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.

Video-Delivered Family Therapy for Perinatal Women With Depressive Symptoms and Family Conflict: Feasibility, Acceptability, Safety, and Tolerability Results From a Pilot Randomized Trial.

BACKGROUND: Although individual-level treatments exist for pregnant and postpartum women with depression, family conflict is a significant factor that can contribute to the development and severity of perinatal depressive symptoms. Yet, there is a lack of research on family therapy for perinatal women with moderate to severe depressive symptoms and family conflict. Further, research is needed on the feasibility, acceptability, safety, and tolerability of family therapies for perinatal depression that are delivered using Health Insurance Portability and Accountability Act-compliant videoconferencing technology (VCT). OBJECTIVE: This paper describes the feasibility, acceptability, safety, and tolerability of a VCT-based family therapeutic intervention, Resilience Enhancement Skills Training (REST), for perinatal women with moderate to severe depressive symptoms and moderate to high conflict with their family members. METHODS: This paper includes data from an ongoing randomized trial that compares an experimental family therapeutic intervention (REST) to standard of care (VCT-based problem-solving individual therapy) for the treatment of moderate to severe depressive symptoms in perinatal women with moderate to high family conflict. Both interventions were delivered by masters-level therapists using VCT. A total of 83 perinatal women and their adult family members (N=166 individuals) were recruited for participation in the study. Feasibility, defined as therapist adherence to ≥80% of REST session content, was assessed in audio-recorded sessions by 2 expert raters. Acceptability was defined as ≥80% of families completing REST, including completion of ≥80% homework assignments and family report of satisfaction with REST. Completion of REST was assessed by review of therapist session notes, and satisfaction was assessed by participant completion of a web-based questionnaire. The Beck Depression Inventory-Second Edition was administered to perinatal women by research assistants (blind to study group assignment) to assess safety, defined as a reduction in depressive symptoms during the treatment phase. The Family Environment Scale-Family Conflict subscale was administered by therapists to participants during the treatment phase to assess tolerability, defined as a reduction in family conflict during the treatment phase. RESULTS: On average, the therapists achieved 90% adherence to REST session content. Of the families who started REST, 84% (32/38) of them completed REST, and on average, they completed 89% (8/9) of the homework assignments. Families reported satisfaction with REST. The results showed that REST is safe for perinatal women with moderate to severe depressive symptoms, and none discontinued due to worsened depressive symptoms. The results showed that REST is well tolerated by families, and no families discontinued due to sustained family conflict. CONCLUSIONS: The results show that REST is feasible, acceptable, safe, and tolerable for families. These findings will guide our interpretation of REST's preliminary effectiveness upon completion of outcome data collection. TRIAL REGISTRATION: ClinicalTrials.gov NCT04741776; https://clinicaltrials.gov/ct2/show/NCT04741776.

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.

A Video-Delivered Family Therapeutic Intervention for Perinatal Women With Clinically Significant Depressive Symptoms and Family Conflict: Indicators of Feasibility and Acceptability.

BACKGROUND: Variation in family therapeutic intervention fidelity has an impact on outcomes. The use of video conferencing technology can strengthen therapist fidelity to family therapeutic interventions. OBJECTIVE: This article explores indicators of feasibility and acceptability for a video-delivered family therapeutic intervention for perinatal women with depressive symptoms and family conflict. The objectives of this article are to describe indicators of feasibility, including therapist fidelity to the intervention and technological factors that relate to implementation of the intervention, as well as indicators of acceptability for participants of the intervention. METHODS: The data included in this article are from an ongoing randomized trial of the Resilience Enhancement Skills Training (REST) video-delivered family therapeutic intervention. Participant recruitment and data collection are still underway for this clinical trial. Of the 106 participants who are currently enrolled in this study, 54 (51%) have been randomized to receive REST from May 2021 through July 2022. Currently, 2 therapists are delivering the intervention, and the training procedures for therapists are summarized herein. Therapist fidelity to the family therapeutic intervention was assessed in 67 audio recorded sessions. The training procedures were summarized for use of video conferencing technology by therapists and the 54 study participants. Knowledge of the video conferencing technology features was assessed in therapists and study participants by the number of attempts required to use the features. Participant responsiveness to the intervention was assessed by the percentage of attended sessions and percentage of complete homework assignments. RESULTS: To date, both therapists have demonstrated high fidelity to the family therapeutic intervention and used all video conferencing technology features on their first attempt. The current participants required 1 to 3 attempts to use 1 or more of the video conferencing technology features. About 59% (n=32) of the current participants immediately accessed the features on the first attempt. Our results show that perinatal women attended all sessions, and their family members attended 80% of the sessions. To date, participants have completed 80% of the homework assignments. CONCLUSIONS: These early findings describe indicators of the feasibility and acceptability of the video-delivered family therapeutic intervention for use with this high priority population. Upon completion of recruitment and data collection, a subsequent article will include a mixed methods process evaluation of the feasibility and acceptability of the video-delivered family therapeutic intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT04741776; https://clinicaltrials.gov/ct2/show/NCT04741776.

Accept Yourself! A Pilot Randomized Controlled Trial of a Self-Acceptance-Based Treatment for Large-Bodied Women With Depression.

A pilot parallel randomized controlled trial compared a self-acceptance, non-weight-loss intervention, Accept Yourself! (AY), to a weight loss program, Weight Watchers (WW), in order to provide preliminary safety, feasibility, and efficacy data in preparation for a definitive RCT of AY as an intervention to enhance the mental and physical health of larger-bodied women with Major Depressive Disorder (MDD). Adult women with MDD and a Body Mass Index ≥30 were eligible. Nineteen women were randomized by random number table into AY (n = 9) or WW (n = 10). Intake, pretreatment, posttreatment, 3-, 6-, 9-, and 12-month follow-up assessments occurred at a rural academic medical center. Primary outcomes included depression severity and cardiovascular fitness. Chi-square and t-tests assessed attrition and participant preferences for treatment; other analyses used intention-to-treat, linear mixed-effects models for repeated measures, including all participants' available data. Both groups improved in self-reported, F(5, 43.81) = 7.45, p < .001, partial η2 = .38, and blinded-clinician-rated depression, F(6, 62.03) = 10.41, p < .001, partial η2 = .5. AY was superior to WW in self-reported depression, F(5, 43.81) = 2.72, p = .03, partial η2 = .11. Neither group improved in fitness. Eating disorder symptoms and weight gain worsened in WW. AY appeared safe, feasible, and offered initial evidence of efficacy for depression; it should be investigated in a definitive RCT, with modifications to increase potency. WW may not be suitable as a comparator intervention for AY because of risk to participants.

Evaluation of a brief psychosocial intervention for health anxiety delivered by medical assistants in primary care: Study protocol for a pilot hybrid trial.

Health anxiety is a chronic mental health condition that exerts substantial personal and economic burdens on patients, providers, and the larger healthcare system. Patients with health anxiety experience persistent worry and dread over the possibility that they are presently ill with an undetected or poorly defined physical illness or may soon become ill despite an absence of evidence and physician reassurance of wellness. A complication of health anxiety is that the sufferer frequently denies the presence of excessive anxiety, typically attributing their distress to an inability of the medical team to correctly identify the feared illness. As a result, these patients are challenging to engage in evidence-based psychosocial interventions. The present study protocol describes a psychosocial intervention based on cognitive-behavioral therapy that is adapted for delivery by Medical Assistants in the primary care setting. The rationale for this approach is that delivery by Medical Assistants has the potential to overcome barriers to engagement that prevent effective care. Moreover, deploying a task-shifted intervention relieves strain on the care team by sharing the responsibility for helping the patient manage health anxiety. The aim of this study is to demonstrate the effectiveness of this intervention and approach on health anxiety, while simultaneously collecting data on the barriers and facilitators of implementation, consistent with a hybrid type 1 study design. We will compare patient-level outcomes for participants randomized to the study intervention versus routine referral to mental health services and characterize the potential for implementation using qualitative data drawn from patient and clinical stakeholders.

Effect of Telehealth Treatment by Lay Counselors vs by Clinicians on Depressive Symptoms Among Older Adults Who Are Homebound: A Randomized Clinical Trial.

