A Spiritual Health Intervention (PATH) for Improving Spiritual, Religious and Emotional Distress in Cancer Patients

NCT07545291 | Not Yet Recruiting

• 3 other identifiers: RG1126171NCI-2026-0225421101
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial tests the feasibility and effectiveness of a spiritual health intervention (Personal Archetypes Toward Healing Trial \[PATH\]) for improving spiritual, religious and existential distress in patients with cancer. Many patients with cancer find their diagnosis to elicit challenges to their sense of connection, meaning, and purpose. This distress can significantly impact their quality of life. However, spiritual care interventions are often overlooked. PATH builds on multiple theories and therapeutic practices such as role-playing, archetype psychology, cognitive theory, emotion regulation therapy, and dignity therapy. PATH sessions cover topics such as individuation, intrapersonal meaning and worth, intrapersonal distress and faith, interpersonal distress and faith, and transpersonal distress and faith. The PATH intervention may help cancer patients shift their perspectives and access new insights for working through their spiritual, religious and existential distress.

Conditions

Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (5)

• Accrual rates (feasibility) (Aim 1)

  Feasibility will be examined by conducting frequency and descriptive statistics for enrollment rates. The benchmark for feasibility is ≥ 50% of screened eligible patients enroll in the study. To test this, will perform a one-sample proportion test to examine if the proportion of participants meeting the benchmark for feasibility is significantly higher than 0.50. Feasibility process outcomes will be analyzed to determine whether the intervention is feasible for future dissemination and implementation efforts and recruitment of a full-scale randomized controlled trial.

  At time of enrollment

• Rates of intervention completion (feasibility) (Aim 1)

  Intervention completion metrics will include all 6 intervention sessions as well as both follow-up timepoints (days 42 and 84). Patients will be required to attend at least 70% of all sessions (5 of 6). Feasibility will be examined by conducting frequency and descriptive statistics for intervention completion. The benchmark for feasibility is ≥ 70% of enrolled patients completing the intervention. To test this, will perform a one-sample proportion test to examine if the proportion of participants meeting the benchmark for feasibility is significantly higher than 0.70. Feasibility process outcomes will be analyzed to determine whether the intervention is feasible for future dissemination and implementation efforts and recruitment of a full-scale randomized controlled trial.

  Up to day 84

• Acceptability (Aim 1)

  Acceptability will be assessed by the Theoretical Framework of Acceptability (TFA) questionnaire and three additional quality improvement questions. To analyze intervention acceptability, scores on the TFA questionnaire will be calculated using the total mean score of seven TFA items. In this study, will use a cutoff of \>= 70% of patients agreeing (or rating as confident, liking, acceptable or 4 out of 5 or higher on the TFA) as being acceptable for use.

  Up to day 42

• Satisfaction (Aim 1)

  Satisfaction will be assessed by using three items assessing overall satisfaction. Satisfaction thresholds will require an average or mean of 7 out of 10 on each of the three items.

  Up to day 42

• Spiritual, religious and existential (SRE) distress (Aim 2)

  Will be assessed by the Religious and Spiritual Struggles scale.

  At baseline and 1- and 6-week follow-up (days 42 and 84)

Secondary Outcomes (3)

• Self-transcendence (Aim 2)

  At baseline and 1- and 6-week follow-up (days 42 and 84)

• Distress (Aim 2)

  At baseline and 1- and 6-week follow-up (days 42 and 84)

• Anxiety (Aim 2)

  At baseline and 1- and 6-week follow-up (days 42 and 84)

Study Arms (1)

Supportive care (PATH)

EXPERIMENTAL

Patients attend 1 individual PATH session with the interventionist on day 1 and then attend group PATH workshop sessions weekly for 5 sessions (days 7, 14, 21, 28, and 35).

Procedure: Spiritual Therapy; Other: Survey Administration; Other: Interview

Interventions

Spiritual Therapy PROCEDURE

Attend PATH workshops

Supportive care (PATH)

Survey Administration OTHER

Ancillary studies

Supportive care (PATH)

Interview OTHER

Ancillary studies

Supportive care (PATH)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years of age or older
• English speaking
• Able to provide informed consent
• Current diagnosis of cancer at any stage, engaged in active treatment or surveillance at Fred Hutch Cancer Center
• Scores of "Somewhat" or above on at least 1 item the Religious and Spiritual Struggles scale (RSS-5) (e.g., Somewhat = 3 on a 1-to-5 Likert scale)

You may not qualify if:

• Non-oncology Fred Hutch patients

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Interventions

Spiritual Therapies; Interviews as Topic

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• RaeAnne Wiseman

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

RaeAnne Wiseman

CONTACT

206-606-8215; rwiseman@fredhutch.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 22, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)