A Randomized Controlled Trial of a Nurse-Led Supportive Care Package (SurvivorCare) for Survivors of Colorectal Cancer

Abstract

Introduction. Colorectal cancer (CRC) and its treatments can cause distressing sequelae. We conducted a multicenter randomized controlled trial aiming to improve psychological distress, supportive care needs (SCNs), and quality of life (QOL) of patients with CRC. The intervention, called SurvivorCare (SC), comprised educational materials, needs assessment, survivorship care plan, end‐of‐treatment session, and three follow‐up telephone calls. Methods. At the end of treatment for stage I–III CRC, eligible patients were randomized 1:1 to usual care (UC) or to UC plus SC. Distress (Brief Symptom Inventory 18), SCNs (Cancer Survivors’ Unmet Needs measure), and QOL (European Organization for Research and Treatment of Cancer [EORTC] QOL questionnaires C30 and EORTC CRC module CR29) were assessed at baseline and at 2 and 6 months (follow‐up 1 [FU1] and FU2, respectively). The primary hypothesis was that SC would have a beneficial effect on distress at FU1. The secondary hypotheses were that SC would have a beneficial effect on (a) SCN and QOL at FU1 and on (b) distress, SCNs, and QOL at FU2. A total of 15 items assessed experience of care. Results. Of 221 patients randomly assigned, 4 were ineligible for the study and 1 was lost to FU, leaving 110 in the UC group and 106 in the SC group. Patients’ characteristics included the following: median age, 64 years; men, 52%; colon cancer, 56%; rectal cancer, 35%; overlapping sites of disease, 10%; stage I disease, 7%; stage II, 22%; stage III, 71%. Baseline distress and QOL scores were similar to population norms. Between‐group differences in distress at FU1 (primary outcome) and at FU2, and SCNs and QOL at FU1 and FU2 were small and nonsignificant. Patients in the SC group were more satisfied with survivorship care than those in the UC group (significant differences on 10 of 15 items). Conclusion. The addition of SC to UC did not have a beneficial effect on distress, SCNs, or QOL outcomes, but patients in the SC group were more satisfied with care. Implications for Practice: Some survivors of colorectal cancer report distressing effects after completing treatment. Strategies to identify and respond to survivors’ issues are needed. In a randomized controlled trial, the addition of a nurse‐led supportive care package (SurvivorCare) to usual post‐treatment care did not impact survivors’ distress, quality of life, or unmet needs. However, patients receiving the SurvivorCare intervention were more satisfied with survivorship care. Factors for consideration in the design of subsequent studies are discussed.

Empowering survivors after colorectal and lung cancer treatment: Pilot study of a Self-Management Survivorship Care Planning intervention

“…Baseline anxiety and depression were low overall in this study, similar to findings in a recent RCT of a nurse-led supportive care intervention in colorectal cancer survivors (Jefford et al, 2016). However, other studies found that CRC survivors experience significant levels of anxiety and distress (D’Souza et al, 2016).…”

The effects of an integrated supportive care intervention on quality of life outcomes in outpatients with breast and gynecologic cancer undergoing chemotherapy: Results from a randomized controlled trial

“…To date, supportive interventions including CIM have been tested only within a few studies. These interventions, however, were not specifically integrated to supportive care during CHT, considered exercise as the only intervention element, primarily considered other PROs like fatigue or did not consider a nurse‐led approach . The latter aspect, however, should be prioritized as nurses are often involved in patients’ discussions about CIM, but need more education and evidence‐based healthcare structures for conducting patient‐oriented care …”

“…To date, supportive interventions including CIM have been tested only within a few studies. These interventions, however, were not specifically integrated to supportive care during CHT,34,35 considered exercise as the only intervention element,…”

Patients’ information coping styles influence the benefit of a survivorship care plan in the ROGY Care Trial: New insights for tailored delivery

“…1 Since the first recommendation by the US Institute of Medicine in 2006, 1 SCPs have been the focus of survivorship care research. 3 Randomized controlled trials (RTCs) have failed to identify the benefits of SCP delivery on patient satisfaction, quality of life, and distress in various patient populations, including those with breast, 4,5 gynecologic, 6-8 colorectal, 9 and prostate 10 cancers. 3 Randomized controlled trials (RTCs) have failed to identify the benefits of SCP delivery on patient satisfaction, quality of life, and distress in various patient populations, including those with breast, 4,5 gynecologic, 6-8 colorectal, 9 and prostate 10 cancers.…”