Importance: Older adults who are homebound and have low income have limited access to psychosocial treatments because of their homebound state and geriatric mental health workforce shortages. Objective: To evaluate clinical effectiveness of a brief, aging service-integrated, videoconferenced behavioral activation (tele-BA) treatment delivered by lay counselors compared with videoconferenced problem-solving therapy (tele-PST) delivered by licensed clinicians and attention control (AC; telephone support calls). Design, Setting, and Participants: This 3-group randomized clinical trial using a randomization prior to consent approach included individuals aged 50 years or older who were homebound and had 24-item Hamilton Depression Rating Scale (HAMD) scores of 15 or greater between February 15, 2016, and April 15, 2019. Tele-BA and tele-PST participants received 5 weekly treatment sessions. Assessments were performed at baseline and 12, 24, and 36 weeks after baseline. Intention-to-treat statistical analyses were performed from January 1, 2020, to February 15, 2020. Interventions: Tele-BA participants were taught 5 steps for reinforcing healthy behaviors to improve mood, physical functioning, and social engagement. Tele-PST participants were taught a 7-step approach for problem solving coping skills. Main Outcomes and Measures: The primary outcome was the 24-item HAMD scores. Response (ie, ≥50% reduction in HAMD) and remission (ie, HAMD <10) rates and effect sizes for clinically meaningful differences were examined. Secondary outcomes were disability, social engagement and activity frequency, and satisfaction with participation in social roles. Results: A total of 277 participants were enrolled, including 193 (69.7%) women, 83 (30.0%) who were Black, 81 (29.2%) who were Hispanic, and 255 (92.1%) with income of $35 000 or less. The mean (SD) age was 67.5 (8.9) years. Among these, 90 participants were randomized to tele-BA, 93 participants were randomized to tele-PST, and 94 participants were randomized to the AC. Compared with participants in the AC group, participants in the tele-BA and tele-PST groups had significantly higher response and remission rates and medium to large effect sizes (tele-BA: raw growth modeling analysis d = 0.62 [95% CI, 0.35 to 0.89]; P < .001; tele-PST: raw growth modeling analysis d = 1.00 [95% CI, 0.73 to 1.26]; P < .001) for HAMD scores. While tele-PST was significantly more effective than tele-BA for reducing HAMD scores (t258 = -2.79; P = .006), there was no difference between tele-BA and tele-PST on secondary outcomes. Conclusions and Relevance: In this randomized clinical trial, participants who received tele-BA by lay counselors achieved statistically and clinically meaningful changes in depressive symptoms. Given shortages of licensed mental health clinicians, tele- and lay counselor-delivered services may help improve access to evidence-based depression treatment for large numbers of underserved older adults. Trial Registration: ClinicalTrials.gov Identifier: NCT02600754.

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.

Health Through Activity: Initial Evaluation of an In-Home Intervention for Older Adults With Cancer.

OBJECTIVE: The objective of this study was to assess the feasibility of conducting a future full-scale trial to test the efficacy of an in-home occupational therapy intervention designed to reduce disability in older adult cancer survivors. METHOD: Participants reporting activity limitations during or after cancer treatment were enrolled in a Phase 1 pilot randomized controlled trial comparing the 6-wk intervention (n = 30) to usual care (n = 29). Descriptive data on retention rates were collected to assess feasibility of intervention and study procedures. Potential efficacy was explored through participants' self-reported disability, quality of life, activity level, and behavioral activation at 0, 8, and 16 wk after enrollment. RESULTS: Retention rates were high regarding completion of the intervention (90%) and outcome assessments (90% of usual-care participants and 80% of intervention participants). Outcomes consistently favored the intervention group, although group differences were small. CONCLUSION: The procedures were feasible to implement and acceptable to participants.

Technology-assisted nursing for postpartum support: A randomized controlled trial.

