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The diagnosis of cancer has profound consequences for both patients and their family members [1-4], and its progression brings further challenges for couples that include imposed changes in responsibilities  and the threat of mortality [6, 7]. Distress, including depression and hopelessness, is very common in both partners when facing a diagnosis of metastatic cancer [8-14]. Social support, an important protective factor for patients with cancer , may be most important from a spouse [16, 17].
Although practical support provided by a spouse may facilitate the adjustment of patients with cancer, emotional support may be more closely linked to their psychological well-being . Emotional support refers to the verbal and non-verbal communication of concern and care and includes the ability to listen, to empathize, and to offer comfort and reassurance . The perception of empathic responses from their spouse is seen as salient to patients' experience of positive interactions in that relationship . Communication between patients and spouse caregivers about respective cancer-related concerns can negatively affect the couple's relationship . In that regard, negative, avoidant, and hostile marital interactions can compromise the relational experience of both partners at the end-of-life and can impact the bereaved caregiver following the patients' death [18-21]. In contrast, couples with strong and positive attachment bonds can draw on this stable foundation of mutual trust, affection, and respect during the challenges of terminal cancer [22-30].
The recent trend toward longer survival and home care of patients with cancer has tended to increase the involvement of spouses in the primary caregiving role . For patients with advanced disease, the need for caregiving assistance increases as the disease progresses, with a varying emotional impact on spouses . Spouses who are less satisfied with the marital relationship may experience more caregiving burden . Caregiver burden refers to both objective caregiving, including care-related tasks and time involved in caregiving, as well as subjective caregiving, including the caregiver's experience and feelings about their role as caregiver .
Couple-based interventions for patients with cancer have the potential to reduce marital and psychological distress and caregiver burden and to promote relational growth, when one partner is facing end-of-life [3, 32-36]. Moreover, the bereavement process may be eased and grief therapy facilitated . However, despite advocacy for couples' interventions focused on the specific needs of patients with terminal cancer and their spouses [12, 18, 20, 26, 34, 37-39], the suffering of such couples remains largely under-recognized and undertreated .
The majority of studies that have evaluated couples' interventions for patients with cancer have been limited by small sample sizes, varied study designs, interventions, and measures with only a handful focusing on terminal cancer [2, 13, 17, 32, 40-43]. There have been three randomized control trials (RCTs) evaluating couple-based interventions for couples facing advanced cancer [17, 42, 43]. Porter and colleagues  examined the relational benefit of partner-assisted emotional disclosure in 130 patients with gastrointestinal cancer and their partners. Findings showed that when partners avoided discussion of cancer-related concerns, the partner-assisted emotional disclosure condition resulted in improvements in relationship quality and intimacy compared with the education/support condition.
Northouse et al.  conducted a prospective longitudinal RCT with 134 patient–family caregiver dyads to assess the ‘Family involvement, Optimistic attitude, Coping effectiveness, Uncertainty reduction, Symptom management (FOCUS) program’, a family intervention based on the model of stress appraisal of Lazarus and Folkman [44, 45]. Patients in the ‘FOCUS program’ reported significantly less hopelessness and less negative appraisal of illness than the control group; this was not maintained at 3-month and 6-month follow-up. Caregivers in the FOCUS program also reported less negative appraisal of caregiving, but this was not sustained at post-intervention follow-up. Finally, Kuijer et al.  conducted a smaller RCT to evaluate a brief cognitive intervention based on equity theory. Couples in the intervention showed significant moderate effects with respect to their perceptions of the give-and-take balance (d = 0.50) and higher levels of relationship quality, the latter decreasing at 3-month follow-up. Patients also reported lower levels of psychological distress following the intervention, whereas in contrast, partners did not.
In an attempt to address some of the limitations in the existing literature, we developed a theoretically based couple intervention using Emotionally Focused Therapy (EFT), adapted for use in couples facing non-curative metastatic cancer (i.e., advanced disease) [46-48]. EFT is a well-established treatment for couples in non-cancer populations including those with depression and trauma [46-50]. EFT arises from the synthesis of experiential and systemic approaches. The focus is on intrapsychic processes, interpersonal processes, and a theory of adult love, which is viewed as an attachment process . Attachment behaviors are germane in the face of metastatic cancer due to separation and loss, activating separation distress [35, 46]. Distressed relationships are thought of as insecure bonds in which healthy attachment needs are unable to be met due to rigid patterns of interacting, inhibiting emotional engagement. In emphasizing the quality of the attachment and emotional involvement between spouses, EFT can address both patients and partners' experience of chronic and terminal illness as well as their relationship dynamics, to increase more engagement, flexible response patterns and to strengthen the attachment bond, mitigating grief and loss . A meta-analysis of RCTs of EFT in the general population showed a 70–73% recovery rate from marital distress (Dyadic Adjustment Scale) compared with wait-list control groups [48, 51]. The weighted mean effect size in four of the most rigorous studies was d = 1.31 [48, 52].
