Emotion Regulation and Cancer Caregiving

NCT ID: NCT06123416

Last Updated: 2023-11-13

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-16

Study Completion Date

2019-07-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to determine how the behaviors of cancer caregivers can impact patients.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Cancer Healthy Emotions

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Caregivers

Control participants will write about their daily and future tasks three times.

Expressive Writing

Intervention Type BEHAVIORAL

Caregivers complete three 20-min writing sessions in which they write about an assigned topic - emotional or non-emotional.

Expressive Writing Caregivers

Experimental participants will write about their thoughts and feelings about an emotionally difficult event three times.

Expressive Writing

Intervention Type BEHAVIORAL

Caregivers complete three 20-min writing sessions in which they write about an assigned topic - emotional or non-emotional.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Expressive Writing

Caregivers complete three 20-min writing sessions in which they write about an assigned topic - emotional or non-emotional.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

All participants must:

* Be 21 years or older
* Have access to a computer with internet access

Patients must:

* Be women
* Have a diagnosis of breast cancer (non-recurrent)

Caregivers must be:

-The patient's caregiver (providing support to the patient)

Exclusion Criteria

Participants must not be:

-Younger than 21 years

Patients must not:

* Be men
* Have a diagnosis other than breast cancer (non-recurrent)
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

U.S. National Science Foundation

FED

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lameese Eldesouky, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

James Gross, PhD

Role: STUDY_DIRECTOR

Stanford University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Stanford University

Stanford, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

National Alliance for Caregiving. (2016). Cancer Caregiving in the U.S.: An Intense, Episodic, and Challenging Care Experience.

Reference Type BACKGROUND

Ryerson AB, Eheman CR, Altekruse SF, Ward JW, Jemal A, Sherman RL, Henley SJ, Holtzman D, Lake A, Noone AM, Anderson RN, Ma J, Ly KN, Cronin KA, Penberthy L, Kohler BA. Annual Report to the Nation on the Status of Cancer, 1975-2012, featuring the increasing incidence of liver cancer. Cancer. 2016 May 1;122(9):1312-37. doi: 10.1002/cncr.29936. Epub 2016 Mar 9.

Reference Type BACKGROUND
PMID: 26959385 (View on PubMed)

Lwi SJ, Ford BQ, Casey JJ, Miller BL, Levenson RW. Poor caregiver mental health predicts mortality of patients with neurodegenerative disease. Proc Natl Acad Sci U S A. 2017 Jul 11;114(28):7319-7324. doi: 10.1073/pnas.1701597114. Epub 2017 Jun 27.

Reference Type BACKGROUND
PMID: 28655841 (View on PubMed)

Kershaw, T., Northouse, L., Kritpracha, C., Schafenacker, A., & Mood, D. (2004). Coping strategies and quality of life in women with advanced breast cancer and their family caregivers. Psychology & Health, 19, 139-155.

Reference Type BACKGROUND

Appleton AA, Loucks EB, Buka SL, Kubzansky LD. Divergent associations of antecedent- and response-focused emotion regulation strategies with midlife cardiovascular disease risk. Ann Behav Med. 2014 Oct;48(2):246-55. doi: 10.1007/s12160-014-9600-4.

Reference Type BACKGROUND
PMID: 24570218 (View on PubMed)

Gross, J. J. (1998). The emerging field of emotion regulation: An integrative review. Review of General Psychology, 2, 271-299.

Reference Type BACKGROUND

Gross, J. J. (2015). Emotion regulation: Current status and future prospects. Psychological Inquiry, 26, 1-26.

Reference Type BACKGROUND

Webb TL, Miles E, Sheeran P. Dealing with feeling: a meta-analysis of the effectiveness of strategies derived from the process model of emotion regulation. Psychol Bull. 2012 Jul;138(4):775-808. doi: 10.1037/a0027600. Epub 2012 May 14.

Reference Type BACKGROUND
PMID: 22582737 (View on PubMed)

Srivastava S, Tamir M, McGonigal KM, John OP, Gross JJ. The social costs of emotional suppression: a prospective study of the transition to college. J Pers Soc Psychol. 2009 Apr;96(4):883-97. doi: 10.1037/a0014755.

Reference Type BACKGROUND
PMID: 19309209 (View on PubMed)

Richards JM, Gross JJ. Emotion regulation and memory: the cognitive costs of keeping one's cool. J Pers Soc Psychol. 2000 Sep;79(3):410-24. doi: 10.1037//0022-3514.79.3.410.

Reference Type BACKGROUND
PMID: 10981843 (View on PubMed)

Aldao A, Nolen-Hoeksema S, Schweizer S. Emotion-regulation strategies across psychopathology: A meta-analytic review. Clin Psychol Rev. 2010 Mar;30(2):217-37. doi: 10.1016/j.cpr.2009.11.004. Epub 2009 Nov 20.

Reference Type BACKGROUND
PMID: 20015584 (View on PubMed)

Butler EA, Egloff B, Wilhelm FH, Smith NC, Erickson EA, Gross JJ. The social consequences of expressive suppression. Emotion. 2003 Mar;3(1):48-67. doi: 10.1037/1528-3542.3.1.48.

Reference Type BACKGROUND
PMID: 12899316 (View on PubMed)

Pennebaker, J. W. (1997). Writing about emotional experiences as a therapeutic process. Psychological Science, 8, 162-166.

