Of 76 eligible patients and their informal caregivers, 62 (82%) dyads enrolled in the study, and 14 (18%) declined participation, mostly because participation was considered too burdensome. Of the 62 dyads that provided consent, 2 dyads withdrew consent after enrollment. Thus, T0 was completed by 60 (79%), whereas T1 by 58 (76%) and T2 by 51 dyads (67%). Baseline, caregiving, and treatment characteristics are provided in Table 1. Table 2 displays an overview of what support informal caregivers need before, during, and after a patients’ treatment with adjuvant chemotherapy. When informal caregivers reported they need support, it seemed most needed before starting chemotherapy and focused on practical support and receiving information.
Table 1 Characteristics of informal caregivers and patients Table 2 Informal caregivers’ needs for support before, during, and after adjuvant chemotherapy Course of burden, distress, health-related quality of life, marital satisfaction, discrepancies in social needs, fatigue over time, and informal caregiver self-esteem
Table 3 shows mean scores for informal caregiver well-being over time. Mean scores for informal caregiver burden (F[2,94] = 4.465; p = 0.014), distress (F[1.773,81.574] = 5.497; p = 0.008), role emotional limitations (F[2,94] = 8.814; p < 0.0001), mental health (F[2,94] = 4.949; p = 0.009), social functioning (F[2,98] = 3.985; p = 0.022), and discrepancies in social support (F[2,66] = 3.466; p = 0.037) differed significantly between time points. Post hoc analyses indicated an improvement of all scores over time; i.e., burden, distress, and role emotional limitations decreased, whereas mental health and social functioning increased. Discrepancies in social support decreased during and increased after ending adjuvant chemotherapy. Post hoc analyses are shown in Supplementary Table 1.
Table 3 Informal caregivers’ course of burden, distress, health-related quality of life, marital satisfaction, fatigue, and self-esteem Table 4 displays patients’ mean scores for health-related quality of life, marital satisfaction, discrepancies in social needs, and fatigue over time. Mean patient distress (F[1.771,79.706] = 5.224; p = 0.010), role physical limitations (F[2,94] = 9.551; p < 0.0001), vitality (F[2,96] = 5.295; p = 0.007), social functioning (F[2,96] = 9.157; p < 0.0001), general health (F[2,92] = 6.672; p = 0.002), marital satisfaction (F[2,54] = 5.395; p = 0.007), and fatigue (F[2,92] = 11.393; p < 0.0001) changed significantly over time. Post hoc analyses revealed an overall decrease of distress and increase in role physical limitations and social functioning. Vitality and general health decreased during and increased after ending adjuvant chemotherapy. Marital satisfaction decreased over time. Fatigue increased during and decreased after ending adjuvant chemotherapy. Post hoc analyses are shown in Supplementary Table 2.
Table 4 Patient course of distress, health-related quality of life, marital satisfaction, fatigue, and self-esteem Clinically relevant levels of informal caregiver burden and distress
Moderate or high levels of burden of informal caregivers were found in 17.2% (n = 10/58) and 12.1% (n = 7/58) at baseline, 19.3% (n = 11/57) and 10.5% (n = 6/57) at T1, and 12% (n = 6/50) and 8% (n = 4/50) at T2, respectively. A HADS total score exceeding the cutoff for clinically relevant distress was found in 26.7% (n = 16/60) at baseline, 22.8% (n = 13/57) at T1, and 18.8% (n = 9/48) at T2. Clinically relevant levels of informal caregiver depressive symptoms (HADS-D) were 15% at baseline, 10.5% at T1, and 12.2% at T2. Clinically relevant levels of informal caregiver anxiety (HADS-A) were 21.7% at baseline, 21.1% at T1, and 12.2% at T2. In patients, 22.4% (n = 13/58) exceeded the cutoff at baseline for clinically relevant levels of distress, 31.5% (n = 17/54) at T1, and 18.0% (n = 9/50) at T2. Clinically relevant levels of patient depression were 12.1% at baseline, 16.1% at T1, and 7.8% at T2. Clinically relevant levels of patient anxiety were 17.2% at baseline, 13.0% at T1, and 7.8% at T2. There was no significant difference between the proportions of informal caregivers (p = 0.289) or patients (p = 0.508) with clinically relevant levels of distress at baseline and T2.
Predictors of informal caregiver distress and burden at T1 and T2
Informal caregiver gender, age, burden, distress, fatigue, and patient distress at baseline predicted informal caregiver self-perceived burden at T1 (F[6,53] = 4.493, p = 0.001, R2 = 0.365) and T2 (F[6,46] = 4.523, p < 0.001, R2 = 0.404). Only informal caregiver burden at baseline added significantly to the prediction at T1 (p = 0.002) and T2 (p = 0.002). The multivariate regression model was also used to predict distress at T1 (F[6,53] = 12.305, p < 0.0001, R2 = 0.611) and T2 (F[6,44] = 7.204, p < 0.0001, R2 = 0.532). Only baseline informal caregiver distress (p < 0.001) added significantly to the prediction at T1 (p < 0.001) and T2 (p = 0.001). Details are displayed in Table 5.
Table 5 Multivariate regression analyses to explore associations with informal caregiver burden and distress during and after patients’ treatment with adjuvant chemotherapy Interaction between informal caregivers and patients
Generally, informal caregivers reported higher distress levels (T0 mean 8.47 (SD 6.83); T1 mean 7.42 (SD 6.34); T2 mean 6.50 (SD 7.14)) compared with patients (T0 mean 7.02 (SD 5.80); T1 mean 7.20 (SD 5.93); T2 mean 5.56 (SD 4.69)), but these differences did not reach statistical significance (T0 mean difference 1.45, p = 0.217; T1 mean difference 0.22, p = 0.853; T2 mean difference 0.94, p = 0.445). We did not find significant correlations between informal caregiver and patient distress at baseline (r = 0.134, p = 0.315), T1 (r = 0.263, p = 0.054), or T2 (r = 0.121, p = 0.424). In addition, informal caregiver burden and patient distress did not correlate significantly at T1 (r = 0.209, p = 0.129) or T2 (r = 0.205, p = 0.167). However, at baseline, informal caregiver burden was significantly, but weakly correlated with patient distress (r = 0.261, p = 0.05).