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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06123416
Other study ID # IRB-47800
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 16, 2019
Est. completion date July 15, 2019

Study information

Verified date November 2023
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 15, 2019
Est. primary completion date July 15, 2019
Accepts healthy volunteers
Gender All
Age group 21 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Stanford University Stanford California

Sponsors (2)

Lead Sponsor Collaborator
Stanford University U.S. National Science Foundation

Country where clinical trial is conducted

United States, 

References & Publications (29)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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

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. — View Citation

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.

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. — View Citation

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

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 29 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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