Building on the positive results of a pilot evaluation , we conducted an RCT to further evaluate this intervention. To our knowledge, this study represents the first RCT examining the impact of a modified EFT protocol for advanced cancer care. We hypothesized that following EFT, the intervention (INT) group would demonstrate a greater increase in marital functioning post-intervention when compared with the control (CTL) group. We also expected that the INT group would have a greater decrease in depression, hopelessness, and spouse caregiver burden scores and a greater increase in scores of patients' perception of spouse caregiver empathic behavior.
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Recruitment occurred between January 2008 and June 2009. Of 45 potentially eligible couples, three (6.6%) couples refused to participate, two due to lack of interest, and one due to unexpected disease progression (see Figure 1). In total, 42 patients were enrolled into the study, along with their caregivers, defined as the primary caregiver of the patient and confirmed by both couple members. Twenty-two couple participants were randomly assigned to the INT group and 20 to the CTL group. Two couple participants (10%) in the CTL group dropped out after baseline data collection; one patient unexpectedly died of cancer, and one patient had progressive disease and was too ill to continue (both couples were followed by psychiatrists in POPC). The remaining 18 couples (90%) in the CTL group completed questionnaire packages at all three data collection points. Four patients (18.2%) in the INT group died prior to collection of post-intervention follow-up (T2). The INT group therefore had an 82% completion rate for the questionnaire packages at all three data collection points. Groups were balanced on baseline outcome measures except for the measure for depression (BDI-II), with the INT group having a significantly higher mean than the CTL group (M = 17.05, SD = 7.7, range 3–33 vs M = 10.90, SD = 6.87, range 1–28, respectively; t(78) = 3.72, p = 0.0004).
Figure 1. Consort diagram of the inclusion, random assignment and the retention of the intervention group (EFT) and control group study participants. POPC, Psychosocial Oncology and Palliative Care; SOMC, Short Orientation-Memory-Concentration Test; RDAS, Revised Dyadic Adjustment Scale; KPS, Karnofsky Performance Status; EFT, Emotionally Focused Therapy; T0, baseline; T1, corresponds to post-intervention (eight sessions) of EFT (INT); T2, corresponds to 3-month post-intervention follow-up
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Demographic and clinical characteristics are listed in Table 1. Couple participants who reported a history of marital conflict or difficulty (35.7%) were distributed similarly among INT (53.3%) and CTL (46.6%) study groups. Most participants (92.5%) had an income of ≥$60,000 per year. The most common types of cancer among patients are listed in Table 1. As expected, because of differences in the EFT protocol and standard care, a significant difference was found in the mean number of sessions attended by the INT group versus the CTL group (M = 7.73, SD = 0.94 vs M = 5.22, SD = 2.29, respectively, p ≤ 0.001). These variations were adjusted for in the statistical analyses.
