Breast CancerNCT06123416
Emotion Regulation and Cancer Caregiving
An observational study of Breast Cancer and Cancer, run by Stanford University at 1 site in United States.
Trial summary
The purpose of the study is to determine how the behaviors of cancer caregivers can impact patients. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Breast Cancer, Cancer, Healthy
- What is being tested?
- Expressive Writing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2019to 15 Jul 2019
- How long will I take part?
- 4 Months
- Phase
- Observational
- 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 21 years and older
- All sexes
- Adult, Older adult
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).
Who may be able to join
- 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)
Who cannot join
- Participants must not be:
- -Younger than 21 years
- Patients must not:
- Be men
- Have a diagnosis other than breast cancer (non-recurrent)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to determine how the behaviors of cancer caregivers can impact patients.
- Conditions
- Breast Cancer, Cancer, Healthy, Emotions
- Being tested
- Expressive Writing
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expressive WritingBehavioural
Caregivers complete three 20-min writing sessions in which they write about an assigned topic - emotional or non-emotional.
| Study group | Role | What they receive |
|---|---|---|
| Control Caregivers | Control participants will write about their daily and future tasks three times. Receives: Behavioral: Expressive Writing | |
| Expressive Writing Caregivers | Experimental participants will write about their thoughts and feelings about an emotionally difficult event three times. Receives: Behavioral: Expressive Writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline through 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start16 Jan 2019
- Primary completion15 Jul 2019
- Study completion15 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. National Science Foundation
- Responsible party
- Sponsor
- Investigators
- Lameese Eldesouky, PhD, Principal investigator, Stanford UniversityJames Gross, PhD, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123416
- Sponsor's protocol ID
- IRB-47800
- Status last verified
- Nov 2023
- First submitted
- 17 Jan 2019
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If data is shared it will only be shared upon request and will be de-identified.
Publications
National Alliance for Caregiving. (2016). Cancer Caregiving in the U.S.: An Intense, Episodic, and Challenging Care Experience.
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.
PubMed 26959385Lwi 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.
PubMed 28655841Kershaw, 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.
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.
PubMed 24570218Gross, 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.
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.
PubMed 22582737Srivastava 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.
PubMed 19309209Richards 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.
PubMed 10981843Aldao 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.
PubMed 20015584Butler 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.
PubMed 12899316Pennebaker, J. W. (1997). Writing about emotional experiences as a therapeutic process. Psychological Science, 8, 162-166.
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.
PubMed 9489272Zachariae 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.
PubMed 25871981
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotion Regulation and Cancer Caregiving
- ClinicalTrials.gov ID
- NCT06123416
- Acronym / sponsor ID
- IRB-47800
- Conditions
- Breast Cancer, Cancer, Healthy, Emotions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- U.S. National Science Foundation
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 8 Nov 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 purpose of the study is to determine how the behaviors of cancer caregivers can impact patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 4 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Caregivers | – | Behavioral: Expressive WritingControl participants will write about their daily and future tasks three times. |
| Expressive Writing Caregivers | – | Behavioral: Expressive WritingExperimental participants will write about their thoughts and feelings about an emotionally difficult event three times. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (8 listed)
- Be 21 years or older
- Have access to a computer with internet access
- Be women
- Have a diagnosis of breast cancer (non-recurrent)
- -The patient's caregiver (providing support to the patient)
Key exclusion criteria (5 listed)
- -Younger than 21 years
- Be men
- Have a diagnosis other than breast cancer (non-recurrent)
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 WritingCaregivers complete three 20-min writing sessions in which they write about an assigned topic - emotional or non-emotional. | Behavioural | Control Caregivers, Expressive Writing Caregivers |
Primary outcome
Emotion Regulation Questionnaire
Time frame: Baseline through 3 months post-intervention
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).
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 13 Nov 2023.
- BackgroundNational Alliance for Caregiving. (2016). Cancer Caregiving in the U.S.: An Intense, Episodic, and Challenging Care Experience.
- Background: PubMed 26959385Ryerson 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.
- Background: PubMed 28655841Lwi 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.
- BackgroundKershaw, 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: PubMed 24570218Appleton 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.
- BackgroundGross, J. J. (1998). The emerging field of emotion regulation: An integrative review. Review of General Psychology, 2, 271-299.
- BackgroundGross, J. J. (2015). Emotion regulation: Current status and future prospects. Psychological Inquiry, 26, 1-26.
- Background: PubMed 22582737Webb 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.
- Background: PubMed 19309209Srivastava 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.
- Background: PubMed 10981843Richards 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.
- Background: PubMed 20015584Aldao 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.
- Background: PubMed 12899316Butler 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.
- Individual participant dataSharing planned: Undecided. If data is shared it will only be shared upon request and will be de-identified.
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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.
Lameese Eldesouky, PhD principal investigator
Stanford University
James Gross, PhD study director
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Cancer, run by Stanford 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 8 inclusion and 5 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 13 Nov 2023. 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. 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?
Emotion Regulation Questionnaire (time frame: Baseline through 3 months post-intervention). 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 NCT06123416, which also lists 30 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 13 Nov 2023.