Abstract
BackgroundThere 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.MethodsThe 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.DiscussionThis 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.Trial registrationClinicalTrials.gov identifier: NCT01368380.
Highlights
There is evidence that both breast cancer patients and their partners are affected emotionally, when facing a breast cancer diagnosis
This paper presents the development of the Hand in Hand couple-intervention (HiH) and the design of the randomised controlled trial (RCT) to test it
Primary aim We developed an RCT to evaluate the effect of a couple intervention for breast cancer patients and their partners in the early treatment phase, comparing intervention in addition to usual care to usual care only
Summary
This study is a multisite randomised controlled trial assessing the effectiveness of the Hand in Hand couple intervention (Figure 1). Primary aim We developed an RCT to evaluate the effect of a couple intervention for breast cancer patients and their partners in the early treatment phase, comparing intervention in addition to usual care to usual care only. Due to geographical reasons it was not possible to randomise the psychologists to centres Usual care Both the intervention and control group received usual care at the centres. To avoid participants in the control group receiving counselling by trial psychologists outside the study, or participants in the intervention group receiving more than eight couple sessions, the trial psychologists could not be consulted outside the study until the 10-month follow-up. If couples randomised to the intervention group did not want to schedule the first session at their first contact with a psychologist, they could call back and schedule it within two months after randomisation.
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