Trial of Written Exposure for Metastatic Cancer Patients (EASE)

NCT06042400 | Completed DMC

• 1 other identifier: 21-0243
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Cancer; Solid Tumor Cancer; Lymphoproliferative Disorders; Anxiety; Post-traumatic Stress Symptoms; Fear of Cancer Progression

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• Patient Health Questionnaire (PHQ-8)

  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

  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

  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

  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

  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 (2)

• Intervention Acceptability: Session Feedback Questionnaire

  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

  Assessed and reported two times: 6 weeks after baseline (Post), 3-month follow-up (FU)

Study Arms (1)

EASE Written Exposure Intervention

EXPERIMENTAL

Assigned Intervention

Behavioral: Written Exposure Therapy

Interventions

Written Exposure Therapy BEHAVIORAL

An innovative written exposure therapy intervention that addresses psychosocial needs commonly experienced by patients with late stage cancers.

EASE Written Exposure Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• English-speaking (able to speak, read, and write well in English)
• 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)
• Report elevated cancer-related trauma symptoms or fear of cancer progression on the screening measures: IES-R, FoP-Q 12-item short version.
• No moderate to severe dementia reported by patient or seen during eligibility confirmation in the medical chart
• 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.
• 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.
• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Boulder: lead
• University of Colorado, Denver: collaborator

Study Sites (1)

University of Colorado Boulder

Boulder, Colorado, 80309, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Lymphoproliferative Disorders; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Mental Disorders

Study Officials

• Joanna Arch, PhD

  University of Colorado, Boulder

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Single-arm pilot trial: all participants will receive intervention

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: September 18, 2023
• Study Start: April 18, 2022
• Primary Completion: September 21, 2023
• Study Completion: September 21, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)