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| Name | Class |
|---|---|
| University of Colorado, Denver | OTHER |
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In the face of imminent loss, many adults with metastatic cancer report a range of mental health challenges, including cancer-related trauma symptoms, fear of cancer progression and dying/death, anxiety, depression, and hopelessness, as well as physical symptoms such as fatigue and pain. Cancer patients may report feeling upset or haunted by imagined scenarios in a way that causes them distress and lowers their quality of life.
This study aims to look at the acceptability and feasability of a writing-based intervention for adults with late-stage or recurrent cancer, or actively treated blood cancer. The EASE study uses a writing-based approach to address an individual's worst-case scenario about cancer because previous studies have shown that similar approaches have shown promise in reducing fear in early-stage cancer survivors and among adults with PTSD (posttraumatic stress disorder). The EASE study represents a novel adaptation of this foundational work on written exposure therapy (WET) to address worst-case scenarios among adults with late stage cancers.
The EASE study will include 5 weekly one-on-one online video sessions with a trained therapist where participants will be coached through writing exercises based on a worst-case scenario related to their cancer experience.
This single-arm pilot trial aims to look at the acceptability and feasibility of a writing-based intervention for adults with metastatic or recurrent cancer, or actively treated blood cancer.
The EASE intervention represents a novel adaptation of foundational work on written exposure therapy (WET) to address worst-case scenarios among adults with metastatic cancer, including cancer diagnosed at Stage III or IV, cancer that has recurred, or actively treated lymphoproliferative cancer. The study will consist of 5 weekly one-on-one online sessions with a trained graduate student therapist who will explain the approach and coach participants through writing exercises based on a worst-case scenario related to their fears about cancer.
Remote Delivery.
The intervention will be delivered remotely via videoconferencing software or videoconferencing plus phone. Phone sessions will be available as a backup if a participant has significant technical difficulties with Zoom. All sessions will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EASE Written Exposure Intervention | Experimental | Assigned Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Written Exposure Therapy | Behavioral | An innovative written exposure therapy intervention that addresses psychosocial needs commonly experienced by patients with late stage cancers. |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer-related trauma symptoms | A primary outcome will be change in cancer-related trauma symptoms, assessed by the 22-item Impact of Events Scale-Revised. Possible scores range 0-88 with higher scores indicating greater distress/bother. | Assessed seven times: prior to the intervention (Pre), before each intervention session, 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU) |
| Fear of cancer progression | A primary outcome will be change in fear of cancer progression, assessed by the 12-item Fear of Progression Questionnaire - Short Form and by the four general scale items from the Concerns about Recurrence Scale, with wording adapted to focus on cancer progression rather than recurrence. Range: 12-60, higher scores are associated with higher fear of cancer progression. | Assessed: prior to the intervention (Pre), before each intervention session, 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU) |
| Intervention acceptability | Assessed with the Acceptability of Intervention Scale. Possible scores range from 4-20, with higher scores indicating greater intervention acceptability. | Assessed in order to compare values at 2 timepoints: 6 weeks after baseline (Post) and separately at 1.5-month follow-up (FU) |
| Intervention Feasibility | For participants who begin the intervention, at least 70% complete all intervention sessions | Assessed at each intervention session 1-5, 1 to 5 weeks after baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire (PHQ-8) | Patient-reported depression symptom questionnaire. Range is 0 to 24. Higher scores indicate more depression symptoms | Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post),, at 1.5 and 3-month follow-up (FU) |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Acceptability: Session Feedback Questionnaire | Participant value of the session will be assessed through the Session Feedback. Possible scores range 4-20, with higher scores indicating higher value and acceptability of the session. | Once weekly during intervention period from Pre to Post (6 weeks after baseline, e.g., at the end of each weekly session during the intervention period) |
Inclusion Criteria:
Exclusion Criteria:
1. Current moderate or high suicide risk evaluated by the Columbia Suicide Severity Rating Scale (CSSRS)
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| Name | Affiliation | Role |
|---|---|---|
| Joanna Arch, PhD | University of Colorado, Boulder | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Boulder | Boulder | Colorado | 80309 | United States |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D008232 | Lymphoproliferative Disorders |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Single-arm pilot trial: all participants will receive intervention
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| Generalized Anxiety Disorder-7 Questionnaire |
Patient-reported anxiety symptom questionnaire. Possible scores range from 0-21, with higher scores indicating more anxiety symptoms |
| Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU) |
| The Death Attitude Profile-Revised, Fear of Death and Death Avoidance Scales | Patient-reported fear of death and dying questionnaire. Possible scores range from 12-84, with higher scores indicating greater fear of death and dying | Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU) |
| Hopelessness Assessment in Illness Questionnaire 8-item | Patient-reported hopelessness specifically intended for use with adults with incurable cancer. Possible scores range 0-16, with higher scores indicating greater hopelessness. | Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU) |
| The Patient Reported Outcome Measurement Information System (PROMIS) Fatigue-Short Form v1.0 | Patient-reported levels of fatigue. Possible scores range 6-30, with higher scores indicating greater fatigue. | Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU) |
| The Patient Reported Outcome Measurement Information System (PROMIS) Pain Interference-Short Form v1.0 | Patient-reported dimension of pain interference (e.g., the extent to which pain interferes with daily life and life roles). Possible scores range 6-30, with higher scores indicating greater pain. | Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU) |
| Emotional Approach Coping Scale (COPE): Avoidance coping (process measure) | Patient-reported coping through avoidance using three avoidance coping scales (mental disengagement, denial, physical disengagement) with cancer as the anchor. Possible scores range 8-28, with higher scores indicating greater denial, mental and behavioral disengagement. | Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU) |
| Five Factor Mindfulness Questionnaire, Nonjudge and nonreact scales (process measure) | Patient-reported coping through acceptance. Possible scores range 15-75, with higher scores reflecting greater nonreactivity and nonjudging of inner experience. | Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU) |
| Valuing Questionnaire | Valued engagement in daily life. Possible scores range 0-30 for each of the two subscales with higher scores indicating greater engagement and sense of purpose in life. | Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU) |
| Self-compassion Scale-Short Form | Self-compassion questionnaire. Possible scores range 12-60 with higher scores indicating higher self-compassion. | Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU) |
| Intervention Acceptability: Client Satisfaction Questionnaire-8 | Participant satisfaction will be measured using the Client Satisfaction Questionnaire-8 (adapted to the current intervention). Possible scores range 8-32, with higher scores indicating more satisfaction. | Assessed and reported two times: 6 weeks after baseline (Post), 3-month follow-up (FU) |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001523 | Mental Disorders |