"Pathways": A hope-enhancing intervention for patients undergoing treatment for advanced lung cancer.

OBJECTIVE: Observational data suggest hope is associated with the quality of life and survival of people with cancer. This trial examined the feasibility, acceptability, and preliminary outcomes of "Pathways," a hope intervention for people in treatment for advanced lung cancer. METHODS: Between 2020 and 2022, we conducted a single-arm trial of Pathways among participants who were 3-12 weeks into systemic treatment. Pathways consisted of two individual sessions delivered during infusions and three phone calls in which participants discussed their values, goals, and goal strategies with a nurse or occupational therapist. Participants completed standardized measures of hope and goal interference pre- and post-intervention. Feasibility was defined as ≥60% of eligible patients enrolling, ≥70% of participants completing three or more sessions, ≥70% of participants completing post-assessments, and mean acceptability ratings ≥7 out of 10 on intervention relevance, helpfulness, and convenience. Linear regression fixed effects models with covariates modeled pre-post changes in complete case analysis and multiple imputation models. RESULTS: Fifty two participants enrolled: female (59.6%), non-Hispanic White (84.6%), rural (75.0%), and with low educational attainment (51.9% high school degree or less). Except for enrollment (54%), feasibility and acceptability markers were surpassed (77% adherence, 77% retention, acceptability ratings ≥8/10). There was moderate improvement in hope and goal interference from pre-to post-intervention (d = 0.51, p < 0.05 for hope; d = -0.70, p < 0.005 for goal interference). CONCLUSIONS: Strong feasibility, acceptability, and patient-reported outcome data suggest Pathways is a promising intervention to increase hope and reduce cancer-related goal interference during advanced lung cancer treatment.

A retrospective analysis of VeriStrat status on outcome of a randomized phase II trial of first-line therapy with gemcitabine, erlotinib, or the combination in elderly patients (age 70 years or older) with stage IIIB/IV non-small-cell lung cancer.

PURPOSE: In a multicenter randomized phase II trial of gemcitabine (arm A), erlotinib (arm B), and gemcitabine and erlotinib (arm C), similar progression-free survival (PFS) and overall survival (OS) were observed in all arms. We performed an exploratory, blinded, retrospective analysis of plasma or serum samples collected as part of the trial to investigate the ability of VeriStrat (VS) to predict treatment outcomes. METHODS: Ninety-eight patients were assessable, and the majority had stage IV disease (81%), adenocarcinoma histology (63%), reported current or previous tobacco use (84%), and 26% had a performance status (PS) of 2. RESULTS: In arm A, patients with VS Good (n = 20) compared with VS Poor status (n = 8) had similar PFS (hazard ratio [HR]: 1.21; p = 0.67) and OS (HR: 0.82; p = 0.64). In arm B, patients with VS Good (n = 26) compared with VS Poor (n = 12) had a statistically significantly superior PFS (HR: 0.33; p = 0.002) and OS (HR: 0.40; p = 0.014). In arm C, patients with VS Good (n = 17) compared with Poor (n = 1 5) had a superior PFS (HR: 0.42; p = 0.027) and a trend toward superior OS (HR: 0.48; p = 0.051). In the multivariate analysis for PFS, VS status was statistically significant (p = 0.011); for OS, VS status (p = 0.017) and PS (p = 0.005) were statistically significant. A statistically significant VS and treatment interaction (gemcitabine versus erlotinib) was observed for PFS and OS. CONCLUSIONS: Gemcitabine is the superior treatment for elderly patients with VS Poor status. First-line erlotinib for elderly patients with VS Good status may warrant further investigation.

Racial/ethnic differences in spiritual well-being among cancer survivors.

This study examined racial/ethnic differences in spiritual well-being (SWB) among survivors of cancer. We hypothesized higher levels of Peace and Faith, but not Meaning, among Black and Hispanic survivors compared to White survivors, differences that would be reduced but remain significant after controlling for sociodemographic and medical factors. Hypotheses were tested with data from the American Cancer Society's Study of Cancer Survivors-II. The FACIT-Sp subscale scores, Meaning, Peace, and Faith assessed SWB, and the SF-36 Physical Component Summary measured functional status. In general, bivariate models supported our initial hypotheses. After adjustment for sociodemographic and medical factors, however, Blacks had higher scores on both Meaning and Peace compared to Hispanics and Whites, and Hispanics' scores on Peace were higher than Whites' scores. In contrast, sociodemographic and medical factors had weak associations with Faith scores. The pattern with Faith in bivariate models persisted in the fully adjusted models. Racial/ethnic differences in Meaning and in Peace, important dimensions of SWB, were even stronger after controlling for sociodemographic and medical factors. However, racial/ethnic differences in Faith appeared to remain stable. Further research is needed to determine if racial/ethnic differences in SWB are related to variations in quality of life in survivors of cancer.

