A feasible and acceptable multicultural psychosocial intervention targeting symptom management in the context of advanced breast cancer.

OBJECTIVE: Advanced breast cancer patients around the world experience high symptom burden (ie, distress, pain, and fatigue) and are in need of psychosocial interventions that target symptom management. This study examined the feasibility, acceptability, and engagement of a psychosocial intervention that uses cognitive-behavioral strategies along with mindfulness and values-based activity to enhance patients' ability to manage symptoms of advanced disease in a cross-cultural setting (United States and Singapore). Pre-treatment to post-treatment outcomes for distress, pain, and fatigue were compared between intervention recipients and waitlisted controls. METHODS: A pilot randomized controlled trial included women with advanced breast cancer (N = 85) that were recruited in the United States and Singapore. Participants either received the four session intervention or be put on waitlist. Descriptive statistics and effect size of symptom change were calculated. RESULTS: The psychosocial intervention was found to be feasible as indicated through successful trial accrual, low study attrition (15% ), and high intervention adherence (77% completed all sessions). Acceptability (ie, program satisfaction and cultural sensitivity) and engagement to the study intervention (ie, practice of skills taught) were also high. Anxiety, depression, and fatigue scores remained stable or improved among intervention participants while the same symptoms worsened in the control group. In general, effect sizes are larger in the US sample compared with the Singapore sample. CONCLUSIONS: The cognitive-behavioral, mindfulness, and values-based intervention is feasible, acceptable, and engaging for advanced breast cancer patients in a cross-cultural setting and has potential for efficacy. Further larger-scaled study of intervention efficacy is warranted.

Improving symptom management for survivors of young adult cancer: rationale and study protocol for a pilot randomized controlled trial.

BACKGROUND: Young adult (YA) cancer survivors are a growing, yet underserved population who often face significant and long-lasting cancer-related physical (e.g., pain, fatigue) and emotional (e.g., psychological distress) symptoms. Post-treatment symptoms can persist, disrupting YA's abilities to complete goals consistent with their developmental stage (e.g., completing their education, achieving autonomy and independence, building their careers, establishing peer and romantic relationships, building their families). While symptom management has been identified as a significant issue in YA's transitions to survivorship, the symptom management needs of this population largely go unmet. METHODS: We developed an eight-session, group-based behavioral intervention that is delivered using videoconferencing to address the unique symptom management needs of YA cancer survivors. The intervention was developed in conjunction with YA survivors, leading to the novel combination of traditional behavioral symptom coping strategies, home-based physical activity, strategies from contemporary cognitive-behavioral approaches (e.g., those derived from acceptance and commitment therapy, strategies to foster self-compassion), concepts from meaning centered psychotherapy, and behavioral strategies to improve communication and health care engagement. Participants receive printed intervention materials and access to a study-specific mobile application, both of which are used throughout the program. Herein, we report on a pilot study that is in progress. Recruitment has been completed. YA cancer survivors were recruited in cohorts of n = 10 or n = 11 (n = 61) and randomized to the intervention or waitlist control arms. All participants completed a baseline assessment and four additional assessments over 1 year, with each involving a battery of self-report measures. DISCUSSION: The primary objective is to evaluate intervention feasibility and acceptability. As a secondary objective, we will examine patterns of change in intervention targets (i.e., pain, fatigue, emotional distress, symptom interference). Changes from baseline among intervention targets will be estimated for each patient and compared between arms using unadjusted statistical testing. Unadjusted and adjusted multilevel modeling will be used to estimate the effect of the intervention on changes in intervention targets. Interaction models will be used to compare the trajectory of change over time between arms. We expect that this pilot trial will inform our future approach to identify, recruit, and retain participants and provide preliminary data to support a larger, fully powered randomized controlled trial evaluating the intervention. TRIAL REGISTRATION: NCT04035447 at clinicaltrials.gov; registered July 29, 2019.

Improving therapist psychological flexibility while training acceptance and commitment therapy: a pilot study.

