pain 
knowledge but no significant reductions in patient reported pain intensity or increases in patient pain self-
efficacy.18 In a literature review about motivational interviewing (MI), Jensen et al. reported that MI was 
effective for increasing self-care efficacy, and self-efficacy had been correlated with long-term pain coping, 
severity, and interference outcomes.21  
 
Cancer pain can be acute, chronic, and breaking through at unexpected times, so early adaptive pain coping 
could be crucial for preventing pain crises and hospitalizations, as well as anxiety and distress over the course 
of the cancer illness trajectory. Vallerand et al. conducted an RCT of 317 African American patients with recent 
cancer pain ratings equal to or greater than 4/10, with 34% of the control group and 26% the intervention group 
having metastasized cancers.9 They reported that for participants in the Power Over Pain intervention group, 
perceived control over pain was significantly correlated with increased function (p=0.121) and decreased 
distress (p=-0.09).9 Wang et al. provided a telephone intervention to 137 patients with severe cancer pain (≥6 of 
10) compared to 137 patients in a control group receiving usual care.22 While there were significant reductions 
in self-reported pain severity over the 12-month study period, the reductions were associated with patients who 
reported lower initial pain scores, were of higher socio-economic status, lower co-morbid burden, and 
concurrently reported reduced levels of depression.22 Vancleef & Peters studied relationships in 79 healthy 
volunteers who were randomly assigned to perceived pain control and self-efficacy groups and exposed to 
painful stimuli. They found significantly lower anticipated and actual pain intensity reporting in the high self-
efficacy group, and nonsignificant but improved anticipated and actual pain intensity in the perceived control 
group.23 Although the exact mechanisms which modulate self-efficacy and related symptoms have not been 
identified, interventions to increase patient self-efficacy in managing cancer pain have been studied.23 Kelleher 
et al. reported that in a descriptive study of patient reported outcomes in cancer (n=178 breast and GI cancer 
patients), there were significant correlations between pain self-efficacy and intensity scores (-.31, p<.001) and 
pain self-efficacy and functioning (-.29, p<.001).24  
4.3 The Gap in Assessing and Managing Pain Clinically Using Cancer Pain Goals 
Notable gaps in clinical practice research for cancer pain management exist for the processes of assessing and 
setting goals. Few studies have reported on use and testing of patient pain goals. Several recent studies assessed 
the feasibility of clinicians asking for and documenting use of personal pain goals (PPGs), where patients are 
asked to report a number between zero and ten at which their pain is tolerable. Fainsinger et al. conducted a 
descriptive longitudinal research study of 300 patients with cancer pain to compare stabilized-pain outcomes 
from PPGs with those from the Edmonton Classification System for Cancer Pain (ECS-CP) definition.12 They 
found no significant differences in sensitivity and specificity of the two measures, except that for persons rating 
their initial pain as severe, the PPG, or patient reported goal, was more sensitive for detecting stabilized-pain 
later in the study than the ECS-CP.12 No research studies have implemented this recent finding that points to the 
potential utility of this patient-reported outcome variable, the PPG. However, Zylla et al. conducted an 
institution-wide quality improvement initiative to determine feasibility and practice change in clinician 
assessment of PPGs.13 The investigators reviewed approximately 3,000 pain values from electronic health 

Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
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records each month over the 12-month program implementation period. Although there was a 71% increase (ᵡ2 
p < .001) in clinician use of PPGs in conjunction with clinician and patient educational interventions, there were 
no decreases in reported pain for patients with moderate-to-severe rates (data not provided).13 Koller et al. 
included open-ended goal-setting in their RCT intervention study but did not test for statistical effects of this 
element of the intervention.14 Because cancer patients describe good pain days as those when they can function 
with as much normalcy as possible,11 and functionality is associated with reduced anxiety,2 less fear of pain,6 
and feelings of empowerment,9 research which explicitly solicits FPGs from patients during clinical pain 
management encounters is warranted. Accordingly, our study will test feasibility of using MI as a nurse-led 
intervention for patient-reported cancer pain goal-setting. 
4.4 Theoretical Framework and Preliminary Data  
This study approaches the problem of cancer pain from a social processes theoretical framework illustrated in 
Figure 1,11 as well as Prochaska and DiClemente’s transtheoretical model of change that was developed for use 
in psychotherapy.25 The cancer pain social processes theoretical framework identified behaviors and thought 
processes that were used by patients, family caregivers, and nurses in daily pain management in the home. 
These included pain goals, efficacy, perception, physical-emotional distance, communication, and agreement.11 
Social processes underpinned cancer pain management behaviors in complex ways. By viewing these processes 
in a context of multiple pain management collaborators (patients, caregivers, and nurses), clinicians and 
researchers can pinpoint areas of need. A lack of communication about personal and functional pain goals was 
evident between patients and caregivers, and patients and nurses in the participants of the grounded theory 
research study from which the framework was constructed.11 In the study proposed here, we will specifically 
target setting of patient reported cancer pain goals by focused communication between a nurse and patient that 
uses motivational interviewing.  
4.5 Motivational Interviewing to Set Patient-Reported Functional Pain Goals 
MI is a cognitive behavioral approach that promotes coping by guiding patients to assess their circumstances 
and choose interventions specific to their needs and values. Working with patients to increase feelings of 
control is inherent to MI. MI has been used in both brief and extended clinical healthcare settings.26 Two cancer 
pain studies have included MI as an element of a comprehensive intervention. Thomas et al. studied the effect 
of an MI-based telephone coaching intervention by a clinical nurse specialist as part of an RCT to help 318 
patients manage their cancer-related pain.27 Significant findings were increased function and improved mental 
and overall health in the intervention group, with no significant changes in pain intensity or attitudes over 12 
weeks.27 Coolbrandt et al. used MI as one component of an early overall symptom management intervention for 
143 cancer patients beginning chemotherapy, randomized to intervention and control groups.28 The 
interventions included use of MI and tailored nurse coaching in an initial inpatient session followed by a nurse 
phone session between two and four weeks later. They found that participants in the intervention group had 
significantly higher overall symptom self-efficacy scores at six weeks post-intervention than the control group 
(M 74, M 69, p.02 respectively).28 To date, studies measuring the effect of MI on patient reported perceived 
control over cancer pain and pain self-efficacy have not been conducted. Nor have feasibility or patient 
acceptability of MI for cancer pain management been studied. However, feasibility studies have been conducted 
in other healthcare populations. For example, MI feasibility and fidelity were demonstrated in an RCT where 
trained community health workers delivered a brief culturally-tailored MI intervention to increase breast cancer 
screening rates for African American women visiting emergency departments.29  
 
