Compassion Meditation for Cancer Survivor-Caregiver Dyads: Feasibility and Preliminary Efficacy of Cognitively-Based Compassion Training (CBCT®) for Solid Tumor Cancer Survivors and Their Informal Caregivers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- change in depression features
研究概览
简要总结
Survivors of solid tumor cancers and their informal caregivers (family, friends) experience impairments in health-related quality of life (HRQOL) including disruptions in psychological, physical, social, and spiritual well-being. Our prior work demonstrates that impairments in depression, anxiety, fatigue, and negative affect experienced by cancer survivors across time are interdependent those experienced by their informal caregivers. These findings suggest that interventions directed simultaneously toward both members of the cancer survivor-caregiver dyad may be especially impactful in improving HRQOL in cancer survivors and informal caregivers. Although a number of interventions have been developed and tested to support the survivor or the caregiver, few have attempted to simultaneously intervene with both to improve HRQOL within the collective survivor-caregiver dyad. CBCT®, Cognitively-Based Compassion Training (already piloted by members of this team with breast cancer survivors, is an 8-week manualized meditation-based program that starts with attention and mindfulness training and builds to contemplation about compassion for the self and others. The proposed pilot feasibility study builds upon this work to intervene with caregivers in addition to survivors of solid tumor cancers. The major aim of the proposed project is to test the feasibility and acceptability of CBCT® for survivors of solid tumor cancer and their informal caregivers after the end of cancer treatment. The project will also determine in a preliminary manner whether or not CBCT® (compared to a cancer health education [CHE] comparison group) has a positive impact on different measures of HRQOL (e.g. features of depression and anxiety, fatigue, social isolation), stress-related biomarkers of inflammation and cortisol, and assessments related to healthcare utilization.
IMPORTANT READER NOTE: ==> A prior version of this study protocol on clinicaltrials.gov incorrectly stated information about interpretation of scores of the Morisky Medication Adherence Scale-8 (MMAS-8). ==> Individuals interested in using the MMAS-8 are directed to https://morisky.org for information about the scale, as well as for licensing and other requirements for using the MMAS-8 in their research or clinical practice. Dr. Pace and his colleagues sincerely regret any incorrect information posted previously about the MMAS-8 on this clinicaltrials.gov trial website.
详细描述
The overarching purpose of this research is to determine the feasibility, acceptability, and preliminary efficacy of Cognitively-Based Compassion Training (CBCT®) compared to a cancer health education (CHE) attention on dimensions of health-related quality of life (HRQOL), biomarkers of inflammation and diurnal cortisol rhythm, and healthcare utilization-related endpoints including healthcare-related patient activation. To address this goal the study will be conducted to address four specific aims:
Aim 1: To obtain evidence of preliminary efficacy of CBCT® versus CHE for survivors of solid tumor cancer and their informal caregivers to improve health-related quality of life outcomes. The objective of this aim is to estimate effect sizes for the differences between CBCT® and CHE at weeks 9 and 13 on HRQOL-related outcomes including psychological (depression*, anxiety, positive affect), physical (fatigue), social (empathy, feelings of social connection/isolation, dyadic function), and spiritual (self-compassion) domain as well as global well-being. The noted endpoint (*) is considered primary, and the others are secondary. We predict that CBCT® will result in better primary and secondary outcomes than CHE at weeks 9 and 13 (Study Hypothesis 2).
Aim 2: To obtain preliminary evidence of efficacy of CBCT® versus CHE for survivors of solid tumor cancer and their informal caregivers to influence stress-related biomarkers of inflammation and diurnal cortisol rhythm. The objective of this aim is to estimate group differences at weeks 9 and 13 on stress-related biomarkers of inflammation (plasma IL-6, IL-1β, TNF-α), as well as diurnal saliva cortisol rhythm in survivor-caregiver dyads randomized to CBCT® compared to survivor-caregiver dyads randomized to CHE. For this aim we predict that CBCT® will result in lower proinflammatory cytokines (decreased IL-6, IL-1β, TNF-α) than CHE at weeks 9 and 13 (Study Hypothesis 3). We also predict that CBCT® will result in steeper slope (i.e. more dynamic diurnal cortisol rhythm) than CHE at weeks 9 and 13 (Study Hypothesis 4).
Aim 3: To obtain preliminary evidence of efficacy of CBCT® versus CHE for survivors of solid tumor cancer and their informal caregivers to improve health care utilization and patient activation in both survivors of solid tumor cancers and their informal caregivers over 13 weeks of the study. The objective of this aim is to estimate effect sizes for the differences between CBCT® and CHE at weeks 9 and 13 on health care utilization (i.e. keeping appointments, use of preventive services, hospitalizations, and use of urgent care or emergency department services), and patient activation (i.e. motivation, knowledge, skills and confidence in managing personal health). For this aim, we predict that CBCT® will result in better healthcare utilization (lower hospitalizations, use of urgent care or emergency department services, greater keeping of the appointments and use of preventive services), and greater patient activation than CHE over weeks 1-9 and 10-13 of the study (Study Hypothesis 5).
