Adaptation of Ca-HELP Intervention in Rural Geriatric Cancer Patient Population

Pain Clinical Trial

Official title:

Adaptation of Ca-HELP Intervention in Rural Geriatric Cancer Patient Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04262232
• Other study ID #: 19-04020220
• Secondary ID: P30AG022845-16
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: May 5, 2022

Study information

• Verified date: March 2023
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 5, 2022
• Est. primary completion date: May 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Behavioral:
• 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).

Locations

Country	Name	City	State
United States	Maury Regional Medical Center	Columbia	Tennessee

Sponsors (5)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Brown University, Fred Hutchinson Cancer Center, Maury Regional Medical Center, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility (Aim 2), as Measured by Number of Subjects Accrued to the Study	Number of subjects accrued	Two weeks post-intervention
Primary	Feasibility (Aim 2), as Measured by Number of Subjects to Complete the Intervention	Number of subjects to complete intervention	Two weeks post-intervention
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.	Two weeks post-intervention
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.	Two weeks post-intervention
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.	Two weeks post-intervention
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.	Two weeks post-intervention
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.	Two weeks post-intervention
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).	Baseline, two weeks post-intervention
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.	Baseline, two weeks post-intervention
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.	Two weeks post-intervention
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).	Baseline, two weeks post-intervention
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).	Baseline, two weeks post-intervention
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).	Baseline, two weeks post-intervention