A randomized phase II trial of first-line treatment with gemcitabine, erlotinib, or gemcitabine and erlotinib in elderly patients (age ≥70 years) with stage IIIB/IV non-small cell lung cancer.

INTRODUCTION: Single-agent gemcitabine is a standard of care for elderly patients with advanced non-small cell lung cancer, but novel therapies are needed for this patient population. METHODS: We performed a noncomparative randomized phase II trial of gemcitabine, erlotinib, or the combination in elderly patients (age ≥70 years) with stage IIIB or IV non-small cell lung cancer. Patients were randomized to arms: A (gemcitabine 1200 mg/m on days 1 and 8 every 21 days), B (erlotinib 150 mg daily), or C (gemcitabine 1000 mg/m on days 1 and 8 every 21 days and erlotinib 100 mg daily). Arms B and C were considered investigational; the primary objective was 6-month progression-free survival. RESULTS: Between March 2006 and May 2010, 146 eligible patients received protocol therapy. The majority of the patients (82%) had stage IV disease, 64% reported adenocarcinoma histology, 90% reported current or previous tobacco use, and 28% had a performance status of 2. The 6-month progression-free survival rate observed in arms A, B, and C was 22% (95% confidence interval [CI] 11-35), 24% (95% CI 13-36), and 25% (95% CI 15-38), respectively; the median overall survival observed was 6.8 months (95% CI 4.8-8.5), 5.8 months (95% CI 3.0-8.3), and 5.6 months (95% CI 3.5-8.4), respectively. The rate of grade ≥3 hematological and nonhematological toxicity observed was similar in all three arms. The best overall health-related quality of life response did not differ between treatment arms. CONCLUSIONS: Erlotinib or erlotinib and gemcitabine do not warrant further investigation in an unselected elderly patient population.

An examination of the 3-factor model and structural invariance across racial/ethnic groups for the FACIT-Sp: a report from the American Cancer Society's Study of Cancer Survivors-II (SCS-II).

OBJECTIVES: Recent confirmatory factor analysis (CFA) of the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp) Scale in a sample of predominantly white women demonstrated that three factors, Meaning, Peace, and Faith, represented a psychometric improvement over the original 2-factor model. The present study tested these findings in a more diverse sample, assessed the stability of the model across racial/ethnic groups, and tested the contribution of a new item. METHODS: In a study by the American Cancer Society, 8805 cancer survivors provided responses on the FACIT-Sp, which we tested using CFA. RESULTS: A 3-factor model provided a better fit to the data than the 2-factor model in the sample as a whole and in the racial/ethnic subgroups (Deltachi(2), p<0.001, for all comparisons), but was not invariant across the groups. The model with equal parameters for racial/ethnic groups was a poorer fit to the data than a model that allowed these parameters to vary (Deltachi(2)(81)=2440.54, p<0.001), suggesting that items and their associated constructs might be understood differently across racial/ethnic groups. The new item improved the model fit and loaded on the Faith factor. CONCLUSIONS: The 3-factor model is likely to provide more specific information for studies in the field. In the construction of scales for use with diverse samples, researchers need to pay greater attention to racial/ethnic differences in interpretation of items.

A 3-factor model for the FACIT-Sp.

