Feasibility of a Positive Psychology Intervention for Hematopoietic Cell Transplant Survivors to Improve Quality of Life

Fred Hutchinson Cancer Center2 个研究点分布在 1 个国家目标入组 29 人开始时间: 2018年5月18日最近更新: 2020年3月4日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Fred Hutchinson Cancer Center
入组人数: 29
试验地点: 2
主要终点: Study enrollment rates

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This trial studies a positive psychology intervention designed to improve quality of life in stem cell transplant survivors and their caregivers. Positive psychology (PP) uses systematic exercises (e.g., gratitude letters, acts of kindness) to potentially boost levels of optimism, resilience, and life enjoyment. PP interventions are often enjoyable, easy to understand, and can be delivered via telephone. PP intervention may improve the quality of life of participants who have undergone a stem cell transplant or their caregivers.

详细描述

PRIMARY OBJECTIVES:

I. Pilot a positive psychology intervention delivered to hematopoietic cell transplantation (HCT) survivors and interested caregivers over an 8 week period.

II. Determine the proportion of patients who enroll and the immediate benefit to participants, as measured by pre- and post-exercise measures of happiness and optimism.

III. Pilot outcome data collection mechanisms in preparation for a randomized clinical trial.

OUTLINE:

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
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

•Written informed consent
•English as primary language
•At least 1 year after HCT

排除标准

•Major psychiatric diagnosis that impairs cognitive functioning or is not controlled at the time of the approach.
•Medical conditions precluding participation in the intervention or likely to lead to death within 6 months, as determined by the principal investigator (PI)

结局指标

主要结局

Study enrollment rates

时间窗: Up to 8 weeks

The analysis of the study will mainly be descriptive. The proportion of participants who consent to enroll in the study will be computed based on the number approached through each method. Reasons for non-participation will be summarized. A larger randomized trial will be considered feasible if the enrollment rate for patients approached in person or over the phone is \> 50% (excluding the active opt-out rate) and the overall completeness of follow-up data collection is \> 70%, excluding patients who have died or are hospitalized/ill at the assessment point. Since the number of caregivers who will participate is unknown, caregiver analyses will also be descriptive only.

Positive psychology intervention completion rates

时间窗: Up to 8 weeks

Completeness of follow-up data collection

时间窗: Up to 8 weeks

Completeness is defined by the proportion of instrument scores that can be calculated per given time point. The completeness of follow-up data collection will be calculated and reported as a proportion of successfully completed scales versus scales attempted to be collected or completed by patients.

Changes in happiness after each exercise

时间窗: Baseline up to 8 weeks

Change in happiness for each exercise will be analyzed by change scores. A change of 2 points on a 0-10 scale, with 10 being happiest, is considered clinically meaningful.

Changes in optimism after each exercise

时间窗: Baseline up to 8 weeks

Change in optimism for each exercise will be analyzed by change scores. A change of 2 points on a 0-10 scale, with 10 being most optimistic, is considered clinically meaningful.

Changes in mental health