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

NCT04262232 | Completed Results

• 2 other identifiers: 19-04020220P30AG022845-16
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (9)

• Feasibility (Aim 2), as Measured by Number of Subjects Accrued to the Study

  Number of subjects accrued

  Two weeks post-intervention

• Feasibility (Aim 2), as Measured by Number of Subjects to Complete the Intervention

  Number of subjects to complete intervention

  Two weeks post-intervention

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (4)

• Treatment Fidelity as Measured by Number of Subjects for Which the Intervention Was Delivered With Fidelity

  Two weeks post-intervention

• Change in Self-efficacy for Communicating With Physicians About Pain Severity

  Baseline, two weeks post-intervention

• Change in Pain-related Impairment

  Baseline, two weeks post-intervention

• Change in Pain Severity

  Baseline, two weeks post-intervention

Study Arms (1)

Ca-HELP

EXPERIMENTAL

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).

Behavioral: Adapted Ca-HELP for Geriatric Cancer Patients

Interventions

Adapted Ca-HELP for Geriatric Cancer Patients 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).

Ca-HELP

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Maury Regional Medical Center: collaborator
• Brown University: collaborator
• National Institute on Aging (NIA): collaborator
• Fred Hutchinson Cancer Center: collaborator

Study Sites (1)

Maury Regional Medical Center

Columbia, Tennessee, 38401, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Megan Shen
• Organization: Fred Hutchinson Cancer Center

mshen2@fredhutch.org

206-667-4172

Study Officials

• Cary Reid, MD, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• Megan Shen, PhD

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking due to this being a single arm study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single arm study in which all participants will be exposed to the intervention (Ca-HELP).

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 10, 2020
• Study Start: May 1, 2021
• Primary Completion: May 5, 2022
• Study Completion: May 5, 2022
• Last Updated: March 22, 2023
• Results First Posted: March 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)