Cancer SurvivorsPhase 1/2NCT03459781
Compassion Meditation for Cancer Survivor-Caregiver Dyads
A Phase 1/2 study testing Cognitively-Based Compassion Training and CHE (Cancer Health Education) in people with Cancer Survivors and Informal Cancer Caregivers (Family and Friends of Cancer Survivors), run by Thaddeus Pace at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer Survivors, Informal Cancer Caregivers (Family and Friends of Cancer Survivors)
- What is being tested?
- Cognitively-Based Compassion Training and CHE (Cancer Health Education)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2018to 11 Jan 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
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).
Over the course of the study we will randomize 20 cancer survivor-caregiver dyads to CBCT®, and 20 dyads to the CHE attention group. We will conduct the study in several cohorts, with 4-10 dyads randomized to CBCT® and 4-10 dyads randomized with CHE in each cohort. The research procedures are elaborated below in chronological order of when they will occur for each study cohort. The study will consist of four major phases after recruitment/ screening/ consent:
- Baseline (pre-intervention) assessments
- Intervention phase
- 9-week (post-intervention) assessments
- 3-month (post intervention) assessments
Assessments - Baseline (pre-intervention)
After successful recruitment, screening, and consent we will invite solid tumor cancer survivor-informal caregiver dyads to the College of Nursing for the baseline assessment. Shortly after arrival blood will be collected from participants before starting self-report questionnaires. Blood will be drawn in order to obtain plasma and peripheral blood mononuclear cells (PBMCs). Blood (2 X 7 milliliters) will be collected by venipuncture into EDTA-coated vacutainer tubes by the (TBA) study phlebotomist, and then immediately processed to obtain plasma or PBMCs.
After blood sampling at the baseline assessment is complete we will next ask survivor-caregiver dyads to complete self-report assessments. Self-report instruments to be completed will assess different dimensions of health-related quality of life (HRQOL) and healthcare adherence/ utilization.
Interventions
Within 2 weeks of the baseline assessment study participants will begin either 8 weeks of CBCT® or 8 weeks of CHE, depending on randomization. Study group will be revealed to study participants and study staff after the completion of the baseline assessment.
Upon randomization to either the CBCT® or CHE groups participants will be given a booklet, "Survivorship and Surveillance Guidelines", and another booklet, "Healthy Behaviors for a Healthier Life." Although these booklets will not be referred to directly throughout CBCT® or CHE, participants will be encouraged review them and ask questions about the content of these booklets throughout the study. Participants with questions after reviewing these booklets will be referred to Dr. Badger, clinical co-I. These booklets are being included because they may have an indirect effect on measures of health care adherence/ utilization in both the CBCT® and CHE groups.
Assessments - 9 weeks
Within a week of concluding the study interventions we will schedule all survivor-caregiver dyads to return to the College of Nursing for the 9-week assessment. The 9-week assessment will mirror the baseline assessment except for the healthcare utilization questionnaire, which will use an 9-week version of this questionnaire.
Assessments - 3 months
About 4 weeks later we will have all survivor-caregiver dyads visit the College of Nursing for the final, 3-month assessment time point. As with the 8-week assessment, this visit will mirror the baseline assessment except for a different healthcare utilization questionnaire, which will use a 3-month version of this questionnaire.
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.
- Being tested
- Cognitively-Based Compassion Training, CHE (Cancer Health Education)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitively-Based Compassion TrainingBehavioural
CBCT® was designed at Emory University by Lobsang Tenzin Negi. CBCT® is a secular adaptation of techniques derived from traditional Tibetan Buddhist methods for cultivating compassion known as lo-jong. Over the course of 8 weeks there will a total of 8 CBCT® sessions, one session per week, led by the CBCT® instructor. Dyads will attend the weekly CBCT® classes together. Each weekly session will last for 90 minutes and will begin with brief meditation to focus attention. The instructor will then articulate content and goals of the current week, after which a group discussion led by the instructor will take place. A session will end with a 20-30 minute meditation. Dyads will be encouraged to practice a minimum of 10 minutes per day at home, and together as a dyad if possible.
