Clinical trial · Interventional
Evaluation of the Effects of the Couple-based Family Nursing for Women With Breast Cancer
A Nurse Empowered Spouses to Assist the Women With Breast Cancer Doing Daily Rehabilitation, and Evaluate the Effects on the Shoulder Range of Motion, Quality of Life, and Marital Intimacy.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The women with breast cancer and their spouses experienced physical and mental distresses together, nevertheless, the spouses were the significant supporters for patients during post-surgery rehabilitation. Based on the patient and family-centered care (PFCC), it was hypothesized that the couple engages in post-surgery rehabilitation could help women to have an improved shoulder range of movement, quality of life, and couples have better marital intimacy. All the women were eligible to be included in the randomized control trial if diagnosed with breast cancer, received breast surgery, her spouses were accompanying, and gave written consents. Women were randomized into two groups. The control group continues to receive usual care. The experimental group, who received couple-based family nursing (30-60 minutes couple-based interviews) based on the core concepts of PFCC: dignity and respect, information sharing, participation, and collaboration. The study nurse empowered spouses to assist the women's daily rehabilitation with a special workbook by clear pictures demonstration.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast-Conserving Surgery | — | UNRESOLVED | — |
| Mastectomy | — | UNRESOLVED | — |
| Women | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Couple-based family nursing | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Couple-based family nursing
- description
- Women and their spouses were provided couple-based family nursing based on dignity and respect, information sharing, participation and collaboration for 30-60 minutes with couple-based interviews for arm rehabilitation. Arm rehabilitation begins within 48 hours postoperatively, and each movement should be incrementally increased in terms of exertion and repetition until the patient reaches 10 repetitions, 2-3 times daily, for one month.
- interventionNames
- Other: Couple-based family nursing
- type
- ACTIVE_COMPARATOR
- label
- Treatment as usual
- description
- All women in the control group received hospital standard operative care, and couples attended a routine, 30-60-minute presentation about rehabilitation after breast surgery without any specific couple-based dyad interview.
- interventionNames
- Other: Couple-based family nursing
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of stage 0-3 breast cancer made by a specialist physician * Women and spouses with a legal marriage * Women and spouses aged ≥20 years * Mastectomy or breast-conserving surgery * Women and spouses with no history of mental illness * Spouses who were willing to participate in postoperative care * Women and spouses who could read and write in Chinese. Exclusion Criteria: * Women and spouses without a legal marriage * Diagnosis of terminal breast cancer * Women and spouses aged \<20 years * Planned or had undergone breast reconstruction * Active chemotherapy or radiotherapy * Women and spouses with a history of mental illness * Women and spouses currently undergoing psychotherapy.
References
Publications (19)
- BACKGROUNDAndrzejczak E, Markocka-Maczka K, Lewandowski A. Partner relationships after mastectomy in women not offered breast reconstruction. Psychooncology. 2013 Jul;22(7):1653-7. doi: 10.1002/pon.3197. Epub 2012 Oct 9. PMID 23045167
- BACKGROUNDBaucom DH, Porter LS, Kirby JS, Gremore TM, Wiesenthal N, Aldridge W, Fredman SJ, Stanton SE, Scott JL, Halford KW, Keefe FJ. A couple-based intervention for female breast cancer. Psychooncology. 2009 Mar;18(3):276-83. doi: 10.1002/pon.1395. PMID 18702064
- BACKGROUNDHarris SR, Schmitz KH, Campbell KL, McNeely ML. Clinical practice guidelines for breast cancer rehabilitation: syntheses of guideline recommendations and qualitative appraisals. Cancer. 2012 Apr 15;118(8 Suppl):2312-24. doi: 10.1002/cncr.27461. PMID 22488705
- BACKGROUNDHo PJ, Gernaat SAM, Hartman M, Verkooijen HM. Health-related quality of life in Asian patients with breast cancer: a systematic review. BMJ Open. 2018 Apr 20;8(4):e020512. doi: 10.1136/bmjopen-2017-020512. PMID 29678980
- BACKGROUNDKarki A, Simonen R, Malkia E, Selfe J. Postoperative education concerning the use of the upper limb, and exercise and treatment of the upper limb: cross-sectional survey of 105 breast cancer patients. Support Care Cancer. 2004 May;12(5):347-54. doi: 10.1007/s00520-004-0612-7. Epub 2004 Apr 3. PMID 15064932
- BACKGROUNDKibar S, Dalyan Aras M, Unsal Delialioglu S. The risk factors and prevalence of upper extremity impairments and an analysis of effects of lymphoedema and other impairments on the quality of life of breast cancer patients. Eur J Cancer Care (Engl). 2017 Jul;26(4). doi: 10.1111/ecc.12433. Epub 2016 Jan 13. PMID 26764197
- BACKGROUNDLevy EW, Pfalzer LA, Danoff J, Springer BA, McGarvey C, Shieh CY, Morehead-Gee A, Gerber LH, Stout NL. Predictors of functional shoulder recovery at 1 and 12 months after breast cancer surgery. Breast Cancer Res Treat. 2012 Jul;134(1):315-24. doi: 10.1007/s10549-012-2061-1. Epub 2012 Apr 19.