Behaviors and Mental Disorders

All Conditions

Quality of Life

spiritual therapy

questionnaire administration

survey administration

counseling intervention

psychosocial support for caregiver

psychosocial assessment and care

Jay Thomas

This clinical trial studies spiritual care in improving quality of life of patients, caregivers, and hospital staff. Spiritual care may help understand the impact cancer and its treatment has on patients, caregivers and hospital staff.

OBJECTIVES:

I. To improve the quality of spiritual care provided by palliative care teams. II. To measure the effectiveness of integrating spiritual care recommendations in palliative care at City of Hope (COH) and the impact it has on cancer patients, families, and hospital staff.

OUTLINE:

The expanded psychosocial/spiritual assessment administered by social workers includes a spiritual history and a spiritual needs screening. Social worker knowledge and competence is surveyed at baseline, immediately after the course, and after a bedside chaplain-mentoring process. Inpatient cancer patients' and their caregivers' perceptions about spiritual care is surveyed at baseline prior to the social work curriculum and after the course has been completed and the new psychosocial/spiritual assessment has been implemented. Data collected from patients, family members, and staff includes number of unduplicated palliative care patients screened for spiritual concerns, spiritual history, number and type of spiritual issues, number of referrals to the chaplain, number seen by the chaplain, number of unduplicated palliative care patients with documented spiritual care plan, number of staff development sessions offered and topics, attendance per topic, advance directives, and referrals to hospice.

Spiritual Care in Improving Quality of Life of Patients, Caregivers, and Hospital Staff

Archstone Spiritual Care Demonstration Project: Outcomes for Patients, Families, and Staff

Nonparametric Mann-Whitney University test will be used to test for differences between cohorts of patients and of families at the two different measurement points. The Wilcoxon paired nonparametric test will be used to test for change over time for staff survey results.

Analyzed using Atlas.ti. coding and analysis. Qualitative data, e.g., open ended questions, included narrative responses by staff summarized for reporting purposes.

National Cancer Institute (NCI)

City of Hope Medical Center

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Heart and Blood Diseases

Rare Diseases

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Lymphosarcoma

Patients receive chaplain led compassionate centered spiritual health sessions over 30 minutes, twice per week for up to 2 weeks.

Patients receive a traditional chaplain consultation and care upon request, per standard of care.

Undergo chaplain led compassionate centered spiritual health sessions

Spiritual Therapy

Receive a traditional chaplain consultation and will receive care upon request

Best Practice

Jennifer Mascaro, PhD

Erin Brauer, MPH

This clinical trial tests the feasibility, implementation and acceptability of chaplain delivered compassion meditation in order to improve spiritual care for patients receiving stem cell transplantation. Hospital chaplains play a vital role in delivering emotional and spiritual care to a broad range of both religious and non-religious patients for a wide variety of stressors, and extensive research indicates that spiritual consults impact patient outcomes and satisfaction. Compassion meditation is a secularized, research-based mindfulness and compassion meditation program designed to expand and strengthen compassion for self and others. Practices include training in attentional stability and increased emotional awareness, as well as targeted reflections to appreciate one's relationship with self and others. By centering the mind, controlling debilitating ruminative thoughts, and cultivating personal resiliency and an inclusive and more accurate understanding of others. Engaging in chaplain delivered compassion meditation may improve the spiritual care for patients receiving stem cell transplantation.

PRIMARY OBJECTIVE:

I. To examine the feasibility, adoption, extent of implementation, acceptability and fidelity of chaplain-delivered compassion-centered spiritual health (CCSH).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive chaplain-led compassionate centered spiritual health sessions over 30 minutes, twice per week for up to 2 weeks.

ARM II: Patients receive a traditional chaplain consultation and care upon request, per standard of care.

After completion of study treatment, patients are followed up at 80-100 days and 6 months post treatment.

Chaplain-Delivered Compassion Meditation to Improve Spiritual Care of Patients Receiving Stem Cell Transplantation

Randomized Pilot Study of Chaplain-Delivered Compassion Meditation for Patients Receiving Stem Cell Transplantation

Will measure and characterize the proportion of eligible patient screens who enroll and treatment-specific retention rates.

We will examine whether scores on the chaplain satisfaction survey vary based on patient sociodemographic variables (biological sex, race)

Impact of chaplain-delivered compassion-centered spiritual health on quality of life

Will administer a post- chaplain-based compassion treatment (CBCT) intervention using chaplain satisfaction survey and will ask patients after each session if they would like to continue receiving CBCT sessions.