OBJECTIVE: The 12-item Functional Assessment of Chronic Illness Therapy-Spiritual Well-being Scale (FACIT-Sp) is a popular measure of the religious/spiritual (R/S) components of quality of life (QoL) in patients with cancer. The original factor analyses of the FACIT-Sp supported two factors: Meaning/Peace and Faith. Because Meaning suggests a cognitive aspect of R/S and Peace an affective component, we hypothesized a 3-factor solution: Meaning, Peace, and Faith. METHODS: Participants were 240 long-term female survivors of cancer who completed the FACIT-Sp, the SF-12, and the BSI 18. We used confirmatory factor analysis to compare the 2- and 3-factor models of the FACIT-Sp and subsequently assessed associations between the resulting solutions and QoL domains. RESULTS: Survivors averaged 44 years of age and 10 years post-diagnosis. A 3-factor solution of the FACIT-Sp significantly improved the fit of the model to the data over the original 2-factor structure (Delta chi(2)=72.36, df=2, p<0.001). Further adjustments to the 3-factor model resulted in a final solution with even better goodness-of-fit indices (chi(2)=59.11, df=1, p=0.13, CFI=1.00, SMRM=0.05).The original Meaning/Peace factor controlling for Faith was associated with mental (r=0.63, p<0.000) and physical (r=0.22, p<0.01) health on the SF-12, and the original Faith factor controlling for Meaning/Peace was negatively associated with mental health (r=-0.15, p<0.05). The 3-factor model was more informative. Specifically, using partial correlations, the Peace factor was only related to mental health (r=0.53, p<0.001); Meaning was related to both physical (r=0.18, p<0.01) and mental (r=0.17, p<0.01) health; and Faith was negatively associated with mental health (r=-0.17, p<0.05). CONCLUSION: The results of this study support a 3-factor solution of the FACIT-Sp. The new solution not only represents a psychometric improvement over the original, but also enables a more detailed examination of the contribution of different dimensions of R/S to QoL.

Longitudinal screening and management of fatigue, pain, and emotional distress associated with cancer therapy.

GOALS OF WORK: Fatigue, pain, and emotional distress are common symptoms among patients with cancer. We sought to learn about patient perceptions of these symptoms and their treatment. MATERIALS AND METHODS: At a baseline assessment and two monthly follow-up assessments, we asked a diverse sample of patients with solid tumor or lymphoma (N = 99) about their fatigue, pain and distress, their treatment for these symptoms, and their satisfaction with treatment via standardized questionnaires and semistructured interviews. MAIN RESULTS: In this observational study, patients reported fatigue, pain, emotional distress, and general quality of life at expected levels. Across all assessments, at least half of our sample experienced at least some fatigue, pain, or distress. On the whole, patients and providers do communicate about these concerns, and at least 75% of patients found these discussions helpful when they occurred. CONCLUSIONS: Improved symptom identification and communication may optimize the detection of those at risk of morbidity and decreased quality of life because of excess symptom burden.

Use of a single-item screening tool to detect clinically significant fatigue, pain, distress, and anorexia in ambulatory cancer practice.

Fatigue, pain, distress, and anorexia are four commonly encountered symptoms in cancer. To evaluate the usefulness of a single-item screening for these symptoms, 597 ambulatory outpatients with solid tumors were administered a self-report screening instrument within the first 12 weeks of chemotherapy. Patients rated the severity of each symptom on a 0-10 scale, at its worst over the past three days, with higher ratings associated with higher symptom levels. From this sample, 148 patients also completed a more comprehensive assessment of these symptoms. Two criteria were used to determine optimal cut-off scores on the screening items: 1) the sensitivity and specificity of each screening item to predict clinical cases using receiver-operating characteristics analysis and 2) the proportion of patients at each screening score who reported that some relief of the target symptom would significantly improve their life. Optimal cut-off scores ranged from 4 to 6 depending on the target symptom (area under the curve range=0.68-0.88). Use of single-item screening instruments for fatigue, pain, distress, and anorexia may assist routine clinical assessment in ambulatory oncology practice. In turn, such assessments may improve identification of those at risk of morbidity and decreased quality of life due to excess symptom burden.

Assessment is not enough: a randomized controlled trial of the effects of HRQL assessment on quality of life and satisfaction in oncology clinical practice.

The potential benefits of health-related quality of life (HRQL) assessment in oncology clinical practice include better detection of problems, enhanced disease and treatment monitoring and improved care. However, few empirical studies have investigated the effects of incorporating such assessments into routine clinical care. Recent randomized studies have reported improved detection of and communication about patients' concerns, but few have found effects on patient HRQL or satisfaction. This study examined whether offering interpretive assistance of HRQL results would improve these patient outcomes. Two hundred and thirteen participants with metastatic breast, lung or colorectal cancer were randomly assigned to one of three conditions: usual care; HRQL assessment or HRQL assessment followed by a structured interview and discussion. Interviews about patients' assessment responses were conducted by a research nurse, who then presented HRQL information to the treating nurse. HRQL and treatment satisfaction outcomes were assessed at 3 and 6 months. No significant differences were found between study conditions in HRQL or satisfaction. Results suggest that routine HRQL assessment, even with description of results, is insufficient to improve patient HRQL and satisfaction. It is suggested that positive effects may require supplementing assessment results with specific suggestions for clinical management changes.

