Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2026-01-27 @ 5:50 AM
Study NCT ID:
NCT04262232
Status:
COMPLETED
Last Update Posted:
2023-03-22
First Post:
2020-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Adaptation of Ca-HELP Intervention in Rural Geriatric Cancer Patient Population
Sponsor:
Weill Medical College of Cornell University
Organization:
Study Overview
Official Title:
Adaptation of Ca-HELP Intervention in Rural Geriatric Cancer Patient Population
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30AG022845-16 | NIH | None | https://reporter.nih.gov/quic… | View |