Expressive Writing for Caregivers of Persons With Cancer

Arizona State University (ASU)

Status

Enrolling

Conditions

Quality of Life

Distress, Emotional

Treatments

Behavioral: Expressive writing intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT05859880

STUDY00017135

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

100 participants in 2 patient groups, including a placebo group

Active intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Expressive writing intervention

Waitlist control

Placebo Comparator group

Description:

Procedures are exactly the same as for the experimental arm but delayed.

Treatment:

Behavioral: Expressive writing intervention