Clinical trial · Interventional
Hand in Hand. Psychological Support and Counseling to Breast Cancer Patients and Their Partners
Hand in Hand. Psychological Intervention for Breast Cancer Patients and Their Partners. A Randomised, Controlled Trial.
NCT01368380CI-TRIAL-00016938HIHcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study evaluates the effect of a psychological intervention to breast cancer patients and their partners compared to a control group receiving usual care
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Psychological intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Psychological Intervention
- interventionNames
- Behavioral: Psychological intervention
- type
- NO_INTERVENTION
- label
- Usual care
Primary outcomes (3)
- measure
- Change in Impact of Event Scale (IES)
- timeFrame
- Baseline, 2 weeks post-intervention, 10 months follow-up
- description
- IES assesses traumatic reactions to the breast cancer diagnosis. Assessed by both patients and partners
- measure
- Change in The Hospital Anxiety and Depression Scale (HADS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women newly diagnosed with a primary breast cancer (in the last 4 weeks) * Women cohabiting with a male partner in a romantic relationship * Patient and partner speaks and reads danish Exclusion Criteria: * Patients having a previous cancer diagnosis * Neoadjuvant therapy for breast cancer * Previous hospital admission with diagnosed psychotic episodes
References
Publications (1)
- DERIVEDNicolaisen A, Hansen DG, Hagedoorn M, Flyger HE, Rottmann N, Nielsen P, Soe K, Pedersen AE, Johansen C. Attachment-oriented psychological intervention for couples facing breast cancer: protocol of a randomised controlled trial. BMC Psychol. 2014 Jul 14;2(1):19. doi: 10.1186/2050-7283-2-19. eCollection 2014. PMID 25815190