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Completed

NCT Number: NCT05859880

Expressive Writing for Caregivers of Persons With Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cancer Support Community Arizona

Phoenix, Arizona, 85004, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Expressive writing intervention

Behavioral

4 videoconference-delivered group-based expressive writing sessions

Primary outcomes

  1. Psychological distress

    Time frame: change from baseline psychological distress at 6 weeks

    Profile of Mood States, 2nd edition (0-4, higher values indicate greater distress)

  2. Quality of life, general

    Time frame: change from baseline quality of life at 6 weeks

    World Health Organization Quality of Life - Abbreviated version (0-100, higher values indicate greater quality of life)

  3. Quality of life, caregiver-specific

    Time frame: change from baseline caregiver-specific quality of life at 6 weeks

    Caregiver Quality of Life Index-Cancer (0-140, higher values indicate greater quality of life)

Secondary outcomes

  1. Depression

    Time frame: change from baseline depression at 6 weeks

    Center for Epidemiologic Studies Depression-10 (0-30, higher values indicate greater depression)

  2. Perceived stress

    Time frame: change from baseline perceived stress at 6 weeks

    Perceived Stress Scale (0-40, higher values indicate greater stress)

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 16, 2023
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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