National Center for Complementary and Integrative Health (NCCIH)

Emory University

Principal Investigator

Symptoms and General Pathology

Leukemia

Pain

Chronic Graft Versus Host Disease

ASCENT study interventionists complete an interview on study.

Medical oncology providers participate in a focus group on study.

Acupuncture Therapy

Cancer Pain Management

Cognitive Behavior Therapy

Discussion

Receive self-guided pain management education materials

Educational Intervention

Exercise

Interview

Massage Therapy

Mindfulness Relaxation

Pain Therapy

Palliative Therapy

Undergo visits with PCM and CHW for pain management

Patient Navigation

Referral

Spiritual Care Referral

Survey Administration

Clinical Trials Referral Office

Donald W. Northfelt, M.D.

Andrea L. Cheville, M.D.

This clinical trial tests how well a pain management intervention preparatory to a future pragmatic trial works in rural dwelling and Hispanic cancer survivors. Cancer pain is a key case study in health disparities in the United States. Cancer pain is prevalent, under treated, and remains a major cause of suffering, impairment, and disability for millions of Americans. Individual pain interventions and care models show promise for cancer pain in controlled settings. Hispanic and rural-dwelling cancer survivors stand to benefit the most from electronic health record innovations, as each of these health disparities populations experience profound disparities in pain outcomes, including marked under- and over-prescribing of opioids. Additionally, Hispanics not only comprise a steadily growing proportion of cancer survivors, but are also increasingly immigrating to rural communities, potentially placing them at "double risk" for poor outcomes. This trial will allow for the refinement of pain management intervention components that could help the management of cancer-related pain in rural dwelling and Hispanic cancer survivors.

PRIMARY OBJECTIVE:

I. To refine and pilot test components of a validated collaborative care model-based intervention aimed at improving pain control among rural dwelling and Hispanic cancer survivors.

OUTLINE: Participants are assigned to 1 of 3 groups.

GROUP I: Participants meet with pain care manager (PCM) and community health worker (CHW) via telephone or video visit to discuss the cancer-related pain. Participants receive self-guided pain management education materials and receive an action plan with suggestions or referrals to participate in tier 1 interventions that include exercise, cognitive behavioral therapy, medication and/or tier 2 interventions that include integrative medicine (massage, acupuncture and mindfulness relaxation), spiritual support, pain clinic referral and palliative and spiritual care referrals during the intake visit. Participants undergo a planning visit 2 weeks later to give an update on their pain and may receive additional resources from the PCM and/or CHW. Participants then undergo a final visit 4 weeks later with the PCM and/or CHW and receive final recommendations and referrals. Participants may receive a follow up call between intake and visit 2 and/or between visit 2 and the final visit from the CHW or PCM to assess pain levels on study.

GROUP II: ASCENT study interventionists complete an interview on study.

GROUP III: Medical oncology providers participate in a focus group on study.

Evaluation of a Pain Management Intervention Preparatory to a Future Pragmatic Trial, ASCENT Study

Pilot Test of a Pain Management Intervention Preparatory to a Future Pragmatic Trial (ASCENT)

Assessed by the proportion of patients calling the ASCENT 1-800 line to express interest

Assessed by the proportion of participants who open and completed the PCIG Questionnaire, a 0-6 scale where 0 is very much improved and 6 is very much worse

Assessed by the proportion of participants who open and completed the EQ-5D-3L questionnaire. Page 1 of the EQ-5D-3L descriptive system is comprised of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Responses are expressed in a 5-digit number that describes the patient's health state.Page 2 is a vertical visual analog (sliding) scale (VAS) with the opposite endpoints labeled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.

Assessed by the proportion of participants who open and completed the PCS Questionnaire, which consists of 13 statements containing a number of thoughts and feelings one may experience when having pain. The items are divided into the categories of rumination, magnification and helplessness, with each item scored on a 5-point scale where 0=Not at all; 1=to a Slight Degree; 2=To a Moderate Degree; 3=To a Great Deal; and 4=All the Time.

Assessed by the proportion of participants who open and completed the PHQ-8, a depression measure which consists of 8 questions, with each item scored on a 4-point scale: Not at all; Several days; More than half the days; Nearly every day.

Assessed by the proportion of participants who open and completed the GAD-7, an anxiety measure which consists of 7 questions, with each item scored on a 4-point scale: Not at all; Several days; More than half the days; Nearly every day.

Assessed by the proportion of participants who open and completed the PSEQ, a 10-item questionnaire developed to assess the confidence people with ongoing pain have in performing activities while in pain. Each item is scored on a 0-6 scale where 0=Not at all confident and 6=Completely.

