title: Attachment-oriented psychological intervention for couples facing breast cancer: protocol of a randomised controlled trial.
abstract: BACKGROUND
  There is evidence that both breast cancer patients and their partners are affected emotionally, when facing a breast cancer diagnosis. Several couple interventions have been evaluated, but there is a need for couple intervention studies with a clear theoretical basis and a strong design. The Hand in Hand intervention is designed to enhance interdependent coping in the couples and to address patients and partners that are both initially distressed and non-distressed.
  
  
  METHODS
  The Hand in Hand study is a randomised controlled trial among 199 breast cancer patients and their partners. Couples were randomised to 4-8 couple sessions with a psychologist in addition to usual care, or to usual care only, approximately 2 months after the patients' primary surgery date. The intervention was delivered within 3 months, and outcomes were assessed prior to randomisation and 5 and 10 months after primary surgery date. The primary outcome is patients' cancer-specific distress at the 5-month follow-up measured by the Impact of Event Scale. Secondary outcomes are assessed for both breast cancer patients and partners. These outcomes are: general distress, symptoms of anxiety and depression, health-related quality of life and measures of dyadic adjustment, intimacy and partner involvement. Cancer-specific distress is also assessed for partners. Eligible patients were women ≥ 18 years newly diagnosed with primary breast cancer, cohabiting with a male partner, having no previous cancer diagnoses, receiving no neo-adjuvant treatment, having no history of hospitalisation due to psychosis, and able to read and speak Danish. Partners were eligible if they could read and speak Danish and were ≥ 18 years.
  
  
  CONCLUSIONS
  This study investigates the effect of an attachment-oriented psychological intervention for breast cancer patients and their partners. The intervention has a theoretical framework and a strong design. If proven effective, this intervention would be helpful in optimising psychosocial care and rehabilitation of couples coping with breast cancer.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT01368380.
authors: National Research Centre for Cancer Rehabilitation, Research Unit of General Practice, University of Southern Denmark, J. B. Winsløws Vej 9A, Odense, C DK-5000 Denmark.
authors: Anne
authors: A
authors: Nicolaisen
authors: National Research Centre for Cancer Rehabilitation, Research Unit of General Practice, University of Southern Denmark, J. B. Winsløws Vej 9A, Odense, C DK-5000 Denmark.
authors: Dorte G
authors: DG
authors: Hansen
authors: Department of Health Sciences, Health Psychology Research Section, University Medical Center Groningen, University of Groningen, Ant Deusinglaan 1, Groningen, 9713 AV The Netherlands.
authors: Mariët
authors: M
authors: Hagedoorn
authors: Department of Breast Surgery, Herlev University Hospital, Herlev Ringvej 75, Herlev, DK-2730 Denmark.
authors: Henrik E
authors: HE
authors: Flyger
authors: National Research Centre for Cancer Rehabilitation, Research Unit of General Practice, University of Southern Denmark, J. B. Winsløws Vej 9A, Odense, C DK-5000 Denmark.
authors: Nina
authors: N
authors: Rottmann
authors: Authorised privately practicing psychologist, Odense, DK-5000 Denmark.
authors: Per
authors: P
authors: Nielsen
authors: Department of Breast Surgery, Odense University Hospital, Sdr. Boulevard 29, Odense, C DK-5000 Denmark.
authors: Katrine
authors: K
authors: Søe
authors: Department of Breast Surgery, Ringsted Hospital, Bøllingsvej 30, Ringsted, DK-4100 Denmark.
authors: Anne E
authors: AE
authors: Pedersen
authors: Danish Cancer Society Research Center, Survivorship, Danish Cancer Society, Strandboulevarden 49, Copenhagen, DK-2100 Denmark.
authors: Christoffer
authors: C
authors: Johansen
keywords: Attachment; Breast cancer; Partners; Psychological intervention; RCT