Table 1. Baseline demographics and clinical characteristics of patients and caregivers by group assignment
|Intervention (EFT: n = 22)||Control (SC: n = 20)||p for difference||Intervention (EFT: n = 22)||Control (SC: n = 20)||p for difference|
|Age||M = 51.83||M = 49.45||0.503||M = 48.82||M = 50.89||0.570|
|SD = 9.10||SD = 12.42|| ||SD = 13.38||SD = 9.27|
|Duration of partnership||M = 22.44||M = 19.14||0.404||M = 19.18||M = 22.44||0.413|
|SD = 12.00||SD = 12.61|| ||SD = 12.69||SD = 12.01|
|Number of children||M = 1.83||M = 1.41||0.140||M = 1.45||M = 1.6||0.481|
|SD = 0.78||SD = 0.96|| ||SD = 0.91||SD = 0.97|
|Male||10 (24.0%)||9 (21.0%)||0.949||12 (29.0%)||11 (26.0%)||0.949|
|Female||12 (29.0%)||11 (26.0%)|| ||10 (24.0%)||9 (21.0%)|
|English||22 (52.0%)||16 (38.0%)||0.200||22 (52.0%)||17 (40.0%)||0.346|
|French||0||1 (2.5%)|| ||0||1 (2.5%)|| |
|Spanish||0||1 (2.5%)|| ||0||1 (2.5%)|| |
|Other||0||(2.5%)|| || ||1 (2.5%)|
|Graduate||4 (9.5%)||4 (9.5%)||0.534||5 (11.9%)||5 (11.9%)||0.754|
|Undergraduate||10 (23.8%)||7 (16.6%)|| ||4 (9.5%)||3 (7.1%)|| |
|College||3 (7.2%)||4 (9.5%)|| ||5 (11.9%)||4 (9.5%)|| |
|Trade school||1 (2.4%)||2 (4.8%)|| ||3 (7.1%)||3 (7.1%)|| |
|High school||3 (7.1%)||1 (2.4%)|| ||3 (7.1%)||2 (4.8%)|| |
|Grade school||1 (2.4%)||0|| ||2 (4.8%)||1 (2.5%)|| |
|Professional school||0||2 (4.8%)|| ||0||2 (4.8%)|| |
|SOMC||M = 25.89||M = 26.05||0.816||M = 26.55||M = 26.78||0.686|
|SD = 2.42||SD = 1.81|| ||SD = 2.15||SD = 1.22|| |
|KPS||M = 71.11||M = 69.09||0.547|| || || |
|SD = 11.82||SD = 9.21|| || || || |
|Blood||4 (9.5%)||3 (7.1%)||0.113|| || || |
|Breast||2 (4.8%)||8 (19.0%)|| || || || |
|CNS||1 (2.4%)||4 (9.5%)|| || || || |
|GI||1 (2.4%)||1 (2.4%)|| || || || |
|Gyne||4 (9.5%)||2 (4.8%)|| || || || |
|Lung||2 (4.8%)||0|| || || || |
|GU||2 (4.8%)||2 (4.8%)|| || || || |
|Head and neck||4 (9.5%)||0|| || || || |
|Skin||1 (2.4%)||0|| || || || |
|Neuroendocrine||1 (2.4%)||0|| || || || |
|Years since diagnosis||M = 3.94||M = 1.97||0.054|| || || |
|SD = 3.83||SD = 2.37|| || || |
|Yes||7 (16.6%)||5 (11.9%)||0.271|| || || |
|No||15 (35.7%)||15 (35.7%)|| || || |
Changes in primary and secondary outcomes at post-intervention
Table 2 presents the means of the primary and secondary outcome measures at each of the time points.
Table 2. Means and standard deviations at three points of measure for six outcome measures
|M (SD)||M (SD)||M (SD)||M (SD)||M (SD)||M (SD)|
|PT||43.14 (4.8)||44.22 (7.6)||56.27 (4.6)||43.44 (10.3)||55.39 (6.3)||44.17 (10.2)|
|CG||46.41 (7.0)||42.94 (7.2)||54.32 (4.6)||42.39 (6.9)||54.72 (5.8)||44.56 (10.3)|
|PT||17.86 (7.7)||13.11 (6.9)||15.00 (6.4)||12.94 (7.6)||15.89 (11.7)||14.33 (10.9)|
|CG||16.23 (7.9)||8.69 (6.3)||13.82 (8.8)||10.33 (7.7)||13.33 (8.1)||9.67 (7.3)|
|PT||6.69 (5.7)||4.83 (4.3)||7.78 (3.9)||5.62 (5.4)||6.95 (5.8)||5.78 (6.0)|
|CG||6.32 (4.7)||4.56 (3.6)||6.64 (5.1)||4.72 (3.9)||6.94 (5.4)||5.39 (3.9)|
|PT||30.05 (8.1)||30.78 (8.8)||33.73 (5.4)||30.94 (9.6)||32.67 (10.0)||29.00 (10.1)|
|CG||2.96 (0.9)||2.52 (1.2)||2.85 (1.0)||2.60 (1.0)||2.58 (1.2)||2.70 (1.3)|
|CG||1.97 (0.7)||1.81 (0.8)||1.90 (0.8)||2.05 (1.0)||1.84 (0.8)||1.98 (1.1)|
Marital functioning (primary outcome)
At T1 there was a significant difference on the RDAS (p < 0.0001), with the INT having higher mean scores (better marital functioning) than the CTL group. The actual calculated effect size for this difference was Cohen's d = 1.00, which is in the large range. We found that patients had marginally higher mean scores (i.e., experienced more marital distress) compared with caregivers in both the INT and the CTL groups (see Table 3). T0 scores (baseline) were highly correlated with T1 scores. There was no significant effect for sex, and there were no significant interactions for primary or secondary outcomes. The multilevel modeling analysis, with couple as one of the levels, provides the same conclusions, except that the effect of patient/caregiver status is even stronger than that reported in Table 3 (F(1,38.5) = 6.05, p = 0.02).