Reference Type BACKGROUND

Smyth JM. Written emotional expression: effect sizes, outcome types, and moderating variables. J Consult Clin Psychol. 1998 Feb;66(1):174-84. doi: 10.1037//0022-006x.66.1.174.

Reference Type BACKGROUND
PMID: 9489272 (View on PubMed)

Zachariae R, O'Toole MS. The effect of expressive writing intervention on psychological and physical health outcomes in cancer patients--a systematic review and meta-analysis. Psychooncology. 2015 Nov;24(11):1349-59. doi: 10.1002/pon.3802. Epub 2015 Apr 14.

Reference Type BACKGROUND
PMID: 25871981 (View on PubMed)

Ferrell B, Wittenberg E. A review of family caregiving intervention trials in oncology. CA Cancer J Clin. 2017 Jul 8;67(4):318-325. doi: 10.3322/caac.21396. Epub 2017 Mar 20.

Reference Type BACKGROUND
PMID: 28319263 (View on PubMed)

Pennebaker JW. Putting stress into words: health, linguistic, and therapeutic implications. Behav Res Ther. 1993 Jul;31(6):539-48. doi: 10.1016/0005-7967(93)90105-4.

Reference Type BACKGROUND
PMID: 8347112 (View on PubMed)

Lepore, S. J., & Smyth, J. (Eds.). (2003). The writing cure: How expressive writing influences health and well-being. Washington, DC: American Psychological Association.

Reference Type BACKGROUND

Pennebaker, J. W., & Graybeal, A. (2001). Patterns of natural language use: Disclosure, personality, and social integration. Current Directions in Psychological Science, 10, 90-93.

Reference Type BACKGROUND

Gross JJ, John OP. Individual differences in two emotion regulation processes: implications for affect, relationships, and well-being. J Pers Soc Psychol. 2003 Aug;85(2):348-62. doi: 10.1037/0022-3514.85.2.348.

Reference Type BACKGROUND
PMID: 12916575 (View on PubMed)

Antoni MH, Lutgendorf SK, Cole SW, Dhabhar FS, Sephton SE, McDonald PG, Stefanek M, Sood AK. The influence of bio-behavioural factors on tumour biology: pathways and mechanisms. Nat Rev Cancer. 2006 Mar;6(3):240-8. doi: 10.1038/nrc1820.

Reference Type BACKGROUND
PMID: 16498446 (View on PubMed)

Kim Y, Schulz R, Carver CS. Benefit-finding in the cancer caregiving experience. Psychosom Med. 2007 Apr;69(3):283-91. doi: 10.1097/PSY.0b013e3180417cf4. Epub 2007 Apr 9.

Reference Type BACKGROUND
PMID: 17420443 (View on PubMed)

DiMatteo MR. Variations in patients' adherence to medical recommendations: a quantitative review of 50 years of research. Med Care. 2004 Mar;42(3):200-9. doi: 10.1097/01.mlr.0000114908.90348.f9.

Reference Type BACKGROUND
PMID: 15076819 (View on PubMed)

Porter LS, Keefe FJ, Lipkus I, Hurwitz H. Ambivalence over emotional expression in patients with gastrointestinal cancer and their caregivers: associations with patient pain and quality of life. Pain. 2005 Oct;117(3):340-348. doi: 10.1016/j.pain.2005.06.021.

Reference Type BACKGROUND
PMID: 16153771 (View on PubMed)

Pennebaker JW, Colder M, Sharp LK. Accelerating the coping process. J Pers Soc Psychol. 1990 Mar;58(3):528-537. doi: 10.1037//0022-3514.58.3.528.

Reference Type BACKGROUND
PMID: 2324942 (View on PubMed)

Pennebaker JW, Kiecolt-Glaser JK, Glaser R. Disclosure of traumas and immune function: health implications for psychotherapy. J Consult Clin Psychol. 1988 Apr;56(2):239-45. doi: 10.1037//0022-006x.56.2.239. No abstract available.

Reference Type BACKGROUND
PMID: 3372832 (View on PubMed)

Crawford J, Wilhelm K, Robins L, Proudfoot J. Writing for Health: Rationale and Protocol for a Randomized Controlled Trial of Internet-Based Benefit-Finding Writing for Adults With Type 1 or Type 2 Diabetes. JMIR Res Protoc. 2017 Mar 14;6(3):e42. doi: 10.2196/resprot.7151.

Reference Type BACKGROUND
PMID: 28292741 (View on PubMed)

Kelley JE, Lumley MA, Leisen JC. Health effects of emotional disclosure in rheumatoid arthritis patients. Health Psychol. 1997 Jul;16(4):331-40. doi: 10.1037//0278-6133.16.4.331.

Reference Type BACKGROUND
PMID: 9237085 (View on PubMed)

Riddle JP, Smith HE, Jones CJ. Does written emotional disclosure improve the psychological and physical health of caregivers? A systematic review and meta-analysis. Behav Res Ther. 2016 May;80:23-32. doi: 10.1016/j.brat.2016.03.004. Epub 2016 Mar 19.

Reference Type BACKGROUND
PMID: 27017529 (View on PubMed)

Eldesouky L, Gross JJ. Using expressive writing to improve cancer caregiver and patient health: A randomized controlled feasibility trial. Eur J Oncol Nurs. 2024 Jun;70:102578. doi: 10.1016/j.ejon.2024.102578. Epub 2024 Mar 21.

Reference Type DERIVED
PMID: 38522170 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB-47800

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Mindfulness-Based Self-Compassion Program
NCT06846060 NOT_YET_RECRUITING NA