Pain
Conditions
Brief summary
The Cancer Health Empowerment for Living without Pain (Ca-HELP) is an evidence-based communication tool that empowers and engages patients to communicate effectively with their physicians about pain. The Ca-HELP intervention is rooted in social-cognitive theory which posits that behavior change and maintenance depends largely on individuals' ability and self-efficacy to execute a specific behavior. Ca-HELP coaches patients to ask questions, make requests, and signal distress to their physicians in order to achieve improved pain control. Previous research indicates significant improvement among cancer patients in their self-efficacy to communicate about their pain to their oncologists and reductions in pain misconceptions and pain-related impairment. Although a promising tool among geriatric cancer patients, Ca-HELP is not currently designed for optimal dissemination in rural settings.
Detailed description
Overall study objective: The objectives of this Stage I pilot study are to 1) adapt Ca-HELP for use in rural settings, and 2) inform research and trial design choices by engaging community partners. Following the completion of formative tasks about this adaptive design approach, investigators will conduct an open trial to test the feasibility and acceptability of methods and procedures for later use on a large scale R01-level RCT. Specific Aims: Aim 1: To adapt the Ca-HELP intervention for use with older adults with cancer in rural settings. This intervention adaptation will be informed by: (1) social-cognitive theory;12,13 (2) mixed methods analysis; and (3) semi-structured interviews from key stakeholder groups including patients, caregivers, and providers and hospital administration staff in rural clinic settings. Aim 2: To evaluate the feasibility and acceptability of the adapted Ca-HELP intervention among older adults with cancer in rural clinic settings. Hypothesis 2a: To evaluate feasibility, ≥70% of participants will meet the benchmark for feasibility defined by participant retention and adherence to the intervention. Hypothesis 2b: To evaluate acceptability, ≥70% of participants will meet the benchmark for acceptability defined by responses on self-report measures of perceived helpfulness, satisfaction, and impact. Aim 3: To test the preliminary efficacy of the Ca-HELP intervention adaptation on older adults with cancer to improve pain self-management (primary outcome) as well as pain misconceptions; self-efficacy to communicate with their physicians regarding pain severity, pain-related impairment, and pain severity (secondary outcomes). Hypothesis 3: We hypothesize that the intervention will reduce patients' pain misconceptions, pain-related impairment, and pain severity and improve pain self-management and self-efficacy to communicate about pain with their physicians. For Aim 1, investigators will collect feedback from older adults with cancer (n=10 patients), their caregivers (n=10), and providers and staff working in rural clinic settings (n=10) to determine the appropriateness of this intervention framework and best methods for implementation (e.g., in person health coach, telephone-based, etc.). Following these formative tasks, Aims 2 and 3 will be achieved through an open trial in rural Tennessee to test the intervention with n=30 older (65 years+) cancer patients in rural clinics and assess outcomes at baseline, post-intervention, and three months post-intervention.
Interventions
BEHAVIORALAdapted Ca-HELP for Geriatric Cancer Patients
Intervention group: This intervention will be informed by social-cognitive theory10-13 and modeled after the tailored education and coaching intervention (TEC) used for Ca-HELP previously and consists of six components: (1) Assessment of current knowledge, attitudes, and preferences; (2) clarification and correction of misconceptions about cancer pain control; (3) teaching of relevant concepts (education about cancer pain control); (4) planning (identifying goals of care, creating achievable goals of care, and creating strategies to communicate goals of care to providers and family members); (5) rehearsal of communication strategies using role play exercises; and (6) portrayal of learned skills (patient applies skills in visit with healthcare provider).
Sponsors
Maury Regional Medical Center
Brown University
National Institute on Aging (NIA)
Fred Hutchinson Cancer Center
Weill Medical College of Cornell University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
No masking due to this being a single arm study.
Intervention model description
This is a single arm study in which all participants will be exposed to the intervention (Ca-HELP).
