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Stage IV Lung CancerPRaCTISNCT07176559

Pilot Randomized Clinical Trial of Informational Support Versus Spiritual Care

A study testing Spiritual Care and Informational Support in people with Stage IV Lung Cancer and Stage IV Gastrointestinal Cancer, run by Indiana University at 4 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to address the need for effective spiritual care support for patients with lung and gastrointestinal cancer. This study will examine how spiritual care affects spiritual wellbeing, anxiety, depression, satisfaction with spiritual care, and quality of communication. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Spiritual Care and Informational Support
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
43 participants
Where
4 sitesUnited States
Study dates
9 Sep 2025to Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 18 years old at the time of informed consent
  • Ability to provide informed consent and HIPAA authorization
  • 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
  • Subject has a reliable phone and is willing to participate in 4 sessions with the chaplain
  • Eastern Cooperative Oncology Group (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)
  • Has low Spiritual Well-Being score of 35 or less on the FACIT-Sp
  • Subject makes 2 or fewer errors on the Callahan 6-item cognitive screener administered during screening

Who cannot join

  • Subject makes 3 or more errors on the Callahan 6-item cognitive screener 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
  • Currently receiving hospice care Note: subjects who enroll in hospice during the trial will have the option of continuing trial participation
  • Have had a visit with a healthcare chaplain within the past 3 months

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • IU Health Joe and Shelly Schwarz Cancer Center

    Carmel, Indiana, 46032

  • Indiana University Melvin & Bren Simon Comprehensive Cancer Center

    Indianapolis, Indiana, 46202

  • Sidney and Lois Eskenazi Hospital

    Indianapolis, Indiana, 46202

  • IU Health Arnett Hospital

    Lafayette, Indiana, 47905

Other trials in United States

About this study

The purpose of this study is to address the need for effective spiritual care support for patients with lung and gastrointestinal cancer. This study will examine how spiritual care affects spiritual wellbeing, anxiety, depression, satisfaction with spiritual care, and quality of communication.

Read the detailed description

This study is an individually randomized trial of chaplain-led intervention utilizing the Spiritual Care Assessment and Intervention (SCAI) framework compared to an attention control comparator. The chaplain intervention will consist of 4 spiritual care visits with a board-certified or board-eligible chaplain once a week for approximately 4 weeks. The attention control comparator will consist of 4 informational support visits with a trained social worker once a week for approximately 4 weeks.

Participants will be randomized 1:1 to the chaplain-led intervention or the attention control comparator.

Being tested
Spiritual Care, Informational Support
Keywords
lung cancer, gastrointestinal cancer, spiritual care, spiritual wellbeing, spirituality
Medical subject headings
Lung Neoplasms, Gastrointestinal Neoplasms

What participants receive

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

  • Spiritual CareBehavioural

    Participants in the Spiritual Care intervention discuss topics consistent with the Spiritual Care Assessment and Intervention (SCAI) framework including meaning and purpose, relationships, transcendence and peace, and self-worth and identity.

  • Informational SupportBehavioural

    Participants in the Informational Support comparator arm discuss topics including quality of life, financial resources, and evaluating health information.

Study groups in NCT07176559
Study groupRoleWhat they receive
Spiritual CareExperimentalEligible and consented patients randomly assigned to the spiritual care intervention will receive a total of 4 visits with a board-certified or board-eligible chaplain. The intervention will utilize the Spiritual Care Assessment and Intervention (SCAI) framework. These visits will occur weekly for approximately 4 weeks either by telephone or through a HIPAA compliant video platform. The visits will last an average of 30 minutes each.
Receives: Behavioral: Spiritual Care
Informational SupportPlacebo comparatorEligible and consented patients randomly assigned to the Informational Support comparator will receive 4 visits with a trained social worker. The comparator intervention will include discussion of topics including quality of life, financial resources, and evaluating health information. These visits will be conducted weekly for approximately 4 weeks. Each visit will take place for approximately 30 minutes.
Receives: Behavioral: Informational Support

What is being measured

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

  1. Evaluation of feasibility of the Spiritual Care Assessment and Intervention (SCAI) framework vs informational support

    Percentage of participants 1) enrolling; 2) completing 3 or more intervention sessions; 3) completing all study interviews

    Measured: Visits 1-4, approximately weekly, within 3 months of enrollment

  2. Evaluation of acceptability of the Spiritual Care Assessment and Intervention (SCAI) framework vs informational support

    Acceptability Intervention Measure (AIM) This 4-item scale was developed as part of the Consolidated Framework for Implementation Research (CFIR) to evaluate intervention acceptability. Each item is rated on a 5-point scale, ranging from 1 (completely disagree) to 5 (completely agree). Responses are averaged to create a scale score. Higher scores indicate greater acceptability. This is a primary outcome for patients.

