NCT06875414

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

November 14, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
12 months until next milestone

First Posted

Study publicly available on registry

March 13, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2025

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

1.3 years

First QC Date

March 15, 2023

Last Update Submit

March 12, 2025

Conditions

Breast NeoplasmsQuality of Life

Keywords

breast cancerquality of liferesiliencedepression

Outcome Measures

Primary Outcomes (1)

  • EORTC-QLQ C30

    The questionnaire EORTC-QLQ C30 (Kaasa, S., Bjordal, K., Aaronson, N.,1995) will evaluate the quality of life and will be administered to patients and their partners during a scheduled check-up visit at the Institute

    24 months

Secondary Outcomes (3)

  • Marital Adjustment Test

    24 months

  • PHQ-9 Scale

    24 months

  • Resilience Scale

    24 months

Study Arms (1)

Couple

The adaptation strategies that the couple uses

Behavioral: Nursing care model

Interventions

Nursing care modelBEHAVIORAL

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

Couple

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of 40 couples with women affected by breast cancer who had lived together for at least six months before the diagnosis of breast cancer

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Regina Elena National Cancer Institute

Roma, Rome, 00144, Italy

RECRUITING

Related Publications (12)

  • 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: 22573418RESULT

  • 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: 23045191RESULT

  • 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: 21823795RESULT

  • 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: 21882286RESULT

  • 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: 24279379RESULT

  • 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: 23456213RESULT

  • 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: 18067437RESULT

  • 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: 23348665RESULT

  • Fergus KD, Gray RE. Relationship vulnerabilities during breast cancer: patient and partner perspectives. Psychooncology. 2009 Dec;18(12):1311-22. doi: 10.1002/pon.1555.

    PMID: 19353517RESULT

  • Hoga LA, Mello DS, Dias AF. Psychosocial perspectives of the partners of breast cancer patients treated with a mastectomy: an analysis of personal narratives. Cancer Nurs. 2008 Jul-Aug;31(4):318-25. doi: 10.1097/01.NCC.0000305748.43367.1b.

    PMID: 18600120RESULT

  • Hubbard G, Menzies S, Flynn P, Adams S, Haseen F, Thomas I, Scanlon K, Reed L, Forbat L. Relational mechanisms and psychological outcomes in couples affected by breast cancer: a systematic narrative analysis of the literature. BMJ Support Palliat Care. 2013 Sep;3(3):309-17. doi: 10.1136/bmjspcare-2012-000274. Epub 2012 Oct 25.

    PMID: 24644749RESULT

  • Jun EY, Kim S, Chang SB, Oh K, Kang HS, Kang SS. The effect of a sexual life reframing program on marital intimacy, body image, and sexual function among breast cancer survivors. Cancer Nurs. 2011 Mar-Apr;34(2):142-9. doi: 10.1097/NCC.0b013e3181f1ab7a.

    PMID: 20885305RESULT

MeSH Terms

Conditions

Breast NeoplasmsDepression

Interventions

Models, Nursing

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Models, TheoreticalInvestigative Techniques

Central Study Contacts

Ilaria Farina, MSN

CONTACT

0652666804ilaria.farina@ifo.it

Silvia Takanen, Dr

CONTACT

silvia.takanen@ifo.it

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor Principal Investigator

Study Record Dates

First Submitted

March 15, 2023

First Posted

March 13, 2025

Study Start

November 14, 2022

Primary Completion

March 15, 2024

Study Completion

November 14, 2025

Last Updated

March 13, 2025

Record last verified: 2025-03

Locations

IT(1)