CHE (Cancer Health Education)Behavioural
Also called Cancer Health Education
The cancer health education (CHE) intervention is an adaptation of the in-person program called Health Discussion, a protocol used by our group previously. The CHE will focus on relevant topics to health and cancer including 1) cancer advocacy, 2) health and cancer biology, 3) nutrition, 4) lifestyle interventions such as physical activity and goals for physical activity, 5) the importance of good sleep, 6) the impact of stress, and 7) mental health and social support. CHE will also discuss current events related to cancer. Over the course of 8 weeks there will be a total of 8 sessions, one session per week. Each session will last for approximately 90 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Cognitively-Based Compassion Training | Experimental | 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®. Receives: Behavioral: Cognitively-Based Compassion Training |
| CHE (Cancer Health Education) | Active comparator | 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. Receives: Behavioral: CHE (Cancer Health Education) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in depression features
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.
Measured: change from baseline depression score at 9 weeks
Secondary outcomes (23)
change in negative affect
Change in negative effect from from before to immediately after the 8-week interventions will be measured with the 10-item Positive and Negative Affect Schedule.
Measured: change from baseline 10-item Positive and Negative Affect Schedule score at 9 weeks
change in negative affect
Change in negative effect from from before to one month after the 8-week interventions will be measured with the 10-item Positive and Negative Affect Schedule.
Measured: change from baseline 10-item Positive and Negative Affect Schedule score at 3 months
change in dyadic function
Change in dyadic function from from before to immediately after the 8-week interventions will be measured with the Relationship Assessment Scale. This 7-item scale is designed to measure general relationship satisfaction. Respondents answer each item using a 5-point scale ranging from 1 (low satisfaction) to 5 (high satisfaction). Higher total scores indicate higher relationship satisfaction. The range of scores is from 7 to 35.
Measured: change from baseline Relationship Assessment Scale score at 9 weeks
change in dyadic function
Change in dyadic function from from before to one month after the 8-week interventions will be measured with the Relationship Assessment Scale. This 7-item scale is designed to measure general relationship satisfaction. Respondents answer each item using a 5-point scale ranging from 1 (low satisfaction) to 5 (high satisfaction). Higher total scores indicate higher relationship satisfaction. The range of scores is from 7 to 35.
Measured: change from baseline Relationship Assessment Scale score at 3 months
change in self-compassion
Change in self-compassion from from before to immediately after the 8-week interventions will be measured with the Neff Self-Compassion Scale. This 26-item scale is designed to assess compassion for the self. Subscale scores are computed by calculating the mean of subscale item responses. To compute a total self-compassion score, reverse score the negative subscale items before calculating subscale means - self-judgment, isolation, and over-identification (i.e., 1 = 5, 2 = 4, 3 = 3. 4 = 2, 5 = 1) - then compute a grand mean of all six subscale means. Researchers can choose to analyze their data either by using individual sub-scale sores or by using a total score.
Measured: change from baseline Self-Compassion Scale score at 9 weeks
change in self-compassion
Change in self-compassion from from before to one month after the 8-week interventions will be measured with the Neff Self-Compassion Scale. This 26-item scale is designed to assess compassion for the self. Subscale scores are computed by calculating the mean of subscale item responses. To compute a total self-compassion score, reverse score the negative subscale items before calculating subscale means - self-judgment, isolation, and over-identification (i.e., 1 = 5, 2 = 4, 3 = 3. 4 = 2, 5 = 1) - then compute a grand mean of all six subscale means. Researchers can choose to analyze their data either by using individual sub-scale sores or by using a total score.
Measured: change from baseline Self-Compassion Scale score at 3 months
change in global well-being
Change in global well-being from from before to immediately after the 8-week interventions will be measured with the Quality of Life Index.
Measured: change from baseline Quality of Life Index score at 9 weeks
change in global well-being
Change in global well-being from from before to one month after the 8-week interventions will be measured with the Quality of Life Index.
Measured: change from baseline Quality of Life Index score at 3 months
change in inflammatory biomarkers
Change in systemic inflammation from before to immediately after the 8-week interventions will be measured with plasma interleukin [IL]-6, IL-1 beta, and tumor necrosis factor (TNF)- alpha.
Measured: change from baseline inflammation markers at 9 weeks
change in inflammatory biomarkers
Change in systemic inflammation from before to one month after the 8-week interventions will be measured with plasma interleukin [IL]-6, IL-1 beta, and tumor necrosis factor (TNF)- alpha.
