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Trial of Written Exposure for Metastatic Cancer Patients (EASE)

Primary Purpose

Metastatic Cancer, Solid Tumor Cancer, Lymphoproliferative Disorders

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Written Exposure Therapy

About this trial

This is an interventional supportive care trial for Metastatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Colorado BoulderRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EASE Written Exposure Intervention

Arm Description

Assigned Intervention

Outcomes

Primary Outcome Measures

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.

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.

Intervention acceptability

Assessed with the Acceptability of Intervention Scale. Possible scores range from 4-20, with higher scores indicating greater intervention acceptability.

Intervention Feasibility

For participants who begin the intervention, at least 70% complete all intervention sessions

Secondary Outcome Measures

Patient Health Questionnaire (PHQ-8)

Patient-reported depression symptom questionnaire. Range is 0 to 24. Higher scores indicate more depression symptoms

Generalized Anxiety Disorder-7 Questionnaire

Patient-reported anxiety symptom questionnaire. Possible scores range from 0-21, with higher scores indicating more anxiety symptoms

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

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.

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.

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.

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.

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.

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.

Self-compassion Scale-Short Form

Self-compassion questionnaire. Possible scores range 12-60 with higher scores indicating higher self-compassion.

Full Information

NCT ID

NCT06042400

First Posted

May 16, 2022

Last Updated

September 13, 2023

Sponsor

University of Colorado, Boulder

Collaborators

University of Colorado, Denver

1. Study Identification

Unique Protocol Identification Number

NCT06042400

Brief Title

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

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 18, 2022 (Actual)

Primary Completion Date

April 18, 2024 (Anticipated)

Study Completion Date

October 18, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Colorado, Boulder

Collaborators

University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single-arm pilot trial: all participants will receive intervention

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

EASE Written Exposure Intervention

Arm Type

Experimental

Arm Description

Assigned Intervention

Intervention Type

Behavioral

Intervention Name(s)

Written Exposure Therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Cancer-related trauma symptoms

Description

Time Frame

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)

Title

Fear of cancer progression

Description

Time Frame

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)

Title

Intervention acceptability

Description

Assessed with the Acceptability of Intervention Scale. Possible scores range from 4-20, with higher scores indicating greater intervention acceptability.

Time Frame

Assessed in order to compare values at 2 timepoints: 6 weeks after baseline (Post) and separately at 1.5-month follow-up (FU)

Title

Intervention Feasibility

Description

For participants who begin the intervention, at least 70% complete all intervention sessions

Time Frame

Assessed at each intervention session 1-5, 1 to 5 weeks after baseline.

Secondary Outcome Measure Information:

Title

Patient Health Questionnaire (PHQ-8)

Description

Patient-reported depression symptom questionnaire. Range is 0 to 24. Higher scores indicate more depression symptoms

Time Frame

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)

Title

Generalized Anxiety Disorder-7 Questionnaire

Description

Patient-reported anxiety symptom questionnaire. Possible scores range from 0-21, with higher scores indicating more anxiety symptoms

Time Frame