    Measured: Visits 1-4, approximately weekly, within 3 months of enrollment; survey 1-week post-intervention

  3. Test the effects of spiritual care on the outcome of spiritual wellbeing

    Measured by the Functional Assessment of Chronic Illness Therapy - Spirituality (FACIT-Sp): Spiritual wellbeing will be assessed using the Functional Assessment of Chronic Illness Therapy-Spirituality (FACIT-Sp) 12-item measure. Each item is rated when considering the past week on a scale from 0 (not at all) to 4 (very much). Scores are the sum of individual items with total scores ranging from 0 to 48. Higher scores indicate higher spiritual well-being. This is a primary outcome for patients.

    Measured: 1, 6, and 12 weeks post intervention

Secondary outcomes (6)

  1. Effects of Spiritual Care Assessment and Intervention (SCAI) framework on anxiety

    Generalized Anxiety Disorder - 7 (GAD-7): Anxiety will be measured by the Generalized Anxiety Disorder-7 item survey. Each item is rated when considering the past two weeks on a scale from 0 (not at all) to 3 (nearly every day). Scores are the sum of individual items with total scores ranging from 0 to 21. Scores of 5-9, 10-14, and 15 and above indicate mild, moderate, and severe anxiety, respectively. This is a secondary outcome for patients.

    Measured: 1, 6, and 12 weeks post intervention

  2. Effects of Spiritual Care Assessment and Intervention (SCAI) framework on depression

    Patient Health Questionnaire-8 (PHQ-8): Depressive symptoms will be measured using the Patient Health Questionnaire-8 item survey. Each item is rated when considering the past two weeks on a scale from 0 (not at all) to 3 (nearly every day). Scores are the sum of individual items with total scores ranging from 0 to 24. Scores of 5-9, 10-14, and 15 and above indicate mild, moderate, and severe depression, respectively. This is a secondary outcome for patients.

    Measured: 1, 6, and 12 weeks post intervention

  3. Effects of Spiritual Care Assessment and Intervention (SCAI) framework on satisfaction with spiritual care

    Client Satisfaction Questionnaire (CSQ):

    Satisfaction will be assessed using the 8-item Client Satisfaction Questionnaire. Each item is rated on a scale from 1 to 4. Items # 1, 3, 6, and 7 are reverse-scored and then the 8 items are summed with higher total scores indicating greater satisfaction. This is a secondary outcome for patients.

    Measured: 1, 6, and 12 weeks post intervention

  4. Effects of Spiritual Care Assessment and Intervention (SCAI) framework on meaning and purpose

    Patient-Reported Outcomes Measurement Information System (PROMIS) Meaning \& Purpose Short Form: Meaning and purpose will be assessed using this 7-item PROMIS measure. Each item is rated when considering the past week on a scale from 1 (not at all) to 5 (very much). The 7 items are summed with higher total scores indicating greater meaning and purpose. This is a secondary outcome for patients.

    Measured: 1, 6, and 12 weeks post intervention

  5. Effects of Spiritual Care Assessment and Intervention (SCAI) framework on religious coping

    Brief Religious Coping Scale (RCOPE): Religious coping will be measured using the 14-item Brief Religious Coping Scale, which includes two subscales of 7 items each: positive religious coping and negative religious coping. Each item is rated on a scale from 0 (not at all) to 3 (a great deal). Subscale scores are calculated separately as sum scores. Scores range from 0 to 21 for each subscale, with higher scores indicating higher usage. The subscale scores are analyzed independently, as they are often uncorrelated. This is a secondary outcome for patients.

    Measured: 1, 6, and 12 weeks post intervention

  6. Effects of Spiritual Care Assessment and Intervention (SCAI) framework on positive affect

    Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect Short Form: Positive affect will be assessed using this 15-item PROMIS measure. Each item is rated when considering the past week on a scale from 1 (not at al) to 5 (very much). The 15 items are summed with higher total scores indicating greater positive affect. This is a secondary outcome for patients.

    Measured: 1, 6, and 12 weeks post intervention

Timeline

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

  1. First posted16 Sep 2025
  2. Study start9 Sep 2025
  3. Primary completionSep 2028 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07176559
Sponsor's protocol ID
IUSCCC-0936
Acronym
PRaCTIS
Status last verified
Oct 2026
First submitted
29 Aug 2025
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Spiritual Care and Informational Support in people with Stage IV Lung Cancer and Stage IV Gastrointestinal Cancer, run by Indiana University at 4 sites 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 7 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: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

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?

Evaluation of feasibility of the Spiritual Care Assessment and Intervention (SCAI) framework vs informational support (time frame: Visits 1-4, approximately weekly, within 3 months of enrollment). The study lists 3 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 NCT07176559.

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 28 Oct 2026.

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