Clinical trial NCT04262232: Adaptation of Ca-HELP Intervention in Rural Geriatric Cancer Patient Population
Official title: Adaptation of Ca-HELP Intervention in Rural Geriatric Cancer Patient Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Maury Regional Medical Center
name: Brown University
name: National Institute on Aging (NIA)
name: Fred Hutchinson Cancer Center
First posted: 2020-02-10
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single arm study in which all participants will be exposed to the intervention (Ca-HELP).
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Feasibility (Aim 2), as Measured by Number of Subjects Accrued to the Study
timeFrame: Two weeks post-intervention
measure: Feasibility (Aim 2), as Measured by Number of Subjects to Complete the Intervention
timeFrame: Two weeks post-intervention
measure: Acceptability (Aim 2), as Measured by Qualitative Feedback
timeFrame: Two weeks post-intervention
measure: Acceptability (Aim 2), as Measured by Helpfulness
timeFrame: Two weeks post-intervention
measure: Acceptability (Aim 2), as Measured by Satisfaction
timeFrame: Two weeks post-intervention
measure: Acceptability (Aim 2), as Measured by Usability
timeFrame: Two weeks post-intervention
measure: Acceptability (Aim 2), as Measured by Readability
timeFrame: Two weeks post-intervention
measure: Change in Pain Self-management (Aim 3)
timeFrame: Baseline, two weeks post-intervention
measure: Change in Pain Misconceptions (Aim 3)
timeFrame: Baseline, two weeks post-intervention
Secondary outcomes:
measure: Treatment Fidelity as Measured by Number of Subjects for Which the Intervention Was Delivered With Fidelity
timeFrame: Two weeks post-intervention
measure: Change in Self-efficacy for Communicating With Physicians About Pain Severity
timeFrame: Baseline, two weeks post-intervention
measure: Change in Pain-related Impairment
timeFrame: Baseline, two weeks post-intervention
measure: Change in Pain Severity
timeFrame: Baseline, two weeks post-intervention
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Maury Regional Medical Center
state: Tennessee
Study officials:
affiliation: Weill Medical College of Cornell University
name: Cary Reid, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fred Hutchinson Cancer Center
name: Megan Shen, PhD
role: PRINCIPAL_INVESTIGATOR
References: