Hematopoietic and Lymphatic System NeoplasmNCT07545291
A Spiritual Health Intervention (PATH) for Improving Spiritual, Religious and Emotional Distress in Cancer Patients
A study testing Spiritual Therapy, Survey Administration and Interview in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Spiritual Therapy, Survey Administration and Interview
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 31 Mar 2027
- 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
- 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)
Who cannot join
- Non-oncology Fred Hutch patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
RaeAnne Wiseman, 206-606-8215, rwiseman@fredhutch.org
RaeAnne Wiseman
About this study
Official title: Personal Archetypes Toward Healing (PATH) Trial
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.
Read the 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.
- Being tested
- Spiritual Therapy, Survey Administration, Interview
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spiritual TherapyProcedure or surgery
Attend PATH workshops
Survey AdministrationOther
Ancillary studies
InterviewOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Spiritual Therapy; Other: Survey Administration; Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Spiritual, religious, and existential (SRE) distress will be measured using the Religious and Spiritual Struggles Scale-5 (RSS-5), a valid and reliable 5-item Likert-type self-report measure of spiritual struggle. Each item is rated on a 5-point scale ranging from 1 ("not at all") to 5 ("a great deal"). Item scores are summed or averaged to create an overall SRE distress score. Total mean score ranges from 1 to 5, with higher scores indicating greater levels of SRE distress. Change in SRE distress will be assessed at baseline and at 1- and 6-week follow-up.
Measured: At baseline and 1- and 6-week follow-up (days 42 and 84)
Secondary outcomes (3)
Change in self-transcendence as measured by the Self-Transcendence Scale (STS) (Aim 2)
Self-transcendence will be measured using the Self-Transcendence Scale (STS), a validated 15-item Likert-type self-report measure assessing individuals' sense of connection to something greater in 4 realms (intrapersonal, interpersonal, temporal and transpersonal). Each item is rated on a 4-point scale ranging from 1 ("not at all") to 4 ("very much"), and item scores are summed or averaged to generate an overall self-transcendence score. Total mean score ranges from 1 to 4, with higher scores indicating greater levels of self-transcendence. Change in self-transcendence will be assessed at baseline and at 1- and 6-week follow-up.
Measured: 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)
Psychological distress will be measured using the Patient Health Questionnaire-8 (PHQ-8), a well-validated 8-item Likert-type self-report measure of depressive symptoms commonly used in cancer populations. Each item is rated on a 4-point scale ranging from 0 ("not at all") to 3 ("nearly every day"), and all items are summed to produce a total score. Total scores can range from 0 to 24, with higher scores indicating greater levels of psychological distress. Change in distress will be assessed at baseline and at 1- and 6-week follow-up.
Measured: 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)
Anxiety will be measured using the Generalized Anxiety Disorder-7 (GAD-7), a validated 7-item Likert-type self-report measure of anxiety severity. Each item is rated on a 4-point scale ranging from 0 ("not at all") to 3 ("nearly every day"), and item scores are summed to create a total anxiety score. Total scores can range from 0 to 21, with higher scores indicating greater levels of anxiety. Change in anxiety will be assessed at baseline and at 1- and 6-week follow-up.
Measured: At baseline and 1- and 6-week follow-up (days 42 and 84)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphatic System NeoplasmStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- RaeAnne Wiseman, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545291
- Sponsor's protocol ID
- RG1126171
- Other IDs
- NCI-2026-02254, 21101
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personal Archetypes Toward Healing (PATH) Trial
- ClinicalTrials.gov ID
- NCT07545291
- Acronym / sponsor ID
- RG1126171
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (PATH) | Experimental | Procedure: Spiritual Therapy, Other: Survey Administration, Other: InterviewPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- Non-oncology Fred Hutch patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spiritual TherapyAttend PATH workshops | Procedure or surgery | Supportive care (PATH) |
| Survey AdministrationAncillary studies | Other | Supportive care (PATH) |
| InterviewAncillary studies | Other | Supportive care (PATH) |
Primary outcome
Accrual rates (feasibility) (Aim 1)
Time frame: At time of enrollment
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.
Rates of intervention completion (feasibility) (Aim 1)
Time frame: Up to day 84
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.
Acceptability (Aim 1)
Time frame: Up to day 42
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.
Satisfaction (Aim 1)
Time frame: Up to day 42
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.
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)
Spiritual, religious, and existential (SRE) distress will be measured using the Religious and Spiritual Struggles Scale-5 (RSS-5), a valid and reliable 5-item Likert-type self-report measure of spiritual struggle. Each item is rated on a 5-point scale ranging from 1 ("not at all") to 5 ("a great deal"). Item scores are summed or averaged to create an overall SRE distress score. Total mean score ranges from 1 to 5, with higher scores indicating greater levels of SRE distress. Change in SRE distress will be assessed at baseline and at 1- and 6-week follow-up.
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
RaeAnne Wiseman principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spiritual Therapy, Survey Administration and Interview in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Fred Hutchinson Cancer Center at 1 site 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 5 inclusion and 1 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: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Contact RaeAnne Wiseman (206-606-8215, rwiseman@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accrual rates (feasibility) (Aim 1) (time frame: At time of enrollment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2026.