NCT06123416

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 16, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 17, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2019

Completed
4.3 years until next milestone

First Posted

Study publicly available on registry

November 8, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

January 17, 2019

Last Update Submit

November 8, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Emotion Regulation Questionnaire

    Emotion regulation refers to the ways people influence which emotions they have, and how they experience and express these emotions. Participants will rate their habitual pursuit of pro-hedonic, contra-hedonic, pro-social, and impression management goals using the ERGS. The items will be rated on the same 7-point scale (1 = never; 7 = always).

    Baseline through 3 months post-intervention

Study Arms (2)

Control Caregivers

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

Behavioral: Expressive Writing

Expressive Writing Caregivers

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

Behavioral: Expressive Writing

Interventions

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

Control CaregiversExpressive Writing Caregivers

Eligibility Criteria

Age21 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Nonrecurrent breast cancer patients and their caregivers (unpaid person who is close to the patient and provides emotional, medical and/or financial support).

You may qualify if:

  • 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)

You may not qualify if:

  • Participants must not be:
  • Younger than 21 years
  • Patients must not:
  • Be men
  • Have a diagnosis other than breast cancer (non-recurrent)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (30)

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

    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.

    PMID: 26959385BACKGROUND
  • 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.

    PMID: 28655841BACKGROUND
  • 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.

    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.

    PMID: 24570218BACKGROUND
  • Gross, J. J. (1998). The emerging field of emotion regulation: An integrative review. Review of General Psychology, 2, 271-299.

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

    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.

    PMID: 22582737BACKGROUND
  • 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.

    PMID: 19309209BACKGROUND
  • 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.

    PMID: 10981843BACKGROUND
  • 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.

    PMID: 20015584BACKGROUND
  • 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.

    PMID: 12899316BACKGROUND
  • Pennebaker, J. W. (1997). Writing about emotional experiences as a therapeutic process. Psychological Science, 8, 162-166.

    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.

    PMID: 9489272BACKGROUND
  • 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.

    PMID: 25871981BACKGROUND
  • 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.

    PMID: 28319263BACKGROUND
  • 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.

    PMID: 8347112BACKGROUND
  • Lepore, S. J., & Smyth, J. (Eds.). (2003). The writing cure: How expressive writing influences health and well-being. Washington, DC: American Psychological Association.

    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.

    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.

    PMID: 12916575BACKGROUND
  • 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.

    PMID: 16498446BACKGROUND
  • 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.

    PMID: 17420443BACKGROUND
  • 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.

    PMID: 15076819BACKGROUND
  • 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.

    PMID: 16153771BACKGROUND
  • 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.

    PMID: 2324942BACKGROUND
  • 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.

    PMID: 3372832BACKGROUND
  • 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.

    PMID: 28292741BACKGROUND
  • 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.

    PMID: 9237085BACKGROUND
  • 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.

    PMID: 27017529BACKGROUND
  • 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.

MeSH Terms

Conditions

Breast NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Lameese Eldesouky, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR
  • James Gross, PhD

    Stanford University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
4 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2019

First Posted

November 8, 2023

Study Start

January 16, 2019

Primary Completion

July 15, 2019

Study Completion

July 15, 2019

Last Updated

November 13, 2023

Record last verified: 2023-11

Locations