Measured: change from baseline inflammation markers at 3 months
change in diurnal saliva cortisol rhythm
Change in diurnal cortisol rhythm from from before to immediately after the 8-week interventions will be measured with the concentrations of cortisol in saliva collected in the morning shortly after waking and in the evening about 2 hours before bedtime.
Measured: change from baseline diurnal saliva cortisol rhythm at 9 weeks
change in diurnal saliva cortisol rhythm
Change in diurnal cortisol rhythm from from before to one month after the 8-week interventions will be measured with the concentrations of cortisol in saliva collected in the morning shortly after waking and in the evening about 2 hours before bedtime.
Measured: change from baseline diurnal saliva cortisol rhythm at 3 months
change in healthcare activation / utilization
Change in health care activation and utilization from from before to immediately after the 8-week interventions will be measured with the investigator-written questionnaire that will measure intent to use cancer-related survivorship plans [survivor] and management plans of other chronic conditions [survivor and caregiver].
Measured: change from baseline healthcare activation/ utilization at 9 weeks
change in healthcare activation / utilization
Change in health care activation and utilization from from before to one month after the 8-week interventions will be measured with the investigator-written questionnaire that will measure intent to use cancer-related survivorship plans [survivor] and management plans of other chronic conditions [survivor and caregiver].
Measured: change from baseline healthcare activation/ utilization 3 months
change in depression features one month after the end of the intervention
The difference in the change in depression features between the intervention arms from before to one month after the 8-week interventions will be measured with the PROMIS-short form 8a depression scale.
Measured: change from baseline depression score at 3 months
change in anxiety features one month after the end of the intervention
The difference in the change in anxiety features between the intervention arms from before to one month after the 8-week interventions will be measured with the PROMIS-short form 8a anxiety scale.
Measured: change from baseline anxiety score at 3 months
change in fatigue one month after the end of the intervention
The difference in the change in fatigue between the intervention arms from before to one month after the 8-week interventions will be measured with the PROMIS-short form 7a fatigue scale.
Measured: change from baseline fatigue score 3 months
change in empathy one month after the end of the intervention
The difference in the change in empathy between the intervention arms from before to one month after the 8-week interventions will be measured with the Interpersonal Reactivity Index (IRI).
Measured: change from baseline IRI total score 3 months
change in feelings of social isolation / connection one month after the end of the intervention
The difference in the change in feelings of social isolation between the intervention arms from before to one month after the 8-week interventions will be measured with the Social Connectedness Scale-Revised (SCS-R).
Measured: change from baseline Social Connectedness Scale-Revised score 3 months
change in anxiety features
The difference in the change in anxiety features between the intervention arms from before to immediately after the 8-week interventions will be measured with the PROMIS-short form 8a anxiety scale.
Measured: change from baseline anxiety score at 9 weeks
change in fatigue
The difference in the change in fatigue between the intervention arms from before to immediately after the 8-week interventions will be measured with the PROMIS-short form 7a fatigue scale.
Measured: change from baseline fatigue score at 9 weeks
change in empathy
The difference in the change in empathy between the intervention arms from before to immediately after the 8-week interventions will be measured with the Interpersonal Reactivity Index (IRI).
Measured: change from baseline IRI total score at 9 weeks
change in feelings of social isolation / connection
The difference in the change in feelings of social isolation between the intervention arms from before to immediately after the 8-week interventions will be measured with the Social Connectedness Scale-Revised (SCS-R). The SCS-R is a 20-item scale, with higher total scores indicating higher connectedness to others. The range of possible total scores is from 20 to 120. There are no subscales.
Measured: change from baseline Social Connectedness Scale-Revised score at 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start14 Mar 2018
- Primary completion11 Jan 2020
- Study completion11 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer SurvivorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Over the course of the study we will randomize 20 survivor-caregiver dyads to CBCT®, and 20 dyads to the CHE. We will conduct the study in several cohorts, with 4-10 dyads randomized to CBCT® and 4-10 dyads randomized with CHE in each cohort.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thaddeus Pace
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thaddeus Pace, University of Arizona
- Investigators
- Thaddeus Pace, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459781
- Sponsor's protocol ID
- EJC001
- Status last verified
- Feb 2022
- First submitted
- 27 Feb 2018
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pace TWW, Dodds SE, Sikorskii A, Badger TA, Segrin C, Negi LT, Harrison T, Crane TE. Cognitively-Based Compassion Training versus cancer health education to improve health-related quality of life in survivors of solid tumor cancers and their informal caregivers: study protocol for a randomized controlled pilot trial. Trials. 2019 Apr 29;20(1):247. doi: 10.1186/s13063-019-3320-9.