Table 3. Results of three-way analyses of covariance for the primary and secondary outcomes at T0 and T1
|Measure at T1||Treatment||Measure at T0||Patient status||Sex||Least square means|
|RDAS total score||80.68||<0.0001||35.38||<0.0001||4.26||0.04||ns||INT = 54.91; CTL = 43.60; PT = 50.50; CG = 48.01|
|BDI prorated total score||0.55||0.46||30.43||<0.0001||ns||ns||ns||ns|
|BHS prorated total score||1.38||0.24||38.87||<0.0001||ns||ns||ns||ns|
|RFCS total score||5.84||0.02||71.67||<0.0001||ns||ns||ns||INT = 34.13; CTL = 30.74|
After controlling for baseline differences (p = 0.46), BDI-II did not remain significant in the INT group compared with the CTL group (p = 0.03). There was no difference in BHS between treatment groups.
Patient-perceived empathic behavior and caregiver burden
Patients in the INT group had significantly higher mean scores at T1, indicating higher patient-perceived caregiver empathic behavior, compared with patients in the CTL group (p = 0.02). The actual calculated effect size for this difference was Cohen's d = 1.00, which is in the large range. There was also no significant difference (p = 0.09) between groups in caregivers subjective difficulty in caregiving for their ill spouses.
Clinical significance of treatment effects on marital distress
We examined the proportion of patients and caregivers in each group who met criteria for a clinically significant improvement in marital distress across time points (see Figure 2). On the basis of individual RDAS scores, the proportion of INT patients versus CTL patients who were clinically improved was 3.25:1 [percentage: 91% of INT patients vs 28% of CTL patients (χ2 = 16.8, p < 0.0001)] and the proportion of INT versus CTL caregivers who were clinically improved was 4.54:1 [percentage: 50% of INT caregivers vs 11% of CTL caregivers (χ2 = 6.825, p = 0.01)] and moved from marital distress (RDAS ≤ 47) to non-marital distress (RDAS ≥ 48) from T0 to T1.
Figure 2. Bar graphs showing the percentage of participants who had a change in score from baseline (T0) to 3-month post-intervention (T2) for marital distress. EFT, Emotionally Focused Therapy; SC, standard care; PT, patient; CG, caregiver
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Sustainability of the intervention effects on marital distress, psychological distress, patient-perceived caregiver empathic responses, and caregiver burden
Using three-way ANCOVAs to control for baseline scores, we examined whether the INT and CTL groups differed on any of the outcome variables at T2. As at T1, the INT group had significantly higher RDAS scores compared with the CTL group (least square means: 55.04 vs 44.40, respectively, p ≤ 0.001). In addition, patients in the INT group had higher scores for RFCS compared with patients in the CTL group (least square means: 33.84 vs 28.25, p = 0.028). There were no significant differences for Caregiver Burden Scale, BDI-II or BHS scores.
We found that there were no significant changes from T1 to T2 in overall mean scores, suggesting stability of scores between post-intervention and 3-month post-intervention follow-up (see Table 4). In addition, a total of 89% of patients in the INT group versus 50% of the patients in the CTL group remained above the cut-off (non-distressed) on the RDAS scale at T2 (p = 0.01); 89% of INT caregivers versus 39% of CTL caregivers remained above the cut-off (p = 0.001).
Table 4. Results of three-way analyses of covariance for the primary and secondary outcomes at T2
|Measure at T2||Treatment||Measure at T1||Patient status||Sex|
|RDAS total score||0.11||0.74||91.08||<0.0001||ns||ns|
|BDI prorated total score||0.17||0.68||33.62||<0.0001||ns||ns|
|BHS prorated total score||0.11||0.75||78.35||<0.0001||ns||ns|
|RFCS total score||0.09||0.76||65.41||<0.0001||ns||ns|
The least square means from the ANCOVA (i.e., treatment means adjusted for differences in sex and patient status) were examined and showed the difference between the two groups. Significant differences between EFT and standard care were found on the RDAS (+11.31 with a 95% CI, p ≤ 0.0001) and the RFCS (+3.44 with a 95% CI, p = 0.02).