Applying MI techniques for patients with cancer pain approaches the complex relationships underlying self-
efficacy and perception of pain intensity, along with functional capacity by acknowledging the complicated 
nature of psychosocial and environmental issues. For example, we used constructivist grounded theory methods 
to generate the hospice caring triad cancer pain social processes framework, from which we identified social 

Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
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processes and their breakdowns in nursing pain management with patients and family caregivers.11 Differences 
were reported in perception of pain control, communication about pain goals was lacking, and differences in 
physical-emotional distance occurred within groups of patients, caregivers, and nurses managing cancer pain at 
the end of life. Our theoretical framework (see Figure 1) provided an evidence-based outline of potential 
problem areas that researchers can use in developing interventions for improving pain outcomes when usual 
evidence-based practices do not seem to be effective in clinical contexts. The key problem identified in our 
study was the lack of communication with patients about any pain goals in developing plans for managing 
pain.11 
5.0 
Inclusion and Exclusion Criteria* 
5.1 Screening Procedures:  
The PI or another member of the research team will view the ambulatory palliative care consult schedule 
weekly to identify eligible patient participants. The PI will then contact the scheduled provider to inform that 
the patient is eligible and to request permission to approach the patient in clinic after the scheduled consultation 
visit.  
5.2 Sample Inclusion Criteria:  
• At least 18-years of age 
• Has an appointment with DFCI ambulatory palliative care service for cancer-related pain  
• Can speak English  
5.3 Exclusion Criteria: 
• Diagnosis of delirium or other cognitive impairment 
5.4 Special populations:  
• None 
6.0 
Study-Wide Number of Subjects* 
 
• We anticipate an overall study sample of 54 participants.  
 
7.0 
Study Timelines* 
7.1 Participant duration in study:  
Each participant will be enrolled in the study for the time it takes to return for their four scheduled intervention 
sessions, as long as those visits end by the time data collection closes, at the end of study month 10 (August 
2019). The exact duration for each participant will be dependent on their clinic schedules with which the MI 
study intervention sessions will be aligned, as well as how many of the four MI intervention sessions individual 
participants complete. An example of brief participation is a participant who completes the initial session and 
returns for a second and final session one week later. An example of full participation is a participant who 
completes the initial session and returns for a total of four sessions prior to the study ending. Please see the 
study schema for a graphic depiction of the study timeline.  
7.2 Estimated study completion time:  
We anticipate that this research study will be ongoing for one year. Recruitment will occur over nine months. 
Data collection will begin at the time of recruitment and end when the last participant recruited in that period 
has completed up to four intervention sessions. Data analysis will take approximately two months. Complete 
analysis and processing of results is anticipated to conclude twelve months after the first day of recruitment.  

Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
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8.0 
Study Endpoints* 
 
8.1 Data collection instruments:  
To measure the study endpoints outlined in the specific aims, we will use the following 
instruments: 
 
8.2 Measures:  
8.21 Intervention feasibility (Aim one): Feasibility and total intervention usage rates will be calculated by 
extracting number of visits per participant from the research study registration spreadsheet. Intervention 
feasibility will be assessed by calculating the proportion of enrolled participants completing at least one follow-
up MI session (at least two sessions total). The proportion of patients completing at least one follow-up 
intervention session will be estimated along with an exact 90% confidence interval.  The MI intervention will be 
considered feasible if a 60% follow-up completion rate can be reached. With 54 participants, at least 26 (41%, 
90% CI 36-60%) need to complete a follow-up interview to ensure that the upper bound of the exact 90% 
confidence interval contains 60%. Feasibility will be met for all participants completing at least two MI 
intervention sessions. The total intervention usage rate for each participant will be described by the number of 
interventions sessions attended divided by the total possible number of interventions sessions reported as the 
sample mean; the usage rate will be described (mean/std, median/range)..  
Intervention Feasibility 
(Aim 1) 
Rate of participants completing at least two MI 
intervention sessions; study spreadsheet 
Participant Total 
Intervention Usage 
(Aim1) 
Rate of completed interventions out of four 
possible; study spreadsheet 
Patient Intervention 
Acceptability 
(Aim 1) 
Patient Experience Questionnaire (investigator-
developed) 
Attitudinal Barriers 
(Aim 2) 
Barriers Questionnaire II (Ward & Gunnarsdottir, 
2002) 
Pain Self-Efficacy 
(Aim 2) 
Pain Self-Efficacy Questionnaire (Nicholas, 1989) 
MI Patient 
Engagement in Goals-
Setting (Aim 2) 
Observed Engagement Table (investigator-
developed) 
MI Fidelity  
Motivational Interviewing Skills in Health Care 
Encounters (Petrova et al., 2015) 

Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
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8.22 Participant intervention acceptability (Aim one): The Patient Experience Questionnaire (PEQ), developed 
by the investigator, will be used to summarize overall patient-reported acceptability in this study. Summary 
measures of median/range and mean/SD for total categorical PEQ scores, the time in weeks from the initial to 
follow-up intervention visit, and the number of completed intervention sessions will be reported. 
 
8.23 Participant pain barriers (Aim two): Attitudinal barriers to pain management will be measured using the 
BQ-II which measures four attitudinal realms with 27 self-rated questions about pain beliefs. The BQ-II has 
been used in cancer pain studies with psychometrics demonstrating validity and reliability. For cancer patients, 
internal consistency of 0.89 (mean 1.52, SD 0.73) was reported and higher barriers were significantly correlated 
with increased age (r=0.18, P=0.02).30 The total score for the BQ-II and PSEQ will be calculated at study entry 
and after the first follow-up visit and scores will be summarized (median/range, mean/SD). The paired 
difference in PSEQ and BQII will be estimated along with a 90% confidence interval. If additional sessions are 
completed, the scores for PSEQ and BQII will be plotted over time and trends will be explored with graphical 
methods. Spearman’s correlation between the PSEQ and BQII will be estimated along with a 90% confidence 
interval at each measured time point.  
 
8.24 Participant self-efficacy (Aim two): The study team will look at the correlation among the measures being 
explored, described herein: Pain self-efficacy will be measured using the PSEQ. In patients with a history of 
chronic pain and mean pain level rated at 6.2 out of 10, PSEQ demonstrated excellent internal consistency with 
an alpha of 0.92 and a test-retest reliability from baseline to three months of r=0.73, P<0.001.31 The total score 
for the BQ-II and PSEQ will be calculated at study entry and after the first follow-up visit and scores will be 
summarized (median/range, mean/SD). The paired difference in PSEQ and BQII will be estimated along with a 
90% confidence interval. If additional sessions are completed, the scores for PSEQ and BQII will be 
plotted over time and trends will be explored with graphical methods. Spearman’s correlation between the 
PSEQ and BQII will be estimated along with a 90% confidence interval at each measured time point.  
 
