Symptom burden and quality of life among patient and family caregiver dyads in advanced cancer.

PURPOSE: Symptom management among patients diagnosed with advanced cancer is a high priority in clinical care that often involves the support of a family caregiver. However, limited studies have examined parallel patient and caregiver symptom burden and associations with their own and each other's quality of life (QOL). This study seeks to identify patient and caregiver symptom clusters and investigate associations between identified clusters and demographic, clinical, and psychosocial factors (cognitive appraisals and QOL). METHODS: This study was a secondary analysis of self-reported baseline survey data collected from a randomized clinical trial of 484 adult advanced cancer patients and their caregivers. Latent class analysis and factor analysis were used to identify symptom clusters. Bivariate statistics tested associations between symptom clusters and demographic, clinical, and psychosocial variables. RESULTS: The most prevalent symptom for patients was energy loss/fatigue and for caregivers, mental distress. Low, moderate, and high symptom burden subgroups were identified at the patient, caregiver, and dyad level. Age, gender, race, income, chronic conditions, cancer type, and treatment type were associated with symptom burden subgroups. Higher symptom burden was associated with more negative appraisals of the cancer and caregiving experience, and poorer QOL (physical, social, emotional, functional, and overall QOL). Dyads whose caregivers had more chronic conditions were more likely to be in the high symptom burden subgroup. CONCLUSION: Patient and caregiver symptom burden influence their own and each other's QOL. These findings reinforce the need to approach symptom management from a dyadic perspective.

Illness uncertainty and quality of life in patients with advanced cancer and their family caregivers: An actor-partner interdependence model analysis.

OBJECTIVE: The relationship between illness uncertainty and quality of life (QOL) has been examined for either the patient or caregiver, but not among the patient-caregiver dyads. This study examined relationships between illness uncertainty and QOL among patients with advanced cancer and family caregivers. METHODS: We conducted a secondary analysis of data from a randomized clinical trial that examined the effects of a dyadic-based intervention on psychological outcomes for patients with advanced cancer and family caregivers (N = 484 dyads). Illness uncertainty and QOL were measured using the shorten version of the Mishel Uncertainty in Illness Scale for Adult and the Functional Assessment of Cancer Therapy, respectively. The actor-partner interdependence model was used to examine whether an individual's uncertainty (either a patient's or caregiver's) was associated with their own QOL (i.e., an actor effect) and/or their partner's QOL (i.e., a partner effect). RESULTS: Significant actor effects included a negative association between patients' uncertainty and their own QOL (b = -0.422; p < 0.001) and a negative association between caregivers' uncertainty and their own QOL (b = -0.408; p < 0.001). In terms of partner effects, patients' uncertainty was negatively associated with caregivers' QOL (b = -0.095; p < 0.01). No partner effect was found for caregivers, suggesting that caregivers' uncertainty was not related to patients' QOL. CONCLUSIONS: Study findings support targeted interventions offered to both patients and their family caregivers to manage their illness uncertainty and improve their QOL.

Symptom Experiences Among Individuals With Prostate Cancer and Their Partners: Influence of Sociodemographic and Cancer Characteristics.

OBJECTIVES: To determine if subgroups of individuals with prostate cancer and their partners could be identified based on their distinct symptom profiles and to identify and characterize subgroups based on sociodemographic and cancer characteristics. SAMPLE & SETTING: 263 individuals with prostate cancer and 263 partners recruited from three academic cancer centers in the Midwest. METHODS & VARIABLES: Latent class analysis was applied to divide individuals into subgroups based on symptom prevalence. Multinomial logistic regression models were used to estimate the prevalence of each symptom, predict subgroup membership, and adjust for direct or indirect effects of covariates on the symptoms. RESULTS: Three distinct subgroups (low, moderate, and high symptoms) were identified among individuals with prostate cancer and partners, respectively. Education and household income of individuals with prostate cancer were associated with different symptom burdens. Partners' household income differentiated among the subgroups. IMPLICATIONS FOR NURSING: Understanding the influence of sociodemographic and cancer characteristics can inform risk stratification and tailored symptom management interventions.

A self-management psychoeducational eHealth program to support and empower people with advanced cancer and their family caregivers: Development using the scrum methodology.

Background: eHealth programs could be a flexible and scalable resource to support and empower people with advanced cancer and their family caregivers. A face-to-face intervention that has demonstrated effectiveness is the "FOCUS" program, developed and tested in the USA. Recently the FOCUS program was translated and adapted to the European context as part of an international study in six European countries, resulting in the "FOCUS+" program. FOCUS+ served as the basis for development of the web-based iFOCUS program. Objective: We aim to (1) describe the development process of the iFOCUS program, (2) outline the challenges we encountered and how they were overcome, and (3) present findings regarding the acceptability and usability of iFOCUS. Methods: We used the four phased agile Scrum methodology to develop iFOCUS and applied set timeframes of rapid program development and evaluation (sprints). Five teams were involved in the development i.e. a core development group, a web development team, an international consortium, audio-visual experts, and potential end-users. Results: Development followed seven steps, integrated across the four phases of Scrum: (1) concept design, (2) development of mock-ups, (3) Feedback from the international consortium, (4) technical development of iFOCUS, (5) creating versions for the six participating countries, (6) preliminary testing of iFOCUS and (7) implementing the final version in a randomized controlled trial. User testing included 42 participants (twenty patient-family caregiver dyads and two bereaved family caregivers) who reviewed the iFOCUS program. Users found the iFOCUS program to be acceptable and usable. Feedback mainly focused on text size and fonts. Minor changes to the content, tailoring, and program flow were required. During development we encountered program specific and general challenges. Using the Scrum methodology facilitated iterative development to address these issues. For some challenges, such as tailoring, we had to make pragmatic choices due to time and resource limitations. Conclusions/discussion: The development of a tailored, self-managed psychoeducational eHealth program for people with advanced cancer and their family caregivers is an intense process and requires pragmatic choices. By keeping the emphasis on the target population during development, no specific remarks pertaining to advanced cancer were identified. Some challenges we encountered are common to eHealth development, others were related to program specific requirements. Using the Scrum methodology allows teams to efficiently collaborate during program development and increases the flexibility of the development process. Interpersonal contact between research staff and potential end-users is recommended during and after the development of eHealth programs.

A Web-Based Dyadic Intervention to Manage Psychoneurological Symptoms for Patients With Colorectal Cancer and Their Caregivers: Protocol for a Mixed Methods Study.

BACKGROUND: Patients with colorectal cancer (CRC) receiving chemotherapy often experience psychoneurological symptoms (PNS; ie, fatigue, depression, anxiety, sleep disturbance, pain, and cognitive dysfunction) that negatively impact both patients' and their caregivers' health outcomes. Limited information is available on PNS management for CRC patient and caregiver dyads. OBJECTIVE: The purposes of this study are to (1) develop a web-based dyadic intervention for patients with CRC receiving chemotherapy and their caregivers (CRCweb) and (2) evaluate the feasibility, acceptability, and preliminary effects of CRCweb among patient-caregiver dyads in a cancer clinic. METHODS: A mixed methods approach will be used. Semistructured interviews among 8 dyads will be conducted to develop CRCweb. A single-group pre- and posttest clinical trial will be used to examine the feasibility, acceptability, and preliminary effects of the intervention (CRCweb) among 20 dyads. Study assessments will be conducted before (T1) and after intervention (T2). Content analysis will be performed for semistructured interviews. Descriptive statistics will be calculated separately for patients and caregivers, and pre-post paired t tests will be used to evaluate treatment effects. RESULTS: This study was funded in November 2022. As of April 2023, we have obtained institutional review board approval and completed clinical trial registration and are currently recruiting patient-caregiver dyads in a cancer clinic. The study is expected to be completed in October 2024. CONCLUSIONS: Developing a web-based dyadic intervention holds great promise to reduce the PNS burden in patients with CRC receiving chemotherapy and their caregivers. The findings from this study will advance intervention development and implementation of symptom management and palliative care for patients with cancer and their caregivers. TRIAL REGISTRATION: ClinicalTrials.gov NCT05663203; https://clinicaltrials.gov/ct2/show/NCT05663203. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/48499.

"Ultimately, You Realize You're on Your Own": The Impact of Prostate Cancer on Gay and Bisexual Men Couples.

