IMPACT: Improving Access to Cancer Survivorship Via Telehealth
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 261
- 试验地点
- 1
- 主要终点
- Initial participation rate of cancer survivors identified from community-based or partner practices, and Cancer Surveillance System of Western Washington
研究概览
简要总结
This trial studies how well self-generated survivorship care plans and telehealth education works in improving knowledge and self-efficacy in cancer survivors living in rural areas. Patients living in rural areas often face barriers to survivorship care and report unmet needs. A survivorship care plan created by the patient (self-generated) may help them to better transition from oncology to primary care and improve communication between care teams in order to meet these needs and create better health outcomes. Telehealth is a way of delivering health care services from a distance, including patient education. Combining a self-generated survivorship care plan with telehealth education may help to improve knowledge and self-efficacy in cancer survivors.
详细描述
OUTLINE:
Patients complete a questionnaire at baseline (paper, online, or telephone-based) and have medical records reviewed and are assigned to 1 of 3 cohorts.
COHORTS A AND B: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive a self-generated SCP (i.e., generated from baseline questionnaire responses).
ARM II: Patients receive a self-generated SCP as in Arm I. Patients also receive a 30-minute telephone-based educational counseling session on survivorship care administered by trained lay health counselors.
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
- Double (Care Provider, Investigator)
盲法说明
Personnel other than the statisticians and lay health educators
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cancer survivors who have completed curative therapy within the past 5 years (may still currently be on long-term/targeted non-cytotoxic agent maintenance therapy, e.g., tamoxifen or aromatase inhibitors for breast cancer survivors; androgen deprivation therapy for prostate cancer survivors)
- •History of either adult-onset (age >= 18) lymphoma, breast, colorectal, lung, or prostate cancer
- •Able to perform all study requirements, including responding to questionnaires
- •Willing to be randomized
- •Capable of providing informed consent
- •Consent to release oncology and primary care medical records
- •English or Spanish speakers
- •PRIMARY CARE PROVIDERS: PCPs responsible for delivering primary care to IMPACT study participants will be contacted about participating in the study after participant enrollment into the study.
- •ONCOLOGY STAFF: Oncology Staff (Oncologists, Nurse Practitioners, Physician's assistants) will be recruited from sites involved in the IMPACT study
- •CLINIC ADMINISTRATORS: Clinic administrators will be recruited from sites involved in the IMPACT study
排除标准
- •Currently on palliative or hospice care, or considering transferring to such care within the next 3 months
- •Lacks telephone access
- •Lacks mailing address or ability to receive study materials electronically
- •Currently being followed in a pediatric clinical setting (either for primary care or for cancer care)
- •History of having had > 1 cancer type diagnosed and treated (exception is for skin cancers treated with surgical excision alone; also, individuals who only have had relapse of their initial cancer remain eligible so long as they have completed curative therapy and meet all other eligibility criteria)
研究组 & 干预措施
Arm I (patient-generated SCP)
Patients receive a self-generated SCP (i.e., generated from baseline questionnaire responses).
干预措施: Survivorship Care Plan (Other)
Arm I (patient-generated SCP)
Patients receive a self-generated SCP (i.e., generated from baseline questionnaire responses).
干预措施: Questionnaire Administration (Other)
Arm II (patient-generated SCP, counseling)
Patients receive a self-generated SCP as in Arm I. Patients also receive a 30-minute telephone-based educational counseling session on survivorship care administered by trained lay health counselors.
干预措施: Survivorship Care Plan (Other)
Arm II (patient-generated SCP, counseling)
Patients receive a self-generated SCP as in Arm I. Patients also receive a 30-minute telephone-based educational counseling session on survivorship care administered by trained lay health counselors.
干预措施: Educational Intervention (Other)
Arm II (patient-generated SCP, counseling)
Patients receive a self-generated SCP as in Arm I. Patients also receive a 30-minute telephone-based educational counseling session on survivorship care administered by trained lay health counselors.
干预措施: Questionnaire Administration (Other)
Arm III (generic information)
Patients receive generic information on survivorship care on study.
干预措施: Questionnaire Administration (Other)
Arm III (generic information)
Patients receive generic information on survivorship care on study.
干预措施: Supportive Care (Other)
Arm IV (generic information, patient-generated SCP)
Patients receive generic information on survivorship care and a self-generated SCP as in Arm I on study.
干预措施: Questionnaire Administration (Other)
Arm IV (generic information, patient-generated SCP)
Patients receive generic information on survivorship care and a self-generated SCP as in Arm I on study.
干预措施: Supportive Care (Other)
Arm IV (generic information, patient-generated SCP)
Patients receive generic information on survivorship care and a self-generated SCP as in Arm I on study.
干预措施: Survivorship Care Plan (Other)
Arm V (generic information, patient-generated SCP, counseling)
Patients receive generic information on survivorship care as well as a self-generated SCP as in Arm I and a telephone-based educational counseling session as in Arm II on study.
干预措施: Survivorship Care Plan (Other)
Arm V (generic information, patient-generated SCP, counseling)
Patients receive generic information on survivorship care as well as a self-generated SCP as in Arm I and a telephone-based educational counseling session as in Arm II on study.
干预措施: Educational Intervention (Other)
Arm V (generic information, patient-generated SCP, counseling)
Patients receive generic information on survivorship care as well as a self-generated SCP as in Arm I and a telephone-based educational counseling session as in Arm II on study.
干预措施: Questionnaire Administration (Other)
Arm V (generic information, patient-generated SCP, counseling)
Patients receive generic information on survivorship care as well as a self-generated SCP as in Arm I and a telephone-based educational counseling session as in Arm II on study.
干预措施: Supportive Care (Other)
结局指标
主要结局
Initial participation rate of cancer survivors identified from community-based or partner practices, and Cancer Surveillance System of Western Washington
时间窗: Up to 8 weeks
Accuracy of survivors' self-generated survivorship care plans (SCPs) in relation to those based on medical record abstraction
时间窗: Up to 8 weeks
Will measure the accuracy of participants' SCPs by comparing their self-reported medical history collected via questionnaire, with data abstracted from medical records. Accuracy will be reported by percentage of missing data in the self-generated SCP compared to medical records, and percentage of incorrect data in the self-generated SCP compared to medical records.
Proportion of survivors who receive the phone-based education session within the study time period
时间窗: Up to 8 weeks
Proportion of survivors who complete the follow-up questionnaire within the study time period
时间窗: Up to 8 weeks
Response rate among primary care providers (PCPs) to the PCP survey
时间窗: Up to 8 weeks
次要结局
- PCP self-efficacy towards survivorship care(Up to 8 weeks)
- Participant perceived self-efficacy: questionnaire using the PROMIS Global 10 and health related self-efficacy scales(Up to 8 weeks)
- Survivorship knowledge(Up to 8 weeks)
- Local oncology clinics' attitudes towards survivorship care implementation(Up to 8 weeks)