Trial Outcomes & Findings for Adaptation of Ca-HELP Intervention in Rural Geriatric Cancer Patient Population (NCT NCT04262232)
NCT ID: NCT04262232
Last Updated: 2023-03-22
Results Overview
Number of subjects accrued
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Two weeks post-intervention
Results posted on
2023-03-22
Participant Flow
Participant milestones
| Measure |
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).
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Overall Study
STARTED
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30
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Overall Study
COMPLETED
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30
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adaptation of Ca-HELP Intervention in Rural Geriatric Cancer Patient Population
Baseline characteristics by cohort
| Measure |
Ca-HELP
n=30 Participants
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).
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Age, Continuous
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73.0 years
STANDARD_DEVIATION 5.1 • n=5 Participants
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Sex: Female, Male
Female
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17 Participants
n=5 Participants
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Sex: Female, Male
Male
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13 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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30 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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5 Participants
n=5 Participants
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Race (NIH/OMB)
White
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24 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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30 participants
n=5 Participants
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Insurance status
Insured
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30 Participants
n=5 Participants
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Insurance status
Not insured
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0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Two weeks post-interventionNumber of subjects accrued
Outcome measures
| Measure |
Ca-HELP
n=30 Participants
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).
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Feasibility (Aim 2), as Measured by Number of Subjects Accrued to the Study
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30 Participants
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PRIMARY outcome
Timeframe: Two weeks post-interventionNumber of subjects to complete intervention
Outcome measures
| Measure |
Ca-HELP
n=30 Participants
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).
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Feasibility (Aim 2), as Measured by Number of Subjects to Complete the Intervention
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30 Participants
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PRIMARY outcome
Timeframe: Two weeks post-interventionSemi-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.
Outcome measures
| Measure |
Ca-HELP
n=30 Participants
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).
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Acceptability (Aim 2), as Measured by Qualitative Feedback
Satisfaction (Liked participating in intervention)
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25 Participants
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Acceptability (Aim 2), as Measured by Qualitative Feedback
Helpfulness (Stated intervention was helpful)
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30 Participants
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PRIMARY outcome
Timeframe: Two weeks post-interventionLikert scale item assessing perceived helpfulness. Likert scale from 1 (not at all helpful) to 5 (very helpful), with 5 indicating higher levels of acceptability.
Outcome measures
| Measure |
Ca-HELP
n=30 Participants
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).
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Acceptability (Aim 2), as Measured by Helpfulness
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4.8 score on a scale
Standard Deviation 0.5
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PRIMARY outcome
Timeframe: Two weeks post-interventionLikert scale item assessing perceived satisfaction. Likert scale from 1 (not at all satisfied) to 5 (very satisfied), with 5 indicating higher levels of acceptability.
Outcome measures
| Measure |
Ca-HELP
n=30 Participants
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).
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Acceptability (Aim 2), as Measured by Satisfaction
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4.7 score on a scale
Standard Deviation 0.64
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PRIMARY outcome
Timeframe: Two weeks post-interventionLikert 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.
Outcome measures
| Measure |
Ca-HELP
n=30 Participants
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).
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Acceptability (Aim 2), as Measured by Usability
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4.7 score on a scale
Standard Deviation 1.02
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PRIMARY outcome
Timeframe: Two weeks post-interventionPopulation: 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.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, two weeks post-interventionTwo 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).
Outcome measures
| Measure |
Ca-HELP
n=30 Participants
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).
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Change in Pain Self-management (Aim 3)
Baseline
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6.2 score on a scale
Standard Deviation 1.97
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Change in Pain Self-management (Aim 3)
Two weeks post-intervention
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8.0 score on a scale
Standard Deviation 1.23
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PRIMARY outcome
Timeframe: Baseline, two weeks post-interventionAssessed 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.
Outcome measures
| Measure |
Ca-HELP
n=30 Participants
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).
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Change in Pain Misconceptions (Aim 3)
Baseline
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2.9 score on a scale
Standard Deviation 0.54
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Change in Pain Misconceptions (Aim 3)
Two weeks post-intervention
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1.5 score on a scale
Standard Deviation 0.32
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SECONDARY outcome
Timeframe: Two weeks post-interventionTreatment fidelity will be assessed with a checklist that captures whether session content was delivered and appropriate techniques were utilized.
Outcome measures
| Measure |
Ca-HELP
n=30 Participants
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).
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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)
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27 Participants
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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)
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30 Participants
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SECONDARY outcome
Timeframe: Baseline, two weeks post-interventionAssessed 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).
Outcome measures
| Measure |
Ca-HELP
n=30 Participants
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).
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Change in Self-efficacy for Communicating With Physicians About Pain Severity
Baseline
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20.3 score on a scale
Standard Deviation 5.28
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Change in Self-efficacy for Communicating With Physicians About Pain Severity
Two weeks post-intervention
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23.1 score on a scale
Standard Deviation 2.85
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SECONDARY outcome
Timeframe: Baseline, two weeks post-interventionPopulation: 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.
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).
Outcome measures
| Measure |
Ca-HELP
n=30 Participants
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).
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Change in Pain-related Impairment
Baseline
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13.8 score on a scale
Standard Deviation 6.58
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SECONDARY outcome
Timeframe: Baseline, two weeks post-interventionPopulation: A total of 29 out of 30 participants data were analyzed because n=1 patient was missing post-intervention assessments for 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).
Outcome measures
| Measure |
Ca-HELP
n=29 Participants
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).
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Change in Pain Severity
Baseline
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3.7 score on a scale
Standard Deviation 3.02
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Change in Pain Severity
Two weeks post-intervention
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3.2 score on a scale
Standard Deviation 2.76
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Adverse Events
Ca-HELP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place