Optimization of mHealth behavioral interventions for patients with chronic lymphocytic leukemia: the HEALTH4CLL study.

PURPOSE: This pilot study of a diet and physical activity intervention (HEALTH4CLL) was conducted to reduce fatigue and improve physical function (PF) in patients with chronic lymphocytic leukemia (CLL). METHODS: The HEALTH4CLL study used a randomized factorial design based on the multiphase optimization strategy (MOST). Patients received diet, exercise, and body weight management instructional materials plus a Fitbit and were randomized to undergo one of 16 combinations of 4 evidence-based mHealth intervention strategies over 16 weeks. Patients' fatigue, PF, health-related quality of life, behavior changes, and program satisfaction and retention were assessed. Paired t-tests were used to examine changes in outcomes from baseline to follow-up among patients. Factorial analysis of variance examined effective intervention components and their combinations regarding improvement in fatigue and PF scores. RESULTS: Among 31 patients, we observed significant improvements in fatigue (+ 11.8; t = 4.08, p = 0.001) and PF (+ 2.6; t = 2.75, p = 0.01) scores. The combination of resistance and aerobic exercise with daily self-monitoring was associated with improved fatigue scores (ß = 3.857, SE = 1.617, p = 0.027). Analysis of the individual components of the MOST design demonstrated greater improvement in the PF score with resistance plus aerobic exercise than with aerobic exercise alone (ß = 2.257, SE = 1.071, p = 0.048). CONCLUSIONS: Combined aerobic and resistance exercise and daily self-monitoring improved PF and reduced fatigue in patients with CLL. IMPLICATIONS FOR CANCER SURVIVORS: This pilot study supported the feasibility of a low-touch mHealth intervention for survivors of CLL and provided preliminary evidence that exercising, particularly resistance exercise, can improve their symptoms and quality of life.

Relationships between T-lymphocytes and physical function in adults with chronic lymphocytic leukemia: Results from the HEALTH4CLL pilot study.

OBJECTIVE: Examine physical function and T-cell phenotype in patients with chronic lymphocytic leukemia (CLL) before and after a physical activity (PA) intervention. METHODS: Physical function measures and blood samples were collected from CLL patients (Rai stage 0-4, 50% receiving targeted therapy, N = 24) enrolled in a 16-week intervention of at-home aerobic and/or resistance exercise. Flow cytometry characterized T-cells in cryopreserved peripheral blood cells. Wilcoxon signed-rank test compared physical function and T-cell phenotype at baseline and 16-weeks; Kendall's Tau assessed associations between variables. RESULTS: Godin leisure-time PA score increased from baseline to 16-weeks (mean difference: 14.61, p < .01) and fatigue decreased (mean difference: 6.71, p < .001). At baseline, lower fatigue correlated with a lower proportion of CD8+ T-cells (τ = 0.32, p = .03) and cardiorespiratory fitness (CRF) inversely correlated with the percentage of PD-1+CD8+ T-cells (τ -0.31, p = .03). At 16-weeks, CRF inversely correlated with the proportion of PD-1+CD4+ T-cells (τ -0.34, p = .02). Reduced fatigue at 16-weeks correlated with an increased CD4:CD8 ratio (τ = 0.36, p = .02) and lower percentage of HLA-DR+PD-1+CD4+ T-cells (τ = -0.37, p = .01). CONCLUSIONS: This intervention increased leisure-time PA and decreased fatigue in CLL patients. These changes correlated with an increased CD4:CD8 T-cell ratio and reduced proportion of T-cells subsets previously associated with poor outcomes in CLL patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02194387.

Optimization of an mHealth lifestyle intervention for families with hereditary cancer syndromes: Study protocol for a multiphase optimization strategy feasibility study.

BACKGROUND: Individuals at increased hereditary risk of cancer are an important target for health promotion and cancer prevention interventions. Health-4-Families uses the Multiphase Optimization STrategy (MOST) framework and is designed to pilot digital delivery strategies for a distance-based, 16-week intervention to promote weight management, healthy diet, and increased physical activity among individuals with BRCA1/BRCA2 or DNA mismatch repair (MMR) pathogenic germline variants. This communication describes participant recruitment and the design of the Health-4-Families pilot study. METHODS: Health-4-Families is a full-factorial (16 condition) randomized pilot study of four lifestyle intervention components: social networking, telephone or email coaching, text messaging, and self-monitoring. The primary outcome was feasibility and satisfaction with these study components. Participants with pathogenic germline variants were identified via clinic surveillance lists and advocacy organizations and were invited to participate with family members. All participants had to report meeting at least one of the following criteria: (1) having a BMI ≥ 25 kg/m2, (2) consuming <5 servings of fruit and vegetables per day, or (3) getting <150 min of moderate-to-vigorous intensity activity per week. RESULTS: The majority of screened potential participants with pathogenic variants (83%) were eligible; 86% of those eligible provided informed consent and 79% (n = 104) completed baseline. A total of 206 family members were nominated by study participants and 49% (n = 102) completed baseline. DISCUSSION: Recruitment data suggest that individuals with pathogenic germline variants, who are at increased risk for hereditary cancers, are motivated to participate in digital lifestyle interventions. This recruitment success highlights the importance of identifying and prioritizing effective and efficient intervention components for hereditary cancer families. We intend to use the outcomes of our pilot study to inform a fully-powered factorial study for this community.