Efficacy of expressive helping in adult hematologic cancer patients undergoing stem cell transplant: : Protocol for the Writing for Insight, Strength, and Ease (WISE) study’s two-arm randomized controlled trial

Funding Information: This study was supported by the National Cancer Institute of the National Institutes of Health under award number R01CA223963. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The funding body had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Publisher Copyright: © 2021, The Author(s).Background: During, shortly after, and sometimes for years after hematopoietic stem cell transplant, a large proportion of hematological cancer patients undergoing transplant report significant physical and psychological symptoms and reduced health-related quality of life. To address these survivorship problems, we developed a low-burden, brief psychological intervention called expressive helping that includes two theory- and evidence-based components designed to work together synergistically: emotionally expressive writing and peer support writing. Building on evidence from a prior randomized control trial showing reductions in physical symptoms and distress in long-term transplant survivors with persistent survivorship problems, the Writing for Insight, Strength, and Ease (WISE) trial will evaluate the efficacy of expressive helping when used during transplant and in the early post-transplant period, when symptoms peak, and when intervention could prevent development of persistent symptoms. Methods: WISE is a multi-site, two-arm randomized controlled efficacy trial. Adult hematological cancer patients scheduled for a hematopoietic stem cell transplant will complete baseline measures and then, after hospitalization but prior to transplant, they will be randomized to complete either expressive helping or a time and attention “neutral writing” task. Both expressive helping and neutral writing involve four brief writing sessions, beginning immediately after randomization and ending approximately 4 weeks after hospital discharge. Measures of symptom burden (primary outcome), distress, health-related quality of life, and fatigue (secondary outcomes) will be administered in seven assessments coinciding with medically relevant time points from baseline and to a year post-intervention. Discussion: The steady and continuing increase in use of stem cell transplantation has created growing need for efficacious, accessible interventions to reduce the short- and long-term negative physical and psychosocial effects of this challenging but potentially life-saving treatment. Expressive helping is a psychological intervention that was designed to fill this gap. It has been shown to be efficacious in long-term transplant survivors but could have even greater impact if it is capable of reducing symptoms during and soon after transplant. The WISE study will evaluate these benefits in a rigorous randomized controlled trial. Trial registration: Clinicaltrial.govNCT03800758. Registered January 11, 2019Peer reviewe

The Effect of Systematic Light Exposure on Sleep in a Mixed Group of Fatigued Cancer Survivors.

STUDY OBJECTIVES:Sleep disturbances are commonly reported by cancer survivors. Systematic light exposure using bright light has been used to improve sleep in other populations. In this secondary data analysis, the effect of morning administration of bright light on sleep and sleep quality was examined in a mixed group of fatigued cancer survivors. METHODS:Forty-four cancer survivors screened for cancer-related fatigue were randomized to either a bright white light or a comparison dim red light condition. Participants were instructed to use a light box every morning for 30 minutes for 4 weeks. Wrist actigraphy and the Pittsburgh Sleep Quality Index were administered at 4 time points: prior to light treatment (baseline), 2 weeks into the intervention, during the last week of the intervention, and 3 weeks postintervention. Thirty-seven participants completed the end-of-intervention assessment. RESULTS:Repeated-measures linear mixed models indicated a statistically significant time × treatment group interaction effect with sleep efficiency improving more in the bright light condition over time compared with the dim light condition (F3,42 = 5.55; P = .003) with a large effect size (partial η2 = 0.28). By the end of the intervention and 3 weeks postintervention, mean sleep efficiency in the bright light group was in the normal range. Medium to large effect sizes were also seen in sleep quality, total sleep time, and wake after sleep onset for participants favoring the bright light condition. CONCLUSIONS:The results suggest that systematic bright light exposure in the morning may have beneficial effects on sleep in fatigued cancer survivors. Larger scale efficacy trials are warranted. CLINICAL TRIAL REGISTRATION:Registry: ClinicalTrials.gov, Title: Treating Cancer-Related Fatigue Through Systematic Light Exposure, Identifier: NCT01873794, URL: https://clinicaltrials.gov/ct2/show/NCT01873794