Assessed by the proportion of participants who provide complete Social Determinants of Health (SDOH) histories by answering a series of 6 questions related to homelessness, safety in the home, health, and mood.

Assessed by the proportion of participants who complete the Pain NRS, a 0-10 scale where 0 is no pain and 10 is the worst pain imaginable

Assessed by the proportion of participants who complete the IT Assessment, which consists of 4 questions related to technology access and usage.

Assessed by the proportion of participants who complete the TAPS-1 Questionnaire, the tool's first-stage screening component, which consists of five questions related to usage of four substance categories (tobacco, alcohol, prescriptions, or other substances) in the past 12 months. Response option are 0-Daily or Almost Daily, 1-Weekly, 2-Monthly, 3-Less Than Monthly, or 4-Never.

Assessed by the proportion of participants who select a Tier 1 pain management intervention or request review of Tier 2 pain management options

Assessed on an 11-point numerical rating scales (NRS) by Pain Care Managers and/or Community Health Workers who are conducting intake interviews.

Assessed by the proportion of participants who request revisions to the recommended plan

Assessed by the proportion of participants who develop a SMART (Specific, Measurable, Achievable, Relevant, and Time-Bound) Goal

Assessed by the proportion of participants who complete a SMART (Specific, Measurable, Achievable, Relevant, and Time-Bound) Goal

Assessed by the category of pain intervention selected during the planning visit as the initial focus of a multi-modal pain care plan, either Tier 1 (Exercise, Cognitive Behavior Therapy \[CBT\], and Medicine) or Tier 2 (Integrative Medicine \[Massage, Acupuncture, Mindfulness\], Spiritual Support, Pain Clinic Referrals, and/or Palliative and Spiritual Care Referrals).

Recorded as the category/ies of barriers impeding receipt of recommended pain care, as assessed by a brief survey

Assessed by the proportion of participants completing surveys by administration mode (electronic health record portal, video visit, or phone interview, or printed questionnaire)

Assessed by the proportion of participants completing surveys by administration mode, cause of pain escalation (categorical), and participant-perceived barriers (categorical).

Assessed by participant-reported categories of barriers impeding receipt of recommended pain care

Overall participant response rates will be assessed according to the number of patient-reported outcome measure (PROM) assessments, recruitment questionnaires, and remote pain assessments completed.

Mayo Clinic

Patients undergo 4 to 8 sessions (2-4 per week) of Compassion Centered Spiritual Health (CCSH) over 30 minutes with a chaplain while impatient.

Quality-of-Life Assessment

Questionnaire Administration

Deliver or undergo Compassion Centered Spiritual Health (CCSH) session

This clinical trial tests whether chaplain-delivered compassion centered spiritual health (CCSH) works to improve quality of life in patients receiving a stem cell transplant. Compassion Centered Spiritual Health (CCSH) is a secularized, research-based mindfulness and compassion meditation program designed to expand and strengthen compassion for self and others. Practices include training in attentional stability and increased emotional awareness, as well as targeted reflections to appreciate one's relationship with self and others. By centering the mind, controlling negative thoughts, and cultivating personal resiliency and an inclusive and more accurate understanding of others, Compassion Centered Spiritual Health (CCSH) may help improve response to stress and reduce inflammation.

PRIMARY OBJECTIVE:

I. To examine the feasibility, adoption, extent of implementation, and fidelity of chaplain-delivered Compassion Centered Spiritual Health (CCSH).

OUTLINE:

Patients undergo 4 to 8 sessions (2-4 per week) of Compassion Centered Spiritual Health (CCSH) over 30 minutes with a chaplain while impatient.

Chaplain-Delivered Compassion Meditation to Improve Quality of Life in Patients Receiving a Stem Cell Transplant

A Feasibility Study of Chaplain-Delivered Compassion Meditation for Patients Receiving Stem Cell Transplantation

Chaplains will deliver between four and eight 30-minute sessions (2-4 times per week) to evaluate the fidelity of implementation (FOI).

Administer the (4 min) Scottish Patient Reported Outcome Measure. The Patient Reported Outcome Measure is an 18-item Likert-scale that assesses how a hospitalized patient felt about the pastoral care visit both during the consult and after it.

The scale will indicate the following range: 5-25, with higher scores indicating more improvement as a result of the chaplain visit and lower scores indicating less improvement as a result of the chaplain visit.