Trusting God and medicine: spirituality in advanced cancer patients volunteering for clinical trials of experimental agents.

The purpose of this study was to examine the role of spirituality in terminally ill cancer patients who volunteer for clinical trials of experimental agents. Information about spirituality (FACIT-Sp), quality of life (FACT-G), awareness of prognosis, and decision-making preferences was obtained from 162 advanced cancer patients who volunteered for phase I trials. In a multivariable model, phase I patients had slightly higher levels of spirituality (p<0.001) than a group of 156 advanced cancer patients who were not participants in phase I trials. For the phase I patients, spirituality was positively associated with quality of life (Spearman rho=0.36, p<0.001). There was little association between either spirituality or religious problem-solving style and phase I patients' awareness of their prognosis or decision-making preferences. One phase I patient who said, 'I put faith in doctors and God,' expressed these patients' willingness to trust both God and medicine.

A combination of distribution- and anchor-based approaches determined minimally important differences (MIDs) for four endpoints in a breast cancer scale.

OBJECTIVE: To determine distribution- and anchor-based minimal important difference (MID) estimates for four scores from the Functional Assessment of Cancer Therapy-Breast (FACT-B): the breast cancer subscale (BCS), Trial Outcome Index (TOI), FACT-G (the general version), and FACT-B. STUDY DESIGN AND SETTING: We used data from a Phase III clinical trial in metastatic breast cancer (ECOG study 1193; n=739) and a prospective observational study of pain in metastatic breast cancer (n=129). One third and one half of the standard deviation and 1 standard error of measurement were used as distribution-based criteria. Clinical indicators used to determine anchor-based differences included ECOG performance status, current pain, and response to treatment. RESULTS: FACT-B scores were responsive to performance status and pain anchors, but not to treatment response. By combining the results of distribution- and anchor-based methods, MID estimates were obtained: BCS=2-3 points, TOI=5-6 points, FACT-G=5-6 points, and FACT-B=7-8 points. CONCLUSION: Distribution- and anchor-based estimates of the MID do show convergence. These estimates can be used in combination with other measures of efficacy to determine meaningful benefit and provide a basis for sample size estimation in clinical trials.

The impact of age on toxicity, response rate, quality of life, and survival in patients with advanced, Stage IIIB or IV nonsmall cell lung carcinoma treated with carboplatin and paclitaxel.

BACKGROUND: The optimal treatment strategy for elderly patients with advanced nonsmall cell lung carcinoma has not been defined to date. The authors performed a retrospective analysis of a Phase III trial that treated patients who had Stage IIIB or IV nonsmall cell lung carcinoma with carboplatin and paclitaxel and analyzed the impact of age on response rate, survival, toxicity, and quality of life. METHODS: Patients with Stage IIIB or IV NSCLC were randomized to receive either 4 cycles of carboplatin at an area under the curve (AUC) of 6 and paclitaxel at a dose of 200 mg/m(2) every 21 days or treatment with carboplatin and paclitaxel (C/P) until they developed disease progression. At the time of disease progression, all patients on both arms were to receive second-line weekly paclitaxel at a dose of 80 mg/m(2) per week. In this analysis, patients age 70 years and older were compared with patients younger than age 70 years. In addition, a minimum log rank P value analysis was performed in an attempt to identify other potential age splits that may have been significant. RESULTS: Two hundred thirty patients were randomized. Sixty-seven patients were age 70 years or older (29%). The median number of cycles delivered for both age groups was 4 cycles (range, 0-19 cycles). No statistically significant differences in any of the most common toxicities (Grade >or= 2) associated with C/P were identified (data from Cycles 1-4) for patients younger than age 70 years compared with patients age 70 years and older, respectively, including neutropenia (38% vs. 35%), neuropathy (13% vs. 16%), leukopenia (7% vs. 13%), myalgia/arthralgia (15% vs. 9%), malaise (8% vs. 15%), anemia (9% vs. 4%), thrombocytopenia (7% vs. 9%), anorexia (8% vs. 4%), and nausea/emesis (14% vs. 15%). In addition, no potential age splits that may have been significant were found using a minimum log rank P value analysis. CONCLUSIONS: The current analysis demonstrated that C/P exhibited similar toxicity profiles in patients age 70 years and older compared with patients younger than age 70 years. The survival rates were not different between the two age groups, and there was no difference in progression of quality-of-life outcomes. In fit, elderly patients, C/P represented a reasonable standard regimen.