Feasibility and Preliminary Efficacy of a Bright Light Intervention in Ovarian and Endometrial Cancer Survivors

Cancer-related sleep disturbance is common and can adversely affect physical and mental health. Bright light (BL) therapy is a novel intervention that targets sleep by promoting circadian regulation. Emerging evidence suggests BL can improve sleep disturbance, symptom burden, and health-related quality of life in cancer and other populations; however, this research is limited. The present two-phase pilot study assessed the feasibility and preliminary intended effects of BL therapy on sleep in ovarian and endometrial cancer survivors, and explored biologic and chronobiologic factors that may underlie intervention effects. In phase I, focus groups were conducted with 12 survivors and 9 gynecologic oncology clinicians to evaluate and gather feedback about the proposed study. In phase II, a pilot randomized controlled trial was conducted with 18 ovarian or endometrial cancer survivors who were randomized 1:1 to receive 45 min of BL or dim light (DL) for 4 weeks. Participants wore wrist actigraphs; completed sleep diaries and self-report questionnaires; and provided blood, saliva, and urine samples at baseline (T1), post-intervention (T2), and 3-month follow-up (T3). Study procedures were modified according to focus group results. Enrollment, retention, and adherence were all ≥ 80%. Mixed-model ANOVAs demonstrated that the number of nighttime awakenings per actigraphy, and sleep quality and depression per self-report, trended toward improvements in the BL condition compared to the DL condition. These variables improved from T1 to T2 before returning to baseline at T3. Effect sizes were generally medium to large. Study findings suggest that BL therapy is feasible among ovarian and endometrial cancer survivors. It may be an effective, non-pharmacological approach to reduce sleep disturbance and symptom burden in this population

Supplemental material for Examining the Efficacy of Bright Light Therapy on Cognitive Function in Hematopoietic Stem Cell Transplant Survivors

Supplemental material, sj-pdf-1-jbr-10.1177_07487304221107833 for Examining the Efficacy of Bright Light Therapy on Cognitive Function in Hematopoietic Stem Cell Transplant Survivors by Lisa M. Wu, Heiddis B. Valdimarsdottir, Ali Amidi, Kathryn J. Reid, Sonia Ancoli-Israel, Katrin Bovbjerg, Rina S. Fox, Lauren Walker, Amreen Matharu, Erin T. Kaseda, John P. Galvin, Kehinde Adekola, Gary Winkel, Frank Penedo and William H. Redd in Journal of Biological Rhythm

Examining the Efficacy of Bright Light Therapy on Cognitive Function in Hematopoietic Stem Cell Transplant Survivors

Patients who have undergone hematopoietic stem cell transplant (HSCT) may experience cognitive impairment that can persist after treatment. Several studies have shown that bright light therapy may improve cognition, potentially due to its effects on the circadian system via brain regions that respond preferentially to light. In this double-blind randomized controlled trial, the efficacy of bright light therapy on cognition was examined in HSCT survivors. Forty-seven HSCT survivors at an urban hospital in the United States were screened for mild cognitive impairment, randomized to either bright white light (BWL) or comparison dim red light (DRL) conditions using a block randomization approach, and instructed to use their assigned light box every morning upon awakening for 30 min for 4 weeks. Assessments occurred at baseline, the end of the second week of the intervention, the end of the intervention, and at follow-up (8 weeks later). The primary outcome was objective cognitive function as measured by a global composite score on neuropsychological tests. Secondary outcomes included cognitive performance in individual domains, self-reported cognitive function, fatigue, sleep and sleep quality, and circadian rhythm robustness. Repeated-measures linear mixed models for both objective and self-reported cognitive function indicated significant main effects for time (ps < 0.05) suggesting significant improvements in both conditions over time. Time by light condition interaction effects were not significant. Models focused on secondary outcomes yielded no significant effects. Both BWL and DRL groups demonstrated significant improvements in objective cognitive and self-reported cognitive function over time, but there was no hypothesized effect of BWL over DRL nor associations with circadian rhythm robustness. Therapeutic effects of both light conditions, practice effects, and/or placebo effects may account for the findings.Trial registration: ClinicalTrials.gov Identifier: NCT02677987 (9 February 2016)