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient Inclusion Criteria: * 65 years of age or older * Diagnosed with cancer * English speaking * Reside in non-institutional, rural settings * Receive care at community-based clinic in rural area * Ability to provide informed consent * Have identified an informal caregiver. Patient
Exclusion criteria
* Severe cognitively impairment (Short Portable Mental Status Questionnaire scores of \<6); * Receiving hospice at time of enrollment. Caregiver eligibility criteria include the following * The person (family member or friend) whom the patient indicates provides most of their informal care * Able to provide informed consent. Provider eligibility criteria: -Currently works with geriatric cancer patients OR in a healthcare system serving this patient population. Providers will include social workers, nurses, oncologists, and healthcare administrators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Misconceptions (Aim 3) | Baseline, two weeks post-intervention | Assessed using the 11 items based on the short version of the Barriers Questionnaire. Items are rated on a five-point Likert scale (1=disagree very much, 5=agree very much). Scores range from 1 (low misconception) to 5 (high misconception) as an average across all 11 items. |
| Acceptability (Aim 2), as Measured by Satisfaction | Two weeks post-intervention | Likert scale item assessing perceived satisfaction. Likert scale from 1 (not at all satisfied) to 5 (very satisfied), with 5 indicating higher levels of acceptability. |
| Acceptability (Aim 2), as Measured by Usability | Two weeks post-intervention | Likert scale item assessing perceived usability by assessing how difficult the intervention content was to understand. Likert scale from 1 (not at all) to 5 (very much). The item was reverse scored so that 5 indicates higher levels of acceptability. |
| Acceptability (Aim 2), as Measured by Readability | Two weeks post-intervention | Yes/no items assessing perceived readability (wording was too complicated, ideas were too complicated, there was too much information, there was not enough information). Individual items will be summed to create a total readability score. Scores can range from 0 (no issues/ good readability) to 4 (poor readability). \*Note these questions were only answered among participants who indicated that the intervention content was difficult to understand (eg, poor usability) by scoring \>1 on the 1 to 5 Likert-scale of usability. |
| Change in Pain Self-management (Aim 3) | Baseline, two weeks post-intervention | Two items from the pain management subscale of the Chronic Pain Self-Efficacy scale. Items rated on a 5-point Likert scale (1 = not at all certain and 5 = extremely certain). Scores range from 2 (low self-management) to 10 (high self-management). |
| Feasibility (Aim 2), as Measured by Number of Subjects Accrued to the Study | Two weeks post-intervention | Number of subjects accrued |
| Feasibility (Aim 2), as Measured by Number of Subjects to Complete the Intervention | Two weeks post-intervention | Number of subjects to complete intervention |
| Acceptability (Aim 2), as Measured by Qualitative Feedback | Two weeks post-intervention | Semi-structured interview assessing perceived satisfaction, helpfulness, usability, and readability. This interview will be coded qualitatively for themes that assess these components for assessment of overall acceptability. Qualitative data was analyzed as number of subjects endorsing specific themes. Themes around usability and readability did not emerge from the semi-structured interviews, thus no data on usability or readability were available to analyze. |
| Acceptability (Aim 2), as Measured by Helpfulness | Two weeks post-intervention | Likert scale item assessing perceived helpfulness. Likert scale from 1 (not at all helpful) to 5 (very helpful), with 5 indicating higher levels of acceptability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-efficacy for Communicating With Physicians About Pain Severity | Baseline, two weeks post-intervention | Assessed using the 5-item Perceived Efficacy in Patient-Physician Interactions scale as modified to refer to communication with oncologists. Items are rated on a five-point Likert scale (1=not at all confident, 5 = very confident). Scores range from 5 (low self-efficacy) to 25 (high self-efficacy). |
| Change in Pain-related Impairment | Baseline, two weeks post-intervention | Measured using the 6-item Medical Outcomes Study (MOS) Pain Impairment Scale. Items are rated on a five-point likert scale (1=not at all, 5 = extremely). Scores can range from 6 (low pain impairment) to 30 (high pain impairment). |
| Change in Pain Severity | Baseline, two weeks post-intervention | Assessed as the mean of the average and worst pain over the past two weeks on a 0 to 10 scale (0 = no pain and 10 = worst pain imaginable). |
| Treatment Fidelity as Measured by Number of Subjects for Which the Intervention Was Delivered With Fidelity | Two weeks post-intervention | Treatment fidelity will be assessed with a checklist that captures whether session content was delivered and appropriate techniques were utilized. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ca-HELP This intervention arm will consist of six components: (1) Assessment of current knowledge, attitudes, and preferences; (2) clarification and correction of misconceptions about cancer pain control; (3) teaching of relevant concepts (education about cancer pain control); (4) planning (identifying goals of care, creating achievable goals of care, and creating strategies to communicate goals of care to providers and family members); (5) rehearsal of communication strategies using role play exercises; and (6) portrayal of learned skills (patient applies skills in visit with healthcare provider).