A qualitative exploration of the experiences of lesbian and heterosexual patients with breast cancer.

PURPOSE/OBJECTIVES: To explore similarities and differences between lesbian and heterosexual survivors of breast cancer regarding cancer experiences, medical interactions related to cancer treatment, and quality of life (QOL). DESIGN: Qualitative study using focus groups. SETTING: Urban, community-based health center. SAMPLE: A convenience sample of lesbians (n = 13) and heterosexual women (n = 28) with a diagnosis of breast cancer within the past five years. Participants were recruited via posted advertisements. METHODS: Focus groups were conducted as part of a larger study exploring coping and adjustment in lesbian survivors of breast cancer. Transcribed focus group data were analyzed through thematic and representative case study methods. MAIN RESEARCH VARIABLES: Broad aspects of medical interactions and the patient-provider relationship that may be associated with improved QOL of lesbian and heterosexual patients with cancer. FINDINGS: Data suggested similarities between lesbians and heterosexual women in their overall QOL. However, differences did emerge between the groups. Lesbians reported higher stress associated with diagnosis, lower satisfaction with care received from physicians, and a trend toward lower satisfaction with the availability of emotional support. CONCLUSIONS: Study findings have important implications for future research on adjustment and coping among lesbian patients with breast cancer and for the improvement of their mental and physical healthcare services. IMPLICATIONS FOR NURSING: Study findings may help improve healthcare services for lesbians with cancer.

Measuring spiritual well-being in people with cancer: the functional assessment of chronic illness therapy--Spiritual Well-being Scale (FACIT-Sp).

A significant relation between religion and better health has been demonstrated in a variety of healthy and patient populations. In the past several years, there has been a focus on the role of spirituality, as distinctfrom religion, in health promotion and coping with illness. Despite the growing interest, there remains a dearth of well-validated, psychometrically sound instruments to measure aspects of spirituality. In this article we report on the development and testing of a measure of spiritual well-being, the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp), within two samples of cancer patients. The instrument comprises two subscales--one measuring a sense of meaning and peace and the other assessing the role offaith in illness. A total score for spiritual well-being is also produced. Study 1 demonstrates good internal consistency reliability and a significant relation with quality of life in a large, multiethnic sample. Study 2 examines convergent validity with 5 other measures of religion and spirituality in a sample of individuals with mixed early stage and metastatic cancer diagnoses. Results of the two studies demonstrate that the FACIT-Sp is a psychometrically sound measure of spiritual well-being for people with cancer and other chronic illnesses.

Combining anchor and distribution-based methods to derive minimal clinically important differences on the Functional Assessment of Cancer Therapy (FACT) anemia and fatigue scales.

Magnitude differences in scores on a measure of quality of life that correspond to differences in function or clinical course are called clinically important differences (CIDs). Anchor-based and distribution-based methods were used to provide ranges of CIDs for five targeted scale scores of the Functional Assessment of Cancer Therapy-Anemia (FACT-An) questionnaire. Three samples of cancer patients were used: Sample 1 included 50 patients participating in a validation study of the FACT-An; Sample 2 included 131 patients participating in a longitudinal study of chemotherapy-induced fatigue; sample 3 included 2,402 patients enrolled in a community-based clinical trial evaluating the effectiveness and safety of a treatment for anemia. Three clinical indicators (hemoglobin level; performance status; response to treatment) were used to determine anchor-based differences. One-half of the standard deviation and 1 standard error of measurement were used as distribution-based criteria. Analyses supported the following whole number estimates of a minimal CID for these five targeted scores: Fatigue Scale = 3.0; FACT-G total score = 4.0; FACT-An total score = 7.0; Trial Outcome Index-Fatigue = 5.0; and Trial Outcome Index-Anemia = 6.0. These estimates provide a basis for sample size estimation when planning for a clinical trial or other longitudinal study, when the purpose is to ensure detection of meaningful change over time. They can also be used in conjunction with more traditional clinical markers to assist investigators in determining treatment efficacy.