Menu
Recruiting NCT06875414

Breast Cancer and Resilience in Couple

Observational Breast Neoplasms Quality of Life

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nursing care model.
Who it may be relevant to
Registry conditions: Breast Neoplasms, Quality of Life. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Breast Cancer, Resilience, Quality of Life and Depression in Couples From Diagnosis to 24 Months Later: Prospective Pilot Study

Overview

This is a prospective pilot study examining the couple's dyadic attitudes from diagnosis to 24 months later when one member is affected by illness and the adaptive strategies the couple employs when stressful events occur.

Detailed description

The patients taking part in the study and their partners are examined from the time of the woman's breast cancer diagnosis up to 24 months later with the help of questionnaires and a focus group in order to understand the couple's coping strategies.

Interventions

  • Behavioral Nursing care model
    Describe relation between resilience, quality of life and depression and marital adaptation in the population considered from diagnosis to 24 months later.

Primary outcome measures

  • EORTC-QLQ C30 [Time frame: 24 months]
Secondary outcome measures (3)
  • Marital Adjustment Test [Time frame: 24 months]
  • PHQ-9 Scale [Time frame: 24 months]
  • Resilience Scale [Time frame: 24 months]

Eligibility criteria

Inclusion criteria

  • Woman diagnosed with stage 1, 2 or 3 breast cancer
  • age> 18 years (patient and partner)
  • The partner must have lived with the woman for at least 6 months at diagnosis and treatment
  • Patients under treatment at the radiotherapy clinic
  • Subjects available and able to answer questionnaires, interviews, and / or participate in focus groups
  • Informed consent

Exclusion criteria

Cognitive deficits and / or inability to comply with the provisions of the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Italy · 1 center
  • IRCCS Regina Elena National Cancer Institute — Roma

Publications

  • Badger TA, Segrin C, Hepworth JT, Pasvogel A, Weihs K, Lopez AM. Telephone-delivered health education and interpersonal counseling improve quality of life for Latinas with breast cancer and their supportive partners. Psychooncology. 2013 May;22(5):1035-42. doi: 10.1002/pon.3101. Epub 2012 May 10. PMID 22573418
  • Badr H, Krebs P. A systematic review and meta-analysis of psychosocial interventions for couples coping with cancer. Psychooncology. 2013 Aug;22(8):1688-704. doi: 10.1002/pon.3200. Epub 2012 Oct 9. PMID 23045191
  • Belcher AJ, Laurenceau JP, Graber EC, Cohen LH, Dasch KB, Siegel SD. Daily support in couples coping with early stage breast cancer: maintaining intimacy during adversity. Health Psychol. 2011 Nov;30(6):665-73. doi: 10.1037/a0024705. Epub 2011 Aug 8. PMID 21823795
  • Bigatti SM, Steiner JL, Makinabakan N, Hernandez AM, Johnston E, Storniolo AM. Matched and mismatched cognitive appraisals in patients with breast cancer and their partners: implications for psychological distress. Psychooncology. 2012 Nov;21(11):1229-36. doi: 10.1002/pon.2028. Epub 2011 Sep 1. PMID 21882286
  • Brandao T, Schulz MS, Matos PM. Psychological intervention with couples coping with breast cancer: a systematic review. Psychol Health. 2014;29(5):491-516. doi: 10.1080/08870446.2013.859257. Epub 2013 Nov 27. PMID 24279379
  • Christie KM, Meyerowitz BE, Stanton AL, Rowland JH, Ganz PA. Characteristics of breast cancer survivors that predict partners' participation in research. Ann Behav Med. 2013 Aug;46(1):107-13. doi: 10.1007/s12160-013-9477-7. PMID 23456213
  • Dalton WT 3rd, Nelson DV, Brobst JB, Lindsay JE, Friedman LC. Psychosocial variables associated with husbands' adjustment three months following wives' diagnosis of breast cancer. J Cancer Educ. 2007 Winter;22(4):245-9. doi: 10.1007/BF03174124. PMID 18067437
  • Duggleby W, Doell H, Cooper D, Thomas R, Ghosh S. The quality of life of male spouses of women with breast cancer: hope, self-efficacy, and perceptions of guilt. Cancer Nurs. 2014 Jan-Feb;37(1):E28-35. doi: 10.1097/NCC.0b013e31827ca807. PMID 23348665

Identifiers

NCT: NCT06875414 · RS1718/22(2657)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