Quality of LifeNCT05859880
Expressive Writing for Caregivers of Persons With Cancer
A study testing Expressive writing intervention in people with Quality of Life and Distress, Emotional, run by Arizona State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Distress, Emotional
- What is being tested?
- Expressive writing intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2023to 6 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -Caregiver for pediatric cancer patient
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Support Community Arizona
Phoenix, Arizona, 85004
About this study
Official title: A Community-based Video-conference-delivered Expressive Writing Intervention 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:
- Does participation in a group-based, videoconference-delivered expressive writing intervention improve mood and quality of life for caregivers of persons with cancer?
- 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?
- Is benefit greater for certain subgroups of caregivers, such as those who are younger or who identify as female in gender?
Read more
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.
Read the 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.
- Conditions
- Quality of Life, Distress, Emotional
- Being tested
- Expressive writing intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expressive writing interventionBehavioural
4 videoconference-delivered group-based expressive writing sessions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Expressive writing intervention |
| Waitlist control | Placebo comparator | Procedures are exactly the same as for the experimental arm but delayed. Receives: Behavioral: Expressive writing intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological distress
Profile of Mood States, 2nd edition (0-4, higher values indicate greater distress)
Measured: 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)
Measured: 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)
Measured: change from baseline caregiver-specific quality of life at 6 weeks
Secondary outcomes (2)
Depression
Center for Epidemiologic Studies Depression-10 (0-30, higher values indicate greater depression)
Measured: change from baseline depression at 6 weeks
Perceived stress
Perceived Stress Scale (0-40, higher values indicate greater stress)
Measured: change from baseline perceived stress at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start8 Jun 2023
- Primary completion6 Apr 2025
- Study completion6 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Waitlist control
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859880
- Sponsor's protocol ID
- STUDY00017135
- Status last verified
- Aug 2025
- First submitted
- 16 Mar 2023
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be made available to other researchers
Publications
Glajchen M. The emerging role and needs of family caregivers in cancer care. J Support Oncol. 2004 Mar-Apr;2(2):145-55.
PubMed 15328817Jayani 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.
PubMed 23107179Areia 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.
PubMed 29478419Geng 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.
PubMed 30278483Northouse 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.
PubMed 23107181Girgis 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.
PubMed 23942921Teixeira 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.
PubMed 29872357Stanton 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.
PubMed 12377959Frattaroli 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.
PubMed 17073523Smyth 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.
PubMed 10208146Pennebaker 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.
PubMed 3745650Andresen 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.
PubMed 8037935Development 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.
PubMed 9626712Weitzner 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.
PubMed 10457738Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community-based Video-conference-delivered Expressive Writing Intervention for Caregivers of Persons With Cancer
- ClinicalTrials.gov ID
- NCT05859880
- Acronym / sponsor ID
- STUDY00017135
- Conditions
- Quality of Life, Distress, Emotional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 6 Apr 2025 (actual)
- Study completion
- 6 Apr 2025 (actual)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does participation in a group-based, videoconference-delivered expressive writing intervention improve mood and quality of life for caregivers of persons with cancer?
- 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?
- 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
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Waitlist control
| Arm | Type | Receives |
|---|---|---|
| Active intervention | Experimental | Behavioral: Expressive writing interventionParticipants 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. |
| Waitlist control | Placebo comparator | Behavioral: Expressive writing interventionProcedures are exactly the same as for the experimental arm but delayed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- -Caregiver for pediatric cancer patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expressive writing intervention4 videoconference-delivered group-based expressive writing sessions | Behavioural | Active intervention, Waitlist control |
Primary outcome
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)
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)
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)
2 secondary outcomes
Depression
Time frame: change from baseline depression at 6 weeks
Perceived stress
Time frame: change from baseline perceived stress at 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Background: PubMed 15328817Glajchen M. The emerging role and needs of family caregivers in cancer care. J Support Oncol. 2004 Mar-Apr;2(2):145-55.
- Background: PubMed 23107179Jayani 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.
- Background: PubMed 29478419Areia 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.
- Background: PubMed 30278483Geng 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.
- Background: PubMed 23107181Northouse 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.
- Background: PubMed 23942921Girgis 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.
- Background: PubMed 29872357Teixeira 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.
- Background: PubMed 12377959Stanton 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.
- Background: PubMed 17073523Frattaroli 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.
- Background: PubMed 10208146Smyth 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.
- Background: PubMed 3745650Pennebaker 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.
- Background: PubMed 8037935Andresen 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.
- Individual participant dataSharing planned: Yes. De-identified data will be made available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expressive writing intervention in people with Quality of Life and Distress, Emotional, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological distress (time frame: change from baseline psychological distress at 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05859880, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.