Clinical trial NCT03823313: Feasibility, Acceptability and Preliminary Effects of the Spiritual Care Assessment and Intervention
Official title: Feasibility, Acceptability and Preliminary Effects of the Spiritual Care Assessment and Intervention (SCAI) Framework for Adults With Advanced Cancer and Their Caregivers (FCGs): A Clinical Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Cancer
Metastatic Cancer
Keywords: Spiritual Care
Religion
Spirituality
Caregiver
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Indiana University Health
First posted: 2019-01-30
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to test a spiritual care intervention for adults with advanced cancer and their caregivers. This intervention will assess 4 areas of spiritual experience: meaning and purpose, relationships, transcendence and peace, self-worth and identity. Participants will be asked to complete questionnaires and participate in 4 sessions with research chaplains.

Detailed description: Several studies have shown that cancer affects multiple dimensions of a patient's life as well as the lives of caregivers and others close to the patient who, when faced with life crises, may use religion and spirituality (R/S) to cope. This study is the first of its kind to incorporate a semi-structured spiritual care and intervention (SCAI) framework into the spiritual care of advanced cancer patients while maintaining proper controls in order to investigate its feasibility, acceptability and potential effects on the emotional and spiritual outcomes of advanced cancer patients and their caregivers. This framework will assess 4 areas of spiritual experience: meaning and purpose, relationships, transcendence and peace, self-worth and identity. Additionally, not only will this study assess acceptability and feasibility of the intervention, it will also track and document coping, satisfaction, anxiety, depression, quality of life outcomes and follow-up with both patient and caregivers following Spiritual Care Assessment and Intervention (SCAI).

Specific Aim 1: To evaluate the feasibility and acceptability of the SCAI intervention for adults with advanced cancer and their caregivers.

Specific Aim 2: To establish our ability to collect outcome data to support a future efficacy trial for patients and their caregivers in the outpatient clinic and home setting.

Specific Aim 3: To test the preliminary impact of the SCAI intervention on patient and caregiver spiritual wellbeing (primary outcome) and quality of life, religious coping, depression, and anxiety (secondary outcomes)

Eligibility criteria: Inclusion Criteria:

* Patient is at least 18 years of age.
* Patient is at least 2 weeks post-diagnosis of an incurable and advanced stage (IV) lung, colorectal, GI neuroendocrine and Hepatobiliary, testicular and esophageal solid malignancy and receiving cancer care at IU Simon Cancer Center.
* Patient is willing and able to consent, has a reliable phone and willing to participate in 4 sessions of 30 (+/- 5) minutes per session.
* Patient has a family member or eligible friend considered to be a caregiver and interested in participating in the study.
* Patient has adequate English fluency for completion of data collection.
* Family Caregiver (FCG) is at least 18 years of age.
* Family Caregiver (FCG) has been invited to participate in the trial with a patient who meets eligibility criteria above.
* Family Caregiver (FCG) is willing and able to consent and to participate in 4 sessions of 30 (+/- 5) minutes per session
* Family Caregiver (FCG) has adequate English fluency for completion of data collection.

Exclusion Criteria:

* Patient makes 3 or more errors on a validated 6-item cognitive screener (Appendix A) or exhibits significant psychiatric or cognitive impairment (e.g., dementia/delirium, retardation, active psychosis) that in the judgment of the investigators would preclude providing informed consent and study participation.
* Currently receiving hospice care (patients who enroll in hospice during the trial will have the option of continuing trial participation).
* Family Caregiver (FCG) exhibits significant psychiatric or cognitive impairment (e.g., dementia/delirium, retardation, active psychosis) that in the judgment of the investigators would preclude providing informed consent and study participation.

Primary outcomes:
measure: Rate of enrollment
timeFrame: from recruitment to enrollment (i.e. up to 30 days)
measure: Attendance Rate
timeFrame: 4 weeks
measure: Mean Satisfaction Score
timeFrame: 4 weeks
measure: Functional assessment of chronic illness therapy-Spiritual Well-being Scale Scores
timeFrame: baseline, 1-2 weeks after session 4, 6 weeks, 3 months
Secondary outcomes:
measure: Percentage of completed baseline surveys
timeFrame: baseline
measure: Percentage of completed follow up surveys
timeFrame: baseline, 1-2 weeks after session 4, 6 weeks, 3 months
measure: McGrill Quality of Life Questionnaire score
timeFrame: baseline, 1-2 weeks after session 4, 6 weeks, 3 months
measure: Caregiver Quality of Life Index-Cancer Questionnaire score
timeFrame: baseline, 1 week, 6 weeks, 3 months
measure: Caregiver Quality of Life Index-Cancer Questionnaire score
timeFrame: baseline, 1-2 weeks after session 4, 6 weeks, 3 months
measure: Generalized Anxiety Disorder Scale Scores
timeFrame: baseline, 1-2 weeks after session 4, 6 weeks, 3 months
measure: Patient Health Questionnaire Depression Scale (PHQ-8)
timeFrame: baseline, 1 week, 6 weeks, 3 months
measure: Brief RCOPE score
timeFrame: baseline, 1-2 weeks after session 4, 6 weeks, 3 months
measure: Intervention Satisfaction Questionnaire score
timeFrame: baseline, 1-2 weeks after session 4, 6 weeks, 3 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Melvin & Bren Simon Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University
name: Alexia Torke, MD
role: PRINCIPAL_INVESTIGATOR
References: