Implementing Communication Strategies to Improve the Quality of Life of Cancer Survivors and Caregivers
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 298
- 试验地点
- 1
- 主要终点
- 1. Symptom Severity Index- Comparison of Two Groups Created by First Randomization at weeks 1-13 and week 17 using the modified General Symptom Distress Scale (GSDS).
研究概览
简要总结
Caregivers, typically family members or friends, provide more than half of the care needed for cancer survivors, often with negative health consequences. At least 30% of survivors and their caregivers report psychological distress (depression and anxiety) and such distress may interfere with optimal symptom management. This study will support both members of the survivor-caregiver dyad in the management of the survivor’s cancer- and treatment-related symptoms and the dyad’s psychological distress. There are no such studies reported from India on the integration of two potentially synergistic interventions, SMT, and TIP-C to achieve outcomes that are better than a simple sum of the two because, as argued under the scientific premise. SMART design will be used for this study over alternative designs (e.g., implementation designs) because the SMART design allows a precision or personalized approach to determine the right treatment at the right dose with the right sequence for the right survivor-caregiver dyad. The objectives of this study are to determine if dyads in the TIP- C+SMT as compared to the SMT alone will have lower depression, anxiety, and summed severity of 13 other symptoms, lower use of healthcare services (hospitalizations, and emergency care), greater self-efficacy, social support, and lower caregiver burden. It will also test the interdependence in survivor’s and caregiver’s primary and secondary outcomes.
We will use two evidence-based interventions: Symptom Management Toolkit (SMT) and Telephone Interpersonal Counseling (TIP-C). Although we have established the overall efficacy of these interventions, individuals differ in responses. We will enroll 298 survivors with elevated depression or anxiety who are undergoing radiotherapy, chemotherapy, or targeted therapy for a solid tumor and their 298 caregivers. Dyads will be initially randomized to SMT alone or TIP-C +SMT. Outcome data will be collected at baseline, weeks 13 (post-intervention) and 17 (follow-up). Assessments during weeks 1-12 will document changes in symptoms, intervention receipt, enactment, and fidelity. Caregivers’ and survivors’ symptoms will be measured using the adapted General Symptom Distress Scale (GSDS). Caregivers’ and survivors’ depression and anxiety, self-efficacy, and social support will be measured by PROMIS-short forms 8. Findings will be used to improve symptom management and reduce distress in survivor-caregiver dyads.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion Criteria for cancer survivor
- •age 18 or older
- •undergoing chemotherapy, hormonal therapy, or targeted therapy for a solid tumor cancer
- •able to perform basic activities of daily living
- •cognitively oriented to time, place, and person (determined by recruiter)
- •reporting severity of more than 2 on depression or more than 4 on anxiety using a 0-10 standardized scale
- •able to speak and understand English or Hindi
- •access to a telephone
- •has a caregiver who can be in any relationship role e.g., spouse, sibling, parent, friend, who can participate with them.
- •access to a telephone
- •not currently receiving counseling and/or psychotherapy
- •not currently treated for cancer.
排除标准
- •diagnosis of a psychotic disorder in the health record; nursing home resident; bedridden; currently receiving counseling and/or psychotherapy.
结局指标
主要结局
1. Symptom Severity Index- Comparison of Two Groups Created by First Randomization at weeks 1-13 and week 17 using the modified General Symptom Distress Scale (GSDS).
时间窗: 1. 1-13 week, 17 week | 2. 5-13 weeks and per week | 3. weekly 13 week, 17 week
2. Symptom Severity Index- Comparison of Two Groups Created by Second Randomization at weeks 5-13 and per week using the modified General Symptom Distress Scale (GSDS).
时间窗: 1. 1-13 week, 17 week | 2. 5-13 weeks and per week | 3. weekly 13 week, 17 week
3. Change in Number and Distress Associated with Caregivers and Survivors Symptoms weekly for 13 weeks and follow-up at 17 weeks
时间窗: 1. 1-13 week, 17 week | 2. 5-13 weeks and per week | 3. weekly 13 week, 17 week
次要结局
- Depressive Symptoms- Comparison of Two Groups Created by First Randomization at week 13(and week 17 using Center for Epidemiological Studies- Depression (CES-D) 20-item scale.)
- Depressive Symptoms- Comparison of Two Groups Created by Second Randomization at week(13 and week 17 using Center for Epidemiological Studies- Depression (CES-D) 20-item scale.)
- Anxiety Symptoms- Comparison of Two Groups Created by First Randomization at week 13 and(week 17 using Patient-Reported Outcomes Measurement Information System (PROMIS)-Anxiety)
- Anxiety Symptoms- Comparison of Two Groups Created by Second Randomization at week 13 and(week 17 using Patient-Reported Outcomes Measurement Information System (PROMIS)-Anxiety 8a)
- Change in Hospitalizations, provider visits, urgent care or Emergency Department visits at baseline,(week 13, 17))
- Change in Depression and Anxiety of Survivor and Caregiver at baseline, week 13, 17) using Patient(Reported Outcomes Information System (PROMIS) depression and anxiety 8 item short form scales.)
- Change in Survivor and Caregiver Self-Efficacy at baseline, week 13, 17) using PROMIS Self-Efficacy(for managing symptoms-sf4a.)
- Change in Survivor and Caregiver Social Support at baseline, weeks 13, 17) using PROMIS(Informational and Emotional Support-8 item short forms.)
- Change in Caregiver Reactions at baseline, weeks 13, 17 using Caregiver Reaction Assessment Tool.(0 week, 13 week, 17 week)
研究者
Abhishek Shankar
All India Institute of Medical Sciences