Telephone-Based Rehabilitation Intervention to Optimize Activity Participation After Breast Cancer: A Randomized Clinical Trial.

Importance: Following treatment, breast cancer survivors face challenges participating in valued activities. Objective: To determine whether a telephone-based coaching rehabilitation intervention enhances activity participation in the year following breast cancer treatment. Design, Setting, and Participants: In this multisite, single-blind randomized clinical trial (Optimizing Functional Recovery of Breast Cancer Survivors), recruitment occurred between August 28, 2019, and April 30, 2022. Data collection was completed by April 1, 2023. Participants were recruited from 2 cancer centers (Dartmouth College and the University of Alabama at Birmingham) and via social media advertisements. Women aged 18 years or older who had completed primary treatment for stage I to III breast cancer within 1 year and reported participation restrictions were eligible to participate. Randomization was stratified by site, treatment, and time since treatment. Interventions: The intervention, delivered via telephone over 9 sessions, used behavioral activation and problem-solving principles to promote activity participation. The education-based attention control condition was delivered via telephone at matched intervals. Main Outcomes and Measures: The primary outcome was participation, assessed using 5 measures, including Patient-Reported Outcomes Measurement Information System (PROMIS) social participation-satisfaction measure. One individualized outcome allowed participants to specify activities for which they wanted to foster recovery. Outcomes were collected by telephone by blinded coordinators at baseline and at 8, 20, and 44 weeks. The individualized outcome was assessed at the first and last intervention and control session. Results: Among 1996 patients identified, 303 were eligible and enrolled. Of these, 284 women (94%; mean [SD] age, 56.1 [10.2] years) completed baseline assessments and were randomized, and 81% or more of each group completed the final assessment with no adverse events. Of those who completed the final assessment, 118 of 114 (82%) were in the intervention group, and 113 of 140 (81%) were attention control participants. Between-group differences were not statistically significant for the main measures of PROMIS satisfaction (week 20: Cohen d, 0.1 [95% CI, -0.09 to 0.29] and week 44: Cohen d, -0.08 [95% CI, -0.27 to 0.11]) and ability (week 20: Cohen d, 0.15 [95% CI, -0.06 to 0.37] and week 44: Cohen d, -0.08 [95% CI, -0.27 to 0.11]). On the individualized outcome, intervention participants reported significantly greater improvements in activity satisfaction (Cohen d, 0.76 [95% CI, 0.48-1.02]) and performance (Cohen d, 0.60 [95% CI, 0.32-0.87]). Conclusions and Relevance: In this randomized clinical trial, the intervention catalyzed greater improvements in self-selected activity participation and goal disengagement but did not otherwise accelerate recovery compared with the control condition. Future research should determine what intervention features may lead to the greatest reductions in participation restrictions and other measures that may detect functional recovery. Trial Registration: ClinicalTrials.gov Identifier: NCT03915548.

Strategies to support cancer survivors at work: content analysis of cancer survivor, healthcare provider, and employer perspectives.

PURPOSE: To (1) describe the challenges identified by cancer survivors, healthcare providers, and employers related to work maintenance and optimization during and after cancer treatment and (2) identify strategies that can address those challenges. METHODS: We conducted content analysis of semi-structured interview data collected from cancer survivors, healthcare providers, and employers regarding workplace challenges that cancer survivors face and strategies to address them. Challenges and strategies were summarized according to whether they related to the cancer survivor, the work demands, or the work environment. RESULTS: Forty-five total participants identified challenges and strategies primarily related to the cancer survivor's signs and symptoms of treatment. Healthcare providers (n = 17) focused primarily on challenges and strategies related to the cancer survivor, while employers (n = 5) focused on the work environment-especially policies and procedures that facilitate time off work and the importance of bidirectional communication between cancer survivors and employers. Cancer survivors (n = 23) identified challenges and suggestions in all three categories, though they uniquely focused on challenges relating to work demands and adjustments to those demands that would facilitate employment maintenance. CONCLUSIONS: Efforts to address the many challenges that cancer survivors experience at work should include the views of cancer survivors, healthcare providers, and employers reflecting their respective domains of expertise in work demands, cancer survivors' medical care, and the work environment. IMPLICATIONS FOR CANCER SURVIVORS: Survivors and healthcare providers are able to address many side effects that can create work challenges, but improved collaboration between survivors and employers may identify ways to modify work demands and environments to maximize employment maintenance.

A Process Evaluation of Intervention Delivery for a Cancer Survivorship Rehabilitation Clinical Trial Conducted during the COVID-19 Pandemic.