AIM: To determine if an electronic nursing intervention during the first 6 months postpartum was effective in improving mood and decreasing stress. BACKGROUND: Unmet needs postpartum can have a negative impact on mood and parenting stress. Technology-assisted nursing care may provide needed support and reduce risk. DESIGN: Randomized controlled trial (RCT) with three conditions. METHODS: Enrollment began on 11 May 2017. Participants were randomized into one of three groups after completion of the baseline survey. Intervention I participants received standardized electronic messages four times/week for 6 months postpartum. Intervention II participants additionally received the option for nurse contact. Depression and parenting stress as measured using the Edinburgh Postnatal Depression Scale (EPDS) and Parenting Stress Index-Short form (PSI-SF) was obtained at 3 weeks, 3 months and 6 months postpartum and results compared with a usual care group. Patient satisfaction and nursing factors were measured. RESULTS: Significantly higher satisfaction scores were found in both intervention groups as compared with control, but there were no significant changes in EPDS or PSI-SF. CONCLUSION: The interventions were perceived as helpful and not burdensome. Better nurse-sensitive outcome measures are needed to adequately assess effectiveness. IMPACT: Postpartum women report unmet needs for support and education. The interventions were perceived as being helpful but did not significantly reduce depressive symptoms or parenting stress. Nurses can use this research to inform development of innovative approaches to support postpartum women. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT02843022.

Leveraging digital technology to intervene on personality processes to promote healthy aging.

The scientific evidence is clear that personality processes (particularly conscientiousness and neuroticism) play an important role in healthy aging. Assuming it would be desirable to assist individuals to change their personality in directions that would promote healthy aging, the next step is designing interventions for the task. During the past decade, technological advances have made it possible to develop and evaluate interventions delivered via web and mobile digital technologies. The purpose of this article is to discuss the possibilities for leveraging technology to intervene on personality processes to promote healthy aging, with a specific emphasis on applications for older adults. We begin by reviewing interventions that target personality change to treat mental health problems and physical health, followed by the scant research leveraging digital technologies in targeting personality processes. We present a rationale for adopting a transdiagnostic model to guide intervention development and review the brief literature supporting transdiagnostic interventions when adapted for digital delivery (transdiagnostic Internet-based cognitive-behavioral therapy). We then summarize the literature on designing technology interventions to meet the specific needs of older adults and some of the impressive results from digital technology (Internet-based cognitive-behavioral therapy) intervention studies. We conclude with suggestions for addressing gaps in this important but understudied area of research, with a focus on research targeted to older adults. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Preventing Cognitive Decline in Black Individuals With Mild Cognitive Impairment: A Randomized Clinical Trial.

Importance: Mild cognitive impairment (MCI) is a transition state between normal cognitive aging and dementia that increases the risk for progressive cognitive decline. Preventing cognitive decline is a public health priority. Objective: To determine whether behavioral activation prevents cognitive and functional decline over 2 years in black individuals with MCI. Design, Setting, and Participants: Single-center, single-masked, attention-controlled randomized clinical trial. Participants were enrolled from June 21, 2011, to October 3, 2014, and follow-up ended December 13, 2016. Community-based recruitment and treatment of black individuals older than 65 years with amnestic MCI. Volunteer sample of 1390 persons with memory complaints were screened. Overall, 536 individuals had baseline assessment, and 315 (58.8%) were ineligible, most often owing to normal cognition (205 of 315 [65%]) or dementia (59 of 315 [18.7%]); 221 fully eligible participants were randomized. Analyses were intention to treat. Interventions: Participants were randomized to behavioral activation, which aimed to increase cognitive, physical, and social activity (111 [50.2%]), or supportive therapy, an attention control treatment (110 [49.8%]). Main Outcomes and Measures: The prespecified primary outcome was a decline of 6 or more recalled words on the total recall score of the Hopkins Verbal Learning Test-Revised assessed at 6, 12, 18, and 24 months. The secondary outcome was functional decline. Results: Of 221 randomized participants (mean [SD] age, 75.8 [7.0] years, 175 women [79%]), 77 behavioral activation participants (69.4%) and 87 supportive therapy participants (79.1%) had 2-year outcome assessments. After baseline, behavioral activation participants engaged in significantly more cognitive activities than supportive therapy participants. The 2-year incidence of memory decline was 1.2% (95% CI, 0.2-6.4) for behavioral activation vs 9.3% (95% CI, 5.30-16.4) for supportive therapy (relative risk, 0.12; 95% CI, 0.02-0.74; P = .02). Behavioral activation was associated with stable everyday function, whereas supportive therapy was associated with decline (difference in slopes, 2.71; 95% CI, 0.12-5.30; P = .04). Rates of serious adverse events for behavioral activation and supportive therapy, respectively, were: falls (14 [13%] vs 28 [25%]), emergency department visits (24 [22%] vs 24 [22%]), hospitalizations (36 [32%] vs 31 [28%]), and deaths (7 [5%] vs 3 [4%]). Conclusions and Relevance: Behavioral activation prevented cognitive and functional decline, but this finding requires further investigation. Black individuals have almost twice the rate of dementia as white individuals; behavioral activation may reduce this health disparity. Trial Registration: ClinicalTrials.gov Identifier: NCT01299766.