8.25 Participant engagement in goal-setting (Aim two): Observed Engagement will be evaluated using the 
instrument developed by the investigator for this study in which behaviors indicative of active goal setting will 
be tabulated by the PI or RA. Observed engagement will be summarized categorically, and salient quotes will 
be extracted into the OET to give voice to participant experiences in study results dissemination.  
8.25.1 The study team will look at the correlation among the measures being explored, specifically, pain 
barriers (BQII) and self-efficacy (PSEQ). The paired difference in BQII and PSEQ scores from sessions 
one and four will be estimated, along with a 90% confidence interval. If additional sessions are 
completed, the scores for BQII and PSEQ will be plotted over time and trends will be explored with 
graphical methods. Spearman’s correlation between BQII and PSEQ will be estimated along with a 90% 
confidence interval at each measured time point.  
 
8.26 MI intervention fidelity: Fidelity to MI methods will be assessed on 33% of interviews using the MISHCE 
which was developed specifically to measure fidelity in brief healthcare encounters. MISCHE evaluates the 
degree to which the person providing the MI session follows five domains key to MI. The domains are: 1) MI 
philosophy, 2) health interviewing, 3) motivation, 4) MI principles, and 5) interpersonal process. Each domain 
has specific behaviors that are rated as 1) deficient, 2) developing, 3) accomplished, or 4) N/A. MISHCE 
demonstrated acceptable internal consistency (0.75, CI 95%), good inter-rater reliability (15 of 22 intraclass 
correlation coefficients were excellent, 5 were good, 1 was fair and 1 was poor), and good-to-excellent test-
retest reliability.32 Fidelity assessment will be conducted by the PI or RA.  
9.0 
Procedures Involved* 

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9.1 Study design:  
This is a single-arm pilot study to assess feasibility and acceptability of a motivational interviewing intervention 
which will entail two-to-four intervention sessions per participant, participant completion of a battery of 
questionnaires specific to the intervention session, an investigator-led MI intervention at each session, and 
summary statistics (described below).  
9.2 Study Procedures:  
After written informed consent has been obtained and verbal consent confirmed participation in this study will 
involve between two and four intervention sessions.  
 
9.21 Study Participation Compensation: Participants will be compensated with $25 gift cards at the first and last 
visits (anticipated to be visits 1 and 4). Pending receipt of additional funding for participant compensation, 
participants may also be compensated at visits 2 and 3, if these are in addition to the first and last visits, and if 
this funding is granted to the research study.  
 
9.22 Intervention Sessions: Each intervention session will include a battery of questionnaires, an MI 
intervention, and the investigator completing a goal(s) summary for the participant to take away. Participants 
may opt to complete Intervention Sessions 2, 3, and 4 in person on the DFCI campus or via telephone (or a 
mix). Session-specific content is outlined below. Session-specific content outlined below. 
 
 
 

Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
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Session 1:  
Questionnaires: 
Demographics survey* 
Pain location diagram (paper and pencil) 
BQ-II* 
PSEQ* 
MI Intervention  
Investigator-led discussion (described below) 
Goals 
Summary 
Completed by investigator 
Gift Card ($25) 
Disbursed 
* Paper and pencil form or tablet computer per participant preference.  
Sessions 2 & 3:  
Questionnaires: 
BQ-II* 
PSEQ* 
MI Intervention  
Investigator-led discussion (described below) 
Goals 
Summary 
Completed by investigator 
Gift Card ($25) 
None (Pending additional funding) 
* Paper and pencil form or tablet computer per participant preference.  
 
        Session 4:  
 
Questionnaires: 
BQ-II* 
PSEQ* 
PEQ* 
MI Intervention  
Investigator-led discussion (described below) 
Goals 
Summary 
Completed by investigator 
Gift Card ($25) 
Disbursed 
* Paper and pencil form or tablet computer per participant preference.  
 
 
 

Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
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Motivational Interviewing Sessions: 
Motivational Interviewing 
Intervention: 
An investigator-led discussion 
about the participant’s pain 
experience which is focused on the 
participant reporting of functional 
pain goals (FPGs). The 
investigator will elicit questions and 
goals that participants will be 
encouraged to discuss with their 
palliative care providers. 
 
Key elements of intervention: 
• Establish rapport 
• Open and closed questions 
• Reflecting 
• Gaging ambivalence 
• Permission to give 
information 
• Pain-related problems 
• Feelings related to pain 
meaning 
• Perceptions about what will 
happen with the pain 
• Desired pain management 
outcomes (FPGs) 
• Pain management 
interventions acceptable to 
participant 
 9.3 Data to be collected:  
Source data will be collected in the battery of questionnaires described above. All source data questionnaires are 
included at the end of this protocol. These source data documents and records, except for the IRB-approved 
written informed consent document will be labeled with numeric identifiers only to protect participants 
confidentiality. All paper versions will be filed in a secure locked filing cabinet in the PI’s office at the Cantor 
Center, accessible to research study team members. All digital data source records will be retained in REDCap 
(demographics, BQ-II, PSEQ, PEQ) or in study spreadsheets in the Cantor Center shared drive protected by 
Partners IS, or on the encrypted laptop computer of the PI.  
9.4 Participant Registration:  
Institutions will register eligible participants in the Clinical Trials Management System (CTMS) OnCore as 
required by DF/HCC SOP REGIST-101. 
 
10.0 Data Banking* 
10.1 Questionnaires 
Survey data from the questionnaires, including demographics, BQ-II, PSEQ, and OET, and MI intervention 
session audio-recordings will be stored in the Cantor Center shared drive protected by Partners IS, or on the 
encrypted laptop computer of the PI for the IRB-required time frame.  

Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
15 
 
10.2 Transcripts 
De-identified transcripts from the MI intervention sessions will be banked by the Cantor Center for future 
research purposes such as qualitative data analysis. These files will be stored securely in the Cantor Center 
shared drive protected by Partners IS.  
10.3 Accessing 
Researchers, including investigators from collaborating institutions, can request de-identified data from this 
study for new research. Data may also be shared with outside non-profit academic investigators. Researchers 
may request access by making a request in writing to the PI and submitting appropriate IRB approval processes.  
 
11.0 Data Management* and Confidentiality 
11.1 Analysis:  
Statistical data analysis will be conducted by the research team statistician. Testing procedures were outlined in 
section 8.2, above.  
 
MI intervention fidelity testing will be conducted on 33% of the audio-recorded sessions, by the PI or RA, as 
described above. The number of sessions to be reviewed assuming a total sample of 54 participants, seen for 
two interventions at least (108 x .33) will be 37, and will be conducted on a bi-weekly schedule. 
11.2 Training:  
The study will be reviewed and approved by the Dana Farber Cancer Institute IRB. The PI and study staff will 
have completed the Collaborative Institutional Training Initiative Human Subjects Training Program and all 
other training required by DFCI. In addition, the PI and study staff will also practice the informed consent 
process with the RA(s). Before beginning the research study, the PI will obtain written and dated approval from 
the IRB for the study protocol, written informed consent form, EMR abstraction forms, subject recruitment 
procedures, and any written information to be provided to subjects. Any future protocol amendments or consent 
form updates must also be approved by the IRB. 
 