The purpose of the present study was to conduct a process evaluation of intervention delivery for a randomized controlled trial (RCT) conducted during the COVID-19 pandemic (NCT03915548). The RCT tested the effects of a telephone-delivered behavioral intervention on changes in breast cancer survivors' satisfaction with social roles and activities, as compared to an attention control condition. This process evaluation examined (a) fidelity monitoring scores; (b) participants' perceived benefit ratings for gaining confidence, reducing distress, adjusting habits and routines, setting goals, and increasing exercise; and (c) field notes, email communications, and transcripts of coach supervision and debriefing sessions. The behavioral and attention control conditions were delivered with a high degree of fidelity (global quality rating score for the BA/PS condition was M = 4.6 (SD = 0.6) and M = 4.9 (SD = 0.3) for the attention control condition, where "5" is the highest rating). The behavioral intervention participants perceived greater benefits than the control participants pertaining to goal setting, t(248) = 5.73, p = <0.0001, adjusting habits and routines, t(248) = 2.94, p = 0.0036, and increasing exercise, t(248) = 4.66, p = <0.0001. Moreover, coaches' perceptions regarding the behavioral intervention's therapeutic aspects aligned with the study's a priori conceptual model including the use of a structured process to set small, observable goals and facilitate the independent use of problem-solving skills. However, coaches also noted that aspects of the attention control condition, including the perceived relevance of the educational content and opportunities for social support, may have made it more therapeutically potent than intended. The pandemic may have affected the activity goals behavioral intervention participants could set as well as augmented the relevancy of social support provided in both conditions.

Enhancing Efficiency and Reach Using Facebook to Recruit Breast Cancer Survivors for a Telephone-Based Supportive Care Randomized Trial During the COVID-19 Pandemic.

PURPOSE: Evidence supporting social media-based recruitment of cancer survivors is limited. This paper describes how we used Facebook during the COVID-19 pandemic to augment our recruitment of breast cancer survivors for our two-site telephone-based randomized clinical trial (RCT) at Dartmouth-Hitchcock Medical Center and the University of Alabama at Birmingham. METHODS: Originally a two-site RCT of a telephone-delivered breast cancer survivorship intervention, we extended our clinic-based recruitment to Facebook. Participant characteristics, geographic reach, and baseline outcomes were compared across recruitment sources (ie, two clinics and Facebook) using descriptive statistics and effect sizes. RESULTS: Enrollment rates (20%-29%) were comparable across recruitment sources. The 21-month Facebook marketing campaign accounted for 59% (n = 179/303) of our total sample and had the greatest geographic reach, recruiting women from 24 states. The Facebook campaign reached a total of 51,787 unique individuals and cost $88.44 in US dollars (USD) per enrolled participant. Clinic samples had a greater proportion of women who were widowed (8% v 1%; P = .03) and Facebook had a higher proportion of women with a household income over $40,000 USD (83% v 71%; P = .02). There were no statistically significant differences between Facebook and the two clinics on baseline survey scores. CONCLUSION: Augmenting traditional recruitment with Facebook increased our RCT's geographic and sociodemographic reach and supported meeting recruitment goals in a timely way. In the wake of the COVID-19 pandemic, cancer survivorship researchers should consider using social media as a recruitment strategy while weighing the advantages and potential biases introduced through such strategies.

Exploring Acceptability of Employment Interventions to Support People Living With Cancer: Qualitative Study of Cancer Survivors, Health Care Providers, and Employers.

