Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sigma Theta Tau International Honor Society of Nursing | OTHER |
Not provided
Not provided
Not provided
Not provided
This research study is evaluating the acceptability and feasibility of using a cognitive behavioral intervention called Motivational Interviewing to help persons with pain from cancer set goals for managing that pain.
This study is being conducted to evaluate a new way that clinicians can help identify the goals that cancer participants have for managing their pain. This new method uses discussion between a patient and a clinician, in this case a registered nurse, during which one or more goals may be set. At this time, there are no tested methods that clinicians can use for helping patients set these kinds of goals.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motivational Interviewing | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational Interviewing | Behavioral | An investigator-led discussion about the participant's pain experience which is focused on the participant reporting of functional pain goals (FPGs) |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Motivational Interviewing intervention | The proportion of enrolled participants completing at least one follow-up Motivational Interviewing session (at least two sessions total). The proportion of participants completing at least one follow-up intervention session will be estimated along with an exact 90% confidence interval. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Motivational Interviewing intervention usage rate | The number of interventions sessions attended divided by the total possible number of interventions sessions reported as the sample mean. | 1 year |
| Participant intervention acceptability |
Not provided
Inclusion Criteria:
Exclusion Criteria:
-Diagnosis of delirium or other cognitive impairment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Olga Ehrlich, PhD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 9, 2022 | Apr 15, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The Participant Experience Questionnaire, 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 scores, the time in weeks from the initial to follow-up intervention visit, and the number of completed intervention sessions will be reported.
| 1 year |
| Attitudinal barriers to pain | Attitudinal barriers to pain management will be measured using the Barriers Questionnaire-II which measures four attitudinal realms with 27 self-rated questions about pain beliefs. The total score will be calculated at study entry and after the first follow-up visit and scores will be summarized (median/range, mean/SD). If additional sessions are completed, the scores will be plotted over time and trends will be explored with graphical methods. | 1 year |
| Pain Self-Efficacy | Pain self-efficacy will be measured using the Pain Self-Efficacy Questionnaire in which participants rate their confidence in daily living activities despite pain using a Likert-type scale.The total score will be calculated at study entry and after the first follow-up visit and scores will be summarized (median/range, mean/SD). If additional sessions are completed, the scores will be plotted over time and trends will be explored with graphical methods. | 1 year |
| Observed engagement in goals-setting | Observed engagement will be evaluated using the instrument developed by the investigator for this study in which discussions of behaviors indicating active goal setting will be tabulated and salient quotes will be extracted for dissemination. Categories are:
| 1 year |
| Motivational Interviewing intervention fidelity | Fidelity to Motivational Interviewing methods will be assessed on 33% of interviews using the Motivational Interviewing Skills for Health Care Encounters which is used to evaluate the degree to which the person providing the intervention follows five domains key to Motivational Interviewing.The domains are:
Each domain has specific behaviors that are rated as:
| 1 year |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |