Many survivors of critical illness and their family members experience significant psychological distress after patient discharge.
To compare the effects of a coping skills training (CST) program ...with an education program on patient and family psychological distress.
In this five-center clinical trial, adult patients who received mechanical ventilation for more than 48 hours and one family member of each patient were randomized to six weekly CST telephone sessions plus access to a study website or a critical illness education program.
The primary outcome was the patient Hospital Anxiety and Depression Scale (HADS) score at 3 months. Secondary outcomes included 3- and 6-month HADS subscales and the Impact of Events Scale-Revised. Among the 175 patients randomized to CST (n = 86) or education (n = 89), there was no significant difference between CST and education in either 3-month HADS scores (difference, 1.3; 95% confidence interval CI, -0.9 to 3.4; P = 0.24) or secondary patient and family outcomes. In prespecified analyses, among patients with high baseline distress (n = 60), CST recipients had greater improvement in 6-month HADS score (difference, -4.6; 95% CI, -8.6 to -0.6; P = 0.02) than the education group. Among patients ventilated longer than 7 days (n = 47), education recipients had greater improvement in 3-month HADS score (difference, -4.0; 95% CI, -8.1 to -0.05; P = 0.047) than the CST group.
CST did not improve psychological distress symptoms compared with an education program. However, CST improved symptoms of distress at 6 months among patients with high baseline distress, whereas the education program improved distress at 3 months among those ventilated for more than 7 days. Future efforts to address psychological distress among critical illness survivors should target high-risk populations. Clinical trial registered with www.clinicaltrials.gov (NCT01983254).
Behavioral pain management interventions are efficacious for reducing pain in patients with cancer. However, optimal dosing of behavioral pain interventions for pain reduction is unknown, and this ...hinders routine clinical use. A Sequential Multiple Assignment Randomized Trial (SMART) was used to evaluate whether varying doses of Pain Coping Skills Training (PCST) and response-based dose adaptation can improve pain management in women with breast cancer. Participants (N = 327) had stage I-IIIC breast cancer and a worst pain score of > 5/10. Pain severity (a priori primary outcome) was assessed before initial randomization (1:1 allocation) to PCST-Full (5 sessions) or PCST-Brief (1 session) and 5 to 8 weeks later. Responders ( > 30% pain reduction) were rerandomized to a maintenance dose or no dose and nonresponders (<30% pain reduction) to an increased or maintenance dose. Pain severity was assessed again 5 to 8 weeks later (assessment 3) and 6 months later (assessment 4). As hypothesized, PCST-Full resulted in greater mean percent pain reduction than PCST-Brief (M SD = -28.5% 39.6% vs M SD= -14.8% 71.8%; P = 0.041). At assessment 3 after second dosing, all intervention sequences evidenced pain reduction from assessment 1 with no differences between sequences. At assessment 4, all sequences evidenced pain reduction from assessment 1 with differences between sequences ( P = 0.027). Participants initially receiving PCST-Full had greater pain reduction at assessment 4 ( P = 0.056). Varying PCST doses led to pain reduction over time. Intervention sequences demonstrating the most durable decreases in pain reduction included PCST-Full. Pain Coping Skills Training with intervention adjustment based on response can produce sustainable pain reduction.
Although guidelines recommend in-person counseling before BRCA1/BRCA2 gene testing, genetic counseling is increasingly offered by telephone. As genomic testing becomes more common, evaluating ...alternative delivery approaches becomes increasingly salient. We tested whether telephone delivery of BRCA1/2 genetic counseling was noninferior to in-person delivery.
Participants (women age 21 to 85 years who did not have newly diagnosed or metastatic cancer and lived within a study site catchment area) were randomly assigned to usual care (UC; n = 334) or telephone counseling (TC; n = 335). UC participants received in-person pre- and post-test counseling; TC participants completed all counseling by telephone. Primary outcomes were knowledge, satisfaction, decision conflict, distress, and quality of life; secondary outcomes were equivalence of BRCA1/2 test uptake and costs of delivering TC versus UC.
TC was noninferior to UC on all primary outcomes. At 2 weeks after pretest counseling, knowledge (d = 0.03; lower bound of 97.5% CI, -0.61), perceived stress (d = -0.12; upper bound of 97.5% CI, 0.21), and satisfaction (d = -0.16; lower bound of 97.5% CI, -0.70) had group differences and confidence intervals that did not cross their 1-point noninferiority limits. Decision conflict (d = 1.1; upper bound of 97.5% CI, 3.3) and cancer distress (d = -1.6; upper bound of 97.5% CI, 0.27) did not cross their 4-point noninferiority limit. Results were comparable at 3 months. TC was not equivalent to UC on BRCA1/2 test uptake (UC, 90.1%; TC, 84.2%). TC yielded cost savings of $114 per patient.
Genetic counseling can be effectively and efficiently delivered via telephone to increase access and decrease costs.
Abstract Context Pain coping skills training (PCST) interventions have shown efficacy for reducing pain and providing other benefits in patients with cancer. However, their reach is often limited ...because of a variety of barriers (e.g., travel, physical burden, cost, time). Objectives This study examined the feasibility and acceptability of a brief PCST intervention delivered to patients in their homes using mobile health (mHealth) technology. Pre-to-post intervention changes in pain, physical functioning, physical symptoms, psychological distress, self-efficacy for pain management, and pain catastrophizing also were examined. Methods Patients with a diagnosis of breast, lung, prostate, or colorectal cancer who reported persistent pain ( N = 25) participated in a four-session intervention delivered using mHealth technology (videoconferencing on a tablet computer). Participants completed measures of pain, physical functioning, physical symptoms, psychological distress, self-efficacy for pain management, and pain catastrophizing. We also assessed patient satisfaction. Results Participants completed an average of 3.36 (SD = 1.11) of the four intervention sessions for an overall session completion rate of 84%. Participants reported that the program was of excellent quality and met their needs. Significant preintervention to postintervention differences were found in pain, physical symptoms, psychological distress, and pain catastrophizing. Conclusion The use of mHealth technology is a feasible and acceptable option for delivery of PCST for patients with cancer. This delivery mode is likely to dramatically increase intervention access for cancer patients with pain compared to traditional in-person delivery. Preliminary data also suggest that the program is likely to produce pretreatment to post-treatment decreases in pain and other important outcomes.
To determine whether a social cognitive theory (SCT)-based intervention improves resistance training (RT) maintenance and strength, and reduces prediabetes prevalence.
Sedentary, overweight/obese ...(BMI: 25-39.9 kg/m2) adults aged 50-69 (N = 170) with prediabetes participated in the 15-month trial. Participants completed a supervised 3-month RT (2×/wk) phase and were randomly assigned (N = 159) to one of two 6-month maintenance conditions: SCT or standard care. Participants continued RT at a self-selected facility. The final 6-month period involved no contact. Assessments occurred at baseline and months 3, 9, and 15. The SCT faded-contact intervention consisted of nine tailored transition (i.e., supervised training to training alone) and nine follow-up sessions. Standard care involved six generic follow-up sessions. Primary outcomes were prevalence of normoglycemia and muscular strength.
The retention rate was 76%. Four serious adverse events were reported. After 3 months of RT, 34% of participants were no longer prediabetic. This prevalence of normoglycemia was maintained through month 15 (30%), with no group difference. There was an 18% increase in the odds of being normoglycemic for each % increase in fat-free mass. Increases in muscular strength were evident at month 3 and maintained through month 15 (P<0.001), which represented improvements of 21% and 14% for chest and leg press, respectively. Results did not demonstrate a greater reduction in prediabetes prevalence in the SCT condition.
Resistance training is an effective, maintainable strategy for reducing prediabetes prevalence and increasing muscular strength. Future research which promotes RT initiation and maintenance in clinical and community settings is warranted.
ClinicalTrials.gov NCT01112709.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
This is a tutorial on designing a persuasive pilot study of a psychosocial intervention (e.g., behavioral symptom management) in the palliative care setting. This tutorial is most relevant for early ...stages of intervention research that aims to progress toward a randomized controlled trial with a high degree of internal validity. Broadly, a pilot study aims to address multiple elements of feasibility and acceptability so that investigators are well positioned for the next study in their program of research. To assist investigators in writing compelling grant applications we designed this tutorial as an annotated checklist of goals that a pilot study within the palliative care domain should seek to accomplish. These goals include the following: 1) begin with the end in mind, 2) use a formal conceptual model, 3) use measures with strong psychometric properties, 4) justify the timing of study sessions and assessments, 5) test recruitment methods, 6) estimate retention, 7) assess interventionist fidelity, 8) assess acceptability of the intervention, 9) assess feasibility, and 10) identify barriers to the next study. We elaborate on these goals by describing an ongoing pilot study testing the feasibility and acceptability of a psychosocial pain management intervention for patients with advanced cancer. Pilot studies are crucial for building a successful program of research, but they are also limited in terms of their sample size and overall objectives. A persuasive pilot study is one that is limited yet useful rather than limited and trivial.
Objective
Behavioral cancer pain interventions are efficacious for improving important pain outcomes; yet, traditional in‐person delivery limits patient access. This study compared ...videoconference‐delivered mobile health pain coping skills training (mPCST) to in‐person pain coping skills training (PCST‐traditional).
Methods
This study was a randomized, noninferiority trial with cancer patients. Participants (N = 178) were randomly assigned to four, 45‐minute sessions of mPCST or PCST‐traditional. Session content focused on evidence‐based cognitive and behavioral pain management skills. Assessments were completed at baseline, posttreatment, and 3‐month posttreatment, and included measures of primary intervention outcomes (ie, pain severity and pain interference) and secondary intervention outcomes (ie, physical symptoms, psychological distress, physical well‐being, and self‐efficacy). The main study aim tested whether mPCST was more accessible (defined as feasibility, acceptability, patient burden, and engagement) than PCST‐traditional. The second aim tested whether mPCST was noninferior to PCST‐traditional.
Results
mPCST demonstrated significantly greater feasibility (ie, attrition, adherence, and time to completion) than PCST‐traditional. Both groups reported similar patient burden and engagement as well as a high degree of acceptability. All intervention outcomes demonstrated noninferiority at posttreatment and, with the exception of physical symptoms, 3‐month posttreatment. Concerning the primary intervention outcomes, 95% CIs for the mean differences (d) were below the noninferiority margin of 1 for pain severity (posttreatment d = 0.09, 95% CI, −0.63‐0.81; 3 months d = −0.43 95% CI, −1.22‐0.36) and pain interference (posttreatment d = −0.11, 95% CI, −0.99‐0.76; 3 months d = −0.26 95% CI, −1.14‐0.62).
Conclusion
mPCST is highly accessible and noninferior to PCST‐traditional.
Pain is a challenge for patients following hematopoietic stem cell transplantation (HCT).
This study aimed to develop and test the feasibility, acceptability, and initial efficacy of a Web-based ...mobile pain coping skills training (mPCST) protocol designed to address the needs of HCT patients.
Participants had undergone HCT and reported pain following transplant (N=68). To guide intervention development, qualitative data were collected from focus group participants (n=25) and participants who completed user testing (n=7). After their input was integrated into the mPCST intervention, a pilot randomized controlled trial (RCT, n=36) was conducted to examine the feasibility, acceptability, and initial efficacy of the intervention. Measures of acceptability, pain severity, pain disability, pain self-efficacy, fatigue, and physical disability (self-report and 2-min walk test 2MWT) were collected.
Participants in the focus groups and user testing provided qualitative data that were used to iteratively refine the mPCST protocol. Focus group qualitative data included participants' experiences with pain following transplant, perspectives on ways to cope with pain, and suggestions for pain management for other HCT patients. User testing participants provided feedback on the HCT protocol and information on the use of videoconferencing. The final version of the mPCST intervention was designed to bridge the intensive outpatient (1 in-person session) and home settings (5 videoconferencing sessions). A key component of the intervention was a website that provided personalized messages based on daily assessments of pain and activity. The website also provided intervention materials (ie, electronic handouts, short videos, and audio files). The intervention content included pain coping advice from other transplant patients and instructions on how to apply pain coping skills while engaging in meaningful and leisure activities. In the RCT phase of this research, HCT patients (n=36) were randomized to receive the mPCST intervention or to proceed with the treatment as usual. Results revealed that the mPCST participants completed an average of 5 out of 6 sessions. The participants reported that the intervention was highly acceptable (mean 3/4), and they found the sessions to be helpful (mean 8/10) and easy to understand (mean 7/7). The mPCST participants demonstrated significant improvements in pre- to post-treatment pain, self-efficacy (P=.03, d=0.61), and on the 2MWT (P=.03, d=0.66), whereas the patients in the treatment-as-usual group did not report any such improvements. Significant changes in pain disability and fatigue were found in both groups (multiple P<.02); the magnitudes of the effect sizes were larger for the mPCST group than for the control group (pain disability: d=0.79 vs 0.69; fatigue: d=0.94 vs 0.81). There were no significant changes in pain severity in either group.
Using focus groups and user testing, we developed an mPCST protocol that was feasible, acceptable, and beneficial for HCT patients with pain.
ClinicalTrials.gov NCT01984671; https://clinicaltrials.gov/ct2/show/NCT01984671 (Archived by WebCite at http://www.webcitation.org/6xbpx3clZ).
Purpose
Colorectal cancer survivors report pain and psychological distress to be burdensome long-term cancer consequences. Quality cancer survivorship care includes interventions for managing these ...symptoms. Yet, no studies have tested the efficacy of an accessible behavioral intervention for colorectal cancer survivors with pain and comorbid psychological distress. This paper reports on the feasibility (i.e., accrual, attrition, and adherence to study procedures), engagement, acceptability, and descriptive outcomes of a telephone-based coping skills training (CST) intervention.
Methods
This randomized pilot trial assigned colorectal cancer patients (
N
=31) to 5 sessions of CST or standard care. CST sessions focused on cognitive-behavioral theory-based coping skills tailored to colorectal cancer symptoms of pain and psychological distress. Participants completed assessments of pain severity, self-efficacy for pain management, health-related quality of life, and psychological distress at baseline, post-treatment, and 3-month follow-up.
Results
Data indicated strong feasibility, evidenced by high completion rates for intervention sessions and assessments (93% completed all sessions;
M
=48.7 days; baseline=100%; post-treatment=97%; 3-month follow-up=94%). Participants demonstrated robust engagement with CST (
M
days per week with reported skills use=3.8) and reported high protocol satisfaction (
M
=3.6/4.0). Descriptive statistics showed self-efficacy for pain management and health-related quality of life improved for all participants.
Conclusion
Findings suggest that a telephone-based CST intervention has strong feasibility, evidenced by accrual, low attrition, and adherence to intervention sessions and assessments. Likewise, participant engagement and acceptability with CST were high. These data provide a foundation for larger randomized efficacy trials of the telephone-based CST intervention.
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