An estimated one in three gay and bisexual (GB) male couples receive a prostate cancer (PCa) diagnosis over their life course with limited understanding of the impacts on their relationships. Psychological distress related to PCa diagnosis and treatment-related side effects have been shown to disrupt established GB partnership dynamics. Communication barriers often develop within GB relationships affected by PCa, further exacerbating couple tensions, isolating partners, and lowering quality of life for both patients and partners. In order to elaborate on these phenomena following a PCa diagnosis, we conducted focus group discussions with GB men in relationships. Men were recruited nationally through PCa support groups, and after completing consent procedures, they were invited to one of two focus group discussions conducted through video conference. Topics discussed included the diagnosis and medical decision making pertaining to PCa; healthcare provider experiences; the emotional, physical, and sexual impact of PCa diagnosis and treatment; sources of support and appraisal of resources; and partner involvement and communication. There were twelve GB men who participated in focus group discussions that were audio-recorded and transcribed, and analyzed using a thematic approach. GB couple experiences with PCa during and after treatment choice and recovery identified common patient-provider communication barriers. In particular, GB men reported difficulties in disclosing their sexuality and relationship to their providers, limiting conversations about treatment choice and partner engagement in care. Both patients and partners experienced times of being alone after treatment, either by choice or to give space to their partner. However, partners often did not explicitly discuss their preferences for being alone or together, which resulted in partners' disengagement in their relationship and the prostate cancer healthcare process. This disengagement could blunt the notable PCa survival benefits of partnership for GB men.

Role, race, and place: Prostate cancer disparities in Patients' and Partners' health outcomes and psychosocial factors.

PURPOSE: This study aimed to examine the effects of participant role (patient vs. partner), race (white vs. non-white), and place (less vs. more neighborhood deprivation) on health outcomes (quality of life [QOL] and symptoms) and stress-coping-related psychosocial factors (appraisals of illness and coping resources). METHODS: This descriptive study included 273 patients and their partners (dyads) who transitioned from PCa treatment to self-management. We used established, psychometrically sound measures to assess health outcomes and psychosocial factors and conducted multilevel modeling analyses. RESULTS: Compared to partners, patients reported worse physical QOL; less frequent anxiety; less pain and fatigue; less bothersome hormonal problems; more bothersome urinary and sexual problems; greater self-efficacy; and more instrumental support. Compared to their white counterparts, non-white dyads reported better overall, emotional, and functional QOL; less depression; more positive appraisals, and greater self-efficacy. Compared to dyads in low ADI neighborhoods, dyads in high ADI (more deprived) neighborhoods reported worse social QOL; more bothersome urinary, sexual, and hormonal symptoms; and less interpersonal support. White patients reported the highest emotional support among all groups, while white partners reported the lowest emotional support. CONCLUSION: Our findings underscore the need to consider social determinants of health at multiple levels when investigating PCa disparities. Considering neighborhood-level socioeconomic factors, in addition to race and role, improves our understanding of the PCa disparities in QOL, symptoms, and psychosocial factors among patients and partners. Targeted multilevel supportive care interventions should tailor to the needs of racially diverse PCa patients and partners residing in deprived neighborhoods are needed.

Guidelines for Sexual Health Care for Prostate Cancer Patients: Recommendations of an International Panel.

BACKGROUND: Patients with prostate cancer suffer significant sexual dysfunction after treatment which negatively affects them and their partners psychologically, and strain their relationships. AIM: We convened an international panel with the aim of developing guidelines that will inform clinicians, patients and partners about the impact of prostate cancer therapies (PCT) on patients' and partners' sexual health, their relationships, and about biopsychosocial rehabilitation in prostate cancer (PC) survivorship. METHODS: The guidelines panel included international expert researchers and clinicians, and a guideline methodologist. A systematic review of the literature, using the Ovid MEDLINE, Scopus, CINAHL, PsychINFO, LGBT Life, and Embase databases was conducted (1995-2022) according to the Cochrane Handbook for Systematic Reviews of Interventions. Study selection was based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Each statement was assigned an evidence strength (A-C) and a recommendation level (strong, moderate, conditional) based on benefit/risk assessment, according to the nomenclature of the American Urological Association (AUA). Data synthesis included meta-analyses of studies deemed of sufficient quality (3), using A Measurement Tool to Assess Systematic Reviews (AMSTAR). OUTCOMES: Guidelines for sexual health care for patients with prostate cancer were developed, based on available evidence and the expertise of the international panel. RESULTS: The guidelines account for patients' cultural, ethnic, and racial diversity. They attend to the unique needs of individuals with diverse sexual orientations and gender identities. The guidelines are based on literature review, a theoretical model of sexual recovery after PCT, and 6 principles that promote clinician-initiated discussion of realistic expectations of sexual outcomes and mitigation of sexual side-effects through biopsychosocial rehabilitation. Forty-seven statements address the psychosexual, relationship, and functional domains in addition to statements on lifestyle modification, assessment, provider education, and systemic challenges to providing sexual health care in PC survivorship. CLINICAL IMPLICATIONS: The guidelines provide clinicians with a comprehensive approach to sexual health care for patients with prostate cancer. STRENGTHS & LIMITATIONS: The strength of the study is the comprehensive evaluation of existing evidence on sexual dysfunction and rehabilitation in prostate cancer that can, along with available expert knowledge, best undergird clinical practice. Limitation is the variation in the evidence supporting interventions and the lack of research on issues facing patients with prostate cancer in low and middle-income countries. CONCLUSION: The guidelines document the distressing sexual sequelae of PCT, provide evidence-based recommendations for sexual rehabilitation and outline areas for future research. Wittmann D, Mehta A, McCaughan E, et al. Guidelines for Sexual Health Care for Prostate Cancer Patients: Recommendations of an International Panel. J Sex Med 2022;19:1655-1669.

