Effect of Aging and Predonation Comorbidities on the Related Peripheral Blood Stem Cell Donor Experience: Report from the Related Donor Safety Study.

The development of reduced-intensity approaches for allogeneic hematopoietic cell transplantation has resulted in growing numbers of older related donors (RDs) of peripheral blood stem cells (PBSCs). The effects of age on donation efficacy, toxicity, and long-term recovery in RDs are poorly understood. To address this we analyzed hematologic variables, pain, donation-related symptoms, and recovery in 1211 PBSC RDs aged 18 to 79 enrolled in the Related Donor Safety Study. RDs aged > 60 had a lower median CD34+ level before apheresis compared with younger RDs (age > 60, 59 × 106/L; age 41 to 60, 81 × 106/L; age 18 to 40, 121 × 106/L; P < .001). This resulted in older donors undergoing more apheresis procedures (49% versus 30% ≥ 2 collections, P < .001) and higher collection volumes (52% versus 32% > 24 L, P < .001), leading to high percentages of donors aged > 60 with postcollection thrombocytopenia <50 × 109/L (26% and 57% after 2 and 3days of collection, respectively). RDs aged 18 to 40 had a higher risk of grades 2 to 4 pain and symptoms pericollection, but donors over age 40 had more persistent pain at 1, 6, and 12 months (odds ratio [OR], 1.7; P = 0.02) and a higher rate of nonrecovery to predonation levels (OR, 1.7; P = .01). Donors reporting comorbidities increased significantly with age, and those with comorbidities that would have led to deferral by National Marrow Donor Program unrelated donor standards had an increased risk for persistent grades 2 to 4 pain (OR, 2.41; P < .001) and failure to recover to predonation baseline for other symptoms (OR, 2.34; P = .004). This information should be used in counseling RDs regarding risk and can assist in developing practice approaches aimed at improving the RD experience for high-risk individuals.

Related peripheral blood stem cell donors experience more severe symptoms and less complete recovery at one year compared to unrelated donors.

Unlike unrelated donor registries, transplant centers lack uniform approaches to related donor assessment and deferral. To test whether related donors are at increased risk for donation-related toxicities, we conducted a prospective observational trial of 11,942 related and unrelated donors aged 18-60 years. Bone marrow (BM) was collected at 37 transplant and 78 National Marrow Donor Program centers, and peripheral blood stem cells (PBSC) were collected at 42 transplant and 87 unrelated donor centers in North America. Possible presence of medical comorbidities was verified prior to donation, and standardized pain and toxicity measures were assessed pre-donation, peri-donation, and one year following. Multivariate analyses showed similar experiences for BM collection in related and unrelated donors; however, related stem cell donors had increased risk of moderate [odds ratios (ORs) 1.42; P<0.001] and severe (OR 8.91; P<0.001) pain and toxicities (OR 1.84; P<0.001) with collection. Related stem cell donors were at increased risk of persistent toxicities (OR 1.56; P=0.021) and non-recovery from pain (OR 1.42; P=0.001) at one year. Related donors with more significant comorbidities were at especially high risk for grade 2-4 pain (OR 3.43; P<0.001) and non-recovery from toxicities (OR 3.71; P<0.001) at one year. Related donors with more significant comorbidities were at especially high risk for grade 2-4 pain (OR 3.43; P<0.001) and non-recovery from toxicities (OR 3.71; P<0.001) at one year. Related donors reporting grade ≥2 pain had significant decreases in Health-Related Quality of Life (HR-QoL) scores at one month and one year post donation (P=0.004). In conclusion, related PBSC donors with comorbidities are at increased risk for pain, toxicity, and non-recovery at one year after donation. Risk profiles described in this study should be used for donor education, planning studies to improve the related donor experience, and decisions regarding donor deferral. Registered at clinicaltrials.gov identifier:00948636.

Quality-of-Life Evaluation After Cytoreductive Surgery with Hyperthermic Intraperitoneal Chemotherapy.

BACKGROUND: Cytoreductive surgery (CS) with hyperthermic intraperitoneal chemotherapy (HIPEC) for peritoneal metastases can alleviate symptoms and prolong survival at the expense of morbidity and quality of life (QoL). This study aimed to monitor QoL and outcomes before and after HIPEC. METHODS: A prospective QoL trial of patients who underwent HIPEC for peritoneal metastases from 2000 to 2015 was conducted. The patients completed the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), the Functional Assessment of Cancer Therapy + Colon Subscale (FACT-C), the Brief Pain Inventory, the Center for Epidemiologic Studies Depression scale, and the Eastern Cooperative Oncology Group (ECOG) performance status at baseline, then 3, 6, 12, and 24 months after HIPEC. The trial outcome index (TOI) was analyzed. Proportional hazards modeled the effect of baseline QoL on survival. RESULTS: The 598 patients (53.8 % female) in the study had a mean age of 53.3 years. The overall 1-year survival rate was 76.8 %, and the median survival period was 2.9 years. The findings showed a minor morbidity rate of 29.3 %, a major morbidity rate of 21.7 %, and a 30-day mortality rate of 3.5 %. The BPI (p < 0.0001) and worst pain (p = 0.004) increased at 3 months but returned to baseline at 6 months. After CS + HIPEC, FACT-C emotional well-being, SF-36 mental component score, and emotional health improved (all p < 0.001). Higher baseline FACT-General (hazard ratio [HR], 0.92; 95 % confidence interval [CI], 0.09-0.96), FACT-C (HR, 0.73; 95 % CI 0.65-0.83), physical well-being (HR, 0.71; 95 % CI 0.64-0.78), TOI (HR, 0.87; 95 % CI 0.84-0.91), and SF-36 vitality (HR, 0.88; 95 % CI 0.83-0.92) were associated with improved survival (all p < 0.001). Higher baseline BPI (HR, 1.1; 95 % CI 1.05-1.14; p < 0.0001), worst pain (HR, 1.06; 95 % CI 1.01-1.10; p = 0.01), and ECOG (HR, 1.74; 95 % CI 1.50-2.01; p < 0.0001) were associated with worse survival. CONCLUSIONS: Although HIPEC is associated with morbidity and detriments to QoL, recovery with good overall QoL typically occurs at or before 6 months. Baseline QoL is associated with morbidity, mortality, and survival after HIPEC.

Patient rated outcomes and survivorship following cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy (CS + HIPEC).

BACKGROUND: Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy (CS + HIPEC) is a treatment combining cytoreductive surgery with hyperthermic chemotherapy directly into the peritoneal cavity. Recipients may gain extended life when compared with best supportive care; yet results often are achieved with substantial morbidity and health-related quality of life (HRQOL) deficits. The purpose of this study was to record patient rated outcomes and the HRQOL of long-term survivors. METHODS: One hundred and two patients living 12+ months post-treatment completed a survey including the Medical Outcomes Study 36-item Short Form Health Survey (SF-36), Functional Assessment of Cancer Therapy-Colon (FACT-C), and Pittsburgh Sleep Quality Index. RESULTS: SF-36 Physical Component scores were significantly lower than general population norms (46.7, z= -2.943, P=0.003), while Mental Component scores were significantly higher (53.6, z=4.208, P ≤ 0.001). FACT scores were higher than general FACT normative scores. The majority (56%) of these survivors reported significant sleep quality impairment. CONCLUSION: Although most HRQOL scores were comparable to or higher than those of the general population, long-term physical and functional deficits remain. These deficits, along with the poor sleep quality of recipients, may be improved by survivorship programs or targeted psychosocial interventions.

Caregiver Quality of Life Before and After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy.

BACKGROUND: Cytoreductive surgery plus intraperitoneal hyperthermic chemotherapy (CRS+HIPEC) is a formidable procedure, often affecting the quality of life (QOL) of the caregiver as well as the patient. We explored the impact of quality of life and depressive symptom burdens of CRS+HIPEC caregivers prospectively. STUDY DESIGN: Patient and caregiver dyads were both consented per IRB-approved protocol; CRS ± HIPEC was performed. The impact on QOL and depressive symptom burdens was assessed on patient-caregiver dyads via the Caregiver Quality of Life (CG QOL-C), CES-D (Center for Epidemiological Studies - Depression) instruments; pre-CS+HIPEC (T1), postoperative (T2), 6 (T3), and 12 (T4) months. RESULTS: Seventy-seven dyads were approached, with 73 participating. Both caregiver and patient depressive symptom trajectories changed significantly. CES-D means for caregivers were (T1-4): 15.1 (SE [standard error] 1.7), 15.0 (1.4), 10.3 (1.4), 13.1 (2.1), p = 0.0008; for patients were: 10.3 (SE 1.1), 13.7 (1.4), 9.0 (1.2), and 10.3 (1.5), p = 0.0002. Preoperatively, caregivers scored 4.8 points (SD 13.4) (p = 0.026) higher than patients. Patients experienced an increase in depression scores at the postoperative visit. At T3, both groups dropped to less concerning levels; yet caregiver CES-D scores increased again at T4 4.7 points (SD 12.5) higher than the patients, and financial well-being became worse from T1 to T3. Possible, probable, and "cases" of depression were higher for caregivers were at all measured time points. CONCLUSIONS: Significant numbers of caregivers endured high depressive symptom burdens and financial concerns. Different caregiver-patient trajectories reflect the need for differential timing of supportive interventions. Evaluation of quality of life and impact of CRS+HIPEC procedures must move beyond assessment of only the patient.

Goals and Adverse Effects: Rate of Concordance Between Patients and Providers.

PURPOSE: Adequate understanding of the goals and adverse effects of cancer treatment has important implications for patients' decision making, expectations, and mood. This study sought to identify the degree to which patients and clinicians agreed upon the goals and adverse effects of treatment (ie, concordance). METHODS: Patients completed a demographic questionnaire, the National Comprehensive Cancer Network Distress Thermometer, the Medical Outcomes Study Social Support Survey, the Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-General questionnaire, the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being questionnaire, and a 13-item questionnaire about the goals and adverse effects of treatment. Providers completed a 12-item questionnaire. RESULTS: One hundred patients (51 female) and 34 providers participated (questionnaire return rate mean difference, 5 days; SD, 16 days). Patient and provider dyads agreed 61% of the time regarding the intent of treatment. In cases of nonagreement, 36% of patients reported more optimistic therapy goals compared to providers. Patients and providers agreed 69% of the time regarding the patient's acknowledgement and understanding of adverse effects. Patients who reported an understanding of likely adverse effects endorsed significantly lower distress scores (mean, 2.5) than those who endorsed not understanding associated adverse effects (mean, 4.1; P = .008). CONCLUSION: Timely data capturing of patient-provider dyadic ratings is feasible. A significant discrepancy exists between a substantial percentage of patients' and providers' views of the intent and adverse effects of treatment. Patients were almost always more optimistic about the intent of treatment. Higher rates of distress were noted in cases of discordance. Providers may benefit from conversational feedback from patients as well as other integrated feedback systems to inform them about patient understanding.

The process of advance care planning in HCT candidates and proxies: self-efficacy, locus of control, and anxiety levels.

The purpose of this study was to examine the relationship between hematopoietic cell transplant candidate and proxy advance care planning (ACP) behavior and attitudes. A total of 49 candidates and 44 proxies completed the Advance Directive Attitudes Survey, Multidimensional Health Locus of Control Scale, Family Decision Making Self-Efficacy Scale, and the State-Trait Anxiety Inventory. In all, 45% of candidates reported completing an advance directive (AD), while only 26% had ADs on file; 80% of candidates discussed ACP wishes with their loved ones and 15% discussed ACP wishes with their medical team. The AD completers were significantly (1) older, (2) more positive about ADs, and (3) were less likely to believe that health events happen by chance. Discrepancies between reported ACP behavior and communication with health care practitioners have implications for end-of-life care.

Hematopoietic stem cell transplant candidate and designated proxy distress levels prior to hematopoietic stem cell transplantation.

Hematopoietic stem cell transplantation (HCT) is associated with a high risk of morbidity, making advance care planning (ACP) essential. The purpose of this study was to assess and compare proxy and HCT candidate distress levels (Distress Thermometer) before (T1) and after (T2) ACP question completion. 79 participants (40 HCT candidates, 39 proxies) rated their distress. The T1, T2 mean distress scores (SD) for HCT candidates were 3.13(2.27), 2.96(2.10); 43% and 38% endorsed clinically significant distress (≥4). Proxies reported 4.21(2.48), 4.33 (2.46); 62% endorsed significant distress at T1, T2. The majority of proxies endorsed distress levels that were clinically significant and comparatively higher (T1 (p = 0.047) and T2 (p = 0.009)) than their paired HCT recipients. Responding to questions about ACP did not increase overall distress ratings.