Acceptance and Commitment Therapy (ACT) training often includes experiential elements aimed at improving therapist psychological flexibility, yet the effects of ACT training on therapist psychological flexibility have yet to be evaluated. This pilot study examines the effects of experiential phone consultation as an adjunct to a standard continuing education workshop on psychological flexibility and burnout among therapists learning ACT. In this study, counselors taking a 2-day ACT workshop were randomly assigned to either six 30-min phone consultation sessions (n = 10) or no additional contact (n = 10). The results show that those in the consultation condition reported higher psychological flexibility at the 3-month follow-up compared to the workshop-only condition. Improvements in ACT knowledge, overall burnout, and personal accomplishment were found in both groups, independent of whether they received phone consultation, and this increase was maintained over time. In conclusion, ACT phone consultation contributed to counselor psychological flexibility above the workshop alone and appears to be feasible as a means to improve counselor psychological flexibility.

Improving Symptom Management for Survivors of Young Adult Cancer: Development of a Novel Intervention.

Purpose: Improved symptom management is a critical although unmet post-treatment need for young adult (YA) cancer survivors (aged 18-39 at diagnosis). This study aimed to develop and refine a behavioral symptom management intervention for YA survivors. Methods: Phase I: YA survivors (N = 21) and oncology providers (N = 11) completed individual interviews and an online, self-report assessment to examine symptom experiences, the need for a behavioral symptom management intervention for YAs, and perceptions about potential intervention components, structure, and format. Phase II: YA survivors (N = 10) completed user testing sessions, providing feedback on the prototype intervention materials (paper manual and mobile application), and completed an online assessment. Quantitative data were examined using descriptive statistics. Rapid qualitative analysis, a methodologically rigorous standardized approach, was used. Results: Pain, fatigue, and distress were ranked as top concerns by most YAs and providers. Phase I interviews underscored the need for a symptom management intervention for YAs. YAs and providers highlighted potential coping strategies and program format/structure suggestions (e.g., small group format) to best meet YAs' needs. A prototype intervention was developed combining the following: traditional behavioral symptom coping skills; home-based physical activity; strategies from Acceptance and Commitment Therapy and Meaning-Centered Psychotherapy; and strategies to foster self-compassion. Phase II user testing sessions highlighted strengths and suggestions for refining the prototype materials. Conclusion: Post-treatment symptoms are common for YAs. A tailored behavioral symptom management program was developed and refined with input from YAs and providers and will be examined for feasibility and acceptability in a pilot randomized controlled trial. Clinical Trial: Clinicaltrials.gov identifier NCT04035447.

An international consensus definition for contextual factors: findings from a nominal group technique.

Objective: Emerging literature suggests contextual factors are important components of therapeutic encounters and may substantially influence clinical outcomes of a treatment intervention. At present, a single consensus definition of contextual factors, which is universal across all health-related conditions is lacking. The objective of this study was to create a consensus definition of contextual factors to better refine this concept for clinicians and researchers. Design: The study used a multi-stage virtual Nominal Group Technique (vNGT) to create and rank contextual factor definitions. Nominal group techniques are a form of consensus-based research, and are beneficial for identifying problems, exploring solutions and establishing priorities. Setting: International. Main outcome measures: The initial stages of the vNGT resulted in the creation of 14 independent contextual factor definitions. After a prolonged discussion period, the initial definitions were heavily modified, and 12 final definitions were rank ordered by the vNGT participants from first to last. Participants: The 10 international vNGT participants had a variety of clinical backgrounds and research specializations and were all specialists in contextual factors research. Results: A sixth round was used to identify a final consensus, which reflected the complexity of contextual factors and included three primary domains: (1) an overall definition; (2) qualifiers that serve as examples of the key areas of the definition; and (3) how contextual factors may influence clinical outcomes. Conclusion: Our consensus definition of contextual factors seeks to improve the understanding and communication between clinicians and researchers. These are especially important in recognizing their potential role in moderating and/or mediating clinical outcomes.