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In this trial, we found that patients with metastatic cancer and their spouses who received a modified EFT demonstrated statistically and clinically significant improvements in marital functioning compared with those couples who received standard care. The change in treatment mean scores on the RDAS (+11.34), which were maintained at 3-month follow-up exceeded the minimum change score difference of seven points that we found in our pilot work . None of the INT group declined, whereas one-third of the CTL group deteriorated in marital functioning at post-treatment.
Encouragingly, when comparing the proportion of patients with improved marital functioning in the INT versus CTL group, the proportion was 3.25:1 (i.e., 91% of INT patients vs 28% of CTL patients, respectively), whereas the proportion of caregivers in INT versus CTL was 4.54:1 (i.e., 50% of INT caregivers vs 11% of CTL caregivers, respectively). This degree of improvement is similar to other reported empirical EFT studies of couples in the non-cancer literature, which show an improvement in marital functioning (range 70–73%) . The significant improvement may in part be due to our eligibility requirement of marital distress. Furthermore, this study is unique, compared with other couple interventions reported in the cancer literature [13, 17, 32, 40, 42, 43], in that a validated measure of marital functioning was employed as a primary outcome.
Additionally, our results showed that patients in the INT group reported significant improvement in their assessment of perceived caregivers' empathic behaviors when compared with the CTL group. It is possible that EFT increased the patients' perception of feeling heard, understood, accepted, and cared about. As expected, these findings suggest that the beneficial effects of EFT on both RDAS and RFCS scores occurred primarily during and at the end of the intervention (T1), being maintained at 3-month post-intervention as well. Receiving EFT may have helped the caregiver in trying to experience the patients' feelings and learning how to best help and comfort the patient as well as improving overall responsiveness.
The high participation rate, retention of couples in the study, and their compliance in regard to completion of questionnaires support the effectiveness of a couple-based intervention tailored for the advanced cancer population.
The study was limited by the relatively small sample size. Furthermore, the results are limited to couples who were referred by their clinical team and met the RDAS cut-off for marital distress. Moreover, the CTL group intervention varied on the basis of the approach considered most suitable by the clinician. Although this study has demonstrated that EFT can provide significant benefits to couples compared with standard care alone, future studies with more equitable control groups of standardized evidence-based couple therapies are now needed. It is unknown if further research with larger samples will demonstrate significant effects on secondary outcomes, such as depression . Our findings in this study are in contrast to our pilot work where we found a significant reduction in mean BDI-II scores from T0 to T3 using EFT for a similar group of participants . The lack of an effect of EFT on hopelessness in both the pilot study and this study is similar. It is possible that such an effect may occur when participants are selected for treatment on the basis of elevations in these symptoms (e.g., EFT studies, see ). Larger RCTs are now needed to confirm our findings. Additionally, qualitative studies may help to further understand the mechanism by which such an intervention may act as well as what may assist in the reduction of symptoms of depression and hopelessness.
In conclusion, our study provides evidence that this newly developed EFT intervention is beneficial in the terminal cancer population, improving both the quality of marital functioning and the patients' perceived experience of being empathically understood by their caregivers. The findings also suggest that couple-based interventions have the potential to result in relational growth during a very challenging and difficult time. The impact of terminal cancer on couples' relationship requires attention in future studies in palliative care programs [3, 8, 35, 36].
Conflict of interest
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The authors have declared that there is no conflict of interest.
Conception and design: Linda Mclean, Gary Rodin, Tara Walton, Mary Jane Esplen, Jennifer Jones
Administrative support: Linda McLean, Tara Walton
Collection and assembly of data: Linda McLean, Tara Walton, Barbara Thomson
Data analysis and interpretation: Linda McLean, Tara Walton, Barbara Thomson, Gary Rodin, Jennifer Jones
Manuscript writing: Linda McLean, Tara Walton, Gary Rodin, Mary Jane Esplen, Jennifer Jones
Final approval of manuscript: Linda McLean, Tara Walton, Mary Jane Esplen, Gary Rodin, Jennifer Jones