The PI will provide education to the research team members about participant eligibility identification, 
recruitment, and consenting training, participant entry into the study data spreadsheet, and use of the MISCHE 
for fidelity evaluation.  
 
12.0 Withdrawal of Subjects* 
12.1 Participant withdrawal:  
Unless the patient’s clinician states that the study is no longer in their best interest, there are no anticipated 
circumstances in which a patient will be withdrawn from the research without their consent. If a patient requests 
to be removed from the research study, we will document their reason for dropping out of the study and update 
their status in OnCore. 
 
13.0 Potential Risks to Subjects* 
There are no physical risks to taking part in this research. The risks related to this study include a risk for loss of 
privacy and also the risk that some items on the questionnaires might cause feelings of unease or distress. If 
talking about their cancer pain experience is upsetting, the researcher will arrange a visit with a medical social 
worker, or provider in the clinic. There is a possibility that participants could experience physical pain from 
their cancer during the interventions sessions. The PI is a board-certified hospice and palliative care nurse with 

Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
16 
 
experience assessing and providing nursing interventions for discomforting symptoms. She will intermittently 
ask participants if they are experiencing discomforting pain. If so, they will be prompted to follow their 
medication orders and asked if they would like to reschedule the intervention appointment. The nature of risks 
to subjects is low, and the anticipated risks are likely to be reversible within minutes-to-hours.  
 
14.0 Potential Benefits to Subjects* 
Participants in this research study may experience improved pain control, less discomfort from pain, or an 
enhanced sense of empowerment about managing their pain. Participants may set functional pain goals which 
could help them discuss their pain management plans with providers and family caregivers.   
 
15.0 Vulnerable Populations* 
• No vulnerable populations will be recruited.  
 
16.0 Sharing of Results with Subjects* 
Sharing overall study results with participants is not planned, however the nature of MI discussions involves 
recapping what has been said to clarify key points in the talking interventions. Participants will be provided 
with the opportunity to learn about their individual barriers and self-efficacy scores. We plan to disseminate 
results of this study in a peer-reviewed journal and at a professional conference.   
 
17.0 Setting 
Participant recruitment will take place in the ambulatory clinics where eligible patients are being seen for their 
scheduled palliative care consultations at DFCI. In-person study intervention visits will take place in private 
areas in the ambulatory clinics, consultation rooms, or meeting rooms on the DFCI campus. For participants 
who opt to have sessions 2, 3, or 4 via telephone, questionnaires will be given in person at session 1 or mailed 
to them in an unmarked envelope. The investigator will read the questionnaire aloud over the telephone as the 
participant reads their copy and the investigator will write their responses on the paper forms to be recorded in 
the Redcap database. Participant permission to audio record the intervention sessions will be obtained prior to 
beginning the motivational interviewing intervention each time. The intervention session(s) will be recorded via 
the telephone using the same recording equipment that is utilized for in-person intervention session interviews. 
 
 
18.0 Resources Available 
18.1 Research team qualifications:  
The study overall PI, Dr. Olga Ehrlich, is a post-doctoral fellow at the Phyllis F. Cantor Center for Research in 
Nursing and Patient Care whose full-time role is dedicated to research training. Dr. Ehrlich has conducted two 
prior research studies with patients experiencing pain from cancer, both in the home hospice setting. In those 
studies, she collaborated with healthcare agency administrators and clinicians to identify and recruit patients, 
nurses, and family caregivers, administered demographics surveys, and conducted extended audio-recorded 
private interviews with all participants to collect data. She has conducted analysis of qualitative data resulting in 
publication and presentation at professional conferences. As an experienced and board-certified hospice and 
palliative care clinician, with training in MI, she is qualified to conduct the MI intervention which will be tested 
for feasibility in this study, with a sample of participants experiencing pain from cancer. Dr. Ehrlich has the 
clinical knowledge and experience to assess and intervene if study participants experience physical or emotional 
discomfort during study interventions sessions. Additionally, she has completed applied biostatistics training 
through the Harvard Catalyst program and is collaborating with Cantor Center biostatistician, Traci Blonquist, 
MS, for statistical testing in this study. Dr. Donna Berry, nurse scientist in the Cantor Center, and Dr. Ehrlich’s 
mentor, is Co-Investigator for this study.  

Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
17 
 
18.2 Facilities support:  
Study staff will conduct administrative and operations procedures at the Cantor Center. Resources available 
through the Center include study managers, research assistants, secure private offices, computers and software, 
secure locked storage for print data, and encrypted digital storage for study computer files, including REDCap. 
Cantor Center research staff have practical and ethical knowledge and training in the DFCI conduct surrounding 
research.  
18.3 Capacity to recruit study sample:  
The study sample will include patients at least 18-years old with any type of cancer who have been referred to 
the Dana-Farber Cancer Institute adult ambulatory palliative care service for cancer-related pain. 
Approximately 63 new patients are seen by the palliative care service per month, and it is estimated that 37 will 
require follow-up visits within the study-required time period of 1-4 weeks for a return visit. Assuming a 50% 
consent rate, it is estimated that approximately 18 participants per month will be accrued over a three-month 
recruitment period for a total sample size of 54 participants, if all eligible participants can be approached on the 
first scheduled day. To accommodate the likelihood of cancelled or rescheduled appointments, or participants 
with appointments scheduled for the same times, we will extend our recruitment period for up to nine months.  
With 54 participants, the exact 90% confidence interval for the proportion of participants completing at least 
one follow-up MI session will be not wider than +/- 11.9%.   
 
19.0 Prior Approvals 
• The PI has obtained approval intent to collaborate from Dr. Douglas Brandoff, and Daniel Gorman,  
NP-C, of the DFCI Palliative Care Service.  
• The PI has applied for, and has received, external funding for this research study.  
 
