Survivorship care plans (SCPs), recommended for cancer survivors by the Institute of Medicine since 2006, are meant to improve patients' quality of care as they move beyond cancer treatment and deal with its aftermath. But do they work?
In a study published online August 24 in the Journal of Clinical Oncology, Dutch researchers found "no evidence of a benefit of SCPs on satisfaction with information provision and care."
However, SCPs did have an impact on other parameters. "SCPs increased patients' concerns, emotional impact, experienced symptoms, and the amount of cancer-related contact with the primary care physician [PCP]," say the resaerchers, headed by Lonneke V. van de Poll-Franse, PhD, CoRPS, from the Department of Medical and Clinical Psychology, Tilburg University, the Netherlands.
"This is an important study from the Dutch group. They have answered some questions and raised others," says Deborah K. Mayer, PhD, RN, director of cancer survivorship, University of North Carolina at Chapel Hill, who coauthored an accompanying editorial.
"Providing SCP is challenging, and the researchers deserve credit for the study," Dr Mayer told Medscape Medical News.
"There are lots of moving parts in the implementation of an SCP," she added. The moving parts relate to tracking and knowing a patient and his or her care, when care is ending, creating the "document," delivering it to the patient, and making sure the PCP receives it.
"SCPs have been promoted for approximately 10 years as a good thing," Dr Mayer commented. "However, it is possible that for some patients, it is worrisome, which may lead to additional PCP visits," she said.
"We should identify patients who may be more vulnerable to getting the SCP or follow up after delivering it to address patient concerns," she added.
The Dutch study was a cluster, randomized Registration System Oncological Gynecology (ROGY) Care trial that longitudinally assessed the effects of SCPs on patient-reported outcomes in clinical practice. This article is the fourth report from this group, but it is the first to focus on patient-centered outcomes.
Twelve hospitals were randomly assigned to deliver SCP (n = 6) or usual care (n = 6) to 221 women (SCP = 119; usual care = 102) after initial surgery for endometrial cancer.
"Random assignment at the hospital level was chosen to avoid potential contamination of usual care with increased information provision of SCP care," Dr van de Poll-Franse and researchers write.
Patients receiving usual care were provided with information on the basis of Dutch follow-up guidelines; the information was predominantly delivered through verbal communication and generic brochures on diagnosis and treatment.
Patients in the intervention arm received automatically generated SCPs after surgery and during follow-up visit. SCPs contained information on their cancer, treatment, and adverse effects and was provided by their gynecologist/gynecologic oncologist and/or the oncology nurse.
For the study, an SCP was automatically generated only at SCP-designated hospitals by combining patient and disease data in a ROGY program. The SCP contained information on diagnostic tests; cancer type, stage, and grade; treatment; hospital and specialist contact information; and a follow-up care plan on short-term and long-term plans, which included information on signs of recurrence, secondary tumors, rehabilitation, and support care services.
The researchers hypothesized that patients receiving SCP care would report "higher satisfaction with information provision, higher satisfaction with care, more threatening illness perceptions, and higher health care use than patients receiving usual care." That is not what they found, however.
Implementation Challenges and "Dose Effect" in SCP Studies
Although the study included only incident cases, with the first SCP provided after diagnosis and surgery (a strength of the study), there was no perceived benefit with regard to patient satisfaction for those receiving SCPs.
As to why that was the case, the editorialists write: "Careful consideration of SCP implementation-related issues is crucial for ensuring that null or negative results of SCP effectiveness studies are truly a reflection of the inherent effectiveness of SCPs, not of poor or inconsistent SCP implementation." According to the editorialists, the results suggested that implementation may be a concern.
"[As with] previous SCP effectiveness studies, the ROGY study omits important details regarding the intervention (ie, the dose) and factors associated with its implementation," the editorialists write.
"To avoid this problem, future studies should consider and describe how the SCP is implemented and how implementation may influence SCP effectiveness," they add.
