Randomized controlled trial of a clinic-based survivorship intervention following adjuvant therapy in breast cancer survivors

Abstract

In 2006, the IOM released a report citing the importance of "survivorship plans" to improve quality of life and care coordination for cancer survivors, but little has been done to evaluate their efficacy. Women with early-stage breast cancer were randomized within 6 weeks of completing adjuvant therapy to a survivorship intervention group (SI) or control group (CG). All subjects were given the NCI publication, "Facing Forward: Life after Cancer Treatment." The SI also met with a nurse/nutritionist to receive a treatment summary, surveillance, and lifestyle recommendations. Both groups completed questionnaires on the impact of cancer (IOC), patient satisfaction (FACIT-TS-PS), and assessment of survivor concerns (ASC) at baseline, 3 and 6 months. Within and between group t tests and linear regression analyses were performed. Among 126 women (60 CG, 66 SI), mean age was 54 years, 48 % were Hispanic, and the groups were well-balanced by baseline characteristics. No significant differences between the CG and SI on the FACIT-TS-PS or IOC at 3 and 6 months were seen. The ASC health worry subscale was lower (less worry) in the SI compared to CG (p = 0.02). At all time-points, Hispanic women had higher (worse) health worry (p = 0.0008), social-life interference (p = 0.009), and meaning of cancer scales (p = 0.0004), and more trust in medical professionals (p = 0.03) compared to non-Hispanic women. While the SI did not lead to significant improvements in most patient-reported outcomes, it was associated with decreased health worry. Future interventions should determine the most efficient and effective method for delivering survivorship care plans.

The expanding role of primary care in cancer control

“…Moreover, randomised trials of survivorship care plans were unable to detect an improvement in outcomes. [195][196][197] Recognising these challenges, eff orts have focused on identifi cation of the essential elements that are necessary for communication and care. 198 The actual form of the plan is a secondary consideration.…”

Views of Family Physicians about Survivorship Care Plans to Provide Breast Cancer Follow-Up Care: Exploration of Results from a Randomized Controlled Trial

“…More recently, two randomized controlled trials (rcts) evaluated the effectiveness of a scp for breast cancer patients 32,33 . The results indicated that, with the exception of cancer worry, a scp delivered within a personal visit is no more effective than either a discharge visit with an oncologist 32 or a 24-page publication from the U.S. National Cancer Institute 32 on a wide range of patient-reported outcomes 33 .…”

The impact of cancer survivorship care plans on patient and health care provider outcomes: a current perspective

“…Three early randomized studies [10][11][12] did not find any differences in satisfaction with care [10][11][12], distress [12] and quality of life [12] between patients who did or did not receive an SCP. Although these studies provided important first insights into the impact of SCPs, there were limitations in the study designs, including the timing of the intervention and outcomes assessment [13].…”

“…First of all, there is no substantial evidence of a benefit of SCPs. Except for the first positive impact on patient outcomes in the recently published small POSTCARE trial [9], no differences in satisfaction with information provision [8], satisfaction with care [10][11][12], distress [12], and quality of life [12] have been found between patients who did or did not receive an SCP. Second, at this point, no definitive statements can be made about the potential negative consequences of SCPs.…”

“…In previous studies, the moment of the delivery of the SCP ranged from newly diagnosed patients to patients who were up to six years post-treatment [8][9][10][11][12]. Although the IOM recommended delivering the SCP at the end of treatment [2], it may be preferable to provide the SCP directly after initial diagnosis, allowing patients to discuss the planned treatment with their oncology providers and family [27].…”