Systematic translation and adaptation of the FOCUS program, a USA-based supportive intervention for persons with cancer and their family caregivers, for use in six European countries.

PURPOSE: Having advanced cancer presents many challenges for patients and family caregivers. The FOCUS program is a psychoeducational nurse-led intervention, developed in the USA, to support dyads of patients with cancer and their family caregivers to live with the illness. The program includes a conversation manual and information resources for dyads. We aimed to develop a version of the program for dyads facing advanced cancer in six European countries. METHOD: The Participatory and Iterative Process Framework for Language Adaptation (PIPFLA) was used to guide the translation of the program to the local contexts of Belgium, Denmark, Ireland, Italy, the Netherlands, and the UK. In several rounds, potential program users (e.g., nurses, clinicians, patients, family caregivers) and researchers from all six countries reviewed program materials and advised on adaptations. RESULTS: The PIPFLA process resulted in one European version of the program in different languages (FOCUS +). The FOCUS + conversation manual is uniform across all countries. The main adaptations included additional attention to both family caregiver and patient needs; more emphasis on self-management, advance care planning, and shared responsibilities; discussing the dyad's outlook rather than optimism; addressing the role of nurses as educational rather than therapeutic; and more suggestions to refer dyads to health care professionals for specific care needs. The information resources for dyads were adapted to fit with local contexts. CONCLUSION: The PIPFLA methodology is an efficient and effective framework to thoroughly translate and culturally adapt a complex USA-based program for use in six European countries in collaboration with end users.

TrueNTH Sexual Recovery Intervention for couples coping with prostate cancer: Randomized controlled trial results.

BACKGROUND: Despite significant sexual dysfunction and distress after localized prostate cancer treatment, patients typically receive only physiologic erectile dysfunction management. The authors performed a randomized controlled trial of an online intervention supporting couples' posttreatment recovery of sexual intimacy. METHODS: Patients treated with surgery, radiation, or combined radiation and androgen deprivation therapy who had partners were recruited and randomized to an online intervention or a control group. The intervention, tailored to treatment type and sexual orientation, comprised 6 modules addressing expectations for sexual and emotional sequelae of treatment, rehabilitation, and guidance toward sexual intimacy recovery. Couples, recruited from 6 sites nationally, completed validated measures at the baseline and 3 and 6 months after treatment. Primary outcome group differences were assessed with t tests for individual outcomes. RESULTS: Among 142 randomized couples, 105 patients (mostly surgery) and 87 partners completed the 6-month survey; this reflected challenges with recruitment and attrition. There were no differences between the intervention and control arms in Patient-Reported Outcomes Measurement Information System Global Satisfaction With Sex Life scores 6 months after treatment (the primary outcome). Three months after treatment, intervention patients and partners reported more engagement in penetrative and nonpenetrative sexual activities than controls. More than 73% of the intervention participants reported high or moderate satisfaction with module content; more than 85% would recommend the intervention to other couples. CONCLUSIONS: Online psychosexual support for couples can help couples to connect and experience sexual pleasure early after treatment despite patients' sexual dysfunction. Participants' high endorsement of the intervention reflects the importance of sexual health support to couples after prostate cancer treatment. LAY SUMMARY: This study tested a web-based program supporting couples' sexual recovery of sexual intimacy after prostate cancer treatment. One hundred forty-two couples were recruited and randomly assigned to the program (n = 60) or to a control group (n = 82). The program did not result in improvements in participants' satisfaction with their sex life 6 months after treatment, but couples in the intervention group engaged in sexual activity sooner after treatment than couples in the control group. Couples evaluated the program positively and would recommend it to others facing prostate cancer treatment.

Testing the efficacy of a couple-focused, tailored eHealth intervention for symptom self-management among men with prostate cancer and their partners: the study protocol.