BACKGROUND: Employment contributes to cancer survivors' quality of life, but this population faces a variety of challenges when working during and after treatment. Factors associated with work outcomes among cancer survivors include disease and treatment status, work environment, and social support. While effective employment interventions have been developed in other clinical contexts, existing interventions have demonstrated inconsistent effectiveness in supporting cancer survivors at work. We conducted this study as a preliminary step toward program development for employment support among survivors at a rural comprehensive cancer center. OBJECTIVE: We aimed (1) to identify supports and resources that stakeholders (cancer survivors, health care providers, and employers) suggest may help cancer survivors to maintain employment and (2) to describe stakeholders' views on the advantages and disadvantages of intervention delivery models that incorporate those supports and resources. METHODS: We conducted a descriptive study collecting qualitative data from individual interviews and focus groups. Participants included adult cancer survivors, health care providers, and employers living or working in the Vermont-New Hampshire catchment area of the Dartmouth Cancer Center in Lebanon, New Hampshire. We grouped interview participants' recommended supports and resources into 4 intervention delivery models, which ranged on a continuum from less to more intensive to deliver. We then asked focus group participants to discuss the advantages and disadvantages of each of the 4 delivery models. RESULTS: Interview participants (n=45) included 23 cancer survivors, 17 health care providers, and 5 employers. Focus group participants (n=12) included 6 cancer survivors, 4 health care providers, and 2 employers. The four delivery models were (1) provision of educational materials, (2) individual consultation with cancer survivors, (3) joint consultation with both cancer survivors and their employers, and (4) peer support or advisory groups. Each participant type acknowledged the value of providing educational materials, which could be crafted to improve accommodation-related interactions between survivors and employers. Participants saw usefulness in individual consultation but expressed concern about the costs of program delivery and potential mismatches between consultant recommendations and the limits of what employers can provide. For joint consultation, employers liked being part of the solution and the possibility of enhanced communication. Potential drawbacks included additional logistical burden and its perceived generalizability to all types of workers and workplaces. Survivors and health care providers viewed the efficiency and potency of peer support as benefits of a peer advisory group but acknowledged the sensitivity of financial topics as a possible disadvantage of addressing work challenges in a group setting. CONCLUSIONS: The 3 participant groups identified both common and unique advantages and disadvantages of the 4 delivery models, reflecting varied barriers and facilitators to their potential implementation in practice. Theory-driven strategies to address implementation barriers should play a central role in further intervention development.

Linking social and built environmental factors to leisure-time physical activity in rural cancer survivors.

BACKGROUND: This study explored associations between social and built environmental factors and leisure-time physical activity (LTPA) in rural cancer survivors (RCS) and whether these associations differed by exercise stage of change (SOC). METHOD: RCS (n = 219) completed questionnaires assessing LTPA, SOC, and social (social status, connectedness, support) and environmental (home environment, neighborhood environment) factors. Linear regression models examined associations between social and built environmental factors and LTPA and tested for moderation by SOC. RESULTS: Half (50.7%) of RCS were physically active, and 49.3% were not active. Social factors positively associated with LTPA included subjective social status in the community (B = 89.0, P = .014) and in the United States (B = 181.3, P < .001), social connectedness (B = 122.3, P = .024), and social support for physical activity from family (B = 41.9, P < .001) and friends (B = 44.3, P < .001). Environmental factors positively associated with LTPA included the home environment (B = 111.2, P < .001), perceived environmental support for PA (B = 355.4, P = .004), and neighborhood attributes, including bicycling infrastructure (B = 191.3, P = .003), proximity to recreation facilities (B = 140.1, P = .021), traffic safety (B = 184.5, P = .025), and aesthetics (B = 342.6, P < .001). SOC statistically significantly moderated the association between social status in the United States and LTPA (B = 160.3, P = .031). CONCLUSIONS: Social and built environmental factors were consistently linked with LTPA and provide context for multilevel interventions promoting LTPA in RCS.

Potential effectiveness of a surgeon-delivered exercise prescription and an activity tracker on pre-operative exercise adherence and aerobic capacity of lung cancer patients.

OBJECTIVES: Pre-operative exercise may improve functional outcomes for lung cancer patients, but barriers associated with cost, resources, and burden make it challenging to deliver pre-operative exercise programs. The goal of this proof-of-concept study was to determine level of moderate-vigorous physical activity (MVPA) and change in aerobic capacity after participation in a home-based pre-operative exercise intervention. MATERIALS AND METHODS: Eighteen patients scheduled for surgery for suspected stage I-III lung cancer received an exercise prescription from their surgeon and wore a commercially-available device that tracked their daily MVPA throughout the pre-operative period. Descriptive statistics were used to calculate adherence to the exercise prescription. A one-sample t-test was used to explore change in aerobic capacity from baseline to the day of surgery. RESULTS: Participants exhibited a mean of 20.4 (sd = 46.2) minutes of MVPA per day during the pre-operative period. On average, the sample met the goal of 30 min of MVPA on 16.4% of the days during the pre-operative period. The mean distance achieved at baseline for the 6-min walk test was 456.7 m (sd = 72.9), which increased to 471.1 m (sd = 88.4) on the day of surgery. This equates to a mean improvement of 13.8 m (sd = 37.0), but this difference was not statistically different from zero (p = 0.14). Eight of the 17 participants (47%) demonstrated a clinically significant improvement of 14 m or more. CONCLUSION: A surgeon-delivered exercise prescription plus an activity tracker may promote clinically significant improvement in aerobic capacity and MVPA engagement among patients with lung cancer during the pre-operative period, but may need to be augmented with more contact with and support from practitioners over time to maximize benefits. TRIAL REGISTRATION: The study protocol was registered with ClinicalTrials.gov prior to initiating participant recruitment (NCT03162718).

