Expressive Writing for Caregivers of Persons With Cancer

NCT05859880 | Completed

• 1 other identifier: STUDY00017135
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.Is benefit greater for certain subgroups of caregivers, such as those who are younger or who identify as female in gender?

Conditions

Quality of Life; Distress, Emotional

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Depression

  change from baseline depression at 6 weeks

• Perceived stress

  change from baseline perceived stress at 6 weeks

Study Arms (2)

Active intervention

EXPERIMENTAL

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

Waitlist control

PLACEBO COMPARATOR

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

Behavioral: Expressive writing intervention

Interventions

Expressive writing intervention BEHAVIORAL

4 videoconference-delivered group-based expressive writing sessions

Active intervention; Waitlist control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Caregiver for pediatric cancer patient

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Cancer Support Community Arizona

Phoenix, Arizona, 85004, United States

Location

Related Publications (16)

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

  PMID: 15328817 BACKGROUND

• 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.

  PMID: 23107179 BACKGROUND

• 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.

  PMID: 29478419 BACKGROUND

• 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.

  PMID: 30278483 BACKGROUND

• 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.

  PMID: 23107181 BACKGROUND

• 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.

  PMID: 23942921 BACKGROUND

• 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.

  PMID: 29872357 BACKGROUND

• 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.

  PMID: 12377959 BACKGROUND

• 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.

  PMID: 17073523 BACKGROUND

• 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.

  PMID: 10208146 BACKGROUND

• 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.

  PMID: 3745650 BACKGROUND

• 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.

  PMID: 8037935 BACKGROUND

• 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.

  PMID: 9626712 BACKGROUND

• 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.

  PMID: 10457738 BACKGROUND

• 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.

  PMID: 6668417 BACKGROUND

• 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.

  PMID: 24978619 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Waitlist control

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: May 16, 2023
• Study Start: June 8, 2023
• Primary Completion: April 6, 2025
• Study Completion: April 6, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Within 6 months of publication of study results
• Access Criteria: Access will be provided on a case by case basis, after review of the requestor's proposed use for the data. Requests will be reviewed by the principal investigator and at least one other investigator.

Locations

US (1)