Development of mini-SSPedi for children 4-7 years of age receiving cancer treatments.

BACKGROUND: The Symptom Screening in Pediatrics Tool (SSPedi) is valid for assessing symptoms in children aged 8-18 years receiving cancer treatments. The objective was to develop a new self-report symptom screening tool for children receiving cancer treatments who are 4-7 years of age (mini-SSPedi), based on SSPedi. METHODS: Respondents were children with cancer or pediatric hematopoietic stem cell transplantation (HSCT) recipients who were 4-7 years of age. We included the same 15 symptoms contained in SSPedi. Using cognitive interviewing, we developed mini-SSPedi in three phases and made decisions based upon respondent understanding. First, we developed questionnaire structure regarding recall period, concept of bother and response option format. Second, we determined wording of each symptom. Third, we evaluated the entire mini-SSPedi instrument for understanding and ease of completion. RESULTS: We enrolled 100 participants in total and included 30, 40 and 30 in each of the three phases. Questionnaire structure was satisfactory with a recall period of "today" and a faces-based 3-point Likert scale. Bother was well-understood. Five symptoms required modification to achieve satisfactory understanding while the remaining 10 SSPedi symptoms did not require modification. Among the last 10 children enrolled, all understood each mini-SSPedi item and none thought mini-SSPedi was hard to complete. CONCLUSION: We developed a symptom screening tool for children with cancer and pediatric HSCT recipients between 4 and 7 years of age that is understandable and easy to complete. Future work will evaluate the psychometric properties of mini-SSPedi and develop an electronic version of the instrument.

Severity, change over time, and risk factors of anxiety in children with cancer depend on anxiety instrument used.

OBJECTIVE: The primary objective was to describe severity of anxiety among children and adolescents receiving chemotherapy for cancer or undergoing hematopoietic stem cell transplantation (HSCT). Secondary objectives were to describe how anxiety changes over time and determine factors associated with anxiety. METHODS: Participants were aged 8 to 18 and either receiving chemotherapy for cancer or undergoing HSCT for any indication. Respondents self-reported three anxiety measurement instruments at chemotherapy cycle or HSCT conditioning start and 3 weeks later. RESULTS: The proportion of participants with severe anxiety ranged from 10/77 (13.0%) to 22/77 (28.6%) depending on instrument used. Change over time also varied across instruments, with significant improvement observed with PedsQL (procedural) (P = 0.037) and PROMIS (P = 0.013). Factors associated with anxiety similarly varied by instrument. Older age was associated with more anxiety on the PedsQL (worry) (P = 0.036), and higher household income was associated with less anxiety on the MASC-10 (P = 0.028). CONCLUSIONS: While we found that a small proportion of patients met or exceeded thresholds for severe anxiety, we also noted that severity, change over time, and predictors of anxiety varied depending on instrument used. Future research should ensure that selected instruments measure the construct of interest and describe how anxiety is conceptualized in the study.

A feasibility study examining the impact of yoga on psychosocial health and symptoms in pediatric outpatients receiving chemotherapy.

PURPOSE: Pediatric cancer patients experience symptoms that negatively impact quality of life; yoga may be an effective intervention. The primary objective was to determine the feasibility of a 10-week, weekly individualized yoga intervention for children and adolescents receiving outpatient cancer therapy primarily delivered remotely using Skype. Secondary objectives were to describe depression, anxiety, anger, fatigue, quality of life, and symptoms at 5 and 10 weeks after enrollment. METHODS: We included English-speaking patients aged 10 to 18 years receiving outpatient chemotherapy for cancer. Weekly individualized yoga sessions were offered for 10 weeks. Weeks 1, 5, and 10 were in-hospital while the remaining sessions were delivered remotely using Skype. Twice weekly, homework was assigned between each session. The primary outcome was feasibility, defined as 80% of participants completing at least 60% of planned in-hospital or remote yoga sessions. RESULTS: Between March and November 2017, 10 patients were enrolled. Two patients discontinued the study after one and two sessions. Only six participants achieved at least 60% of planned yoga sessions and thus, the study did not meet the a priori defined feasibility threshold. Among all participants, only one homework session was performed. CONCLUSIONS: A 10-week individualized in-person and remotely conducted yoga intervention was not feasible in children receiving cancer treatments because of failure to achieve the desired frequency of yoga sessions in a sufficient number of participants. Future research should identify approaches to improve compliance with remote yoga sessions and home practice. TRIAL REGISTRATION: NCT03318068.

Challenges of Implementing Multicenter Studies of Yoga for Pediatric Cancer and Hematopoietic Stem Cell Transplantation Recipients.

The primary objective of this work was to determine the feasibility of a randomized trial of individualized yoga for children receiving intensive chemotherapy and for hematopoietic stem cell transplantation (HSCT) recipients outside of the principal coordinating institution. We evaluated the feasibility of a randomized trial of individualized yoga versus an iPad control program at a site where external yoga instructors were hired and compensated per session. Subjects were children receiving intensive chemotherapy for hematological malignancies and autologous or allogeneic HSCT recipients expected to be hospitalized for 3 weeks. Yoga or iPad control contact occurred daily for 21 days (excluding weekends and holidays); fatigue and quality-of-life outcomes were measured at baseline, day 10, and day 21. Ten eligible subjects were identified; six subjects consented and were enrolled. Three were randomized to the individualized yoga intervention and three to the iPad control program. The median age of participants was 12 (range 8-15) years, and 2 (33%) were boys. Challenges primarily related to the hiring of yoga instructors who were not trained in research methods. We found issues with: (1) logistics of hiring, training, and retaining instructors; (2) communication between teams; (3) fidelity to the protocol and outcome assessments; and (4) ensuring safety. We found that a randomized trial of individualized yoga presented new challenges when relying on externally contracted yoga instructors. Future multicenter studies of yoga should seek to better integrate practitioners within the research team to improve processes, communication, fidelity to the protocol, and safety.