Clinical Trials /

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

NCT03823313

Description:

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.

Related Conditions:
  • Gastrointestinal Neuroendocrine Tumors
  • Malignant Colorectal Neoplasm
  • Malignant Esophageal Neoplasm
  • Malignant Hepatobiliary Neoplasm
  • Malignant Lung Neoplasm
  • Malignant Testicular Neoplasm
Recruiting Status:

Completed

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: 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

Clinical Trial IDs

  • ORG STUDY ID: IUSCC-0665
  • NCT ID: NCT03823313

Conditions

  • Advanced Cancer
  • Metastatic Cancer

Purpose

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)
    

Trial Arms

NameTypeDescriptionInterventions
Spiritual Care Assessment and InterventionExperimental

    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.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:Accepts Healthy Volunteers

    Primary Outcome Measures

    Measure:Rate of enrollment
    Time Frame:from recruitment to enrollment (i.e. up to 30 days)
    Safety Issue:
    Description:number of eligible patients that are consented and enrolled in the trial

    Secondary Outcome Measures

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

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Indiana University

    Trial Keywords

    • Spiritual Care
    • Religion
    • Spirituality
    • Caregiver

    Last Updated