Expressive Writing for Caregivers of Persons With Cancer

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05859880
• Other study ID #: STUDY00017135
• Status: Recruiting
• Phase: N/A
• Start date: June 8, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: June 2023
• Source: Arizona State University
• Contact: Shelby Langer, PhD
• Phone: 206-234-9547
• Email: shelby.langer[@]asu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 30, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Distress, Emotional
• Quality of Life

Intervention

Behavioral:
• Expressive writing intervention
4 videoconference-delivered group-based expressive writing sessions

Locations

Country	Name	City	State
United States	Cancer Support Community Arizona	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Arizona State University

Country where clinical trial is conducted

United States, 

References & Publications (16)

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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. — View Citation

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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. — View Citation

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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. — View Citation

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. — View Citation

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychological distress	Profile of Mood States, 2nd edition (0-4, higher values indicate greater distress)	change from baseline psychological distress at 6 weeks
Primary	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
Primary	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	Depression	Center for Epidemiologic Studies Depression-10 (0-30, higher values indicate greater depression)	change from baseline depression at 6 weeks
Secondary	Perceived stress	Perceived Stress Scale (0-40, higher values indicate greater stress)	change from baseline perceived stress at 6 weeks