Randomized controlled trial of the effect of a reproductive health survivorship care plan on fertility and pregnancy concerns, vasomotor symptoms, sexual health, and contraception in young breast cancer survivors

Abstract

Young breast cancer survivors (YBCS) have unmet reproductive health needs in managing fertility/pregnancy concerns, hot flashes, vaginal dryness, and contraception. Following development of an evidence-based, online educational intervention targeting YBCS and their healthcare providers (HCP), we hypothesized that YBCS who received the Reproductive Health Survivorship Care Plan (SCP-R) would be more likely to improve on fertility/pregnancy concerns, vasomotor symptoms, sexual health, or contraceptive practices, compared to waitlist controls (NCT02667626). Randomized controlled trial. YBCS and their nominated HCP were recruited from cancer advocacy and physician referrals across the U.S. Eligible YBCS were aged 18-45 at diagnosis, 18-50 at enrollment, Stages 0-III, able to read English, access the Internet and complete daily hot flash text messages. Participants had ≥1 of the following reproductive health needs: > moderate fertility/pregnancy concerns, >4 hot flashes/day with >1 of moderate severity, >1 moderate vaginal atrophy symptoms, not contracepting/using less effective methods. YBCS underwent computer-generated, stratified randomization to the study arms and were followed for 24 weeks. The intervention group accessed the online SCP-R; the waitlist controls accessed a curated resource list. HCPs could access their patient’s materials. In an intention-to-treat analysis, the primary outcome of an improvement in at least 1 late effect by 24 weeks was compared by intervention group. A priori sample size calculations based on hot flashes estimated 50 participants per arm to detect a 2.2 decrease in hot flash score (80% power, a=0.05). 182 YBCS (86 intervention, 96 waitlist control), mean age 40.0±5.9 and mean years since diagnosis 4.4± 3.2, were randomized. Loss to follow up was 3%. 61 YBCS (70.9%) in the intervention arm improved in at least one reproductive health outcome, compared to 55 (57.3%) of waitlist controls (OR 1.82, 95% CI 0.99-3.4, p=0.057). Table 1 summarizes improvement of individual reproductive health need by study arm. A novel, web-based intervention improved clinically significant reproductive health late effects for a substantial proportion of YBCS, supporting the importance of dissemination of accessible curated resources to YBCS and their HCPs.Table 1Improvement of individual reproductive health late effects by study arm (n=182)Reproductive Health Late EffectTreatment Arm N(%) (n=86)Waitlist Control Arm N(%) (n=96)OR (95% CI)p-valuePregnancy/fertility concerns ≤324 (53.3)14 (30.4)2.6 (1.1-6.3)0.0350% decrease in hot flash score26 (57.8)24 (51.1)1.3 (0.6-3.0)0.5250% decrease in vaginal atrophy symptoms10 (25.6)11 (23.9)1.1 (0.4-3.0)0.85Reporting tier I/II contraception23 (44.2)21 (34.4)1.5 (0.7-3.2)0.29 Open table in a new tab