Expressive Writing for Caregivers of Persons With Cancer

Study Overview
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Brief Summary
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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: Does participation in a group-based, videoconference-delivered expressive writing intervention improve mood and quality of life for caregivers of persons with cancer? 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? 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
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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.

Official Title
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A Community-based Video-conference-delivered Expressive Writing Intervention for Caregivers of Persons With Cancer

Conditions
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Quality of Life, Distress, Emotional

Intervention / Treatment
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* Behavioral: Expressive writing intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Waitlist control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active intervention<br>Participants will attend four group-based expressive writing sessions led by a trained facilitator. All sessions will be delivered via videoconference. Sessions will occur weekly over the course of 4 consecutive weeks and will not exceed 60 minutes in length. Each session will include a 15- to 20-minute writing stint whereby participants are asked to write about their deepest thoughts and feelings regarding their loved one's cancer and their role as caregiver. All participants will be given a Rocketbook for this purpose, a spiral notebook that has the look and feel of a standard paper notebook but uses a pen with erasable ink. The writing stint will be followed by a group discussion; participants will be invited to share what they wrote about (if so desired) and their reactions to the writing process. Each session will end with a debriefing and erasure of the writing content just created. This will ensure privacy of the material and may be perceived as cleansing. | Behavioral: Expressive writing intervention<br>* 4 videoconference-delivered group-based expressive writing sessions<br>|
| Placebo Comparator: Waitlist control<br>Procedures are exactly the same as for the experimental arm but delayed. | Behavioral: Expressive writing intervention<br>* 4 videoconference-delivered group-based expressive writing sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological distress | Profile of Mood States, 2nd edition (0-4, higher values indicate greater distress) | change from baseline psychological distress at 6 weeks | 
| Quality of life, general | World Health Organization Quality of Life - Abbreviated version (0-100, higher values indicate greater quality of life) | change from baseline quality of life at 6 weeks | 
| Quality of life, caregiver-specific | Caregiver Quality of Life Index-Cancer (0-140, higher values indicate greater quality of life) | change from baseline caregiver-specific quality of life at 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | Center for Epidemiologic Studies Depression-10 (0-30, higher values indicate greater depression) | change from baseline depression at 6 weeks | 
| Perceived stress | Perceived Stress Scale (0-40, higher values indicate greater stress) | change from baseline perceived stress at 6 weeks |