Effects of the WRITE Symptoms Interventions on Symptoms and Quality of Life Among Patients With Recurrent Ovarian Cancers: An NRG Oncology/GOG Study (GOG-0259).

PURPOSE: GOG-259 was a 3-arm randomized controlled trial of two web-based symptom management interventions for patients with recurrent ovarian cancer. Primary aims were to compare the efficacy of the nurse-guided (Nurse-WRITE) and self-directed (SD-WRITE) interventions to Enhanced Usual Care (EUC) in improving symptoms (burden and controllability) and quality of life (QOL). METHODS: Patients with recurrent or persistent ovarian, fallopian, or primary peritoneal cancer with 3+ symptoms were eligible for the study. Participants completed baseline (BL) surveys (symptom burden and controllability and QOL) before random assignment. WRITE interventions lasted 8 weeks to develop symptom management plans for three target symptoms. All women received EUC: monthly online symptom assessment with provider reports; online resources; and every 2-week e-mails. Outcomes were evaluated at 8 and 12 weeks after BL. Repeated-measures modeling with linear contrasts evaluated group by time effects on symptom burden, controllability, and QOL, controlling for key covariates. RESULTS: Participants (N = 497) reported mean age of 59.3 ± 9.2 years. At BL, 84% were receiving chemotherapy and reported a mean of 14.2 ± 4.9 concurrent symptoms, most commonly fatigue, constipation, and peripheral neuropathy. Symptom burden and QOL improved significantly over time (P < .001) for all three groups. A group by time interaction (P < .001) for symptom controllability was noted whereby both WRITE intervention groups had similar improvements from BL to 8 and 12 weeks, whereas EUC did not improve over time. CONCLUSION: Both WRITE Intervention groups showed significantly greater improvements in symptom controllability from BL to 8 and BL to 12 weeks compared with EUC. There were no significant differences between Nurse-WRITE and SD-WRITE. SD-WRITE has potential as a scalable intervention for a future implementation study.

Web-based symptom management for women with recurrent ovarian cancer: a pilot randomized controlled trial of the WRITE Symptoms intervention.

CONTEXT: Little research has focused on symptom management among women with ovarian cancer. Written Representational Intervention To Ease Symptoms (WRITE Symptoms) is an educational intervention delivered through asynchronous web-based message boards between a study participant and a nurse. OBJECTIVES: We evaluated WRITE Symptoms for 1) feasibility of conducting the study via message boards, 2) system usability, 3) participant satisfaction, and 4) initial efficacy. METHODS: Participants were 65 women (mean age, 56.5; SD = 9.23) with recurrent ovarian cancer randomized using minimization with race/ethnicity (non-Hispanic white vs. minority) as the stratification factor. Measures were obtained at baseline and two and six weeks after intervention. Outcomes were feasibility of conducting the study, system usability, participant satisfaction, and efficacy (symptom severity, distress, consequences, and controllability). RESULTS: Fifty-six (87.5%) participants were retained, and the mean usability score (range 1-7) was 6.18 (SD = 1.29). All satisfaction items were scored at 5 (of 7) or higher. There were significant between-group effects at T2 for symptom distress, with those in the WRITE Symptoms group reporting lower distress than those in the control group [t(88.4) = -2.57; P = 0.012], with a similar trend for symptom severity [t(40.4) = -1.95; P = 0.058]. Repeated measures analysis also supported a group effect, with those in the WRITE Symptoms group reporting lower symptom distress than those in the control condition [F(1, 56.7) = 4.59; P = 0.037]. CONCLUSION: Participants found the intervention and assessment system easy to use and had high levels of satisfaction. Initial efficacy was supported by decreases in symptom severity and distress.