20.0 Recruitment Methods 
20.1 Sample:  
Patients who have been referred to the DFCI Palliative Care Service ambulatory program for a pain consultation 
will be considered for participation in the study.  
20.2 Eligibility determination:  
The PI or RA will use the eligibility check list which is part of the written informed consent document to 
determine eligibility when scanning the EPIC schedule for potential participants 
20.3 Recruitment methods:  
During the 3-month long recruitment and enrollment period, the PI and a RA will scan the Palliative Care 
Service ambulatory clinic visit schedule in EPIC, at least weekly to identify study-eligible patients. The 
Palliative Care Service provider who has been scheduled to see the eligible patient(s) will be contacted by the PI 
or RA via Partners secure email to inform them of patient eligibility and to discuss approaching patients for the 
study. Unless the provider(s) indicate that approaching an eligible patient would be inappropriate, the PI or RA 
will approach the eligible patient in the clinic site after their scheduled visit to describe the study and obtain 
informed consent, or to schedule another time to do so. To facilitate recruitment, Palliative Care team providers 
will be prompted to introduce the study to patients when possible.  A brief introduction script will be included 
on the Clinician Prompt Sheet (attached) that a study team member will fill out  for each approved participant. 
This sheet will be attached to the regular visit front sheet by clinical support employees the day prior to each 
planned approach.  
 

Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
18 
 
21.0 Local Number of Subjects 
21.1 Total sample 
• We anticipate a total sample size of 54 participants. 
21.2 Sample size calculations:  
Assuming a 50% consent rate of the 63 patients seen by the palliative care service per month, it is estimated that 
approximately 18 participants per month will be accrued over a three-month recruitment period for a total 
sample size of 54 participants. With 54 participants, the exact 90% confidence interval for the proportion of 
participants completing at least one follow-up MI session will be not wider than +/- 11.9%.  
 
22.0 Provisions to Protect the Privacy Interests of Subjects 
22.1 Steps to protect participant privacy:  
To minimize risks to privacy, all written study materials will be labelled with participant ID numbers instead of 
patient names. Only IRB-approved individuals will have access to the reference list. Data collection forms will 
be stored in a locked cabinet at the Cantor Center and will be de-identified prior to manual data entry into an 
Excel spreadsheet located on the Cantor Center Shared Drive. Questionnaire data will be collected in the study 
REDCap account, monitored by Partners IS. REDCap data will be de-identified and transferred for data analysis 
into Excel study data spread sheets. The research team is permitted to access the patients’ EHR to obtain 
information about their clinicians’ documentation of pain assessment and management (e.g., treatments 
prescribed). MI intervention sessions audio-recordings will be scrubbed of any identifying information (e.g. 
person’s names, place names, institutions) by the PI or RA prior to audio-recordings being sent for 
transcription. Original audio-recordings will be maintained on the encrypted computer of the PI and/or in the 
Cantor Center Shared Drive for the time specified by the IRB.  
22.2 Steps to increase sense of ease:  
At the start of each MI intervention session, participants will be instructed that they do not have to answer 
questions which make them uncomfortable and they need not explain why they choose not to answer. They will 
also be informed that should they feel a sense of unease related to intrusiveness of questions, the PI is willing to 
discuss these feelings with them and make a referral to another appropriate professional, or to the IRB contact. 
22.3 Identifying potential participants 
The PI or RA will have access to the EHRs of potential patients through EPIC and will use the scheduling 
function to identify potentially eligible patients referred to Palliative Care. 
 
23.0 Economic Burden to Subjects 
Participation in this study will not involve added economic burden. There are no costs for study participation. 
  
24.0 Consent Process 
24.1 Written and verbal:  
Written and ongoing verbal informed consent will be obtained. Written informed consent will be obtained in a 
private space at the DFCI clinic where eligible patients are being seen by their provider. To obtain written 
informed consent, the PI or RA will explain what participation in the study entails (number of visits and 
completion of questionnaires, MI intervention sessions), possible risks and benefits of participation, anticipated 
time participation will last, privacy protections to be undertaken, as well as the option to not participate, per the 

Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
19 
 
approved DFCI OHRS written informed consent document (draft attached). The person obtaining consent will 
ask if there are questions and will answer any questions. The eligible patient will then be asked if they would 
like to participate, and if so will sign the IRB-approved consent document, witnessed and signed by the 
consenter. If eligible patients would like time to consider participation and are not ready to sign, they will be 
asked how they would like to follow-up. They may provide contact information and request follow-up contact 
from the study team, or they may request contact information for the PI and follow-up as they wish.  
 
When the investigator meets with enrolled study participants for their first intervention session, she will inform 
them of a new option, approved by the IRB since they provided written consent. This option is for participants 
to complete intervention sessions 2, 3, and 4 via the phone in person or a mix of these. Each participant will be 
asked to state their preferences for in-person or telephone interventions. These preferences, reported verbally, 
will be recorded in the study participant enrollment log. 
24.2 Waiting period:  
There will not be a required waiting period between obtaining written consent and participants beginning the 
first study intervention session. However, participants who have given written consent will be informed that 
they may start the first study session at their next scheduled visit time, or another time that is convenient for 
them to visit DFCI. 
24.3 Ongoing:  
Verbal consent will be obtained by the PI at the beginning of each session and any time during the interventions 
sessions that participants appear uncomfortable or express distress. This verbal consent will involve asking a 
question like, “Are you comfortable continuing your participation in this study?” 
24.4 SOP 
This study will follow “SOP: Informed Consent Process (CON-100).” 
 
25.0 Process to Document Consent in Writing 
The PI or RA will follow “SOP: Informed Consent Process (CON-100)” when creating the informed consent 
document and using it to obtain written consent. The written consent document is attached at the end of this 
protocol (not yet approved by IRB).  
 
 

Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
20 
 
 
26.0 References 
1. van den Beuken-van Everdingen MH, Hochstenbach LM, Joosten EA, Tjan-Heijnen VC, Janssen 
DJ. Update on prevalence of pain in patients with cancer: Systematic review and meta-analysis. J Pain 
Symptom 
Manage. 2016; 51(6):1070-1090.e9. 
2. Turk DC, Sist TC, Okifuji A, et al. Adaptation to metastatic cancer pain, regional/local cancer pain 
and non-cancer pain: Role of psychological and behavioral factors. Pain.1998; 74:247-256. 
3. Bennett MI, Bagnall A, Closs SJ. How effective are patient-based educational interventions in the 
management of cancer pain? Systematic review and meta-analysis. Pain. 2009; 143:192-199. 
doi:10.1016/j.pain.2009.01.016 
4. Green E, Zwaal C, Beals C, et al. Cancer-related pain management: A report of evidence-based 
recommendations to guide practice. Clin J Pain. 2010;26(6):449-462. 
5. van den Beuken-van Everdingen MH, de Rijke JM, Kessels AG, et al. Prevalence of pain in patients 
with cancer: A systematic review of the past 40 years. Ann Oncol. 2007;18(9):1437-1449. 
6. LeMay, K., Wilson, K. G., Buenger, U., Jarvis, V., Fitzgibbon, E., Bhinmji, K., & Dobkin, P. L. (2011). 
Fear of pain in patients with advanced cancer or in patients with chronic noncancer pain. Clinical 
Journal of Pain, 27(2), 116-124. 
7. Gunnarsdottir S, Sigurdardottir V, Kloke M, et al.  A multicenter study of attitudinal barriers to 
cancer pain management. Support Care Cancer. 2017; 25:3595-3602. doi:10.1007/s00520-017-
3791-8 
8. Valeberg BT, Miaskowski C, Paul SM, et al. Comparison of oncology patients’ and their family 
caregivers’ attitudes and concerns toward pain and pain management. Cancer Nurs. 2016;39(4):328-
334.  
9. Vallerand AH, Hasenau SM, Robinson-Lane SG, et al. Improving functional status in African 
Americans with cancer pain: A randomized clinical trial. Oncol Nurs Forum. 2018:45(2):260-272. 
10. Sauzet O, Kleine M, Williams JE Data in longitudinal randomised controlled trials in cancer pain: 
Is there any loss of the information available in the data? Results of a systematic literature review and 
guideline for reporting. BMC Cancer. 2016;16(771):1-7. doi:10.1186/s12885-016-2818-8 
11. Ehrlich O, Walker RK. Cancer pain processes in the hospice caring triad: A grounded theory 
study. ONS 43rd Annual Congress; May 17, 2018. Best of New Research Abstracts (podium paper), 
Washington, DC. 
12. Fainsinger R, Nekolaichuk C, Fainsinger L, et al. What is stable pain control? A prospective 
longitudinal study to assess the clinical value of a personalized pain goal. Palliative Med. 
2017;31(10):913-920. 
13. Zylla D, Larson A, Chuy G, et al. Establishment of personalized pain goals in oncology 
patients to improve care and decrease costs. JOP (online edition). 2017. 201:1-7. 
doi:10.1200/JOP.2016.017616 
14. Koller A, Miaskowski C, De Geest S, et al. Results of a randomized controlled pilot study of a self-
management intervention for cancer pain. EJON. 2013; 17:284-291. 
15. ONS. Pain. https://www.ons.org/practice-resources/pep/pain. Published 2017. Accessed July 3, 
2018. 
16. Paice JA, Portenoy R, Lacchetti C, et al. Management of chronic pain in survivors of adult cancers: 
American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2016;34(27):3325-3347.  
17. Howell D, Harth T, Brown J, et al. Self-management education interventions for patients with 
cancer: a systematic review. Support Care Cancer. 2017; 25:1323-1355. doi: 10.1007/s00520-016-
3500-z 

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18. Koller A, Miaskowski C, De Geest, S, et al. A systematic evaluation of content, structure, and 
efficacy of interventions to improve patients’ self-management of cancer pain. J Pain Symptom 
Manage. 2012;44(2):264-284. 
19. Oldenmenger WH, Geerling JI, Mostovaya I, et al. A systematic review of the effectiveness of 
patient-based educational interventions to improve cancer-related pain. Cancer Treat Rev. 2018; 
63:96-103. 
20. Kravitz RL, Tancredi DJ, Grennan T, et al. Cancer Health Empowerment for Living without Pain 
(Ca-HELP): Effects of a tailored education and coaching intervention on pain and impairment. Pain. 
2011;152(7):1572-1582. 
21. Jensen MP, Nielson WR, Kearns RD. Toward the development of a motivational model of pain 
self-management. J Pain. 2003;4(9):477-492. 
22. Wang H, Kroenke K, Wu J, et al. Predictors of cancer-related pain improvement over time. 
Psycho Som Med. 2012;74(6):642-647. doi:10.1097/PSY.0b013e3182590904 
23. Vancleef LM, Peters ML The influence of perceived control and self-efficacy on the sensory 
evaluation of experimentally induced pain. J Behav Ther Exp Psy. 2011; 42:511-517. 
doi:10.1016/j.jbtep.2011.05.006 
24. Kelleher SA, Somers TJ, Locklear D, et al. Using patient reported outcomes in oncology clinical 
practice. Scand J Pain. 2016; 13:6-11. doi:10.1016/j.sjpain.2016.05.035 
25. Prochaska JO, DiClemente CC. Transtheoretical therapy: Toward a more integrative model of 
change. Psychother-Theor Res. 1982;19(3):276-288. 
26. Rollnick R, Miller WR, Butler CC. Motivational interviewing in Health Care. New York, NY: The 
Guilford Press; 2008. 
27. Thomas ML, Elliott JE, Rao SM, et al. A randomized, clinical trial of education or motivational-
interviewing–based coaching compared to usual care to improve cancer pain management. Oncol 
Nurs Forum. 2012;39(1):39-49. 
28. Coolbrandt A, Wildiers H, Laenen A, et al. Oncol Nurs Forum. 2018;45(1):115-128. 
29. Brandford A, Adegboyega A, Combs B, et al. Training community health workers in motivational 
interviewing to promote cancer screening. Health Promot Pract. 2018; 
doi: 10.1177/1524839918761384. 
30. Gunnarsdottir S, Donovan HS, Serlin SR Patient-related barriers to pain management: The 
barriers questionnaire II (BQ-II). Pain. 2002; 99:385-396.  
31. Nicholas MK. The pain self-efficacy questionnaire: Taking pain into account. Eur J Pain. 
2007;11:153-163. 
32. Petrova T, Kavookjian J, Madson MB, et al. Motivational Interviewing Skills in Health Care 
Encounters (MISHCE): Development and psychometric testing of an assessment tool. Res Soc 
Admin Pharm. 2015;11: 696-707. 
 
 
 

Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
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27.0 Appendices: 
 
Study Documents 
 
A. Electronic Health Record Abstraction Form 
B. Demographic Questionnaire 
C. Pain Self-Efficacy Questionnaire (PSEQ) 
D. Barriers Questionnaire II (BQ-II) 
E. Patient Experience Questionnaire (PEQ) 
F. Observed Engagement Table 
G. Motivational Interviewing Study Goal Summary 
H. MISHCE and instructions 
 
 

Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
23 
 
 
28.0 Appendix A: Eligible Participant Extraction Form 
Electronic Health Record Abstraction Form – Potential Eligible Patients 
(for use with EPIC clinical schedule and EHR) 
 
Clinic 
Appointment 
Date/Time 
(eg-4/2/18 15:45) 
Provider: 
Last/First  
(eg-Carr, F) 
Patient: 
Last/First 
(eg-Garcia, E) 
MRN 
Previous 
pain 
referral 
(eg-
yes/no) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
24 
 
 
29.0 Appendix B: Demographic Questionnaire 
 
Demographic Questionnaire 
 
Age 
 
Gender identity 
Female 
Male 
Other  
Race 
African American 
Asian American 
Native American  
Pacific Islander 
Asian  
African  
Caucasian/White 
Other:  
Ethnicity 
Hispanic 
Non-Hispanic 
Cancer type (for example,  colon.) 
(list all) 
Number of visits for pain treatment since your 
diagnosis (Your best estimate) 
(fill in number) 
Which types of clinicians provided pain 
treatment (for example: primary care MD, 
palliative care NP, oncologist, etc.) 
(list all) 
Is a caregiver involved in your pain 
management?  
Yes 
No 
 
Please mark any area(s) on your body where you have had pain related to your cancer in the past 24 hours.  
[INSERT GRAPHIC OF BODY HERE:] 
 
 

Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
25 
 
 
30.0 Appendix C: Pain Self-Efficacy Questionnaire 
 
Pain Self-Efficacy Questionnaire (M. K. Nicholas, 1989) 
 
 
 
 

Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
26 
 
 
31.0 Appendix D: Barriers Questionnaire II 
 
Barriers Questionnaire II (S. E. Ward & S. Gunnarsdottir, 2002. Permissions follow instrument). 
 
