Efficacy of a stepped care approach to deliver cognitive-behavioral therapy for insomnia in cancer patients: a noninferiority randomized controlled trial

Study ObjectivesCognitive-behavioral therapy for insomnia (CBT-I) is the recommended first-line treatment for cancer-related insomnia, but its accessibility is very limited in routine care. A stepped care approach has been recommended as a cost-effective way to make CBT-I more widely accessible. However, no controlled study has yet been published about the efficacy of this approach. The goal of this noninferiority randomized controlled trial (RCT) was to compare the short and long-term efficacy of a stepped care CBT-I (StepCBT-I) to a standard face-to-face CBT-I (StanCBT-I).MethodsA total of 177 cancer patients were randomized to: (1) StanCBT-I (6 face-to-face CBT-I sessions; n = 59) or (2) StepCBT-I (n = 118). In the StepCBT-I group, patients with less severe insomnia first received a web-based CBT-I (n = 65), while those with more severe insomnia received 6 face-to-face CBT-I sessions (n = 53). In both cases, patients could receive up to three booster sessions of CBT-I if they still had insomnia symptoms following this first step.ResultsResults indicated that the Step-CBT-I group showed an Insomnia Severity Index score reduction and a sleep efficiency (on a sleep diary) increase that was not significantly inferior to that of StanCBT-I at all post-treatment time points. Analyses of secondary outcomes indicated significant time effects (ps < .001) and no significant group-by-time interactions (ps from .07 to .91) on other sleep diary parameters, sleep medication use, depression, anxiety, fatigue, and quality of life scores.Conclusion(s)The efficacy of stepped care CBT-I is not inferior to that of a standard face-to-face intervention and is a valuable approach to making this treatment more widely accessible to cancer patients.Trial registrationClinicalTrials.gov Identifier: NCT01864720 (https://clinicaltrials.gov/ct2/show/NCT01864720?term=Savard&draw=2&rank=6; Stepped Care Model for the Wider Dissemination of Cognitive-Behavioural Therapy for Insomnia Among Cancer Patients).     

Integrating online communities and social networks with computerised treatment for insomnia: a qualitative study

BackgroundInsomnia is a common psychological complaint. Cognitive behavioural therapy for insomnia (CBT-I), although effective, is little used because of lack of trained providers. Computerised CBT-I (CCBT-I) may be a solution to this shortfall in access.AimTo explore patient and health professional perspectives and the role of social networking, to develop a novel CCBT-I programme to increase access to this form of intervention.MethodSemi-structured interviews and focus groups with a purposive sample of health professionals and adults with insomnia.ResultsA total of 23 health professionals and 28 patients were interviewed. Features designed to engender trust and improve functionality were perceived to improve uptake and adherence to CCBT-I. Trust lay in programme accreditation; for professionals, trust derived from evidence of effectiveness; for patients, trust depended on the doctor–patient relationship, professional support, the quality of online peer support, and perceptions of risk. Patients wanted mobile applications; access in short periods; self-assessment; interactive, personalised information on sleep; and moderated contact with other users. Patients and practitioners differed over whether useful information could be distinguished from less useful or potentially incorrect information.ConclusionImproving uptake and adherence to online programmes for insomnia requires design features focusing on trust and functionality. Enabling greater patient control and interaction with other users and professionals may stimulate positive experiences of online therapy. CCBT-I would enable greater access to treatment but is limited by lack of online access or poor computer literacy.     

Clinical utility of family history for cancer screening and referral in primary care: a report from the Family Healthware Impact Trial

PurposeTo assess the effectiveness of computerized familial risk assessment and tailored messages for identifying individuals for targeted cancer prevention strategies and motivating behavior change.MethodsWe conducted a randomized clinical trial in primary care patients aged 35–65 years using Family Healthware, a self-administered, internet-based tool that collects family history for six common diseases including breast cancer, colon cancer, and ovarian cancer, stratifies risk into three tiers, and provides tailored prevention messages. Cancer screening adherence and consultation were measured at baseline and 6-month follow-up.ResultsOf 3283 participants, 34% were at strong or moderate risk of at least one of the cancers. Family Healthware identified additional participants for whom earlier screening (colon cancer, 4.4%; breast cancer, women ages: 35–39 years, 9%) or genetic assessment (colon cancer, 2.5%; breast cancer, 10%; and ovarian cancer, 4%) may be indicated. Fewer than half were already adherent with risk-based screening. Screening adherence improved for all risk categories with no difference between intervention and control groups. Consultation with specialists did not differ between groups.ConclusionFamily Healthware identified patients for intensified cancer prevention. Engagement of clinicians and patients, integration with clinical decision support, and inclusion of nonfamilial risk factors may be necessary to achieve the full potential of computerized risk assessment.     

An 8-week exercise study to improve cancer treatment related fatigue and QOL among African American breast cancer patients undergoing radiation treatment: A pilot randomized clinical trial

BackgroundCancer treatment related fatigue (CTRF) is one of the most debilitating side effects of adjuvant radiation therapy (RT). Several studies have found that physical activity (PA) may be an effective intervention to decrease fatigue and enhance QOL in cancer survivors. The primary objective of the PEDLAR study is to test the feasibility of an easily administered 8-week structured moderate-intensity PA intervention, delivered concurrently with RT, in reducing CTRF and improving health-related QOL among African-American breast cancer patients. This study is also designed to provide pilot data on the acceptability and adherence of PA interventions in African-American women with breast cancer.MethodsIt is a prospective, 2-arm, 8-week feasibility trial. Participants are randomized to either a structured, moderate-intensity aerobic training exercise regimen concurrent with radiotherapy or a control group.ResultsParticipants in intervention group reported high satisfaction with exercise and adherence was >75% for exercise sessions.ConclusionsAfrican-American breast cancer patients in a moderate-intensity 75 min/wk aerobic exercise intervention had marginally lower fatigue at 8-wk follow-up compared to baseline. The control group participants had marginally higher fatigue at 8-wk follow-up compared to baseline. Participants in the intervention group reported slightly better quality of life at 8-wk follow-up compared to baseline (P = 0.06).     

Prospective Randomized Study of Patients with Insomnia and Mild Sleep Disordered Breathing

Background:

Patients with insomnia may present with mild and often unrecognized obstructive sleep apnea (OSA).

Objective:

To evaluate both subjective and objective outcomes of patients with complaints of insomnia and mild OSA who receive surgical treatment for OSA versus behavioral treatment with cognitive behavioral therapy for insomnia (CBT-I).

Methods:

Prospective study with crossover design of 30 patients with complaints of insomnia and mild OSA. Thirty subjects, matched for age and gender, were randomized with stratification to receive either CBT-I or surgical treatment of OSA as primary treatment. Patients were reassessed after completing the initial intervention and reassigned if agreeable to the alternative treatment option and assessed again on completion of both treatment arms. Outcome measures included clinical impression, Epworth Sleepiness Scale (ESS) score, Fatigue Severity Scale (FSS) score, and polysomnography (PSG) results.

Results:

Surgery resulted in greater improvements in total sleep time (TST), slow wave sleep and REM sleep duration, respiratory disturbance index, apnea-hypopnea index, minimum oxygen saturation, FSS, and ESS. CBT-I also improved TST and resulted in shorter sleep latency.

Conclusion:

Surgical intervention for the management of patients with complaints of insomnia and mild OSA demonstrated greater improvement in both subjective and objective outcome measures. Initial treatment of underlying OSA in patients with insomnia was more successful in improving insomnia than CBT-I alone. However CBT-I as initial treatment improved TST compared to baseline; following surgical intervention, it had the additional benefit of further increasing TST and helped to control sleep onset difficulties that may be related to conditioning due to unrecognized symptoms of mild OSA.

Citation:

Guilleminault C; Davis K; Huynh NT. Prospective randomized study of patients with insomnia and mild sleep disordered breathing. SLEEP 2008;31(11):1527–1533     

Adapted Delivery of Cognitive-Behavioral Treatment for Insomnia in Adolescent and Young Adult Cancer Survivors: A Pilot Study

Adolescent and young adult cancer survivors (AYACS) are at risk for the development of insomnia, though it remains vastly undertreated. Limited research has evaluated cognitive-behavioral treatment for insomnia (CBT-I) in AYACS. The present study piloted adapted CBT-I designed to improve treatment accessibility by delivering a three-session intervention in person and via videoconference. AYACS with insomnia (N = 12) enrolled in the study. Ten AYACS completed the intervention, with six in person and four via videoconference. Sleep variables improved immediately postintervention and were sustained at two-month follow-up. Within sample effect sizes of the adapted intervention for sleep, variables were large, and there were no noted differences on sleep outcomes between the in-person and videoconference participants. These pilot findings indicate that an adapted CBT-I intervention is feasible and promising in AYACS populations.     

Trajectory of self-care in people with stable heart failure and insomnia after two self-care interventions

ObjectiveTo describe (1) self-care trajectories among adults with heart failure (HF) and insomnia over 1-year; (2) the extent to which trajectories varied between cognitive behavioral therapy for insomnia (CBT-I) or HF self-care intervention; and (3) the associations between self-care trajectories and clinical and demographic characteristics, sleep, symptoms and stress, and functional performance.MethodsWe conducted secondary analysis of data from a randomized controlled trial of the effects of CBT-I compared with HF self-care education among adults with stable HF and insomnia. We used the Self-Care of Heart Failure Index v6.2. The analytic approaches included t-tests, group-based trajectory modeling, ANOVA, and chi-square.ResultsWe included 175 participants (M age=63.0 (12.9) years, White, N = 100]. We found four self-care trajectories: Low self-care (N = 47, 26.8%); Moderate self-care (N = 68, 38.9%): Adequate self-care (N = 42, 24.0%); and Optimal self-care (N = 18, 10.3%). There was no difference in self-care trajectories between interventions. The low self-care group had the most severe baseline fatigue, anxiety, and perceived stress, and lowest cognitive abilities.ConclusionBoth interventions prevented declining self-care. Future research is needed to determine the most efficacious intervention to improve self-care trajectories.Practice ImplicationsHealthcare providers should provide ongoing self-care support for those with persistently low and moderate self-care.     

Development,validation and evaluation of a patient information booklet for rectal cancer survivors with a stoma: A three-step approach

ObjectiveQuantitatively measure the degree of patient satisfaction and perceived acquired knowledge through the development of a patient information booklet for rectal cancer survivors with a stoma, according to a novel three-step approach.MethodsThe study included a systematic literature review to identify relevant information for the booklet, which was validated by experts based on relevance, clarity and essentiality. It underwent testing on quality, readability, and layout and design and was quantitatively evaluated by rectal cancer survivors with a stoma.ResultsIn total, 145 articles were used for the development of the booklet. It scored 91% for relevance according to 17 experts, 70% for readability, 75.63% for quality and 23 out of 32 for design. The mean score of patient satisfaction was 8.03 out of 10. All 20 patients found the booklet ‘useful’ and 95% felt better informed.ConclusionsThe booklet scored high for patient satisfaction and increased perceived acquired information. It ensured satisfactory levels of quality, readability, and layout and design.Practice implicationsThis study offers a novel three-step approach for development of informational tools for cancer survivors, assuring that a variety of newly created written patient materials would be of increased quality and relevance to any target population.     

Effects of Cognitive Behavioral Therapy for Insomnia on Sleep-Related Cognitions Among Patients With Stable Heart Failure

Objective/Background: Cognitive behavioral therapy for insomnia (CBT-I) improves insomnia and fatigue among chronic heart failure (HF) patients, but the extent to which sleep-related cognitions explain CBT-I outcomes in these patients is unknown. We examined the effects of CBT-I on sleep-related cognitions, associations between changes in sleep-related cognitions and changes in sleep and symptoms after CBT-I, and the extent to which cognitions mediated the effects of CBT-I. Participants: Stable New York Heart Association Class II-III HF patients (total n = 51; n = 26 or 51.0% women; M age = 59.1 ± 15.1 years). Methods: HF patients were randomized in groups to group CBT-I (n = 30) or attention control (HF self-management education, n = 21) and completed actigraphy, the Insomnia Severity Index, Pittsburgh Sleep Quality Index, Dysfunctional Beliefs and Attitudes about Sleep (DBAS) and Sleep Disturbance Questionnaires (SDQ), and self-reported fatigue, depression, anxiety, and sleepiness (baseline, immediately after treatment, six months). We used mixed-effects modeling, mediation analysis with a bootstrapping approach, and Pearson correlations. Results: There was a statistically significant group × mult time effect on DBAS. DBAS mediated the effects of CBT-I on insomnia severity and partially mediated CBT-I effects on fatigue. Improvements in dysfunctional cognitions were associated with improved sleep quality, insomnia severity, sleep latency and decreased fatigue, depression, and anxiety, with sustained effects at six months. Conclusions: Improvement in dysfunctional sleep-related cognitions is an important mechanism for CBT-I effects among HF patients who are especially vulnerable to poor sleep and high symptom burden.     

Mode of delivery of Cognitive Behavioral Therapy for Insomnia: a randomized controlled non-inferiority trial of digital and face-to-face therapy

Study ObjectivesDigital Cognitive Behavioral Therapy for Insomnia (dCBT-I) has demonstrated efficacy in reducing insomnia severity in self-referred and community samples. It is unknown, however, how dCBT-I compares to individual face-to-face (FtF) CBT-I for individuals referred to clinical secondary services. We undertook a randomized controlled trial to test whether fully automated dCBT-I is non-inferior to individual FtF CBT-I in reducing insomnia severity.MethodsEligible participants were adult patients with a diagnosis of insomnia disorder recruited from a sleep clinic provided via public mental health services in Norway. The Insomnia Severity Index (ISI) was the primary outcome measure. The non-inferiority margin was defined a priori as 2.0 points on the ISI at week 33.ResultsIndividuals were randomized to FtF CBT-I (n = 52) or dCBT-I (n = 49); mean baseline ISI scores were 18.4 (SD 3.7) and 19.4 (SD 4.1), respectively. At week 33, the mean scores were 8.9 (SD 6.0) and 12.3 (SD 6.9), respectively. There was a significant time effect for both interventions (p < 0.001); and the mean difference in ISI at week 33 was −2.8 (95% CI: −4.8 to −0.8; p = 0.007, Cohen’s d = 0.7), and −4.6 at week 9 (95% CI −6.6 to −2.7; p < 0.001), Cohen’s d = 1.2.ConclusionsAt the primary endpoint at week 33, the 95% CI of the estimated treatment difference included the non-inferiority margin and was wholly to the left of zero. Thus, this result is inconclusive regarding the possible inferiority or non-inferiority of dCBT-I over FtF CBT-I, but dCBT-I performed significantly worse than FtF CBT-I. At week 9, dCBT-I was inferior to FtF CBT-I as the 95% CI was fully outside the non-inferiority margin. These findings highlight the need for more clinical research to clarify the optimal application, dissemination, and implementation of dCBT-I. Clinicaltrials.gov: NCT02044263: Cognitive Behavioral Therapy for Insomnia Delivered by a Therapist or on the Internet: a Randomized Controlled Non-inferiority Trial.     

Patient Perceptions of Treatment Delivery Platforms for Cognitive Behavioral Therapy for Insomnia

Objective: Stepped care has given rise to the proliferation of abbreviated CBT-I programs and delivery formats. This includes interventions delivered by allied health professionals and those delivered electronically through the Internet. This article aims to explore patient perceptions between electronic and face-to-face (FTF) delivery platforms for (abbreviated) CBT-I. Participants: Patients with insomnia from specialist sleep or psychology clinics and those from the general community in Sydney, Australia. Method: Semistructured interviews were conducted with patients with insomnia, guided by a schedule of questions and a choice task to explore patient perceptions of the different CBT-I treatment delivery platforms (e.g., perceived advantages and disadvantages or willingness to engage with either platform). Interviews were transcribed verbatim and analyzed using Framework Analysis. Participants also completed a battery of clinical mood and insomnia measures. Results: Fifty-one interviews were conducted with patients with insomnia from specialist sleep or psychology clinics (n = 22) and the general community (n = 29). Synthesis of the qualitative data set revealed three themes pertinent to the patients’ perspective toward electronic and FTF CBT-I delivery: Concepts of Efficacy, Concerns About Treatment, and Treatment on My Terms. Participants’ choice to engage with either platform was also informed by diverse factors including perceived efficacy of treatment, personal commitments, lifestyle, and beliefs about sleep and insomnia. Conclusion: Clarifying patient treatment priorities and allaying potential concerns about engaging with an electronic treatment platform represent important steps for disseminating eCBT-I into mainstream practice.     

A novel approach to management of sleep-associated problems in patients with breast cancer (MOSAIC) during chemotherapy : A pilot study

Study ObjectivesThis pilot randomized controlled trial (RCT) was conducted to assess the preliminary effects of Brief Behavioral Therapy for Cancer-Related Insomnia (BBT-CI) delivered by trained research staff in comparison to a sleep hygiene pamphlet control and to assess moderators of treatment effect in patients with breast cancer undergoing chemotherapy.MethodsOf 74 participants recruited, 37 were randomized to BBT-CI and 37 were randomized to the control condition. Trained staff members delivered the intervention during chemotherapy treatments to reduce patients’ burden. Insomnia was assessed with the Insomnia Severity Index (ISI), anxiety was assessed with the Spielberger State-Trait Anxiety Inventory, symptom burden was assessed with the Symptom Inventory (SI), and study staff recorded previous treatments and surgeries received by patients.ResultsPatients randomized to BBT-CI showed significantly greater improvements in their ISI scores compared to the sleep hygiene group. Additionally, several treatment moderators were identified. The effect of BBT-CI was greater among individuals with lower baseline state-trait anxiety, with previous surgery for cancer, and with higher baseline somatic symptom severity.ConclusionsBBT-CI shows preliminary efficacy compared to the sleep hygiene handout on insomnia in cancer patients undergoing chemotherapy. A large-phase III RCT needs to be conducted to replicate the preliminary findings.     

Intraindividual variability in sleep schedule: effects of an internet-based cognitive-behavioral therapy for insomnia program and its relation with symptom remission

Study ObjectivesSleep schedule consistency is fundamental to cognitive-behavioral therapy for insomnia (CBT-I), although there is limited evidence suggesting whether it predicts treatment response. This analysis tested whether: (1) an Internet-based CBT-I program affects intraindividual variability (IIV) in sleep schedule and (2) sleep schedule IIV predicts insomnia symptom remission.MethodsThis secondary analysis compares participants (N = 303) randomized to an Internet-based CBT-I program (SHUTi—Sleep Healthy Using the Internet) or Internet-based patient education (PE). Participants reported daily bedtimes and rising times on 10 online sleep diaries collected over 2 weeks at baseline and 9-week post-intervention assessment. Participants completed the Insomnia Severity Index (ISI) at post-assessment and 6-month follow-up; symptom remission was defined by ISI < 8. Mixed effects location scale modeling was used to examine the effect of SHUTi on bedtime and rising time IIV; a novel two-staged analysis examined the effect of bedtime and rising time IIV on insomnia symptom remission.ResultsAt post-assessment, SHUTi participants reported about 30% less bedtime and 32% less rising time variability compared to PE (ps < 0.03). Bedtime and rising time IIV was not independently associated with likelihood of insomnia symptom remission at the subsequent time point (ps > 0.18), nor did sleep schedule IIV moderate treatment response (ps > 0.12).ConclusionsFindings demonstrate that an Internet-delivered CBT-I program can effectively increase users’ sleep schedule consistency relative to an educational control. This consistency, however, was not related to treatment outcome when defined by insomnia symptom remission, suggesting that enforcing rigid sleep schedules for patients may not be necessary for treatment success.Clinical Trial Registration{"type":"clinical-trial","attrs":{"text":"NCT00328250","term_id":"NCT00328250"}}NCT00328250     

Randomized trial of a question prompt list to increase patient active participation during interactions with black patients and their oncologists

ObjectiveCommunication during racially-discordant interactions is often of poor quality and may contribute to racial treatment disparities. We evaluated an intervention designed to increase patient active participation and other communication-related outcomes during interactions between Black patients and non-Black oncologists.MethodsParticipants were 18 non-Black medical oncologists and 114 Black patients at two cancer hospitals in Detroit, Michigan, USA. Before a clinic visit to discuss treatment, patients were randomly assigned to usual care or to one of two question prompt list (QPL) formats: booklet (QPL-Only), or booklet and communication coach (QPL-plus-Coach). Patient-oncologist interactions were video recorded. Patients reported perceptions of the intervention, oncologist communication, role in treatment decisions, and trust in the oncologist. Observers assessed interaction length, patient active participation, and oncologist communication.ResultsThe intervention was viewed positively and did not increase interaction length. The QPL-only format increased patient active participation; the QPL-plus-Coach format decreased patient perceptions of oncologist communication. No other significant effects were found.ConclusionThis QPL booklet is acceptable and increases patient active participation in racially-discordant oncology interactions. Future research should investigate whether adding physician-focused interventions might improve other outcomes.Practice implicationsThis QPL booklet is acceptable and can improve patient active participation in racially-discordant oncology interactions.     

Manifestations of Insomnia in Sleep Apnea: Implications for Screening and Treatment

The aims of this study were to examine the presence, type, and severity of insomnia complaints in obstructive sleep apnea (OSA) patients and to assess the utility of the Sleep Symptom Checklist (SSC) for case identification in primary care. Participants were 88 OSA patients, 57 cognitive-behavioral therapy for insomnia (CBT-I) patients, and 14 healthy controls (Ctrl). Each completed a sleep questionnaire as well as the SSC, which includes insomnia, daytime functioning, psychological, and sleep disorder subscales. Results showed that OSA patients could be grouped according to 3 insomnia patterns: no insomnia (OSA), n = 21; insomnia (OSA-I), n = 30, with a subjective complaint and disrupted sleep; and noncomplaining poor sleepers (OSA-I-NC), n = 37. Comparisons among the OSA, CBT-I, and Ctrl groups demonstrate distinct profiles on the SSC subscales, indicating its potential utility for both case identification and treatment planning.     

