Clinical trial NCT05859880: Expressive Writing for Caregivers of Persons With Cancer
Official title: A Community-based Video-conference-delivered Expressive Writing Intervention for Caregivers of Persons With Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Quality of Life
Distress, Emotional
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Waitlist control
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to test the effects of an expressive writing intervention for caregivers of persons with cancer. The main questions the study aims to answer are:

1. Does participation in a group-based, videoconference-delivered expressive writing intervention improve mood and quality of life for caregivers of persons with cancer?
2. Is greater improvement associated with writing that is more emotionally expressive or personally revealing, or with group-based sessions characterized by certain linguistic features such as greater emotionality?
3. Is benefit greater for certain subgroups of caregivers, such as those who are younger or who identify as female in gender?

Participants will be asked to join four videoconference-delivered, group-based expressive writing sessions. This will be done in groups of 4-8 caregivers and led by a trained facilitator. During each session, participants will write about their deepest thoughts and feelings about their loved one's cancer and their experiences as a caregiver. They will then discuss as a group any reactions to the writing process.

Participants will be randomly assigned to either active intervention (receiving the intervention as soon as a group is formed) or waitlist control. Researchers will compare active and waitlist control participants on to pre- to post-intervention changes in mood and quality of life.

Detailed description: A diagnosis of cancer reverberates throughout the family. Family caregivers take on a wide range of responsibilities, such as monitoring medical symptoms, communicating with the patient's medical team, managing insurance claims, providing transportation, and assisting with activities of daily living. Psychological distress is common. Caregivers often feel unprepared for their role, and socially isolated from others. Physical impacts have also been documented, from fatigue to sleep disturbance to immune dysfunction. To alleviate some of these difficult sequelae of cancer caregiving, we propose to test the utility of a brief, low-cost, non-pharmacologic, behavioral intervention for persons providing care for a loved one with cancer. Specifically, we will test the effects of an expressive writing (EW) intervention. The basic paradigm asks participants to write for 20 minutes on four separate occasions about a trauma or stressor. Initial work conducted with undergraduate samples showed benefit of EW. Since then, EW studies have been conducted across a variety of populations including persons coping with chronic illness. Benefits have ranged from better lung function among asthmatics to fewer physical symptoms among women with breast cancer. One meta-analysis of 146 studies across 10,994 participants reported positive effect sizes (mental or physical health benefits) for 102 of the studies (70%). Notable gaps in this literature include testing with cancer caregivers (with some exceptions) and use of novel delivery formats.

Specific aims are: (1) To examine the effects of a group-based, videoconference-delivered EW program on emotional, social, and physical well-being among informal caregivers of persons diagnosed with cancer; (2) To identify social and linguistic mechanisms by which participation in the group-based EW intervention may improve distress; and (3) To identify potential moderators of benefit including age, gender identity, relationship to the patient, and baseline social constraints.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Self-identify as informal caregiver for an adult (age 18+) diagnosed with stage II-IV breast, ovarian, prostate, colon, rectal, or lung cancer within the past 2 years
* English speaking and comprehending
* Access to a desktop computer, laptop, tablet or smartphone and Wireless Fidelity (WIFI) to complete surveys and participate in videoconference-based expressive writing sessions

Exclusion Criteria:

-Caregiver for pediatric cancer patient

Primary outcomes:
measure: Psychological distress
timeFrame: change from baseline psychological distress at 6 weeks
measure: Quality of life, general
timeFrame: change from baseline quality of life at 6 weeks
measure: Quality of life, caregiver-specific
timeFrame: change from baseline caregiver-specific quality of life at 6 weeks
Secondary outcomes:
measure: Depression
timeFrame: change from baseline depression at 6 weeks
measure: Perceived stress
timeFrame: change from baseline perceived stress at 6 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Cancer Support Community Arizona
state: Arizona
Study officials:
References:
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