The purpose of this 21-day assessor blinded, randomized-controlled trial was to compare an open-label placebo (OLP) to treatment as usual (TAU) for cancer survivors with fatigue. This was followed by an exploratory 21-day study in which TAU participants received OLPs while OLP participants in the main study were followed after discontinuing placebos. Cancer survivors (N = 74) who completed cancer treatment 6 months to 10 years prior to enrollment reporting at least moderate fatigue (i.e., ≥4 on a 0–10 scale) were randomized to OLP or TAU. Those randomized to OLP took 2 placebo pills twice a day for 21 days. Compared to those randomized to TAU, OLP participants reported a 29% improvement in fatigue severity (average difference in the mean change scores (MD) 12.47, 95% CI 3.32, 21.61; P = 0.008), medium effect (d = 0.63), and a 39% improvement in fatigue-disrupted quality of life (MD = 11.76, 95% CI 4.65, 18.86; P = 0.002), a large effect (d = 0.76). TAU participants who elected to try OLP for 21-days after the main study reported reductions in fatigue of a similar magnitude for fatigue severity and fatigue-disrupted quality of life (23% and 35%, respectively). OLP may reduce fatigue symptom severity and fatigue-related quality of life disruption in cancer survivors.

Scalable, effective interventions are needed to address poor diet, insufficient physical activity, and obesity amongst rising numbers of cancer survivors. Interventions targeting survivors and their friends and family may promote both tertiary and primary prevention. The design, rationale, and enrollment of an ongoing randomized controlled trial (RCT) (NCT04132219) to test a web-based lifestyle intervention for cancer survivors and their supportive partners are described, along with the characteristics of the sample recruited. This two-arm, single-blinded RCT randomly assigns 56 dyads (cancer survivor and partner, both with obesity, poor diets, and physical inactivity) to the six-month DUET intervention vs. wait-list control. Intervention delivery and assessment are remotely performed with 0–6 month, between-arm tests comparing body weight status (primary outcome), and secondary outcomes (waist circumference, health indices, and biomarkers of glucose homeostasis, lipid regulation and inflammation). Despite COVID-19, targeted accrual was achieved within 9 months. Not having Internet access was a rare exclusion (<2%). Inability to identify a support partner precluded enrollment of 42% of interested/eligible survivors. The enrolled sample is diverse: ages 23–81 and 38% racial/ethnic minorities. Results support the accessibility and appeal of web-based lifestyle interventions for cancer survivors, though some cancer survivors struggled to enlist support partners and may require alternative strategies.

(1) Background: Anthropometric and physical performance testing is commonly done in lifestyle research and is traditionally performed in-person. To expand the scalability of lifestyle interventions among cancer survivors, in-person assessments were adapted to remote means and evaluated for feasibility, safety, validity, and reliability. (2) Methods: Cancer survivors and supportive partners were approached to participate in three anthropometric and physical performance testing sessions (two remote/one in-person). Correlations, concordance, and differences between testing modes were evaluated. (3) Results: 110-of-112 individuals approached for testing participated (98% uptake); the sample was 78% female, 64% non-Hispanic White, of mean age 58 years and body mass index = 32.4 kg/m2. ICCs for remote assessments ranged from moderate (8’ walk = 0.47), to strong (8’ get-up-and-go = 0.74), to very strong (30 s chair stand = 0.80; sit-and-reach = 0.86; 2 min step test = 0.87; back scratch = 0.90; weight = 0.93; waist circumference = 0.98) (p-values < 0.001). Perfect concordance (100%) was found for side-by-side and semi-tandem balance, and 87.5–90.3% for tandem balance. No significant differences between remote and in-person assessments were found for weight, 8’ walk, and 8’ get-up-and-go. No adverse events occurred and 75% indicated no preference or preferred virtual testing to in-person. (4) Conclusions: Remote anthropometric and physical performance assessments are reliable, valid, acceptable, and safe among cancer survivors and supportive partners.

Research participants randomized to placebo-control conditions often report improved outcomes and can manifest physiologic responses that mirror those of participants who received the bioactive compound. Recent studies show that placebos can have beneficial effects even when the individual is aware that he/she is receiving a placebo, suggesting that the therapeutic context in which a placebo is delivered can be powerful. This context includes environmental and psychosocial factors, such as information disclosure, expectations, conditioning and empathy, embedded within research and clinical encounters that may influence outcomes. In this article, we review these placebo-related factors (PRFs), consider how they may influence the results typically attributed to diet and lifestyle interventions, and offer suggestions on enhancing PRFs in clinical obesity settings.

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