PubMed 31036091
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03459781
- Acronym / sponsor ID
- EJC001
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Thaddeus PaceUniversity, hospital or other
- Study start
- 14 Mar 2018 (actual)
- Primary completion
- 11 Jan 2020 (actual)
- Study completion
- 11 Jan 2020 (actual)
- First posted
- 9 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Over the course of the study we will randomize 20 cancer survivor-caregiver dyads to CBCT®, and 20 dyads to the CHE attention group. We will conduct the study in several cohorts, with 4-10 dyads randomized to CBCT® and 4-10 dyads randomized with CHE in each cohort. The research procedures are elaborated below in chronological order of when they will occur for each study cohort. The study will consist of four major phases after recruitment/ screening/ consent:
- Baseline (pre-intervention) assessments
- Intervention phase
- 9-week (post-intervention) assessments
- 3-month (post intervention) assessments
Assessments - Baseline (pre-intervention)
After successful recruitment, screening, and consent we will invite solid tumor cancer survivor-informal caregiver dyads to the College of Nursing for the baseline assessment. Shortly after arrival blood will be collected from participants before starting self-report questionnaires. Blood will be drawn in order to obtain plasma and peripheral blood mononuclear cells (PBMCs). Blood (2 X 7 milliliters) will be collected by venipuncture into EDTA-coated vacutainer tubes by the (TBA) study phlebotomist, and then immediately processed to obtain plasma or PBMCs.
After blood sampling at the baseline assessment is complete we will next ask survivor-caregiver dyads to complete self-report assessments. Self-report instruments to be completed will assess different dimensions of health-related quality of life (HRQOL) and healthcare adherence/ utilization.
Interventions
Within 2 weeks of the baseline assessment study participants will begin either 8 weeks of CBCT® or 8 weeks of CHE, depending on randomization. Study group will be revealed to study participants and study staff after the completion of the baseline assessment.
Upon randomization to either the CBCT® or CHE groups participants will be given a booklet, "Survivorship and Surveillance Guidelines", and another booklet, "Healthy Behaviors for a Healthier Life." Although these booklets will not be referred to directly throughout CBCT® or CHE, participants will be encouraged review them and ask questions about the content of these booklets throughout the study. Participants with questions after reviewing these booklets will be referred to Dr. Badger, clinical co-I. These booklets are being included because they may have an indirect effect on measures of health care adherence/ utilization in both the CBCT® and CHE groups.
Assessments - 9 weeks
Within a week of concluding the study interventions we will schedule all survivor-caregiver dyads to return to the College of Nursing for the 9-week assessment. The 9-week assessment will mirror the baseline assessment except for the healthcare utilization questionnaire, which will use an 9-week version of this questionnaire.
Assessments - 3 months
About 4 weeks later we will have all survivor-caregiver dyads visit the College of Nursing for the final, 3-month assessment time point. As with the 8-week assessment, this visit will mirror the baseline assessment except for a different healthcare utilization questionnaire, which will use a 3-month version of this questionnaire.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Over the course of the study we will randomize 20 survivor-caregiver dyads to CBCT®, and 20 dyads to the CHE. We will conduct the study in several cohorts, with 4-10 dyads randomized to CBCT® and 4-10 dyads randomized with CHE in each cohort.
