INSPIRE for Survivorship After Transplant: A Multicenter Randomized Controlled Trial of an Internet and Social-Media Program for Long-Term Hematopoietic Cell Transplantation Survivors
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,600
- 试验地点
- 12
- 主要终点
- Cancer and treatment distress (CTXD) score as reported on the PCA using binary outcomes
研究概览
简要总结
This randomized clinical trial studies an internet and social-media program for improving quality of life in long-term survivors who underwent stem cell transplant. In this study, researchers want to compare a survivorship internet program to the standard treatment of currently available internet sites for transplant survivors to learn which works better for people who have received bone marrow or blood stem cell transplants. A survivorship-focused internet program may improve mood, stress, and preventive health care, and provide useful health resources for transplant survivors. It is not yet known whether currently available internet sites are more effective than a survivorship-focused internet program in improving quality of life in cancer survivors.
详细描述
PRIMARY OBJECTIVES:
I. Determine whether 2-10 year hematopoietic cell transplant (HCT) survivors with elevated depression or cancer-related distress who are randomized to receive access to a tailored internet-based program report reduced depression and distress when compared with control group survivors who receive access to an internet site with links to transplant and cancer-specific online resources and delayed access to the internet site (active control).
II. Determine whether survivors with low survivorship preventive care adherence (PCA) who are randomized to receive access to the tailored internet-based program, including a survivorship preventive care plan, report increased PCA when compared with the active control group survivors.
SECONDARY OBJECTIVES:
I. Secondary outcomes will include process measures of internet study reach and utilization, as well as physical function, physical activity level, and knowledge of survivorship needs. Further analyses will identify risk factors for disparities in survivorship preventive care adherence in HCT survivors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •Received a transplant at a consortium center for a hematologic malignancy or myelodysplasia
- •Currently 2-10 years after first HCT
排除标准
- •Does not have internet and email access; note that survivors otherwise eligible, but excluded from full study participation because of this exclusion, will be asked to fill out a mailed copy of the baseline assessment for use in secondary aims analyses; they will be sent an information form and a copy of the tailored 'My Health Action Plan' health care guideline for transplant survivors also provided to randomized participants
- •English insufficient to complete baseline patient-reported outcomes (PRO) assessments
- •Has received treatment for a recurrent or 2nd cancer that required > surgical excision in the past 2 years or did not have a hematologic malignancy or myelodysplasia diagnosis or did not receive a first transplant between 2-10 years before approach for the study; (these participants will be ineligible for randomization, but will have intervention site access if they complete baseline PRO assessment)
- •Scores 20 or above on the patient health questionnaire (PHQ)-8 depression measure (indicating severe depression); these participants will be contacted by a study psychologist to evaluate and provide resources to address their needs (2% of enrollees in our previous study); they will be ineligible for randomization, but will have intervention site access if they complete baseline PRO assessment
- •Residing in an institution or other living situation where health care decisions are not made by the participant (e.g., hospitalized, prisoners, living in a rehabilitation facility)
- •Does not complete baseline PRO assessment items required to determine stratification or whether the survivor meets inclusion and exclusion criteria
- •Has medical or health issues prohibiting computer use (e.g., vision-impaired, cognitively impaired, illness or accident impairing computer function)
结局指标
主要结局
Cancer and treatment distress (CTXD) score as reported on the PCA using binary outcomes
时间窗: Up to 12 months
PHQ-8 depression score as reported on the PCA, using binary outcomes
时间窗: Up to 12 months
Proportion of adherence to recommended survivorship preventive care and barriers to PCA
时间窗: Up to 12 months
次要结局
- Total minutes per week of moderate to vigorous intensity exercise as assessed by the Godin Leisure Time Exercise Questionnaire(Up to 12 months)
- Health behaviors(Up to 12 months)
- Physical function, as assessed by the Patient Reported Outcomes Measurement Information System scale(Up to 12 months)