Status:

COMPLETED

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

Lead Sponsor:

Indiana University

Collaborating Sponsors:

Indiana University Health

Conditions:

Advanced Cancer

Metastatic Cancer

Eligibility:

All Genders

18+ years

Phase:

NA

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 purp...

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 reli...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

December 10 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 28 2019

Estimated Enrollment :

42 Patients enrolled

Trial Details

Trial ID

NCT03823313

Start Date

December 10 2018

End Date

August 28 2019

Last Update

February 13 2020

Active Locations (1)

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Indiana University Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, United States, 46202

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