Adaptation of Ca-HELP Intervention in Rural Geriatric Cancer Patient Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Feasibility (Aim 2), as Measured by Number of Subjects to Complete the Intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
No masking due to this being a single arm study.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Feasibility (Aim 2), as Measured by Number of Subjects to Complete the Intervention
时间窗: Two weeks post-intervention
Number of subjects to complete intervention
Change in Pain Self-management (Aim 3)
时间窗: Baseline, two weeks post-intervention
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).
Acceptability (Aim 2), as Measured by Qualitative Feedback
时间窗: Two weeks post-intervention
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.
Acceptability (Aim 2), as Measured by Helpfulness
时间窗: Two weeks post-intervention
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.
Feasibility (Aim 2), as Measured by Number of Subjects Accrued to the Study
时间窗: Two weeks post-intervention
Number of subjects accrued
Acceptability (Aim 2), as Measured by Readability
时间窗: Two weeks post-intervention
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.
Acceptability (Aim 2), as Measured by Usability
时间窗: Two weeks post-intervention
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.
Acceptability (Aim 2), as Measured by Satisfaction
时间窗: Two weeks post-intervention
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.
Change in Pain Misconceptions (Aim 3)
时间窗: Baseline, two weeks post-intervention
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.
次要结局
- Change in Self-efficacy for Communicating With Physicians About Pain Severity(Baseline, two weeks post-intervention)
- Change in Pain Severity(Baseline, two weeks post-intervention)
- Treatment Fidelity as Measured by Number of Subjects for Which the Intervention Was Delivered With Fidelity(Two weeks post-intervention)
- Change in Pain-related Impairment(Baseline, two weeks post-intervention)