We are interested in learning about your attitudes toward treatment of pain.  We want to know what you think.  
Some of the questions may seem similar to other ones, but please answer all of the questions.  For each of the 
items below, please circle the number (0, 1, 2, 3, 4, or 5) that comes closest to how much you agree with that 
item. 
1) 
Cancer pain can be relieved. 
 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
Do not agree at all 
 
 
 
 
 
 
         Agree very much 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
2) 
There is a danger of becoming addicted to pain medicine.  
 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
Do not agree at all 
                                                                                         Agree very much  
 
 
 
 
 
 
       
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3) 
Drowsiness from pain medicine is difficult to control. 
 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
Do not agree at all 
                                                                                         Agree very much  
 
 
4) 
Pain medicine weakens the immune system. 
 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
Do not agree at all 
                                                                                         Agree very much  
 
 
5) 
Confusion from pain medicine can not be controlled. 
 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
Do not agree at all 
                                                                                         Agree very much  
 
 
 
 

Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
27 
 
6) 
When you use pain medicine your body becomes used to its effects and pretty soon it won't work any 
more.  
 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
Do not agree at all 
                                                                                         Agree very much  
 
7) 
Using pain medicine blocks your ability to know if you have any new pain. 
 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
Do not agree at all 
                                                                                         Agree very much  
 
8) 
Pain medicine can effectively control cancer pain. 
 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
Do not agree at all 
                                                                                         Agree very much  
 
9) 
Many people with cancer get addicted to pain medicine. 
 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
Do not agree at all 
                                                                                         Agree very much  
 
10) 
 Nausea from pain medicine can not be relieved. 
 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
Do not agree at all 
                                                                                         Agree very much  
 
11) 
It is important to be strong by not talking about pain. 
 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
Do not agree at all 
                                                                                         Agree very much  
 
12) 
It is important for the doctor to focus on curing illness, and not waste time controlling pain. 
 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
Do not agree at all 
                                                                                         Agree very much  
 
13) 
Using pain medicine can harm your immune system. 
 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
Do not agree at all 
                                                                                         Agree very much  
 
 

Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
28 
 
 
14) 
Pain medicine makes you say or do embarrassing things. 
 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
Do not agree at all 
                                                                                         Agree very much  
 
15) 
If you take pain medicine when you have some pain, then it might not work as well if the pain becomes 
worse. 
 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
Do not agree at all 
                                                                                         Agree very much  
 
16) 
Pain medicine can keep you from knowing what's going on in your body. 
 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
Do not agree at all 
                                                                                         Agree very much  
 
17) 
Constipation from pain medicine can not be relieved. 
 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
Do not agree at all 
                                                                                         Agree very much  
 
18) 
If doctors have to deal with pain they won't concentrate on curing the disease. 
 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
Do not agree at all 
                                                                                         Agree very much  
 
19) 
Pain medicine can hurt your immune system. 
 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
Do not agree at all 
                                                                                         Agree very much  
 
20) 
It is easier to put up with pain than with the side effects that come from pain medicine. 
 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
Do not agree at all 
                                                                                         Agree very much  
 
21) 
If you use pain medicine now, it won't work as well if you need it later. 
 
 
Do not agree at all 
                                                                                         Agree very much  
 
 

Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
29 
 
 
22)  
Pain medicine can mask changes in your health. 
 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
Do not agree at all 
                                                                                         Agree very much  
 
23) 
Pain medicine is very addictive. 
 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
Do not agree at all 
                                                                                         Agree very much  
 
24) 
Medicine can relieve cancer pain. 
 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
Do not agree at all 
                                                                                         Agree very much  
 
25) 
Doctors might find it annoying to be told about pain. 
 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
Do not agree at all 
                                                                                         Agree very much  
 
26) 
Reports of pain could distract a doctor from curing the cancer. 
 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
Do not agree at all 
                                                                                         Agree very much  
 
27) 
If I talk about pain, people will think I'm a complainer. 
 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
Do not agree at all 
                                                                                         Agree very much  
 
 

Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
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Scoring the Barriers Questionnaire-II 
1. Items 1,8 and 24 (Fatalism) are reverse scored before analysis 
2. The mean scores on the total scale (27-items) and subscales is used for analysis. 
Subscale 
Items 
# 
Physiological Effects 
 
 
 
Drowsiness from pain medicine is difficult to control. 
3 
 
Confusion from pain medicine can not be controlled. 
5 
 
When you use pain medicine your body becomes used to its effects and pretty 
soon it won't work any more 
6 
 
Using pain medicine blocks your ability to know if you have any new pain. 
7 
 
Nausea from pain medicine can not be relieved 
10 
 
Pain medicine makes you say or do embarrassing things 
14 
 
If you take pain medicine when you have some pain, then it might not work 
as well if the pain becomes worse 
15 
 
Pain medicine can keep you from knowing what's going on in your body 
16 
 
Constipation from pain medicine can not be relieved. 
17 
 
It is easier to put up with pain than with the side effects that come from pain 
medicine 
20 
 
If you use pain medicine now, it won't work as well if you need it later 
21 
 
Pain medicine can mask changes in your health 
22 
 
 
 
Fatalism 
 
 
 
Cancer pain can be relieved. 
1 
 
Pain medicine can effectively control cancer pain 
8 
 
Medicine can relieve cancer pain 
24 
 
 
 
Communication 
 
 
 
It is important to be strong by not talking about pain 
11 
 
It is important for the doctor to focus on curing illness, and not waste time 
controlling pain. 
12 
 
If doctors have to deal with pain they won't concentrate on curing the disease 
18 
 
Doctors might find it annoying to be told about pain 
25 
 
Reports of pain could distract a doctor from curing the cancer. 
26 
 
If I talk about pain, people will think I'm a complainer. 
27 
 
 
 
Harmful Effects 
 
 
 
There is a danger of becoming addicted to pain medicine 
2 
 
Pain medicine weakens the immune system 
4 
 
Many people with cancer get addicted to pain medicine 
9 
 
Using pain medicine can harm your immune system 
13 
 
Pain medicine can hurt your immune system 
19 
 
Pain medicine is very addictive 
23 

Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
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Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
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32.0 Appendix E: Patient Experience Questionnaire 
 
Patient Experience Questionnaire 
 
 
 
Instructions: For questions 1-6, please circle the answer that best describes your experience. 
1) Were these sessions talking about pain helpful for you? 
 