Effectiveness of mandala coloring in reducing anxiety in women with early-stage breast cancer receiving chemotherapy for the first time

ContextMany people with cancer experience fear or anxiety when starting chemotherapy for the first time. Mandala coloring is an art therapy approach commonly used for anti-stress therapy.ObjectiveTo assess whether mandala coloring reduces the anxiety experienced by women with early-stage breast cancer during their first chemotherapy session.DesignA quasi-experimental controlled study with pretest/posttest design.SettingThe study was conducted in the outpatient chemotherapy unit of the Istanbul University Institute of Oncology between March 2017 and May 2018.ParticipantsEight-four women with early-stage breast cancer who presented for their first session of chemotherapy were included, 41 in the intervention group and 43 in the control group.InterventionPatients in the intervention group were asked to color a mandala for 30 min while receiving premedication prior to chemotherapy. No intervention was applied to the control group.Main outcome measuresLevels of distress and anxiety were assessed before and after premedication using the distress thermometer and State–Trait Anxiety Inventory.ResultsThe sample group consisted primarily of women who had primary school education, were married, and were homemakers. Average distress levels were low in both the intervention and control group before premedication, and state anxiety scores did not differ statistically between the groups before or after premedication. However, patients in the intervention group who had high distress levels before premedication showed a significant decrease in state anxiety score after premedication, while patients in the control group showed no decrease.     

Effectiveness of Group Cognitive Behavioral Therapy for Insomnia (CBT-I) in a Primary Care Setting

Objective/Background: Primary care is where many patients with insomnia first ask for professional help. Cognitive-behavioral therapy for insomnia (CBT-I) is the recommended treatment for chronic insomnia. Although CBT-I’s efficacy is well established, its effectiveness in real-life primary care has seldom been investigated. We examined the effectiveness of CBT-I as routinely delivered in a Canadian primary care setting. Participants: The patients were 70 women and 11 men (mean age = 57.0 years, SD = 12.3); 83% had medical comorbidity. Methods: For the first 81 patients who took the six-session group program we compared initial and postprogram sleep diaries, sleep medication use, Insomnia Severity Index (ISI), the Hospital Anxiety and Depression Scale (HADS), and visits to the family physician. Results: Sleep onset latency, wake after sleep onset, total sleep time, sleep efficiency, and ISI scores improved significantly (p < .001). Mood ratings also improved (p < .001). Use of sleep medication decreased (p < .001). Effect sizes were medium to large. Eighty-eight percent of patients no longer had clinically significant insomnia (ISI score ≤ 14) by the last session; 61% showed at least “moderate” improvement (ISI score reduction > 7). Wait-list data from 42 patients showed minimal sleep and mood improvements with the passage of time. Number of visits to the family physician six months postprogram decreased, although not significantly (p = .108). Conclusions: The CBT-I program was associated with improvement on all sleep and mood measures. Effect sizes were similar to, or larger than, those found in randomized controlled trials, demonstrating the real-world effectiveness of CBT-I in an interdisciplinary primary care setting.     

Effectiveness of question prompt lists in patients with breast cancer: A randomized controlled trial

ObjectivesTo evaluate the effectiveness of a question prompt list (QPL) in decision self-efficacy, decision-making participation, patient–physician communication, decisional conflict or regret, and health status in patients with breast cancer.MethodsA total of 240 patients with breast cancer were randomly assigned to a QPL group or control group (n = 120 each). The intervention and control groups received an additional educational QPL booklet and routine care, respectively.ResultsThe intervention group exhibited significant improvements in decision self-efficacy, perceived patient–physician interactions, and patient–physician communication compared with the control group. Multilevel modeling analyses revealed significant group–time interaction effects on decision self-efficacy (β = 9.99, P < 0.01), perceived patient–physician interactions (β = 8.10, P < 0.01), patient–physician communication (β = 5.02, P < 0.01), and anxiety status (β = ?3.78, P < 0.05). The QPL intervention exerted more favorable effects than routine care, with repeated measurements of the same patients and the data of patients under the care of the same surgeons accounted for.ConclusionsThe QPL intervention exerted multidimensional effects on decision-making outcomes among patients with breast cancer.Practical implicationsClinicians can integrate a QPL into routine care for patients with breast cancer.