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Not yet recruiting NCT07545291

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

No phase Interventional Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Spiritual Therapy, Survey Administration, Interview.
Who it may be relevant to
Registry conditions: Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Personal Archetypes Toward Healing (PATH) Trial

Overview

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.

Detailed description

OUTLINE:

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).

After completion of study intervention, patients are followed up on days 42 and 84.

Interventions

  • Procedure Spiritual Therapy
    Attend PATH workshops
  • Other Survey Administration
    Ancillary studies
  • Other Interview
    Ancillary studies

Primary outcome measures

  • Accrual rates (feasibility) (Aim 1) [Time frame: At time of enrollment]
  • Rates of intervention completion (feasibility) (Aim 1) [Time frame: Up to day 84]
  • Acceptability (Aim 1) [Time frame: Up to day 42]
  • Satisfaction (Aim 1) [Time frame: Up to day 42]
  • Change in spiritual, religious, and existential (SRE) distress as measured by the Religious and Spiritual Struggles Scale-5 (RSS-5) (Aim 2) [Time frame: At baseline and 1- and 6-week follow-up (days 42 and 84)]
Secondary outcome measures (3)
  • Change in self-transcendence as measured by the Self-Transcendence Scale (STS) (Aim 2) [Time frame: At baseline and 1- and 6-week follow-up (days 42 and 84)]
  • Change in psychological distress as measured by the Patient Health Questionnaire-8 (PHQ-8) (Aim 2) [Time frame: At baseline and 1- and 6-week follow-up (days 42 and 84)]
  • Change in anxiety as measured by Generalized Anxiety Disorder-7 (GAD-7) (Aim 2) [Time frame: At baseline and 1- and 6-week follow-up (days 42 and 84)]

Eligibility criteria

Inclusion criteria

  • 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)

Exclusion criteria

  • Non-oncology Fred Hutch patients

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Fred Hutch/University of Washington Cancer Consortium — Seattle

Identifiers

NCT: NCT07545291 · RG1126171 · NCI-2026-02254 · 21101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