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Completed

NCT Number: NCT03823313

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SCAI (Spiritual Care Assessment and Intervention)

Behavioral

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)

Primary outcomes

  1. 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

  2. Attendance Rate

    Time frame: 4 weeks

    proportion of participants who attend all four intervention sessions

  3. Mean Satisfaction Score

    Time frame: 4 weeks

    satisfaction score among participants on the satisfaction survey

  4. 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

Secondary outcomes

  1. Percentage of completed baseline surveys

    Time frame: baseline

    percentage of completed baseline surveys in enrolled patients

  2. Percentage of completed follow up surveys

    Time frame: baseline, 1-2 weeks after session 4, 6 weeks, 3 months

  3. McGrill Quality of Life Questionnaire score

    Time frame: baseline, 1-2 weeks after session 4, 6 weeks, 3 months

    Measure of patient quality of life through total score at baseline compared to score at 1 week, 6 weeks, and 3 months

  4. Caregiver Quality of Life Index-Cancer Questionnaire score

    Time frame: baseline, 1 week, 6 weeks, 3 months

    Measure of caregiver quality of life through total score at baseline compared to score at 1 week, 6 weeks, and 3 months

  5. Caregiver Quality of Life Index-Cancer Questionnaire score

    Time frame: baseline, 1-2 weeks after session 4, 6 weeks, 3 months

    Measure of caregiver quality of life through total score at baseline compared to score at 1 week, 6 weeks, and 3 months

  6. Generalized Anxiety Disorder Scale Scores

    Time frame: baseline, 1-2 weeks after session 4, 6 weeks, 3 months

    Measure of Anxiety through total score at baseline compared to score at 1 week, 6 weeks, and 3 months

  7. Patient Health Questionnaire Depression Scale (PHQ-8)

    Time frame: baseline, 1 week, 6 weeks, 3 months

    Measure of depression through total score at baseline compared to score at 1 week, 6 weeks, and 3 months

  8. Brief RCOPE score

    Time frame: baseline, 1-2 weeks after session 4, 6 weeks, 3 months

    Measure of coping through total score at baseline compared to score at 1 week, 6 weeks, and 3 months

  9. Intervention Satisfaction Questionnaire score

    Time frame: baseline, 1-2 weeks after session 4, 6 weeks, 3 months

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Indiana University Health

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 30, 2019
Registry last updated
Feb 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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