| Arm | Type | Receives |
|---|---|---|
| Cognitively-Based Compassion Training | Experimental | Behavioral: Cognitively-Based Compassion TrainingCancer 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®. |
| CHE (Cancer Health Education) | Active comparator | 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitively-Based Compassion TrainingCBCT® was designed at Emory University by Lobsang Tenzin Negi. CBCT® is a secular adaptation of techniques derived from traditional Tibetan Buddhist methods for cultivating compassion known as lo-jong. Over the course of 8 weeks there will a total of 8 CBCT® sessions, one session per week, led by the CBCT® instructor. Dyads will attend the weekly CBCT® classes together. Each weekly session will last for 90 minutes and will begin with brief meditation to focus attention. The instructor will then articulate content and goals of the current week, after which a group discussion led by the instructor will take place. A session will end with a 20-30 minute meditation. Dyads will be encouraged to practice a minimum of 10 minutes per day at home, and together as a dyad if possible. | Behavioural | Cognitively-Based Compassion Training |
| CHE (Cancer Health Education)Also: Cancer Health EducationThe cancer health education (CHE) intervention is an adaptation of the in-person program called Health Discussion, a protocol used by our group previously. The CHE will focus on relevant topics to health and cancer including 1) cancer advocacy, 2) health and cancer biology, 3) nutrition, 4) lifestyle interventions such as physical activity and goals for physical activity, 5) the importance of good sleep, 6) the impact of stress, and 7) mental health and social support. CHE will also discuss current events related to cancer. Over the course of 8 weeks there will be a total of 8 sessions, one session per week. Each session will last for approximately 90 minutes. | Behavioural | CHE (Cancer Health Education) |
Primary outcome
change in depression features
Time frame: 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.
23 secondary outcomes
change in negative affect
Time frame: change from baseline 10-item Positive and Negative Affect Schedule score at 9 weeks
change in negative affect
Time frame: change from baseline 10-item Positive and Negative Affect Schedule score at 3 months
change in dyadic function
Time frame: change from baseline Relationship Assessment Scale score at 9 weeks
change in dyadic function
Time frame: change from baseline Relationship Assessment Scale score at 3 months
change in self-compassion
Time frame: change from baseline Self-Compassion Scale score at 9 weeks
change in self-compassion
Time frame: change from baseline Self-Compassion Scale score at 3 months
change in global well-being
Time frame: change from baseline Quality of Life Index score at 9 weeks
change in global well-being
Time frame: change from baseline Quality of Life Index score at 3 months
change in inflammatory biomarkers
Time frame: change from baseline inflammation markers at 9 weeks
change in inflammatory biomarkers
Time frame: change from baseline inflammation markers at 3 months
change in diurnal saliva cortisol rhythm
Time frame: change from baseline diurnal saliva cortisol rhythm at 9 weeks
change in diurnal saliva cortisol rhythm
Time frame: change from baseline diurnal saliva cortisol rhythm at 3 months
change in healthcare activation / utilization
Time frame: change from baseline healthcare activation/ utilization at 9 weeks
change in healthcare activation / utilization
Time frame: change from baseline healthcare activation/ utilization 3 months
change in depression features one month after the end of the intervention
Time frame: change from baseline depression score at 3 months
change in anxiety features one month after the end of the intervention
Time frame: change from baseline anxiety score at 3 months
change in fatigue one month after the end of the intervention
Time frame: change from baseline fatigue score 3 months
change in empathy one month after the end of the intervention
Time frame: change from baseline IRI total score 3 months
change in feelings of social isolation / connection one month after the end of the intervention
Time frame: change from baseline Social Connectedness Scale-Revised score 3 months
change in anxiety features
Time frame: change from baseline anxiety score at 9 weeks
change in fatigue
Time frame: change from baseline fatigue score at 9 weeks
change in empathy
Time frame: change from baseline IRI total score at 9 weeks
change in feelings of social isolation / connection
Time frame: change from baseline Social Connectedness Scale-Revised score at 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Derived from this study: PubMed 31036091Pace TWW, Dodds SE, Sikorskii A, Badger TA, Segrin C, Negi LT, Harrison T, Crane TE. Cognitively-Based Compassion Training versus cancer health education to improve health-related quality of life in survivors of solid tumor cancers and their informal caregivers: study protocol for a randomized controlled pilot trial. Trials. 2019 Apr 29;20(1):247. doi: 10.1186/s13063-019-3320-9.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thaddeus Pace, PhD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cognitively-Based Compassion Training and CHE (Cancer Health Education) in people with Cancer Survivors and Informal Cancer Caregivers (Family and Friends of Cancer Survivors), run by Thaddeus Pace at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in depression features (time frame: change from baseline depression score at 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03459781, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.