Factors related to dropout in integrative oncology clinical trials: interim analysis of an ongoing comparative effectiveness trial of mindfulness-based cancer recovery and Tai chi/Qigong for cancer health (The MATCH study)

Abstract Objective To examine the factors associated with loss to follow-up (LTFU) in an ongoing preference-based randomized waitlist controlled trial of mindfulness-based cancer recovery (MBCR) and Taichi/Qigong (TCQ) for cancer survivors (the MATCH Study). Hierarchical logistic regression was used to determine the factors associated with LTFU. Predictors included adherence to treatment, preference vs. randomized, type of intervention (MBCR vs. TCQ) and program timing (immediate {IM} vs. waitlist control {WLC} group). Results Data indicated that randomization to the WLC group and, once in the intervention, low adherence were the main predictors of LTFU. Participants in the WLC group were 4 times more likely to be LTFU post-randomization [OR 3.96, 95% CI 2.08–7.56, p < 0.005] than those in the IM group. Participants showing low adherence to treatment were 6 times more likely for LTFU post-intervention [5.87 (2.57–13.400; p < 0.005] and 4 times more likely for LTFU 6 months post-intervention [OR 3.93, 95% CI 1.53–10.02, p = 0.01]

Group versus Individual Acupuncture (AP) for Cancer Pain: A Randomized Noninferiority Trial

Background. A service delivery model using group acupuncture (AP) may be more cost-effective than individual AP in general, but there is little evidence to assess whether group AP is a comparable treatment in terms of efficacy to standard individual AP. The study aimed to compare the group to individual delivery of 6-week AP among cancer patients with pain. Methods. The study design was a randomized noninferiority trial of the individual (gold standard treatment) vs. group AP for cancer pain. The primary outcome was pain interference and severity, measured through the Brief Pain Inventory (BPI). Secondary outcomes included measures of mood, sleep, fatigue, and social support. Changes in outcomes from pre- to postintervention were examined using linear mixed effects modeling and noninferiority was inferred using a noninferiority margin, a difference of change between the two arms and 95% CIs. Pain interference was tested with a noninferiority margin of 1 on the BPI, while pain severity and secondary outcomes were compared using conventional statistical methods. Results. The trial included 74 participants randomly allocated to group (35) or individual (39) AP. The noninferiority hypothesis was supported for pain interference [Ө − 1, Δ 1.03, 95% CI: 0.15–2.20] and severity [Ө − 0.81, Δ 0.52, 95% CI:.33–1.38] as well as for mood [Ө − 7.52, Δ 9.86, 95% CI: 0.85–18.86], sleep [Ө − 1.65, Δ 2.60, 95% CI: 0.33–4.88], fatigue [Ө 8.54, Δ − 15.57, 95% CI: 25.60–5.54], and social support [Ө.26, Δ − 0.15, 95% CI:  − 0.42–0.13], meaning that group AP was not inferior to individual AP treatment. Both arms evidenced statistically significant improvements across all symptoms before and after the intervention. Effect sizes for the group vs. individual AP on outcomes of pain, sleep, mood, and social support ranged from small to very large and were consistently larger in the group condition. The total average cost-per-person for group AP ($221.25) was almost half that of individual AP ($420). Conclusions. This is the first study to examine the noninferiority of group AP with the gold standard individual AP. Group AP was noninferior to individual AP for treating cancer pain and was superior in many health outcomes. Group AP is more cost-effective for alleviating cancer pain and should be considered for implementation trials

Both “Vitamin L for Life” and “One Milligram of Satan”: A Multi-Perspective Qualitative Exploration of Adjuvant Endocrine Therapy Use after Breast Cancer

Adjuvant endocrine therapy (AET) is recommended after hormone receptor-positive breast cancer to reduce risk of recurrence, but adherence is sub-optimal in many women. Behavioral interventions have been ineffective in improving adherence rates to AET. This qualitative descriptive study investigates factors that support women in AET use and suggestions for interventions to improve AET use and management. Interviews with women who persisted with AET (n = 23), women who discontinued AET (n = 15), and healthcare providers (HCPs; oncologists, oncology residents, and pharmacists; n = 9) were conducted, transcribed, and described using thematic analysis. Data collection stopped once saturation occurred (i.e., no new codes or themes emerged during interviews). Two researchers created codes and developed themes in an iterative process; a third researcher verified the representativeness of final themes. This study was approved by the Health Research Ethics Board of Alberta (ID: HREBA.CC-17-0513). Women who persisted described being prepared for side effects and having self-management strategies, strong rationale for AET use, supportive HCPs, and available resources as relevant factors. Women who discontinued described feeling overwhelmed by side effects, information needs, drawbacks of AET, helpful/unhelpful experiences with HCPs, and contextual factors as relevant to their discontinuation. HCPs described health system-related and patient-related barriers, side effect management, and patient-provider interactions as relevant to supporting AET use. The considerable overlap in themes among the three groups suggests broad recognition of salient factors relevant to AET use and that associated strategies to improve use may be acceptable to patients and providers alike. Factors supporting AET use could include the following: education (which may be necessary but insufficient), developing a strong personal rationale for use, being prepared for side effects, having side effect management strategies, reciprocal communication between patients and HCPs, and accessible resources