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Expressive Writing for Caregivers of Persons With Cancer

Sponsor
Arizona State University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05859880
Collaborator
Cancer Support Community Arizona (Other)
100
Enrollment
2
Arms
16
Anticipated Duration (Months)

Study Details

Study Description

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. 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Expressive writing intervention
 N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Waitlist controlWaitlist control
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Community-based Video-conference-delivered Expressive Writing Intervention for Caregivers of Persons With Cancer
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jul 31, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Behavioral: Expressive writing intervention
4 videoconference-delivered group-based expressive writing sessions
Placebo Comparator: Waitlist control

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

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

Outcome Measures

Primary Outcome Measures

  1. Psychological distress [change from baseline psychological distress at 6 weeks]

    Profile of Mood States, 2nd edition

  2. Quality of life (general) [change from baseline quality of life at 6 weeks]

    World Health Organization Quality of Life - Abbreviated version

  3. Quality of life (caregiver-specific) [change from baseline caregiver-specific quality of life at 6 weeks]

    Caregiver Quality of Life Index-Cancer

Secondary Outcome Measures

  1. Depression [change from baseline depression at 6 weeks]

    Center for Epidemiologic Studies Depression-10

  2. Perceived stress [change from baseline perceived stress at 6 weeks]

    Perceived Stress Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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 WIFI to complete surveys and participate in videoconference-based expressive writing sessions

Exclusion Criteria:

-Caregiver for pediatric cancer patient

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Arizona State University
  • Cancer Support Community Arizona

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Arizona State University
ClinicalTrials.gov Identifier:
NCT05859880
Other Study ID Numbers:
  • STUDY00017135
First Posted:
May 16, 2023
Last Update Posted:
May 16, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 16, 2023