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

NCT ID: NCT04262232

Last Updated: 2023-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2022-05-05

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.

Conditions

Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Adapted Ca-HELP for Geriatric Cancer Patients

Intervention Type: BEHAVIORAL

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).

Interventions

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maury Regional Medical Center

OTHER

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cary Reid, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Megan Shen, PhD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Locations

Maury Regional Medical Center

Columbia, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

P30AG022845-16

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-04020220

Identifier Type: -

Identifier Source: org_study_id