Randomized clinical trial of a brief and extensive dyadic intervention for advanced cancer patients and their family caregivers

Abstract

Objective Few intervention programs assist patients and their family caregivers to manage advanced cancer and maintain their quality of life (QOL). This study examined: 1) whether patient-caregiver dyads (i.e., pairs) randomly assigned to a Brief or Extensive dyadic intervention (the FOCUS Program) had better outcomes than dyads randomly assigned to usual care, and 2) if patients' risk for distress (RFD) and other factors moderated the effect of the Brief or Extensive Program on outcomes. Methods Advanced cancer patients and their caregivers (N=484 dyads) were stratified by patients' baseline risk for distress (high versus low), cancer type (lung, colorectal, breast, prostate), and research site, and then randomly assigned to a Brief (3-session) or Extensive (6-session) intervention or Control. The interventions offered dyads information and support. Intermediary outcomes were: appraisals (i.e., appraisal of illness/caregiving, uncertainty, hopelessness) and resources (i.e., coping, interpersonal relationships, and self-efficacy). The primary outcome was QOL. Data were collected prior to intervention and post-intervention (3 and 6 months from baseline). The final sample was 302 dyads. Repeated Measures MANOVA was used to evaluate outcomes. Results Significant Group by Time interactions showed there was improvement in dyads' coping (p<.05), self-efficacy (p<.05), and social QOL (p<.01), and in caregivers' emotional QOL (p<.05). Effects varied by intervention dose. Most effects were found at 3 months only. Risk for distress accounted for very few moderation effects. Conclusions Both Brief and Extensive programs had positive outcomes for patient-caregiver dyads, but few sustained effects. Patient-caregiver dyads benefit when viewed as the “unit of care.”

A preliminary study to develop an intervention to facilitate communication between couples in advanced cancer

“…Given that research in this area is relatively new, testing short interventions that may assist couples suffering the challenges of a terminal disease is an important activity (Hudson et al, 2010;Hudson & Payne, 2011). A randomized controlled trial comparing three brief information and support sessions (two 90-minute home visits and one 30-minute phone session) to six extensive sessions (four 90-minute home visits and two 30-minute phone sessions) with usual care found similar short-term benefits for both (Northouse et al, 2012b). At the same time, regardless of the length of the intervention, studies to date suggest that sustained effects may not be achieved, are limited or only occur for carers, and are often not measured (Northouse et al, 2007;Candy et al, 2011;Northouse et al, 2012b), and longitudinal studies are rare.…”

“…Couples admitted into this study were not screened for initial distress or conflict; as such, it is less clear how couples with fractured communication or those in conflict would benefit. Targeting at-risk couples and identifying effective ways to help them is challenging for this and other couples studies in end-of-life cancer (Candy et al, 2011;Northouse et al, 2012b). Nevertheless, the PDI -CI may be useful as a starting point in identifying which couples would benefit from further assistance from clinically appropriate follow-up.…”

Telemedicine Use Among Caregivers of Cancer Patients: Systematic Review (Preprint)

“…Dyads dealt with different types of cancer at different stages; among included studies, lung and gastrointestinal cancers were the most considered, followed by genitourinary and breast tumours, and haematological neoplasms (see Figure 2). Of the 24 studies, eight focused on advanced cancers [48,51,[54][55][56][57][58][59], two on early-stage tumours [60,61], while other trials included patients with all stages of the disease.…”

“…These improved outcomes were: caregiver self-efficacy, Quality of Life, distress, depression, appraisal of caregiving, and perceived social support. Caregiver self-efficacy both in managing own emotions and in helping the patients to control symptoms was measured in five studies [52,59,61,67,70] and was always statistically significant. Five studies reported significant differences in Quality of Life aspects: three of them showed significant effects in all dimensions of Quality of Life [52,65,67]; Two studies showed significant effects in spiritual and social well-being [59,65], while one study [60] showed significant outcomes in social well-being.…”

“…relationship with partner, perception of patient's health condition). In the former, the most examined constructs are Quality of Life [50,52,54,56,59,62,[64][65][66][67], and Distress [50,52,53,59,61,62,65,[67][68][69]. To assess Quality of Life different tools were used including the Functional Assessment of Cancer Treatment (FACT-G) (n = 4), the Short Form (SF) 36-item and 12-item version (n = 2), the CG QOL Scale-Cancer (CQOL-C) (n = 2), the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) (n = 1), the Medical Outcomes Study 12-item short form (MOS SF-12) (n = 1), the UCLA Prostate Cancer Index (n=1).…”