Adapted Ca-HELP for Geriatric Cancer Patients: Intervention group: This intervention will be informed by social-cognitive theory10-13 and modeled after the tailored education and coaching intervention (TEC) used for Ca-HELP previously and consists of six components: (1) Assessment of current knowledge, attitudes, and preferences; (2) clarification and correction of misconceptions about cancer pain control; (3) teaching of relevant concepts (education about cancer pain control); (4) planning (identifying goals of care, creating achievable goals of care, and creating strategies to communicate goals of care to providers and family members); (5) rehearsal of communication strategies using role play exercises; and (6) portrayal of learned skills (patient applies skills in visit with healthcare provider). | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Ca-HELP |
|---|---|
| Age, Continuous | 73.0 years STANDARD_DEVIATION 5.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Insurance status Insured | 30 Participants |
| Insurance status Not insured | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Acceptability (Aim 2), as Measured by Helpfulness
Likert scale item assessing perceived helpfulness. Likert scale from 1 (not at all helpful) to 5 (very helpful), with 5 indicating higher levels of acceptability.
Time frame: Two weeks post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ca-HELP | Acceptability (Aim 2), as Measured by Helpfulness | 4.8 score on a scale | Standard Deviation 0.5 |
Primary
Acceptability (Aim 2), as Measured by Qualitative Feedback
Semi-structured interview assessing perceived satisfaction, helpfulness, usability, and readability. This interview will be coded qualitatively for themes that assess these components for assessment of overall acceptability. Qualitative data was analyzed as number of subjects endorsing specific themes. Themes around usability and readability did not emerge from the semi-structured interviews, thus no data on usability or readability were available to analyze.
Time frame: Two weeks post-intervention
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ca-HELP | Acceptability (Aim 2), as Measured by Qualitative Feedback | Satisfaction (Liked participating in intervention) | 25 Participants |
| Ca-HELP | Acceptability (Aim 2), as Measured by Qualitative Feedback | Helpfulness (Stated intervention was helpful) | 30 Participants |
Primary
Acceptability (Aim 2), as Measured by Readability
Yes/no items assessing perceived readability (wording was too complicated, ideas were too complicated, there was too much information, there was not enough information). Individual items will be summed to create a total readability score. Scores can range from 0 (no issues/ good readability) to 4 (poor readability). \*Note these questions were only answered among participants who indicated that the intervention content was difficult to understand (eg, poor usability) by scoring \>1 on the 1 to 5 Likert-scale of usability.
Time frame: Two weeks post-intervention
Population: Only 3 out of 30 participants scored \>1 on the Likert-scale item, indicating some difficulty understanding the intervention. Of those 3, no participants indicated yes or no to items assessing possible readability. As such, there was no data available to analyze for this outcome.
Primary
Acceptability (Aim 2), as Measured by Satisfaction
Likert scale item assessing perceived satisfaction. Likert scale from 1 (not at all satisfied) to 5 (very satisfied), with 5 indicating higher levels of acceptability.
Time frame: Two weeks post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ca-HELP | Acceptability (Aim 2), as Measured by Satisfaction | 4.7 score on a scale | Standard Deviation 0.64 |
Primary
Acceptability (Aim 2), as Measured by Usability
Likert scale item assessing perceived usability by assessing how difficult the intervention content was to understand. Likert scale from 1 (not at all) to 5 (very much). The item was reverse scored so that 5 indicates higher levels of acceptability.
Time frame: Two weeks post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ca-HELP | Acceptability (Aim 2), as Measured by Usability | 4.7 score on a scale | Standard Deviation 1.02 |
Primary
Change in Pain Misconceptions (Aim 3)
Assessed using the 11 items based on the short version of the Barriers Questionnaire. Items are rated on a five-point Likert scale (1=disagree very much, 5=agree very much). Scores range from 1 (low misconception) to 5 (high misconception) as an average across all 11 items.