The ROGY study identified appropriate time to discuss the SCP with the patient as a barrier to SCP delivery. In addition, patients' oncologists, gynecologists, or nurses were eligible to deliver the SCP, which may relate to the strength of the intervention received.
Beyond implementation, there is also the "dose effect," which relates to the strength of an SCP and how often it is delivered. Approximately 25% of patients in the SCP arm indicated that they did not receive an SCP; at 12 months' follow-up, 30% indicated that they had received an SCP more than once.
"More comprehensive understanding of the outcomes of SCP use are needed to allow us to assess whether SCPs, like some drugs, require more frequent administration for maximal effectiveness," the editorialists write.
The editorialists ask whether it is enough to give SCP once after treatment or whether intermittent delivery of updated SCPs is necessary for them to be effective.
Dose strength may also be an issue. According to the editorialists, the results indicate that patients in the SCP arm who received an SCP but who reported not receiving it can be perceived as an "SCP intervention that was not as strong as those who reported receiving an SCP."
"For SCP trials, we have skipped the dose and administration step, and that may be why these phase III trials are negative (ineffective dose)," the editorialists point out.
Additionally, a confounding issue in SCP studies may be the quality of care provided in the usual-care arm. Approximately 40% of patients in the usual-care arm reported receiving an SCP.
The researchers indicate that the usual care provided by some oncologists "may have been perceived as an SCP, but none of them actually provided an SCP," or patients may have still received one.
Although this was controlled for statistically, it does raise real issues in conducting this type of study in the real world, where adoption of SCP is increasing, Dr Mayer indicated.
Dr van de Poll-Franse and colleagues point out: "Because the SCP button was only visible in the SCP care arm, it was not possible for patients in the usual care arm to receive the [ROGY- generated] SCP."
SCPs: Beneficial or Harmful?
Finally, SCP delivery was reported to be associated with increased emotional impact, more concern about their illness, and an increase in PCP visits.
"[I]t is unclear whether these effects are harmful or perhaps beneficial for patients," the researchers write.
They indicate that reluctance to provide patients with information about potential late side effects may be associated with a perception that such information may have negative effects on psychological adjustment.
"However, one could also argue that receiving an SCP raises patients' awareness of cancer-related symptoms and empowers them to find the necessary support," Dr van de Poll-Franse and colleagues write.
They point out: "[The] current outcome that patients receiving SCP care reported more cancer-related contact with their primary care physician is in line with this assumption."
"Because follow-up care for cancer survivors is increasingly transferred to the primary care physician, SCPs may be a useful tool to enable this transition," they add.
"Increased PCP visits raise the question of unintended consequences from the increased concerns or more awareness of health needs generated from the SCPs," Dr Mayer told Medscape Medical News.
Effectiveness of SCPs
After four randomized, controlled trials published by the Dutch group, there is no clear answer as to whether SCPs are effective.
In an interview with Medscape Medical News, Dr Mayer echoed what she and her colleagues wrote in their editorial: "There is no evidence that SCPs are effective. Conversely, imperfect studies do not prove that SCPs are ineffective."
The editorialists indicate that SCP effectiveness is dependent on a clear definition and measurement of its intervention and implementation.
"We can improve on previous studies of SCP effectiveness by defining what the intervention is: Is it the document alone? Perhaps the distal outcomes (eg, enhanced adherence for surveillance and screening) are too much to ask of the document alone," the editorialists state.
With respect to SCP implementation, several questions are raised by the editorialists. Who should develop it? Who should deliver it? How should they deliver it? How often? For whom? By the end of the study, the ROGY participants identified the nurse as the most appropriate person to deliver the SCP.
"This information will equip us to more effectively implement SCPs and, ultimately, assess their effectiveness in a more rigorous manner," they conclude.
Dr van de Poll-Franse has received research funds from industry. A coauthor of the study has a consulting or advisory role with Medivation/Astella Pharma.
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Cite this: Effectiveness of Cancer Survivorship Care Plans Questioned - Medscape - Aug 27, 2015.