Preliminary validation of the Cognitive Affective Mindfulness Scale-Revised in cancer populations.

OBJECTIVE: A brief, valid, and comprehensive measure of mindfulness is needed for cancer populations. This study examined the factor structure, internal consistency, construct validity, and measurement invariance of the 10-item Cognitive Affective Mindfulness Scale-Revised (CAMS-R) in patients with cancer. METHODS: Patients with breast, gastrointestinal, lung, or prostate cancer (N = 404, 50% stage IV cancer, 51% women) were recruited from academic and public clinics in Indianapolis, IN. Patients completed the CAMS-R and other psychological measures at one time point. Confirmatory factor analysis (CFA) was used to examine the dimensionality of the CAMS-R. Internal consistency and construct validity were also assessed. Measurement invariance was examined for gender, cancer type, and cancer stage. RESULTS: CFA showed that the original CAMS-R structure with four first-order factors (attention, present focus, awareness, and acceptance) and one second-order factor (mindfulness) had a reasonable fit (RMSEA = 0.09, CFI = 0.95, SRMR = 0.04). Internal consistency was excellent (α = 0.90). The CAMS-R total score showed significant positive associations with several subscales of a widely used mindfulness questionnaire and self-compassion (rs = 0.61-0.66) and significant negative associations with anxiety, depressive symptoms, rumination, psychological inflexibility, and avoidant coping (rs = -0.35-0.58). Measurement invariance testing indicated that the CAMS-R was invariant across populations of varying genders, cancer types, and stages. CONCLUSIONS: Findings provide preliminary support for using the CAMS-R in cancer populations. Future research should assess the responsiveness of the CAMS-R to intervention.

Development and preliminary validation of the Brief Self-Compassion Inventory.

Research and clinical interest in self-compassion has grown due to its associations with physical and mental health benefits. Widely used measures of self-compassion have conceptual and psychometric limitations that warrant attention. The purpose of this project was to develop a new self-compassion measure, the Brief Self-Compassion Inventory (BSCI), and test its psychometric properties. We developed items for the BSCI based on theory, prior research, and expert and cancer patient feedback. The BSCI was then tested with adults diagnosed with breast, gastrointestinal, lung, or prostate cancer (N = 404). Confirmatory factor analysis suggested a unidimensional structure, and internal consistency reliability was excellent. Construct validity of the BSCI was established through its correlations with psychological variables hypothesized to be related to self-compassion, such as mindfulness, acceptance of cancer, and other coping strategies. Furthermore, measurement invariance testing of the BSCI indicated that it could be used across patients of varying genders, cancer types, and stages of illness. In conclusion, the 5-item BSCI was determined to be psychometrically sound and suitable for use with adults of varying genders, cancer types, and stages of disease. The measure warrants testing with other medical and nonclinical populations.

NCCN Guidelines® Insights: Distress Management, Version 2.2023.

These NCCN Guidelines for Distress Management discuss the identification and treatment of psychosocial problems in patients with cancer. All patients experience some level of distress associated with a cancer diagnosis and the effects of the disease and its treatment regardless of the stage of disease. Clinically significant levels of distress occur in a subset of patients, and identification and treatment of distress are of utmost importance. The NCCN Distress Management Panel meets at least annually to review comments from reviewers within their institutions, examine relevant new data from publications and abstracts, and reevaluate and update their recommendations. These NCCN Guidelines Insights describe updates to the NCCN Distress Thermometer (DT) and Problem List, and to the treatment algorithms for patients with trauma- and stressor-related disorders.

Impact of acceptance and commitment therapy on physical and psychological symptoms in advanced gastrointestinal cancer patients and caregivers: Secondary results of a pilot randomized trial.

Patients with advanced gastrointestinal cancer often experience high symptom burden, which is associated with heightened distress in both patients and their family caregivers. Few interventions have been tested to jointly address patient and caregiver symptoms in advanced gastrointestinal cancer. In a randomized pilot trial, telephone-based, dyadic acceptance and commitment therapy (ACT) was found to be feasible in this population. The present secondary analyses examined the impact of this intervention on patient and caregiver physical and psychological symptoms. Patients and caregivers (N = 40 dyads) were recruited from clinics in Indianapolis, Indiana and randomized to either six weeks of telephone-based ACT or education/support, an attention control condition. Outcomes were assessed at baseline and at 2 weeks and 3 months post-intervention. Study group differences in outcomes were not statistically significant. However, when examining within-group change, only ACT patients experienced moderate reductions in pain severity and interference at 2 weeks post-intervention (effect size [ES]=-0.47; -0.51) as well as moderate reductions in depressive symptoms at 2 weeks (ES=-0.42) and 3 months (ES=-0.41) post-intervention. ACT caregivers experienced moderate reductions in sleep disturbance (ES=-0.56; -0.49) and cognitive concerns (ES=-0.61; -0.85) across follow-ups. Additionally, caregivers in both conditions experienced moderate reductions in fatigue (ES=-0.38 to -0.70) and anxiety (ES=-0.40 to -0.49) across follow-ups. Findings suggest that ACT may improve certain symptoms in dyads coping with advanced gastrointestinal cancer and warrant replication in a larger trial.

Comparative responsiveness and minimally important difference of Fatigue Symptom Inventory (FSI) scales and the FSI-3 in trials with cancer survivors.

BACKGROUND: Fatigue is a highly prevalent and disabling symptom in cancer survivors. Although many measures have been developed to assess survivors' fatigue, their ability to accurately capture change following intervention has rarely been assessed in post-treatment survivors. Ultra-brief fatigue measures are preferable in clinical practice but have limited evidence supporting their use with cancer survivors. We examined the psychometric properties of four Fatigue Symptom Inventory (FSI) measures, including the new FSI-3, in cancer survivors. Examined properties included responsiveness to change and minimally important differences (MIDs). METHODS: We analyzed data from three randomized controlled trials with post-treatment cancer survivors (N = 328). Responsiveness to change was evaluated by comparing standardized response means for survivors who reported their fatigue as being better, the same, or worse at 2-3 months. Responsiveness to intervention was assessed via effect sizes, and MIDs were estimated by using several methods. We also computed area under the curve (AUC) values to assess FSI measures' discriminative accuracy compared to an established cut-point. RESULTS: All FSI measures differentiated survivors who reported improvement at 2-3 months from those with stable fatigue, but did not uniformly differentiate worsening fatigue from stable fatigue. Measures showed similar levels of responsiveness to intervention, and MIDs ranged from 0.29 to 2.20 across FSI measures. AUC analyses supported the measures' ability to detect significant fatigue. CONCLUSIONS: Four FSI scales show similar responsiveness to change, and estimated MIDs can inform assessment of meaningful change in fatigue. The FSI-3 shows promise as an ultra-brief fatigue measure for survivors.

Acceptance and commitment therapy for patient fatigue interference and caregiver burden in advanced gastrointestinal cancer: Results of a pilot randomized trial.

BACKGROUND: Fatigue often interferes with functioning in patients with advanced cancer, resulting in increased family caregiver burden. Acceptance and commitment therapy, a promising intervention for cancer-related suffering, has rarely been applied to dyads coping with advanced cancer. AIM: To examine the feasibility, acceptability, and preliminary efficacy of acceptance and commitment therapy for patient-caregiver dyads coping with advanced gastrointestinal cancer. Primary outcomes were patient fatigue interference and caregiver burden. DESIGN: In this pilot trial, dyads were randomized to six weekly sessions of telephone-delivered acceptance and commitment therapy or education/support, an attention control. Outcomes were assessed at baseline and at 2 weeks and 3 months post-intervention. SETTING/PARTICIPANTS: Forty patients with stage III-IV gastrointestinal cancer and fatigue interference and family caregivers with burden or distress were recruited from two oncology clinics and randomized. RESULTS: The eligibility screening rate (54%) and retention rate (81% at 2 weeks post-intervention) demonstrated feasibility. At 2 weeks post-intervention, acceptance and commitment therapy participants reported high intervention helpfulness (mean = 4.25/5.00). Group differences in outcomes were not statistically significant. However, when examining within-group change, acceptance and commitment therapy patients showed moderate decline in fatigue interference at both follow-ups, whereas education/support patients did not show improvement at either follow-up. Acceptance and commitment therapy caregivers showed medium decline in burden at 2 weeks that was not sustained at 3 months, whereas education/support caregivers showed little change in burden. CONCLUSIONS: Acceptance and commitment therapy showed strong feasibility, acceptability, and promise and warrants further testing. TRIAL REGISTRATION: ClinicalTrials.gov NCT04010227. Registered 8 July 2019, https://clinicaltrials.gov/ct2/show/NCT04010227?term=catherine+mosher&draw=2&rank=1.

Referral process to further evaluate poor sleep in breast cancer survivors.

OBJECTIVE: Breast cancer survivors (BCS) are twice as likely to report symptoms of poor sleep as those without cancer. However, sleep disorders are under-assessed and under-treated among BCS. The purpose of this study was to determine the portion of BCS who completed referral visits to a sleep specialist and identify the acceptability, facilitators, and barriers to the screening and referral process. METHODS: BCS, who reported having sleep problems, completed questionnaires to screen for symptoms suggestive of sleep disorders. Those with symptoms suggestive of sleep apnea, movement disorders, narcolepsy, insomnia syndrome, or circadian disorders, they were referred to a sleep medicine physician or behavioral sleep medicine psychologist. Two months after the referral, participants were interviewed about their perceptions of the acceptability, barriers, and facilitators to sleep screenings and referrals. RESULTS: Of 34 BCS assessed for eligibility, 29 were eligible and had sleep problems. Only eight of 29 participants (27.6%) completed the sleep referral process. Most thought the screening and referral process was acceptable. However, BCS identified barriers to completing the referral visit, including time, not seeing the need for treatment, insurance/sick leave concerns, and distance/transportation. CONCLUSION: Adequate evaluation and treatment of sleep disorders in BCS are rare. Creative solutions to address barriers to timely sleep referrals are needed to reduce long-term negative consequences of inadequate sleep.

Spiritual Care Assessment and Intervention (SCAI) for Adult Outpatients With Advanced Cancer and Caregivers: A Pilot Trial to Assess Feasibility, Acceptability, and Preliminary Effects.

BACKGROUND: Although religion and spirituality are important to adults with cancer and their family caregivers, few studies have tested spiritual care interventions in the outpatient setting. AIM: To determine the feasibility, acceptability, and preliminary effects of chaplain-delivered, semi-structured spiritual care to adult outpatients with advanced cancer and their caregivers. DESIGN: In this pre/post pilot intervention study, board-certified chaplains utilized the Spiritual Care Assessment and Intervention (SCAI) framework during 4 individual sessions. Surveys at baseline and at 1, 6, and 12 weeks post-intervention assessed spiritual well-being, quality of life, depression, anxiety, and religious coping. SETTING/PARTICIPANTS: We enrolled U.S. adult outpatients with or without an eligible family caregiver. Eligible patients were at least 18 years old and at least 2 weeks post-diagnosis of incurable and advanced-stage lung or gastrointestinal (GI) cancer. RESULTS: Of 82 eligible patients, 24 enrolled (29.3%); of 22 eligible caregivers, 18 enrolled (81.8%). Four planned chaplain visits were completed by 87.5% of patients and 77.8% of caregivers. All enrolled participants completed baseline surveys, and more than 75% completed follow-up surveys at 2 of 3 time points. More than 80% of patients and caregivers reported they would recommend the sessions to a friend or family member. Patients' spiritual well-being improved significantly at all timepoints compared to baseline: 1-week post (p < .006), 6-weeks post (p < .001), and 12-weeks post (p < .004). CONCLUSIONS: Spiritual care through SCAI is feasible, acceptable, and shows promise in improving spiritual well-being and other important outcomes in advanced-stage cancer patients and family caregivers. Further investigation is warranted.

Symptom experiences in advanced cancer: Relationships to acceptance and commitment therapy constructs.

OBJECTIVE: This study examined relations between acceptance and commitment therapy (ACT) constructs and symptom-based subgroups of advanced cancer patients. METHODS: Patients with advanced breast, gastrointestinal, lung, and prostate cancer (N = 201) completed questionnaires assessing five common symptoms and ACT variables (i.e., psychological inflexibility, cognitive fusion, values obstruction and progress, peaceful acceptance, mindfulness, and activity engagement) on one occasion. RESULTS: Latent profile analysis showed three patient classes: (1) normal levels of all symptoms (32%); (2) normal levels of all symptoms except for mild sleep problems and moderate fatigue (19%); and (3) normal pain, mild levels of sleep problems, anxiety, and depressive symptoms, and moderate fatigue (48%). Controlling for demographic covariates, lower psychological inflexibility, cognitive fusion, and values obstruction were associated with a higher likelihood of being in classes 1 or 2 than class 3. In addition, greater values progress, peaceful acceptance, mindfulness, and activity engagement were associated with a higher likelihood of being in class 1 than class 3. Of these four factors, only greater mindfulness and activity engagement were associated with a higher likelihood of being in class 2 than class 3. CONCLUSIONS: Advanced cancer patients show heterogeneous symptom profiles, and even mild to moderate symptom levels are related to greater withdrawal from personally meaningful activities and less acceptance of cancer and internal experiences (e.g., symptoms, thoughts, feelings). Findings are consistent with the ACT model and support further testing of ACT to address symptom interference with functioning in advanced cancer patients.

Symptom Treatment Preferences of Cancer Survivors: Does Fatigue Level Make a Difference?

BACKGROUND: Cancer-related fatigue (CRF) is among the most prevalent symptoms in cancer survivors and often co-occurs with other symptoms. However, little is known about survivors' preferences for treating CRF and associated symptoms. OBJECTIVE: The aim of this study was to examine cancer survivors' interest in learning skills to manage CRF and associated symptoms and their interest in various nonpharmacologic interventions and modalities. These outcomes were compared between survivors with high and normal fatigue. METHODS: Breast, gastrointestinal, lung, and prostate cancer survivors (N = 338) completed a 1-time survey, including a Patient-Reported Outcomes Measurement Information System fatigue measure and a checklist assessing interest in learning skills to manage CRF and associated symptoms as well as interest in nonpharmacologic interventions and modalities. RESULTS: Many cancer survivors reported interest in learning skills to manage CRF (range, 35%-78%) and associated symptoms (range, 13%-48%). Compared with survivors with normal fatigue (n = 180), highly fatigued survivors (n = 158; Patient-Reported Outcomes Measurement Information System fatigue T score ≥ 55) were more likely to report interest in learning skills to manage various symptoms, self-compassion training, and programs offered individually and in person. Interest in other interventions and modalities did not vary by fatigue level. CONCLUSIONS: Many cancer survivors, especially those with high fatigue, report interest in learning symptom management skills. Given survivors' high level of interest in complementary and integrative health interventions, future research should continue to assess their impact on symptoms and functioning. IMPLICATIONS FOR PRACTICE: Nurses can offer a menu of evidence-based options for symptom management, given survivors' diverse preferences. Nurses can also provide psychoeducation regarding their preferred treatments.

Acceptance and commitment therapy for fatigue interference in advanced gastrointestinal cancer and caregiver burden: protocol of a pilot randomized controlled trial.

BACKGROUND: Fatigue interference with activities, mood, and cognition is one of the most prevalent and bothersome concerns of advanced gastrointestinal (GI) cancer patients. As fatigue interferes with patient functioning, family caregivers often report feeling burdened by increasing responsibilities. Evidence-based interventions jointly addressing cancer patient fatigue interference and caregiver burden are lacking. In pilot studies, acceptance and commitment therapy (ACT) has shown promise for addressing symptom-related suffering in cancer patients. The current pilot trial seeks to test a novel, dyadic ACT intervention for both advanced GI cancer patients with moderate-to-severe fatigue interference and their family caregivers with significant caregiving burden or distress. METHODS: A minimum of 40 patient-caregiver dyads will be randomly assigned to either the ACT intervention or an education/support control condition. Dyads in both conditions attend six weekly 50-min telephone sessions. Outcomes are assessed at baseline as well as 2 weeks and 3 months post-intervention. We will evaluate the feasibility, acceptability, and preliminary efficacy of ACT for improving patient fatigue interference and caregiver burden. Secondary outcomes include patient sleep interference and patient and caregiver engagement in daily activities, psychological flexibility, and quality of life. We will also explore the effects of ACT on patient and caregiver physical and mental health service use. DISCUSSION: Findings will inform a large-scale trial of intervention efficacy. Results will also lay the groundwork for further novel applications of ACT to symptom interference with functioning and caregiver burden in advanced cancer. TRIAL REGISTRATION: ClinicalTrials.gov , NCT04010227 . Registered 8 July 2019.

The mediating role of avoidant coping in the relationships between physical, psychological, and social wellbeing and distress in breast cancer survivors.

OBJECTIVE: Many breast cancer survivors (BCSs) recover from the negative sequelae of cancer treatment. However, some report persistent and disruptive distress well into disease-free survivorship. More information is needed on the predictors of distress in this growing population of BCS, including the role of avoidant coping, or attempts to avoid thoughts, feelings, and reminders of cancer, in mediating the relationship between distress and psychological, physical, and social domains of well-being. METHODS: In a large cross-sectional study, BCS (n = 1,127), who were 3 to 8 years post-diagnosis, completed a survey assessing demographic characteristics, medical history, distress (anxiety and depressive symptoms), avoidant coping, and physical (fatigue), psychological (fear of recurrence, attention, body image), and social (social support from a partner, social constraints from a partner) well-being. Multiple mediation analyses were conducted to determine if avoidant coping mediated the relationship between each distress variable (anxiety and depressive symptoms) and each well-being (fear of recurrence, attention, body image, fatigue, social support, and social constraints) variable. RESULTS: In all six mediation models, avoidant coping significantly (p < 0.001) mediated the relationship between each well-being variable (fear of recurrence, attention, body image, fatigue, social support, and social constraints) and each distress indicator (depression and anxiety). Avoidant coping mediated 19%-54% of the effects of the contributing factors on the distress variables. CONCLUSIONS: Avoidant coping may indicate risk for, or presence of, distress among BCS. Interventions to reduce distress may benefit from addressing avoidant coping styles.

Effects of mindfulness-based interventions on fatigue in cancer survivors: A systematic review and meta-analysis of randomized controlled trials.

This systematic review and meta-analysis was designed to determine the efficacy of mindfulness-based interventions (MBIs) in improving fatigue-related outcomes in adult cancer survivors. Randomized controlled trials (RCTs) were identified from PubMed, MEDLINE, PsycINFO, CINAHL, Web of Science, and EMBASE databases and reference lists of included studies. Separate random-effects meta-analyses were conducted for fatigue and vitality/vigor. Twenty-three studies reporting on 21 RCTs (N = 2239) met inclusion criteria. MBIs significantly reduced fatigue compared to controls at post-intervention (g = 0.60, 95 % CI [0.36, 0.83]) and first follow-up (g = 0.42, 95 % CI [0.20, 0.64]). Likewise, MBIs significantly improved vitality/vigor at post-intervention (g = 0.39, 95 % CI [0.25, 0.52]) and first follow-up (g = 0.35, 95 % CI [0.03, 0.67]). The evidence grade was low due to risk of bias, substantial heterogeneity, and publication bias among studies. MBIs show promise in improving fatigue and vitality/vigor in cancer survivors. More rigorous trials are needed to address current gaps in the evidence base.

Feasibility and acceptability of an acceptance and commitment therapy intervention for caregivers of adults with Alzheimer's disease and related dementias.

BACKGROUND: Caregivers of patients with Alzheimer's disease or a related dementia (ADRD) report high levels of distress, including symptoms of anxiety and depression, caregiving burden, and existential suffering; however, those with support and healthy coping strategies have less stress and burden. Acceptance and Commitment Therapy (ACT) aims to foster greater acceptance of internal events while promoting actions aligned with personal values to increase psychological flexibility in the face of challenges. The objective of this single-arm pilot, Telephone Acceptance and Commitment Therapy Intervention for Caregivers (TACTICs), was to evaluate the feasibility, acceptability, and preliminary effects of an ACT intervention on ADRD caregiver anxiety, depressive symptoms, burden, caregiver suffering, and psychological flexibility. METHODS: ADRD caregivers ≥21 years of age with a Generalized Anxiety Disorder Scale (GAD-7) score ≥ 10 indicative of moderate or higher symptoms of anxiety were enrolled (N = 15). Participants received a telephone-based ACT intervention delivered by a non-licensed, bachelor's-prepared trained interventionist over 6 weekly 1-h sessions that included engaging experiential exercises and metaphors designed to increase psychological flexibility. The following outcome measures were administered at baseline (T1), immediately post-intervention (T2), 3 months post-intervention (T3), and 6 months post-intervention (T4): anxiety symptoms (GAD-7; primary outcome); secondary outcomes of depressive symptoms (Patient Health Questionnaire-9), burden (Zarit Burden Interview), suffering (The Experience of Suffering measure), psychological flexibility/experiential avoidance (Acceptance and Action Questionnaire-II), and coping skills (Brief COPE). RESULTS: All 15 participants completed the study and 93.3% rated their overall satisfaction with their TACTICs experience as "completely satisfied." At T2, caregivers showed large reduction in anxiety symptoms (SRM 1.42, 95% CI [0.87, 1.97], p < 0.001) that were maintained at T3 and T4. At T4, psychological suffering (SRM 0.99, 95% CI [0.41, 1.56], p = 0.0027) and caregiver burden (SRM 0.79, 95% CI [0.21, 1.37], p = 0.0113) also decreased. CONCLUSIONS: Despite a small sample size, the 6-session manualized TACTICs program was effective in reducing anxiety, suggesting that non-clinically trained staff may be able to provide an effective therapeutic intervention by phone to maximize intervention scalability and reach. TRIAL REGISTRATION: Institutional Review Board (IRB) protocol #1904631305 version 05-14-2019. Recruitment began 06-14-2019 and was concluded on 12-09-2019. Recruitment began 06-14-2019 and was concluded on 12-09-2019.

Symptom experiences in post-treatment cancer survivors: associations with acceptance and commitment therapy constructs.

PURPOSE: Acceptance and Commitment Therapy (ACT) has improved symptom and quality-of-life outcomes in pilot research with post-treatment cancer survivors. To further test the ACT model, the present study examined relationships between ACT constructs and subgroups of post-treatment survivors based on the severity of common symptoms. METHODS: Survivors who had completed primary treatment for stage I or II cancer (N = 203) participated in this one-time survey. Latent class analysis (LCA) was used to identify subgroups of survivors based on the severity of fatigue, sleep disturbance, pain, anxiety, and depressive symptoms. Multinomial logistic regressions employing Vermunt's 3-step approach were used to examine ACT constructs (e.g., mindfulness, acceptance, values progress) as correlates of survivor subgroups based on symptoms. RESULTS: The LCA showed three survivor classes: (1) mild-to-moderate levels of all symptoms except for normal pain intensity; (2) mild anxiety, moderate fatigue, and normal levels of all other symptoms; and (3) normal levels of all symptoms. Lower mindfulness, acceptance, and values progress and higher cognitive fusion, psychological inflexibility, and values obstruction were associated with a greater likelihood of being in class 1 or 2 than in class 3. CONCLUSION: Findings are consistent with the ACT model. Survivors with greater symptom burden reported greater withdrawal from personally meaningful activities and less acceptance of their cancer diagnosis and internal experiences (e.g., thoughts, feelings, symptoms). Findings provide strong justification for further testing of ACT to reduce symptom-related suffering in cancer survivors.

Relations of Mindfulness and Illness Acceptance With Psychosocial Functioning in Patients With Metastatic Breast Cancer and Caregivers.

OBJECTIVES: To examine relationships in mindfulness and illness acceptance and psychosocial functioning in patients with metastatic breast cancer and their family caregivers. SAMPLE & SETTING: 33 dyads from an academic cancer center in the United States. METHODS & VARIABLES: Participants completed questionnaires on mindfulness, illness acceptance, relationship quality, anxiety, and depressive symptoms. Dyadic, cross-sectional data were analyzed using actor-partner interdependence models. RESULTS: Greater nonjudging, acting with awareness, and illness acceptance among caregivers were associated with patients' and caregivers' perceptions of better relationship quality. Higher levels of these processes were associated with reduced anxiety and depressive symptoms in patients and caregivers. IMPLICATIONS FOR NURSING: Aspects of mindfulness and illness acceptance in dyads confer benefits that are primarily intrapersonal in nature. Nurses may consider introducing mindfulness and acceptance-based interventions to patients and caregivers with adjustment difficulties.

Protocol of a randomized trial of acceptance and commitment therapy for fatigue interference in metastatic breast cancer.

Fatigue interference with activities, mood, and cognition is one of the most prevalent and distressing concerns of metastatic breast cancer patients. To date, there are no evidence-based interventions for reducing fatigue interference in metastatic breast cancer and other advanced cancer populations. In pilot studies, Acceptance and Commitment Therapy (ACT) has shown potential for reducing symptom-related suffering in cancer patients. The current Phase II trial seeks to more definitively examine the efficacy of telephone-based ACT for women with metastatic breast cancer who are experiencing fatigue interference. In this trial, 250 women are randomly assigned to either the ACT intervention or an education/support control condition. Women in both conditions attend six weekly 50-min telephone sessions. The primary aim of this study is to test the effect of telephone-based ACT on fatigue interference. Secondary outcomes include sleep interference, engagement in daily activities, and quality of life. Outcomes are assessed at baseline, 2 weeks post-intervention, and 3 and 6 months post-intervention. This trial also examines whether increases in psychological flexibility, defined as full awareness of the present moment while persisting in behaviors aligned with personal values, account for the beneficial effect of ACT on fatigue interference. After demonstrating ACT's efficacy, the intervention can be widely disseminated to clinicians who care for metastatic breast cancer patients. Our findings will also inform future ACT trials with various cancer populations and functional outcomes.

Predictors of depression outcomes in adults with cancer: A 12 month longitudinal study.

OBJECTIVES: The prevalence of depression in patients with cancer ranges from 8% to 24% within the first year of receiving a cancer diagnosis. Identifying predictors of depression outcomes may facilitate tailored or more intensive treatment in patient subgroups with a poorer prognosis for depression improvement. The objective of this study was to determine predictors of depression severity and improvement over 12 months among adults with cancer. METHODS: Longitudinal analysis of data from the Indiana Cancer Pain and Depression trial was performed in 309 patients (n = 309) with cancer-related depression. Depression outcomes were assessed at baseline, 1, 3, 6, and 12 months and included depression severity (Hopkins Symptom Checklist-20) and global improvement (Depression Global Rating of Improvement (DGRI)). Multivariable repeated measures analyses, adjusting for treatment group, baseline depression, and time point, were conducted to determine symptom (pain), demographic, and clinical predictors of depression outcomes over 12 months. RESULTS: Pain was particularly important, with a clinically meaningful reduction in pain predicting a 12-24% greater odds of depression global improvement. Other factors that independently predicted better depression outcomes over 12 months included female sex, newly-diagnosed or maintainence/disease-free cancer, fewer comorbid medical conditions, and higher socioeconomic status. As expected, the three covariates adjusted for in the model (treatment group, passage of time, and baseline depression severity) also predicted depression outcomes. CONCLUSION: Pain as well as several demographic and clinical factors predict depression outcomes over 12 months. These findings may help identify patient subgroups requiring closer monitoring and more intensive or tailored depression treatment. Trial Registration clinicaltrials.gov Identifier: NCT00313573.

