RESUMO
(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.
RESUMO
Previous studies have identified catechol-O-methyltransferase (COMT), as a key enzyme influencing sympathetic function. Although the COMT SNP rs4680 and rs4818, are well-studied, little is known about their influence on cancer-related fatigue (CrF) and placebo response. In this study, we examined whether genetic variation in COMT, at the functional SNP rs4680 and linked rs4818, influenced open-label placebo (OLP) responses found in cancer survivors reporting moderate to severe CrF. We randomized cancer survivors (N = 74) reporting moderate-to-severe CrF to receive OLP or to treatment-as-usual (TAU) and assessed if rs4680 and rs4818 were associated with changes in fatigue severity and fatigue-distressed quality of life. At the end of the initial 21 days, the treatments were crossed over and both groups were re-assessed. Participants with the rs4680 high-activity G-allele (G/G or G/A) or rs4818 C/G genotypes reported significant decreases in fatigue severity and improvements in fatigue-distressed quality of life. The COMT rs4818 findings replicated findings in a similar study of OLP in cancer fatigue. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT02522988.
RESUMO
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.