Aim 4: To explore the interdependence of solid tumor cancer survivor and informal caregiver health-related quality of life from before to after CBCT®. The objective of this aim is to determine the degree to which HRQOL measures, biomarkers of inflammation, or diurnal cortisol rhythm in survivors predict the corresponding outcomes in caregivers (and vice-versa).
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 (Investigator)
盲法说明
All investigators will remain blinded, except for the study interventionists who will administ the CBCT® and CHE programs to participants and research coordinator who will inform participants about group assignment. Study interventionists and the study coordinator will not conduct data collection procedures or analyses of data that is collected.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cancer survivor inclusion criteria: 1) age 21 or older, 2) have a solid tumor cancer diagnosis, 3) have completed treatments (surgery, radiation, chemotherapy) except for hormonal therapies (e.g. aromatase inhibitors, androgen suppression therapy) a minimum of 3 months and a maximum of 10 years before starting CBCT® or CHE, 4) able to speak and understand English, and 5) able to travel to a centralized location to attend CBCT® or attention control classes.
- •Informal caregiver inclusion criteria will be: 1) named by the cancer survivor, 2) age 21 or older, 3) able to speak and understand English, 4) cognitively oriented in time, place, and person, and 5) able to travel to a centralized location to attend intervention classes with their solid tumor cancer survivor. Informal caregivers will be excluded if they have ongoing or past regular compassion meditation experience in the last 4 years.
- •In addition to these criteria, either the cancer survivor or the informal caregiver must report at least mild anxiety (PROMIS anxiety 4-item raw score > 6) and/ or mild depressive symptoms (PROMIS anxiety 4-item raw score > 6).
排除标准
- •Cancer survivor exclusionary factors: 1) diagnosis of major mental illness, 2) nursing home resident, and 3) have ongoing or past regular compassion meditation experience in the last 4 years (i.e. more than two compassion meditation session [completed or attempted] per year, either with a group or individually).
- •Informal caregiver exclusionary factors: 1) diagnosis of major mental illness, 2) nursing home resident, and 3) have ongoing or past regular compassion meditation experience in the last 4 years (i.e. more than two compassion meditation session [completed or attempted] per year, either with a group or individually).
研究组 & 干预措施
Cognitively-Based Compassion Training
Cancer survivors and their informal caregivers (family and close friends), one of whom has at least mild depression and/or anxiety features (determined by PROMIS Depression 4a and PROMIS Anxiety 4a, respectively) who are randomized to CBCT®.
干预措施: Cognitively-Based Compassion Training (Behavioral)
CHE (Cancer Health Education)
Cancer survivors and their informal caregivers (family and close friends), one of whom has at least mild depression and/or anxiety features (determined by PROMIS Depression 4a and PROMIS Anxiety 4a, respectively) who are randomized to CHE.
干预措施: CHE (Cancer Health Education) (Behavioral)
结局指标
主要结局
change in depression features
时间窗: change from baseline depression score at 9 weeks
The difference in the change in depression features between the intervention arms from before to immediately after the 8-week interventions will be measured with the PROMIS-short form 8a depression scale.
次要结局
- change in feelings of social isolation / connection one month after the end of the intervention(change from baseline Social Connectedness Scale-Revised score 3 months)
- change in anxiety features(change from baseline anxiety score at 9 weeks)
- change in fatigue(change from baseline fatigue score at 9 weeks)
- change in empathy(change from baseline IRI total score at 9 weeks)
- change in feelings of social isolation / connection(change from baseline Social Connectedness Scale-Revised score at 9 weeks)
- change in negative affect(change from baseline 10-item Positive and Negative Affect Schedule score at 3 months)
- change in dyadic function(change from baseline Relationship Assessment Scale score at 3 months)
- change in self-compassion(change from baseline Self-Compassion Scale score at 3 months)
- change in global well-being(change from baseline Quality of Life Index score at 3 months)
- change in inflammatory biomarkers(change from baseline inflammation markers at 3 months)
- change in diurnal saliva cortisol rhythm(change from baseline diurnal saliva cortisol rhythm at 3 months)
- change in healthcare activation / utilization(change from baseline healthcare activation/ utilization 3 months)
- change in depression features one month after the end of the intervention(change from baseline depression score at 3 months)
- change in anxiety features one month after the end of the intervention(change from baseline anxiety score at 3 months)
- change in fatigue one month after the end of the intervention(change from baseline fatigue score 3 months)
- change in empathy one month after the end of the intervention(change from baseline IRI total score 3 months)
- change in negative affect(change from baseline 10-item Positive and Negative Affect Schedule score at 9 weeks)
- change in dyadic function(change from baseline Relationship Assessment Scale score at 9 weeks)
- change in self-compassion(change from baseline Self-Compassion Scale score at 9 weeks)
- change in global well-being(change from baseline Quality of Life Index score at 9 weeks)
- change in inflammatory biomarkers(change from baseline inflammation markers at 9 weeks)
- change in diurnal saliva cortisol rhythm(change from baseline diurnal saliva cortisol rhythm at 9 weeks)
- change in healthcare activation / utilization(change from baseline healthcare activation/ utilization at 9 weeks)
研究者
Thaddeus Pace
Assistant Professor of Nursing, Psychiatry, and Psychology
University of Arizona