Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Conditions
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.
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
PROCEDURESpiritual Therapy
Attend PATH workshops
OTHERSurvey Administration
Ancillary studies
OTHERInterview
Ancillary studies
Sponsors
Fred Hutchinson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accrual rates (feasibility) (Aim 1) | 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) | 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) | 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) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in self-transcendence as measured by the Self-Transcendence Scale (STS) (Aim 2) | At baseline and 1- and 6-week follow-up (days 42 and 84) | 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. |
| Change in psychological distress as measured by the Patient Health Questionnaire-8 (PHQ-8) (Aim 2) | At baseline and 1- and 6-week follow-up (days 42 and 84) | 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. |
| Change in anxiety as measured by Generalized Anxiety Disorder-7 (GAD-7) (Aim 2) | At baseline and 1- and 6-week follow-up (days 42 and 84) | 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. |
Countries
United States
Contacts
CONTACTRaeAnne Wiseman
PRINCIPAL_INVESTIGATORRaeAnne Wiseman
Fred Hutch/University of Washington Cancer Consortium
Outcome results
None listed