Trial of Written Exposure for Metastatic Cancer Patients (EASE)

Pilot Trial of Written Exposure Intervention for Metastatic Cancer Patients: The EASE Study

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.

Study Overview

• Status: Recruiting
• Conditions: Lymphoproliferative Disorders; Anxiety; Metastatic Cancer; Solid Tumor Cancer; Post-traumatic Stress Symptoms; Fear of Cancer Progression
• Intervention / Treatment: Behavioral: Written Exposure Therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Madeline Nealis, MPH; Phone Number: 720-515-9461; Email: valuedliving@colorado.edu
• Study Contact Backup: Name: Elizabeth Slivjak, MA; Phone Number: ‪720-340-3273‬; Email: elizabeth.slivjak@colorado.edu

Study Locations

• United States
  • Colorado
    • Boulder, Colorado, United States, 80309
      • Recruiting
      • University of Colorado Boulder

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EASE Written Exposure Intervention; Assigned Intervention	Behavioral: Written Exposure Therapy; An innovative written exposure therapy intervention that addresses psychosocial needs commonly experienced by patients with late stage cancers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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)
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)

Other Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: University of Colorado, Boulder
• Collaborators: University of Colorado, Denver
• Investigators: Principal Investigator: Joanna Arch, PhD, University of Colorado, Boulder

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2022
• Primary Completion (Estimated): April 18, 2024
• Study Completion (Estimated): October 18, 2024

Study Registration Dates

• First Submitted: May 16, 2022
• First Submitted That Met QC Criteria: September 13, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Lymphatic Diseases; Immunoproliferative Disorders; Disease Attributes; Neoplastic Processes; Neoplasms; Disease Progression; Neoplasm Metastasis; Lymphoproliferative Disorders; Neoplasms, Second Primary
• Other Study ID Numbers: 21-0243

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No