Measuring outcomes of digital technology-assisted nursing postpartum: A randomized controlled trial.

AIM: To determine if delivering electronic messages from nurses during the first 6 months postpartum is feasible, acceptable and effective in improving mood and decreasing parenting stress. BACKGROUND: Competing demands during the postpartum hospitalization make focused time for nurses to provide education and support difficult. Unmet needs following discharge may increase the incidence of postpartum depression. Untreated depression negatively affects families, especially for vulnerable women with limited access to health care. DESIGN: This is a longitudinal cohort study in three phases. Feasibility and acceptability were assessed during Phases 1 & 2. Phase 3 is a randomized controlled trial (RCT) with three conditions. METHODS: This protocol was approved by the Institutional Review Board of the maternity hospital on 12 May 2015 and reviewed annually. Women are enrolled during the maternity hospitalization, after which randomization occurs. The control group receives usual care. Intervention I participants receive a standardized electronic message four times/week for 6 months postpartum. Intervention II participants receive the messages and the option to request a call from a nurse. Electronic surveys at 3 weeks, 3 months and 6 months postpartum measure depressive symptoms using the Edinburgh Postnatal Depression Scale and parenting stress using the Parenting Stress Index-Short form. Patient satisfaction, nursing time and expertise required are also measured. DISCUSSION: Phase 1 and 2 have demonstrated the intervention is feasible and acceptable to women. Phase 3 enrolment is completed, and the last follow-up surveys were emailed to participants in February 2018. Results will help inform efforts to continue nursing care after hospital discharge.

An online randomized controlled trial, with or without problem-solving treatment, for long-term cancer survivors after hematopoietic cell transplantation.

PURPOSE: This randomized controlled trial examines the efficacy of INSPIRE, an INternet-based Survivorship Program with Information and REsources, with or without problem-solving treatment (PST) telehealth calls, for survivors after hematopoietic cell transplantation (HCT). METHODS: All adult survivors who met eligibility criteria were approached for consent. Participants completed patient-reported outcomes at baseline and 6 months. Those with baseline impaired scores on one or more of the outcomes were randomized to INSPIRE, INSPIRE + PST, or control with delayed INSPIRE access. Outcomes included Cancer and Treatment Distress, Symptom Checklist-90-R Depression, and Fatigue Symptom Inventory. Planned analyses compared arms for mean change in aggregated impaired outcomes and for proportion of participants improved on each outcome. RESULTS: Of 1306 eligible HCT recipients, 755 (58%) participated, and 344 (45%) had one or more impaired scores at baseline. We found no reduction in aggregated outcomes for either intervention (P > 0.3). In analyses of individual outcomes, participants randomized to INSPIRE + PST were more likely to improve in distress than controls (45 vs. 20%, RR 2.3, CI 1.0, 5.1); those randomized to INSPIRE alone were marginally more likely to improve in distress (40 vs. 20%, RR 2.0, CI 0.9, 4.5). CONCLUSIONS: The INSPIRE online intervention demonstrated a marginal benefit for distress that improved with the addition of telehealth PST, particularly for those who viewed the website or were age 40 or older. IMPLICATIONS FOR CANCER SURVIVORS: Online and telehealth programs such as INSPIRE offer opportunities to enhance HCT survivorship outcomes, particularly for mood, though methods would benefit from strategies to improve efficacy.

Goal Attainment and Goal Adjustment of Older Adults During Person-Directed Cancer Rehabilitation.

OBJECTIVE: In this pilot study of a home-based occupational therapy intervention intended to reduce disability and improve quality of life, our objective was to identify rates of goal attainment and patterns of goal adjustment of participants. METHOD: Thirty older adults with cancer were randomized to the intervention arm, and 24 participants identified goals and completed the six-session intervention. An exploratory content analysis of qualitative and quantitative session data was performed. RESULTS: Participants set 63 6-wk goals and attained 62% of them. Most of the goals addressed walking (28%), sedentary leisure (24%), exercising (16%), or instrumental activities of daily living (14%). When 6-wk goals were not attained (n = 24), there were 10 instances of goal disengagement and 14 instances of goal reengagement. CONCLUSION: Although most participants were able to meet their goals, many also changed their goals and priorities after reflection and attempts to resume or initiate meaningful activities.

Content Analysis of a Participant-Directed Intervention to Optimize Activity Engagement of Older Adult Cancer Survivors.

Many older adult cancer survivors reduce their activity level during and after cancer treatment. Occupational therapy interventions need to flexibly address various obstacles to occupational engagement that survivors may face. The aim of this analysis was to describe the content of a participant-directed occupational therapy intervention for older adults with cancer. Content analysis was used to describe the treatment session data from the experimental arm of a pilot randomized controlled trial in terms of activities addressed, obstacles reported, and treatment strategies utilized. Participants predominantly used the intervention to increase exercise engagement or address instrumental activities of daily living. The most common obstacles to occupational engagement included fatigue, finding time, weather, and pain. Regarding treatment strategies, 77% of participants chose to practice the activity with the occupational therapist, 42% requested a piece of equipment, and 11% modified the environment to increase activity engagement. Overall, the participant-directed intervention appears flexible enough to address various activities and obstacles to occupational engagement.

The role of a palliative care intervention in moderating the relationship between depression and survival among individuals with advanced cancer.

OBJECTIVE: Randomized controlled trials (RCTs) of early palliative care interventions in advanced cancer have positively impacted patient survival, yet the mechanisms remain unknown. This secondary analysis of 2 RCTs assessed whether an early palliative care intervention moderates the relationship between depressive symptoms and survival. METHOD: The relationships among mood, survival, and early palliative care intervention were studied among 529 advanced cancer patients who participated in 2 RCTs. The first (N = 322) compared intervention versus usual care. The second (N = 207) compared early versus delayed intervention (12 weeks after enrollment). The interventions included an in-person consultation, weekly nurse coach-facilitated phone sessions, and monthly follow-up. Mood was measured using the Center for Epidemiologic Studies-Depression (CES-D) scale. Cox proportional hazard analyses were used to examine the effects of baseline CES-D scores, the intervention, and their interaction on mortality risk while controlling for demographic variables, cancer site, and illness severity. RESULTS: The combined sample was 56% male (M = 64.7 years). Higher baseline CES-D scores were significantly associated with greater mortality risk (hazard ratio [HR] = 1.042, 95% confidence interval [CI] [1.017, 1.067], p = .001). However, participants with higher CES-D scores who received the intervention had a lower mortality risk (HR = .963, CI [0.933, 0.993], p = .018) even when controlling for demographics, cancer site, and illness-related variables. CONCLUSION: This study is the first to demonstrate that patients with advanced cancer who also have depressive symptoms benefit the most from early palliative care. Future research should be devoted to exploring the mechanisms responsible for these relationships. (PsycINFO Database Record

Qualitative insights into how men with low-risk prostate cancer choosing active surveillance negotiate stress and uncertainty.

BACKGROUND: Active surveillance is a management strategy for men diagnosed with early-stage, low-risk prostate cancer in which their cancer is monitored and treatment is delayed. This study investigated the primary coping mechanisms for men following the active surveillance treatment plan, with a specific focus on how these men interact with their social network as they negotiate the stress and uncertainty of their diagnosis and treatment approach. METHODS: Thematic analysis of semi-structured interviews at two academic institutions located in the northeastern US. Participants include 15 men diagnosed with low-risk prostate cancer following active surveillance. RESULTS: The decision to follow active surveillance reflects the desire to avoid potentially life-altering side effects associated with active treatment options. Men on active surveillance cope with their prostate cancer diagnosis by both maintaining a sense of control over their daily lives, as well as relying on the support provided them by their social networks and the medical community. Social networks support men on active surveillance by encouraging lifestyle changes and serving as a resource to discuss and ease cancer-related stress. CONCLUSIONS: Support systems for men with low-risk prostate cancer do not always interface directly with the medical community. Spousal and social support play important roles in helping men understand and accept their prostate cancer diagnosis and chosen care plan. It may be beneficial to highlight the role of social support in interventions targeting the psychosocial health of men on active surveillance.