YES       NO    NOT SURE 
2) Were these sessions worth your time?  
 
YES        NO   NOT SURE 
3) Would you recommend this type of pain session to others 
with  
pain from cancer? 
 
YES        NO   NOT SURE 
4) Were you able to set a goal of something you hoped to 
achieve by having control of the pain? 
 
YES        NO   NOT SURE 
5) Did you discuss your participation in these sessions, or parts 
of what we talked about, with your healthcare team?  
 
YES        NO   NOT SURE 
6) Would you suggest also including caregivers these sessions?  
 
YES        NO   NOT SURE 
 
For question 7, please write as much or as little as you would like to share. 
 
7) Please let the research team know any other thoughts about your experiences with these sessions: 
 
 
Study ID # (to be filled out by study coordinator):  

Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
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33.0 Appendix F: Observed Engagement Table 
 
Observed Engagement Table  
(For research team use, data collection) 
 
Category 
Count Quote 
A) Pain as obstacle 
 
 
 
 
Example: “I wish I could drive to pick my son up from 
school.” 
B) What helped pain before 
 
 
 
 
Example: “I have used a heating pad on my belly with 
some relief.” 
C) Life with controlled pain 
 
 
 
 
Example: “I would really like to visit my sister in 
Florida next month.” 
D) Suggestions to control 
pain 
 
 
 
 
Example: “Perhaps I should take my oxycodone IR 
every four hours instead of every eight.” 
D) Patient suggestions used 
 
 
 
 
Example: “Since I saw you last time I have been 
taking my oxycodone IR more often, not exactly every 
four hours, but some days that much.” 
E) Patient help-seeking  
 
 
 
 
Example: “I really need someone to explain when I 
can take the as-needed medication versus the long-
acting to my husband.” 
 
 
 

Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
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34.0 Appendix G: Intervention Goal Summary 
 
Motivational Interviewing Study Goal Summary – For Participant Use 
 
At the session on __________________________(date), the following functional pain goal(s) was(were) 
identified: 
1. 
 
2. 
 
3. 
 
4.  
 
 

Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
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35.0 Appendix H: MISHCE  
  
"This instrument has been used with permission by the developer of the Motivational  
Interviewing Skills for Health Care Encounters – MISHCE, Tatjana Petrova, PhD, Specialist in  
Clinical Pharmacy, Associate Professor, Department of Pharmacy Practice at Chicago State  
University. The MISHCE was developed in a project entitled, "Designing an Instrument for  
Measuring Motivational Interviewing Skills Acquisition in Healthcare Professional Trainees" at Auburn 
University."  
   
[Note: Please be advised that there has generally not been a fee for single use of the entire MISHCE when 
undertaken as part of a fellowship, graduate, or undergraduate student project or by researchers based at 
academic institutions or community non-profit organizations who are funded by federal or foundation grants. 
If there are any plans to make use of the MISHCE as part of a non-grant funded health care organization or 
provider Motivational Interviewing project, or if there are plans to do ongoing assessments as part of a larger 
project or make derivative uses of the tool, or if the organization is a for-profit entity, please contact the 
developer].  
   
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
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Motivational Interviewing Skills for Health Care Encounters – MISHCE  
  
  
Trainee:  
Evaluator:  
  
Date:  
  
  
Rating   
0=Deficient (MI-adherent skill not evident in interaction, although skill was necessary for facilitating the 
interaction)  
1=Developing (MI-adherent skill partially present, or skill is present on a basic/simplistic level)  
2=Accomplished (MI-adherent skill is well developed and sophisticated)  
N/A= Not applicable (MI-adherent skill not evident and not necessary for facilitating the interaction)  
  
Specific Guidelines:  
• 
For each skill choose only one of the four options from the scale above.   
• 
Use N/A (Not applicable) when, based on your evaluation, a certain skill was not evident in the 
interaction and it was not necessary for the trainee to use that skill to further facilitate the interviewing 
process.  
• 
Ratings should capture only the health care provider behavior during the interaction.  
• 
The skills in the domains MI Philosophy, Health Interviewing and Motivation are evaluated on a three-
point rating scale. The three rating points are Deficient, Developing and Accomplished. Evaluate each 
skill of these three domains as an episode that occurs during the interaction rather than a certain 
behavior. Focus on the quality of the episode as a whole. Mark “X” in one of the four boxes to the right 
of the item (skill), depending on whether you have evaluated the skill as “Deficient”, “Developing”, 
“Accomplished” or “N/A”.  
• 
The skills in the domains MI Principles and Interpersonal Process are evaluated on the same three-point 
rating scale: Deficient, Developing, or Accomplished. Evaluate each skill of these domains based on 
behavioral occurrences demonstrated by the trainee. When noticing that the trainee has demonstrated the 
behavior, mark “X” in one of the four boxes to the right of the item (skill), depending on whether you 
have evaluated the behavioral occurrence as “Deficient”, “Developing”, “Accomplished” or “N/A”.  
  
 
 

Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals 
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MI PHILOSOPHY  
Deficient  Developing  Accomplished  
N/A  
Exhibits the ‘Spirit of MI’  
  
  
  
  
HEALTH INTERVIEWING  
Deficient  Developing  Accomplished  
N/A  
Elicits / addresses patient’s  
understanding about the illness and 
/ or treatment  
  
  
  
  
Elicits / addresses patient’s 
awareness of susceptibility / risk of 
uncontrolled illness / condition  
  
  
  
  
Elicits / addresses patient’s desired 
health outcomes / goals  
  
  
  
  
MOTIVATION  
Deficient  Developing  Accomplished  
N/A  
Elicits / addresses patient’s 
motivators and barriers for 
behavioral change  
  
  
  
  
Reflects and affirms change talk  
  
  
  
  
MI PRINCIPLES  
Deficient  Developing  Accomplished  
N/A  
Expresses empathy  
  
  
  
  
Supports self-efficacy  
  
  
  
  
Rolls with resistance  
  
  
  
  
Develops discrepancy  
  
  
  
  
INTERPERSONAL PROCESS  
Deficient  Developing  Accomplished  
N/A  
Resists the righting reflex  
  
  
  
  
Uses reflective listening   
  
  
  
  
Uses open-ended questions  
  
  
  
  
Uses agenda setting  
  
  
  
  
Moves smoothly through the 
interaction  
  
  
  
  
 
 
 

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