Psychological Processes and Symptom Outcomes in Mindfulness-Based Stress Reduction for Cancer Survivors: A Pilot Study.

OBJECTIVES: Growing evidence supports the efficacy of mindfulness-based interventions for symptoms in cancer survivors. Identifying theory-based psychological processes underlying their effects on symptoms would inform research to enhance their efficacy and cost-effectiveness. We conducted secondary analyses examining the effect of mindfulness-based stress reduction (MBSR) for cancer-related fatigue on mindfulness facets, self-compassion, and psychological inflexibility. We also examined whether changes in these processes were associated with the symptom outcomes of fatigue interference, sleep disturbance, and emotional distress. METHODS: Thirty-five persistently fatigued cancer survivors (94% female, 77% breast cancer survivors) were randomized to either MBSR for cancer-related fatigue or a waitlist control (WC) condition. Self-report measures were administered at pre-intervention, post-intervention, and 1-month follow-up. Then the WC group received MBSR and completed a post-intervention follow-up. RESULTS: Linear mixed modeling analyses of the first three time points showed steady increases over time for certain mindfulness facets (observing, acting with awareness, and nonjudging) and self-compassion in favor of the MBSR group. When analyzing pre- and post-intervention data across study conditions, none of the psychological processes predicted change in fatigue interference. However, increased nonjudging was associated with decreased sleep disturbance (ß = -.39, p = .003), and increased acting with awareness was associated with decreased emotional distress (ß = -.36, p = .003). Self-compassion did not predict change in symptom outcomes. CONCLUSIONS: Results point to specific psychological processes that may be targeted to maximize the efficacy of future MBSR interventions for cancer survivors.

Acceptance and commitment therapy for breast cancer survivors with fear of cancer recurrence: A 3-arm pilot randomized controlled trial.

BACKGROUND: Fear of cancer recurrence (FCR) has a profound negative impact on quality of life (QOL) for many cancer survivors. Breast cancer survivors (BCS) are particularly vulnerable, with up to 70% reporting clinically significant FCR. To the authors' knowledge, evidence-based interventions for managing FCR are limited. Acceptance and commitment therapy (ACT) promotes psychological flexibility in managing life's stressors. The current study examined the feasibility and preliminary efficacy of group-based ACT for FCR in BCS. METHODS: Post-treatment BCS (91 patients with stage I-III disease) with clinical FCR randomly were assigned to ACT (6 weekly 2-hour group sessions), survivorship education (SE; 6 weekly 2-hour group sessions), or enhanced usual care (EUC; one 30-minute group coaching session with survivorship readings). FCR severity (primary outcome) and avoidant coping, anxiety, post-traumatic stress, depression, QOL, and other FCR-related variables (secondary outcomes) were assessed at baseline (T1), after the intervention (T2), 1 month after the intervention (T3), and 6 months after the intervention (T4) using intent-to-treat analysis. RESULTS: Satisfactory recruitment (43.8%) and retention (94.5%) rates demonstrated feasibility. Although each arm demonstrated within-group reductions in FCR severity over time, only ACT produced significant reductions at each time point compared with baseline, with between-group differences at T4 substantially favoring ACT over SE (Cohen d for effect sizes, 0.80; P < .001) and EUC (Cohen d, 0.61; P < .01). For 10 of 12 secondary outcomes, only ACT produced significant within-group reductions across all time points. By T4, significant moderate to large between-group comparisons favored ACT over SE and EUC with regard to avoidant coping, anxiety, depression, QOL, and FCR-related psychological distress. CONCLUSIONS: Group-based ACT is a feasible and promising treatment for FCR and associated outcomes in BCS that warrants testing in larger, fully powered trials.