Pilot Randomized Clinical Trial of Informational Support Versus Spiritual Care
Alexia Torke
Principal Investigator
Brief Description
Effective interventions are needed to support outpatients with cancer in coping with their disease and making decisions about cancer treatment. Because of the varying roles that religion and/or spirituality can play in the cancer experience, providing religious and spiritual support is an important part of cancer treatment. Our team has developed a chaplain delivered spiritual care intervention to test in a pilot trial in preparation for a fully powered randomized trial.
Patients will be recruited from the IU Simon Comprehensive Cancer Center (IUSCCC) and other cancer practices affiliated with IU Health and Indiana University, as well as Eskenazi Health Oncology Clinics. Prescreening: Patients will be identified through electronic medical record before a scheduled appointment at an IU Health or Eskenazi oncology clinic. The research team will review the EMR to determine eligibility.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed Description
Baseline Interview
The research team will conduct baseline interviews by phone either at the time of consent or at a
later scheduled time within 21 days of enrollment. The baseline interview will take
approximately 40 minutes.
Randomization
After the baseline interview is complete, participants will be randomized by the research team to
either the chaplain intervention (SCAI) group or the attention control group. We will use block
randomization in groups of 4. After randomization, the patient will be called by either the
chaplain delivering SCAI or the social worker delivering the attention control condition within 1
week
Eligibility of study
Inclusion Criteria
1. ≥ 18 years old at the time of informed consent
2. Ability to provide informed consent and HIPAA authorization
3. Subject is at least 2 weeks post-diagnosis of an incurable and advanced stage (IV) lung or
gastrointestinal (GI) malignancy and receiving cancer care at IU Simon Cancer Center,
other IU Health Oncology Clinics, or Eskenazi Health Oncology Clinics
4. Subject has a reliable phone and is willing to participate in 4 sessions with the chaplain
5. Subject has adequate English fluency for completion of data collection
6. ECOG score ranging from 0 (fully active) to 3 (able to conduct limited self-care in bed or
chair more than 50% of waking hours)
7. Has low Spiritual Well-Being score of 35 or less on the FACIT-Sp 3
Exclusion Criteria
1. Subject makes 3 or more errors on a validated 6-item cognitive screener 36 (Appendix 1)
administered during screening, or exhibits significant psychiatric or cognitive impairment
(e.g., dementia/delirium, intellectual disability, active psychosis) that in the judgment of
the research team would preclude providing informed consent and study participation
2. Currently receiving hospice care
Note: subjects who enroll in hospice during the trial will have the option of continuing
trial participation
3. Have had a visit with a healthcare chaplain within the past 3 months