Advanced CancerNCT03823313

Feasibility, Acceptability and Preliminary Effects of the Spiritual Care Assessment and Intervention

A study testing SCAI (Spiritual Care Assessment and Intervention) in people with Advanced Cancer and Metastatic Cancer, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Advanced Cancer, Metastatic Cancer
What is being tested?: SCAI (Spiritual Care Assessment and Intervention)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteUnited States
Study dates: 10 Dec 2018to 28 Aug 2019
Phase: Interventional
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Show all 9Show fewer

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, 46202

Other trials in United States

About this study

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

Read the 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)

Conditions: Advanced Cancer, Metastatic Cancer
Being tested: SCAI (Spiritual Care Assessment and Intervention)
Keywords: Spiritual Care, Religion, Spirituality, Caregiver
Medical subject headings: Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SCAI (Spiritual Care Assessment and Intervention)Behavioural
4 sessions completed with an IU Health chaplain using a framework of questions called the Spiritual Care Assessment And Intervention tool. The weekly sessions will focus on one of the 4 areas of spiritual experience (meaning and purpose, relationships, transcendence and peace, self-worth and identity)

Study groups in NCT03823313
Study group	Role	What they receive
Spiritual Care Assessment and Intervention	Experimental	Not described Receives: Behavioral: SCAI (Spiritual Care Assessment and Intervention)

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of enrollment
number of eligible patients that are consented and enrolled in the trial
Measured: from recruitment to enrollment (i.e. up to 30 days)
Attendance Rate
proportion of participants who attend all four intervention sessions
Measured: 4 weeks
Mean Satisfaction Score
satisfaction score among participants on the satisfaction survey
Measured: 4 weeks
Functional assessment of chronic illness therapy-Spiritual Well-being Scale Scores
Total score at baseline will be compared to score at to the score at 1 week, 6 weeks, and 3 months
Measured: baseline, 1-2 weeks after session 4, 6 weeks, 3 months

Secondary outcomes (9)

Percentage of completed baseline surveys
percentage of completed baseline surveys in enrolled patients
Measured: baseline
Percentage of completed follow up surveys
Measured: baseline, 1-2 weeks after session 4, 6 weeks, 3 months
McGrill Quality of Life Questionnaire score
Measure of patient quality of life through total score at baseline compared to score at 1 week, 6 weeks, and 3 months
Measured: baseline, 1-2 weeks after session 4, 6 weeks, 3 months
Caregiver Quality of Life Index-Cancer Questionnaire score
Measure of caregiver quality of life through total score at baseline compared to score at 1 week, 6 weeks, and 3 months
Measured: baseline, 1 week, 6 weeks, 3 months
Caregiver Quality of Life Index-Cancer Questionnaire score
Measure of caregiver quality of life through total score at baseline compared to score at 1 week, 6 weeks, and 3 months
Measured: baseline, 1-2 weeks after session 4, 6 weeks, 3 months
Generalized Anxiety Disorder Scale Scores
Measure of Anxiety through total score at baseline compared to score at 1 week, 6 weeks, and 3 months
Measured: baseline, 1-2 weeks after session 4, 6 weeks, 3 months
Patient Health Questionnaire Depression Scale (PHQ-8)
Measure of depression through total score at baseline compared to score at 1 week, 6 weeks, and 3 months
Measured: baseline, 1 week, 6 weeks, 3 months
Brief RCOPE score
Measure of coping through total score at baseline compared to score at 1 week, 6 weeks, and 3 months
Measured: baseline, 1-2 weeks after session 4, 6 weeks, 3 months
Intervention Satisfaction Questionnaire score
Measured: baseline, 1-2 weeks after session 4, 6 weeks, 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Dec 201828 Aug 2019

First posted30 Jan 2019
Study start10 Dec 2018
Primary completion28 Aug 2019
Study completion28 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced CancerStudies of the same condition, open and under way.
More trials run by Indiana UniversityThe sponsor's other registered studies.
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 N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03823313
Sponsor's protocol ID: IUSCC-0665
Status last verified: Feb 2020
First submitted: 29 Jan 2019
Last updated: 13 Feb 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms

All Advanced Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03823313
Acronym / sponsor ID: IUSCC-0665
Conditions: Advanced Cancer, Metastatic Cancer
Keywords: Spiritual Care, Religion, Spirituality, Caregiver
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Indiana UniversityUniversity, hospital or other
Collaborators: Indiana University Health
Study start: 10 Dec 2018 (actual)
Primary completion: 28 Aug 2019 (actual)
Study completion: 28 Aug 2019 (actual)
First posted: 30 Jan 2019 (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.

Detailed description

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.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Spiritual Care Assessment and Intervention	Experimental	Behavioral: SCAI (Spiritual Care Assessment and Intervention)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (3 listed)

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.

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
SCAI (Spiritual Care Assessment and Intervention)4 sessions completed with an IU Health chaplain using a framework of questions called the Spiritual Care Assessment And Intervention tool. The weekly sessions will focus on one of the 4 areas of spiritual experience (meaning and purpose, relationships, transcendence and peace, self-worth and identity)	Behavioural	Spiritual Care Assessment and Intervention

Primary outcome

Rate of enrollment
Time frame: from recruitment to enrollment (i.e. up to 30 days)
number of eligible patients that are consented and enrolled in the trial
Attendance Rate
Time frame: 4 weeks
proportion of participants who attend all four intervention sessions
Mean Satisfaction Score
Time frame: 4 weeks
satisfaction score among participants on the satisfaction survey
Functional assessment of chronic illness therapy-Spiritual Well-being Scale Scores
Time frame: baseline, 1-2 weeks after session 4, 6 weeks, 3 months
Total score at baseline will be compared to score at to the score at 1 week, 6 weeks, and 3 months

9 secondary outcomes

Percentage of completed baseline surveys
Time frame: baseline
Percentage of completed follow up surveys
Time frame: baseline, 1-2 weeks after session 4, 6 weeks, 3 months
McGrill Quality of Life Questionnaire score
Time frame: baseline, 1-2 weeks after session 4, 6 weeks, 3 months
Caregiver Quality of Life Index-Cancer Questionnaire score
Time frame: baseline, 1 week, 6 weeks, 3 months
Caregiver Quality of Life Index-Cancer Questionnaire score
Time frame: baseline, 1-2 weeks after session 4, 6 weeks, 3 months
Generalized Anxiety Disorder Scale Scores
Time frame: baseline, 1-2 weeks after session 4, 6 weeks, 3 months
Patient Health Questionnaire Depression Scale (PHQ-8)
Time frame: baseline, 1 week, 6 weeks, 3 months
Brief RCOPE score
Time frame: baseline, 1-2 weeks after session 4, 6 weeks, 3 months
Intervention Satisfaction Questionnaire score
Time frame: baseline, 1-2 weeks after session 4, 6 weeks, 3 months

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 13 Feb 2020.
Individual participant dataSharing planned: No

Related trials for Advanced Cancer

Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms

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.

Alexia Torke, MD principal investigator

Indiana University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SCAI (Spiritual Care Assessment and Intervention) in people with Advanced Cancer and Metastatic Cancer, run by Indiana University 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 9 inclusion and 3 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 13 Feb 2020. 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.

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?

Rate of enrollment (time frame: from recruitment to enrollment (i.e. up to 30 days)). The study lists 4 primary outcomes in all. 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 NCT03823313.

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 13 Feb 2020.