Adherence will be evaluated as the percent of sessions completed by patients and characterized as "low" (\< 70%), "moderate" (70-80%),"high" (\> 80%) adherence.

Dosage is quantified as the amount (percentage) of cognitive based compassion training (CBCT) that patients receive. Characterize the modal number of sessions received as well as the range of sessions completed by all patients. From the range, sessions will be categorized of "low" (\<70%), "moderate" (70-80%),"high" (\> 80%) dosage.

Evaluate the rate of responsiveness in each session, operationalized as "maximally," "moderately", or "minimally" enthusiastic and attentive during each.

National Institutes of Health (NIH)

Patients undergo 4 to 8 sessions (2-4 per week) of CCSH over 30 minutes with a chaplain while impatient.

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Spiritual Therapy: Deliver or undergo CCSH session

Supportive Care (CCSH)

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

This study was not designed to evaluate efficacy, therefore no statistical analysis was developed or associated with this trial.

Dr. Jennifer Mascaro

Patients undergo 4 to 8 sessions (2-4 per week) of Compassion Centered Spiritual Health over 30 minutes with a chaplain while impatient.

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Spiritual Therapy: Deliver or undergo Compassion Centered Spiritual Health session

Supportive Care: Compassion Centered Spiritual Health (CCSH)

Fidelity to Intervention Delivery

Low: participants who had low adherence range

Medium: participants who had medium adherence

High: participants who had high adherence

Supportive Care Compassion Centered Spiritual Health (CCSH)

Evaluated the number of participants categorized as low (\< 70%), medium (70 - 80%) and high (\> 80%) adherence.

Number of Sessions Completed

Number of participants enrolled who did not complete any sessions

Number of Enrolled Participants that Completed a Single Session

Number of Enrolled Participants that Completed Two Sessions

Number of Enrolled Participants that Completed Three Sessions

Number of Enrolled Participants that Completed Four Sessions

Number of Enrolled Participants that Completed Five Sessions

Number of Enrolled Enrolled Participants with High Dosage to CCSH

Number of Enrolled Participants with Moderate Dosage to CCSH

Number of Enrolled Participants with Low Dosage to CCSH

Percentage of Cognitive Based Compassion Training

Number of sessions rated as maximum responsiveness

Number of sessions rated as moderate Responsiveness

Number of sessions rated as minimal Responsiveness

The 30 participants' responsiveness was rated for 54 sessions

Responsiveness

Patients undergo 4 to 8 sessions (2-4 per week) of Compassion Centered Spiritual Health (CCSH) over 30 minutes with a chaplain while impatient.

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Spiritual Therapy: Deliver or undergo Compassion Centered Spiritual Health ssession

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Spiritual Care in Improving Quality of Life of Patients, Caregivers, and Hospital Staff	NCT01432431	Malignant Neopl...	spiritual thera... questionnaire a... survey administ... counseling inte... psychosocial su... psychosocial as...	18 Years -	City of Hope Medical Center
Chaplain-Delivered Compassion Meditation to Improve Spiritual Care of Patients Receiving Stem Cell Transplantation	NCT06328699	Lymphoma Multiple Myelom...	Spiritual Thera... Best Practice	18 Years -	Emory University
Evaluation of a Pain Management Intervention Preparatory to a Future Pragmatic Trial, ASCENT Study	NCT06063603	Chronic Leukemi... Hematopoietic a... Lymphoma Malignant Solid... Multiple Myelom...	Acupuncture The... Cancer Pain Man... Cognitive Behav... Discussion Educational Int... Exercise Interview Massage Therapy Mindfulness Rel... Pain Therapy Palliative Ther... Patient Navigat... Referral Spiritual Thera... Spiritual Care ... Survey Administ...	18 Years -	Mayo Clinic
Chaplain-Delivered Compassion Meditation to Improve Quality of Life in Patients Receiving a Stem Cell Transplant	NCT05274763	Lymphoma Plasma Cell Mye...	Quality-of-Life... Questionnaire A... Spiritual Thera...	18 Years -	Emory University
Evaluation of a Pain Management Intervention Preparatory to a Future Pragmatic Trial, ASCENT Study	NCT06063603	Chronic Leukemi... Hematopoietic a... Lymphoma Malignant Solid... Multiple Myelom...	Acupuncture The... Cancer Pain Man... Cognitive Behav... Discussion Educational Int... Exercise Interview Massage Therapy Mindfulness Rel... Pain Therapy Palliative Ther... Patient Navigat... Referral Spiritual Thera... Spiritual Care ... Survey Administ...	18 Years -	Mayo Clinic

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