Time frame: Baseline, two weeks post-intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ca-HELP | Change in Pain Misconceptions (Aim 3) | Baseline | 2.9 score on a scale | Standard Deviation 0.54 |
| Ca-HELP | Change in Pain Misconceptions (Aim 3) | Two weeks post-intervention | 1.5 score on a scale | Standard Deviation 0.32 |
p-value: <0.000195% CI: [1.17, 1.63]Paired t-test, two-sided
Primary
Change in Pain Self-management (Aim 3)
Two items from the pain management subscale of the Chronic Pain Self-Efficacy scale. Items rated on a 5-point Likert scale (1 = not at all certain and 5 = extremely certain). Scores range from 2 (low self-management) to 10 (high self-management).
Time frame: Baseline, two weeks post-intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ca-HELP | Change in Pain Self-management (Aim 3) | Baseline | 6.2 score on a scale | Standard Deviation 1.97 |
| Ca-HELP | Change in Pain Self-management (Aim 3) | Two weeks post-intervention | 8.0 score on a scale | Standard Deviation 1.23 |
p-value: 0.000195% CI: [-2.6, -0.95]Paired t-test, two-sided
Primary
Feasibility (Aim 2), as Measured by Number of Subjects Accrued to the Study
Number of subjects accrued
Time frame: Two weeks post-intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ca-HELP | Feasibility (Aim 2), as Measured by Number of Subjects Accrued to the Study | 30 Participants |
Primary
Feasibility (Aim 2), as Measured by Number of Subjects to Complete the Intervention
Number of subjects to complete intervention
Time frame: Two weeks post-intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ca-HELP | Feasibility (Aim 2), as Measured by Number of Subjects to Complete the Intervention | 30 Participants |
Secondary
Change in Pain-related Impairment
Measured using the 6-item Medical Outcomes Study (MOS) Pain Impairment Scale. Items are rated on a five-point likert scale (1=not at all, 5 = extremely). Scores can range from 6 (low pain impairment) to 30 (high pain impairment).
Time frame: Baseline, two weeks post-intervention
Population: The data was not collected at two weeks post-intervention due to an error in assessment. Thus, data is not reported for the post-intervention time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ca-HELP | Change in Pain-related Impairment | Baseline | 13.8 score on a scale | Standard Deviation 6.58 |
Secondary
Change in Pain Severity
Assessed as the mean of the average and worst pain over the past two weeks on a 0 to 10 scale (0 = no pain and 10 = worst pain imaginable).
Time frame: Baseline, two weeks post-intervention
Population: A total of 29 out of 30 participants data were analyzed because n=1 patient was missing post-intervention assessments for pain severity.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ca-HELP | Change in Pain Severity | Baseline | 3.7 score on a scale | Standard Deviation 3.02 |
| Ca-HELP | Change in Pain Severity | Two weeks post-intervention | 3.2 score on a scale | Standard Deviation 2.76 |
p-value: 0.5195% CI: [-1.02, 2.02]Paired t-test, two-sided
Secondary
Change in Self-efficacy for Communicating With Physicians About Pain Severity
Assessed using the 5-item Perceived Efficacy in Patient-Physician Interactions scale as modified to refer to communication with oncologists. Items are rated on a five-point Likert scale (1=not at all confident, 5 = very confident). Scores range from 5 (low self-efficacy) to 25 (high self-efficacy).
Time frame: Baseline, two weeks post-intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ca-HELP | Change in Self-efficacy for Communicating With Physicians About Pain Severity | Baseline | 20.3 score on a scale | Standard Deviation 5.28 |
| Ca-HELP | Change in Self-efficacy for Communicating With Physicians About Pain Severity | Two weeks post-intervention | 23.1 score on a scale | Standard Deviation 2.85 |
p-value: 0.0195% CI: [-4.99, -0.61]Paired t-test, two-sided
Secondary
Treatment Fidelity as Measured by Number of Subjects for Which the Intervention Was Delivered With Fidelity
Treatment fidelity will be assessed with a checklist that captures whether session content was delivered and appropriate techniques were utilized.
Time frame: Two weeks post-intervention
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ca-HELP | Treatment Fidelity as Measured by Number of Subjects for Which the Intervention Was Delivered With Fidelity | Fidelity (8-item checklist on communication; eg, pacing, volume, intro to intervention) | 27 Participants |
| Ca-HELP | Treatment Fidelity as Measured by Number of Subjects for Which the Intervention Was Delivered With Fidelity | Fidelity (10-item checklist on delivery of intervention content across all 5 modules) | 30 Participants |