Integrative Palliative Care/Psycho-Oncology Telehealth Group Medical Visits for Patients With Advanced Cancer: A Pilot Study
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
- Retention rate
研究概览
简要总结
This trial investigates whether a joint and integrative approach to cancer care using palliative care and psycho-oncology is possible, and if it's beneficial to patients with cancer that has spread to other places on the body (advanced). The information gained from this study may help patients to learn about the medicinal and non-medicinal strategies to cope with their symptoms and side effects of their diagnosis and treatment while receiving peer support, in addition to standard individualized medical care.
详细描述
PRIMARY OBJECTIVES:
I. To develop and refine a joint Integrative Palliative Care/Psycho-oncology telehealth group medical visit (GMV) intervention based on feedback from an open pilot study with patient exit interviews.
II. To determine the feasibility and acceptability of the telehealth GMVs in a separate, single-arm pilot evaluation among patients with advanced cancer.
SECONDARY OBJECTIVE:
I. To estimate the preliminary efficacy of the GMVs among patients with advanced cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Carry a diagnosis of an advanced solid tumor cancer (locally advanced or metastatic, i.e., stage III or IV cancer)
- •Be age >= 18 years
- •Be able to speak and read English
- •Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet (assessed by participant self-report)
- •Be capable of independently utilizing an online platform for telehealth group medical visits in a private setting (assessed by participant self-report)
- •Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
- •Be able to understand a written informed consent document, and be willing to sign it
排除标准
- •Have a cognitive or psychiatric condition prohibiting study consent or participation determined by co-principal investigators (PIs) or referring provider
- •Be too medically unstable (or expected to become so during the study period) to participate in a telehealth group medical visit determined by co-PIs or referring providers
- •Does not have insurance coverage for telehealth group medical visits
- •Have extensive hearing loss such that ability to participate in the study would be impaired as determined by co-PIs or referring provider
结局指标
主要结局
Retention rate
时间窗: Up to 3 months
The percentage of patients who complete pre and post-treatment questionnaires.
Frequency of Participant Ineligibility Reason
时间窗: Up to 14 days
For potential study candidates who are ineligible, we will log reasons for ineligibility
Frequency of Participant Refusal Reason
时间窗: Up to 14 days
For potential study candidates who decide not to participate, we will log reasons for refusal.
Develop Categories for intervention refinement (Phase 1)
时间窗: Up to 3 months
Qualitative methods to analyze participant feedback obtained during exit interviews and code notes from by the existing domains: session relevance, delivery mode, ease of participation, suggested changes. A thematic content analysis will be performed to determine themes based on patterns and responses in these categories. Two coders will then meet to discuss the themes and reach agreement on final categories used to refine intervention for Phase 2 participants.
Proportion of participants enrolled
时间窗: 14 days
The proportion of eligible and approached patients who consent to participate.
Mean post-treatment participant satisfaction ratings
时间窗: 1 day
Participant ratings on intervention convenience, helpfulness, recommendation to others, worth doing, and feeling connected with University of California, San Francisco (UCSF). Descriptive statistics (frequencies, means, and standard deviations (SDs)) and 95% confidence intervals will summarize patients' ratings
Adherence rate
时间窗: Up to 3 months
Percentage of patients who complete 2 or more sessions. Will use one-sample negative binomial probability and tests of binomial proportions to compare rates of feasibility to hypothesized values.
Number of participants deemed ineligible or refusing to participate
时间窗: Up to 3 months
Number of participants who are determined to be ineligible before 1st virtual visit or refusal to participate before 1st visit and during treatment.
次要结局
- Change in distress score on the Edmonton Symptom Assessment System (ESAS)(Up to 3 months)
- Change in scores on the Patient Health Questionnaire-8 (PHQ-8)(Up to 3 months)
- Change in score on the Cancer Behavior Inventory-Brief (CBI-B)(Up to 3 months)
- Change in score on the PROMIS Sleep Disturbance- Short Form 6a(Up to 3 months)
- Change in score on the PROMIS Fatigue - Short Form 6a(Up to 3 months)
- Change in score on the PROMIS Social Isolation -Short Form 4a Short Form 4a(Up to 3 months)
- Change in score on the Functional Assessment of Cancer Therapy- General (FACT-G)(Up to 3 months)
- Change in score on the Generalized Anxiety Disorder Assessment (GAD-7)(Up to 3 months)
- Change in score on the Patient Reported Outcomes Measurement Information System-Cancer (PROMIS) Pain Interference- Short Form 4a(Up to 3 months)
- Change in scores on the Quality of Life question(Up to 3 months)