Expressive Writing for Caregivers of Persons With Cancer

NCT ID: NCT05859880

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-08

Study Completion Date

2025-04-06

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:

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

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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.

Conditions

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Quality of Life Distress, Emotional

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Waitlist control
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Active intervention

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.

Group Type EXPERIMENTAL

Expressive writing intervention

Intervention Type BEHAVIORAL

4 videoconference-delivered group-based expressive writing sessions

Waitlist control

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

Group Type PLACEBO_COMPARATOR

Expressive writing intervention

Intervention Type BEHAVIORAL

4 videoconference-delivered group-based expressive writing sessions

Interventions

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Expressive writing intervention

4 videoconference-delivered group-based expressive writing sessions

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Arizona State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cancer Support Community Arizona

Phoenix, Arizona, United States

Site Status

Countries

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United States

References

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Glajchen M. The emerging role and needs of family caregivers in cancer care. J Support Oncol. 2004 Mar-Apr;2(2):145-55.

Reference Type BACKGROUND
PMID: 15328817 (View on PubMed)

Jayani R, Hurria A. Caregivers of older adults with cancer. Semin Oncol Nurs. 2012 Nov;28(4):221-5. doi: 10.1016/j.soncn.2012.09.004.

Reference Type BACKGROUND
PMID: 23107179 (View on PubMed)

Areia NP, Fonseca G, Major S, Relvas AP. Psychological morbidity in family caregivers of people living with terminal cancer: Prevalence and predictors. Palliat Support Care. 2019 Jun;17(3):286-293. doi: 10.1017/S1478951518000044. Epub 2018 Feb 26.

Reference Type BACKGROUND
PMID: 29478419 (View on PubMed)

Geng HM, Chuang DM, Yang F, Yang Y, Liu WM, Liu LH, Tian HM. Prevalence and determinants of depression in caregivers of cancer patients: A systematic review and meta-analysis. Medicine (Baltimore). 2018 Sep;97(39):e11863. doi: 10.1097/MD.0000000000011863.

Reference Type BACKGROUND
PMID: 30278483 (View on PubMed)

Northouse LL, Katapodi MC, Schafenacker AM, Weiss D. The impact of caregiving on the psychological well-being of family caregivers and cancer patients. Semin Oncol Nurs. 2012 Nov;28(4):236-45. doi: 10.1016/j.soncn.2012.09.006.

Reference Type BACKGROUND
PMID: 23107181 (View on PubMed)

Girgis A, Lambert S, Johnson C, Waller A, Currow D. Physical, psychosocial, relationship, and economic burden of caring for people with cancer: a review. J Oncol Pract. 2013 Jul;9(4):197-202. doi: 10.1200/JOP.2012.000690. Epub 2012 Dec 4.

Reference Type BACKGROUND
PMID: 23942921 (View on PubMed)

Teixeira RJ, Applebaum AJ, Bhatia S, Brandao T. The impact of coping strategies of cancer caregivers on psychophysiological outcomes: an integrative review. Psychol Res Behav Manag. 2018 May 24;11:207-215. doi: 10.2147/PRBM.S164946. eCollection 2018.

Reference Type BACKGROUND
PMID: 29872357 (View on PubMed)

Stanton AL, Danoff-Burg S, Sworowski LA, Collins CA, Branstetter AD, Rodriguez-Hanley A, Kirk SB, Austenfeld JL. Randomized, controlled trial of written emotional expression and benefit finding in breast cancer patients. J Clin Oncol. 2002 Oct 15;20(20):4160-8. doi: 10.1200/JCO.2002.08.521.

Reference Type BACKGROUND
PMID: 12377959 (View on PubMed)

Frattaroli J. Experimental disclosure and its moderators: a meta-analysis. Psychol Bull. 2006 Nov;132(6):823-65. doi: 10.1037/0033-2909.132.6.823.

Reference Type BACKGROUND
PMID: 17073523 (View on PubMed)

Smyth JM, Stone AA, Hurewitz A, Kaell A. Effects of writing about stressful experiences on symptom reduction in patients with asthma or rheumatoid arthritis: a randomized trial. JAMA. 1999 Apr 14;281(14):1304-9. doi: 10.1001/jama.281.14.1304.

Reference Type BACKGROUND
PMID: 10208146 (View on PubMed)

Pennebaker JW, Beall SK. Confronting a traumatic event: toward an understanding of inhibition and disease. J Abnorm Psychol. 1986 Aug;95(3):274-81. doi: 10.1037//0021-843x.95.3.274. No abstract available.

Reference Type BACKGROUND
PMID: 3745650 (View on PubMed)

Andresen EM, Malmgren JA, Carter WB, Patrick DL. Screening for depression in well older adults: evaluation of a short form of the CES-D (Center for Epidemiologic Studies Depression Scale). Am J Prev Med. 1994 Mar-Apr;10(2):77-84.

Reference Type BACKGROUND
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Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.

Reference Type BACKGROUND
PMID: 9626712 (View on PubMed)

Weitzner MA, Jacobsen PB, Wagner H Jr, Friedland J, Cox C. The Caregiver Quality of Life Index-Cancer (CQOLC) scale: development and validation of an instrument to measure quality of life of the family caregiver of patients with cancer. Qual Life Res. 1999;8(1-2):55-63. doi: 10.1023/a:1026407010614.

Reference Type BACKGROUND
PMID: 10457738 (View on PubMed)

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

Reference Type BACKGROUND
PMID: 6668417 (View on PubMed)

Lee KC, Yiin JJ, Lu SH, Chao YF. The Burden of Caregiving and Sleep Disturbance Among Family Caregivers of Advanced Cancer Patients. Cancer Nurs. 2015 Jul-Aug;38(4):E10-8. doi: 10.1097/NCC.0000000000000166.

Reference Type BACKGROUND
PMID: 24978619 (View on PubMed)

Other Identifiers

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STUDY00017135

Identifier Type: -

Identifier Source: org_study_id

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