N/A
N=30
Adaptation of Ca-HELP Intervention in Rural Geriatric Cancer Patient Population
Pain
Bottom Line
View on ClinicalTrials.gov: NCT04262232 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Feasibility (Aim 2), as Measured by Number of Subjects Accrued to the Study — 30 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Adapted Ca-HELP for Geriatric Cancer Patients (Behavioral)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility (Aim 2), as Measured by Number of Subjects Accrued to the Study |
30 | — |
| PRIMARY Feasibility (Aim 2), as Measured by Number of Subjects to Complete the Intervention |
30 | — |
| PRIMARY Acceptability (Aim 2), as Measured by Qualitative Feedback |
25; 30 | — |
| PRIMARY Acceptability (Aim 2), as Measured by Helpfulness |
4.8 | — |
| PRIMARY Acceptability (Aim 2), as Measured by Satisfaction |
4.7 | — |
| PRIMARY Acceptability (Aim 2), as Measured by Usability |
4.7 | — |
| PRIMARY Acceptability (Aim 2), as Measured by Readability |
— | — |
| PRIMARY Change in Pain Self-management (Aim 3) |
6.2; 8.0 | 0.0001 sig |
| PRIMARY Change in Pain Misconceptions (Aim 3) |
2.9; 1.5 | <0.0001 sig |
| SECONDARY Treatment Fidelity as Measured by Number of Subjects for Which the Intervention Was Delivered With Fidelity |
27; 30 | — |
| SECONDARY Change in Self-efficacy for Communicating With Physicians About Pain Severity |
20.3; 23.1 | 0.01 sig |
| SECONDARY Change in Pain-related Impairment |
13.8 | — |
| SECONDARY Change in Pain Severity |
3.7; 3.2 | 0.51 |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT04262232). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.