Clinical trial NCT06042400: Trial of Written Exposure for Metastatic Cancer Patients (EASE)
Official title: Pilot Trial of Written Exposure Intervention for Metastatic Cancer Patients: The EASE Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Cancer
Solid Tumor Cancer
Lymphoproliferative Disorders
Anxiety
Post-traumatic Stress Symptoms
Fear of Cancer Progression
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
First posted: 2023-09-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm pilot trial: all participants will receive intervention
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. At least 18 years of age
2. English-speaking (able to speak, read, and write well in English)
3. Diagnosed with solid tumor cancer at Stage III (locally metastatic) or Stage IV (distantly metastatic) or solid tumor cancer that has recurred, or actively treated lymphoproliferative cancer (e.g., non-solid tumor cancer)
4. Report elevated cancer-related trauma symptoms or fear of cancer progression on the screening measures: IES-R, FoP-Q 12-item short version.
5. No moderate to severe dementia reported by patient or seen during eligibility confirmation in the medical chart
6. Are capable at time of consent of understanding and voluntarily consenting themselves to the study, attending EASE sessions, and completing the online sessions at home, confirmed by an Eastern Cooperative Group Performance Status Scale of 0 to 2. Given that the study does not require individuals to leave their home, we will make an exception for individuals endorsing an Eastern Cooperative Group Performance Status Scale score of 3 (confined to bed or chair for \<50% of waking hours, able to do only limited selfcare) if they meet all other study criteria, including criteria 7.
7. Report that they are able and willing to complete all study procedures, including the online assessments and the intervention itself, including being physically able to write by hand or type for 30 minutes at a time and do weekly hour-long EASE sessions by Zoom.
8. Has access to a computer with internet connection or are willing to use a study-loaned computer tablet for the study duration, and are willing to conduct sessions via videoconferencing on a computer

Exclusion Criteria:

1. Current moderate or high suicide risk evaluated by the Columbia Suicide Severity Rating Scale (CSSRS)

Primary outcomes:
measure: Cancer-related trauma symptoms
timeFrame: 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)
measure: Fear of cancer progression
timeFrame: 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)
measure: Intervention acceptability
timeFrame: Assessed in order to compare values at 2 timepoints: 6 weeks after baseline (Post) and separately at 1.5-month follow-up (FU)
measure: Intervention Feasibility
timeFrame: Assessed at each intervention session 1-5, 1 to 5 weeks after baseline.
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-8)
timeFrame: 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: Generalized Anxiety Disorder-7 Questionnaire
timeFrame: 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: The Death Attitude Profile-Revised, Fear of Death and Death Avoidance Scales
timeFrame: 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: Hopelessness Assessment in Illness Questionnaire 8-item
timeFrame: 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: The Patient Reported Outcome Measurement Information System (PROMIS) Fatigue-Short Form v1.0
timeFrame: 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: The Patient Reported Outcome Measurement Information System (PROMIS) Pain Interference-Short Form v1.0
timeFrame: 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: Emotional Approach Coping Scale (COPE): Avoidance coping (process measure)
timeFrame: 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: Five Factor Mindfulness Questionnaire, Nonjudge and nonreact scales (process measure)
timeFrame: 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: Valuing Questionnaire
timeFrame: 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: Self-compassion Scale-Short Form
timeFrame: 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)
Other outcomes:
measure: Intervention Acceptability: Session Feedback Questionnaire
timeFrame: 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)
measure: Intervention Acceptability: Client Satisfaction Questionnaire-8
timeFrame: Assessed and reported two times: 6 weeks after baseline (Post), 3-month follow-up (FU)
Locations:
city: Boulder
country: United States
facility: University of Colorado Boulder
state: Colorado
Study officials:
affiliation: University of Colorado, Boulder
name: Joanna Arch, PhD
role: PRINCIPAL_INVESTIGATOR
References: