Personal Archetypes Toward Healing (PATH) Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Accrual rates (feasibility) (Aim 1)
研究概览
简要总结
This clinical trial tests the feasibility and effectiveness of a spiritual health intervention (Personal Archetypes Toward Healing Trial [PATH]) for improving spiritual, religious and existential distress in patients with cancer. Many patients with cancer find their diagnosis to elicit challenges to their sense of connection, meaning, and purpose. This distress can significantly impact their quality of life. However, spiritual care interventions are often overlooked. PATH builds on multiple theories and therapeutic practices such as role-playing, archetype psychology, cognitive theory, emotion regulation therapy, and dignity therapy. PATH sessions cover topics such as individuation, intrapersonal meaning and worth, intrapersonal distress and faith, interpersonal distress and faith, and transpersonal distress and faith. The PATH intervention may help cancer patients shift their perspectives and access new insights for working through their spiritual, religious and existential distress.
详细描述
OUTLINE:
Patients attend 1 individual PATH session with the interventionist on day 1 and then attend group PATH workshop sessions weekly for 5 sessions (days 7, 14, 21, 28, and 35).
After completion of study intervention, patients are followed up on days 42 and 84.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years of age or older
- •English speaking
- •Able to provide informed consent
- •Current diagnosis of cancer at any stage, engaged in active treatment or surveillance at Fred Hutch Cancer Center
- •Scores of "Somewhat" or above on at least 1 item the Religious and Spiritual Struggles scale (RSS-5) (e.g., Somewhat = 3 on a 1-to-5 Likert scale)
排除标准
- •Non-oncology Fred Hutch patients
研究组 & 干预措施
Supportive care (PATH)
Patients attend 1 individual PATH session with the interventionist on day 1 and then attend group PATH workshop sessions weekly for 5 sessions (days 7, 14, 21, 28, and 35).
干预措施: Spiritual Therapy (Procedure)
Supportive care (PATH)
Patients attend 1 individual PATH session with the interventionist on day 1 and then attend group PATH workshop sessions weekly for 5 sessions (days 7, 14, 21, 28, and 35).
干预措施: Survey Administration (Other)
Supportive care (PATH)
Patients attend 1 individual PATH session with the interventionist on day 1 and then attend group PATH workshop sessions weekly for 5 sessions (days 7, 14, 21, 28, and 35).
干预措施: Interview (Other)
结局指标
主要结局
Accrual rates (feasibility) (Aim 1)
时间窗: At time of enrollment
Feasibility will be examined by conducting frequency and descriptive statistics for enrollment rates. The benchmark for feasibility is ≥ 50% of screened eligible patients enroll in the study. To test this, will perform a one-sample proportion test to examine if the proportion of participants meeting the benchmark for feasibility is significantly higher than 0.50. Feasibility process outcomes will be analyzed to determine whether the intervention is feasible for future dissemination and implementation efforts and recruitment of a full-scale randomized controlled trial.
Rates of intervention completion (feasibility) (Aim 1)
时间窗: Up to day 84
Intervention completion metrics will include all 6 intervention sessions as well as both follow-up timepoints (days 42 and 84). Patients will be required to attend at least 70% of all sessions (5 of 6). Feasibility will be examined by conducting frequency and descriptive statistics for intervention completion. The benchmark for feasibility is ≥ 70% of enrolled patients completing the intervention. To test this, will perform a one-sample proportion test to examine if the proportion of participants meeting the benchmark for feasibility is significantly higher than 0.70. Feasibility process outcomes will be analyzed to determine whether the intervention is feasible for future dissemination and implementation efforts and recruitment of a full-scale randomized controlled trial.
Acceptability (Aim 1)
时间窗: Up to day 42
Acceptability will be assessed by the Theoretical Framework of Acceptability (TFA) questionnaire and three additional quality improvement questions. To analyze intervention acceptability, scores on the TFA questionnaire will be calculated using the total mean score of seven TFA items. In this study, will use a cutoff of \>= 70% of patients agreeing (or rating as confident, liking, acceptable or 4 out of 5 or higher on the TFA) as being acceptable for use.
Satisfaction (Aim 1)
时间窗: Up to day 42
Satisfaction will be assessed by using three items assessing overall satisfaction. Satisfaction thresholds will require an average or mean of 7 out of 10 on each of the three items.
Spiritual, religious and existential (SRE) distress (Aim 2)
时间窗: At baseline and 1- and 6-week follow-up (days 42 and 84)
Will be assessed by the Religious and Spiritual Struggles scale.
次要结局
- Self-transcendence (Aim 2)(At baseline and 1- and 6-week follow-up (days 42 and 84))
- Distress (Aim 2)(At baseline and 1- and 6-week follow-up (days 42 and 84))
- Anxiety (Aim 2)(At baseline and 1- and 6-week follow-up (days 42 and 84))