Trial of Written Exposure for Metastatic Cancer Patients (EASE)

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06042400
• Other study ID #: 21-0243
• Status: Completed
• Phase: N/A
• Start date: April 18, 2022
• Est. completion date: September 21, 2023

Study information

• Verified date: December 2023
• Source: University of Colorado, Boulder
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 21, 2023
• Est. primary completion date: September 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety
• Disease Progression
• Lymphoproliferative Disorders
• Metastatic Cancer
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Second Primary
• Post-traumatic Stress Symptoms
• Solid Tumor Cancer

Intervention

Behavioral:
• Written Exposure Therapy
An innovative written exposure therapy intervention that addresses psychosocial needs commonly experienced by patients with late stage cancers.

Locations

Country	Name	City	State
United States	University of Colorado Boulder	Boulder	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Boulder	University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)