A feasibility study of an unsupervised, pre-operative exercise program for adults with lung cancer.

OBJECTIVE: The purpose of this study was to explore the feasibility, acceptability and perceived utility of the provision of a wearable fitness device and an exercise prescription from a surgeon, prior to surgery for lung cancer. METHODS: A single-arm, pre-post feasibility study was conducted with 30 participants scheduled for surgery to treat stage I, II or III lung cancer. Participants were given a Garmin Vivoactive HR device and a prescription for 150 min of moderately to vigorous exercise per week. Participants completed assessments on four occasions and completed a semi-structured interview on two occasions. Descriptive statistics were used to assess the feasibility and acceptability of study procedures, including synchronising the Garmin device and engaging in study assessments. RESULTS: Seventy-nine per cent of enrolled participants completed the pre-operative study activities. Seventy-one per cent of enrolled participants successfully synchronised their device during the pre-operative period. Data were transmitted from the device to the study team for an average of 70% of the pre-operative days. CONCLUSION: This pilot study demonstrated the feasibility and acceptability of a pre-operative exercise program for patients scheduled to undergo surgery for lung cancer. TRIAL REGISTRATION: The study protocol was registered with ClinicalTrials.gov prior to the initiation of participant recruitment (NCT03162718).

Study protocol for a multisite randomised controlled trial of a rehabilitation intervention to reduce participation restrictions among female breast cancer survivors.

INTRODUCTION: Many breast cancer survivors report an inability to fully participate in activities of daily living after completing cancer treatment. Reduced activity participation is linked to negative consequences for individuals (eg, depression, reduced quality of life) and society (reduced workforce participation). There is currently a lack of evidence-based interventions that directly foster cancer survivors' optimal participation in life roles and activities. Pilot study data suggest rehabilitation interventions based on behavioural activation (BA) and problem-solving treatment (PST) can facilitate post-treatment role resumption among breast cancer survivors. METHODS AND ANALYSIS: This protocol describes a multisite randomised controlled trial comparing a 4-month long, nine-session BA and PST-informed rehabilitation intervention (BA/PS) against a time-matched, attention control condition. The overall objective is to assess the efficacy of BA/PS for enhancing breast cancer survivors' activity participation and quality of life over time. A total of 300 breast cancer survivors reporting participation restrictions after completing curative treatment for stage 1-3 breast cancer within the past year will be recruited across two sites (Dartmouth-Hitchcock Medical Center and University of Alabama at Birmingham). Assessments are collected on enrolment (T1) and 8 (T2), 20 (T3) and 44 (T4) weeks later. ETHICS AND DISSEMINATION: Study procedures are approved by the Committee for the Protection of Human Subjects at Dartmouth College, acting as the single Institutional Review Board of record for both study sites (STUDY 00031380). Results of the study will be presented at national meetings and submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03915548; Pre-results.

Genetic Influences on Physiological and Subjective Responses to an Aerobic Exercise Session among Sedentary Adults.

Objective. To determine whether genetic variants suggested by the literature to be associated with physiology and fitness phenotypes predicted differential physiological and subjective responses to a bout of aerobic exercise among inactive but otherwise healthy adults. Method. Participants completed a 30-minute submaximal aerobic exercise session. Measures of physiological and subjective responding were taken before, during, and after exercise. 14 single nucleotide polymorphisms (SNPs) that have been previously associated with various exercise phenotypes were tested for associations with physiological and subjective response to exercise phenotypes. Results. We found that two SNPs in the FTO gene (rs8044769 and rs3751812) were related to positive affect change during exercise. Two SNPs in the CREB1 gene (rs2253206 and 2360969) were related to change in temperature during exercise and with maximal oxygen capacity (VO(2) max). The SLIT2 SNP rs1379659 and the FAM5C SNP rs1935881 were associated with norepinephrine change during exercise. Finally, the OPRM1 SNP rs1799971 was related to changes in norepinephrine, lactate, and rate of perceived exertion (RPE) during exercise. Conclusion. Genetic factors influence both physiological and subjective responses to exercise. A better understanding of genetic factors underlying physiological and subjective responses to aerobic exercise has implications for development and potential tailoring of exercise interventions.