BACKGROUND: Men with localized prostate cancer often experience urinary, sexual, bowel, and hormonal symptoms; general distress; pain; fatigue; and sleep disturbance. For men in an intimate relationship, these symptoms disrupt couples' relationships and intimacy. The symptoms also reduce quality of life for both men and their partners, who are often their primary caregivers. Management of the negative effects of cancer and its treatment is a significantly under-addressed supportive care need for these men and their intimate partners. To address these unmet supportive care needs, our interdisciplinary team developed and pilot tested the usability and feasibility of an evidence-based, couple-focused, tailored eHealth intervention, "Prostate Cancer Education & Resources for Couples" (PERC). Based on the adapted stress and coping theoretical framework and developed with stakeholder involvement, PERC aims to improve quality of life for both men and their partners by enhancing their positive appraisals, self-efficacy, social support, and healthy behaviors for symptom management. METHODS: We will test the efficacy of PERC using a population-based, geographically and demographically diverse cohort in a randomized controlled trial. Primary aim: Assess if patients and partners receiving PERC will report greater improvement in their cancer-related quality of life scores than those in the control group (usual care plus the National Cancer Institute prostate cancer website) at 4, 8, and 12 months post-baseline. Secondary aim: Test if patients and partners in PERC will report significantly more positive appraisals and higher levels of coping resources at follow-ups than those in the control group. Exploratory aim: Determine if patient race and ethnicity, education, type of treatment, or couples' relationship quality moderate the effects of PERC on patient and partner QOL at follow-ups. DISCUSSION: This study will provide a novel model for self-managing chronic illness symptoms that impact couples' relationships, intimacy, and quality of life. It addresses the National Institute of Nursing Research's goal to develop and test new strategies for symptom self-management to help patients and caregivers better manage their illness and improve quality of life. It also responds to calls for programs from the Institute of Medicine and American Cancer Society to address treatment-related effects and improve survivors' QOL. TRIAL REGISTRATION: CT.gov NCT03489057.

Effectiveness of a nurse-delivered (FOCUS+) and a web-based (iFOCUS) psychoeducational intervention for people with advanced cancer and their family caregivers (DIAdIC): study protocol for an international randomized controlled trial.

BACKGROUND: Worldwide, millions of people with advanced cancer and their family caregivers are experiencing physical and psychological distress. Psychosocial support and education can reduce distress and prevent avoidable healthcare resource use. To date, we lack knowledge from large-scale studies on which interventions generate positive outcomes for people with cancer and their informal caregivers' quality of life. This protocol describes the DIAdIC study that will evaluate the effectiveness of two psychosocial and educational interventions aimed at improving patient-family caregiver dyads' emotional functioning and self-efficacy. METHODS: We will conduct an international multicenter three-arm randomized controlled trial in Belgium, Denmark, Ireland, Italy, The Netherlands, and the United Kingdom. In each country, 156 dyads (936 in total) of people with advanced cancer and their family caregiver will be randomized to one of the study arms: 1) a nurse-led face-to-face intervention (FOCUS+), 2) a web-based intervention (iFOCUS) or 3) a control group (care as usual). The two interventions offer tailored psychoeducational support for patient-family caregiver dyads. The nurse-led face-to-face intervention consists of two home visits and one online video session and the web-based intervention is completed independently by the patient-family caregiver dyad in four online sessions. The interventions are based on the FOCUS intervention, developed in the USA, that addresses five core components: family involvement, optimistic outlook, coping effectiveness, uncertainty reduction, and symptom management. The FOCUS intervention will be adapted to the European context. The primary outcomes are emotional functioning and self-efficacy of the patient and the family caregiver, respectively. The secondary outcomes are quality of life, benefits of illness, coping, dyadic communication, and ways of giving support of the patient and family caregiver. DISCUSSION: DIAdIC aims to develop cost-effective interventions that integrate principles of early palliative care into standard care. The cross-country setup in six European countries allows for comparison of effectiveness of the interventions in different healthcare systems across Europe. By focusing on empowerment of the person with cancer and their family caregiver, the results of this RCT can contribute to the search for cost-effective novel interventions that can relieve constraints on professional healthcare. TRIAL REGISTRATION: Registration on ClinicalTrials.gov on 12/11/2020, identifier NCT04626349 . DATE AND VERSION IDENTIFIER: 20211209_DIAdIC_Protocol_Article.

FOCUS Program: Treating Patients With Cancer and Family Caregivers as a Unit of Care.

BACKGROUND: Studies indicate that patients' and caregivers' responses to illness are interdependent; each person affects the other. Existing evidence reinforces the need to recognize family caregivers as equal recipients of care and support. OBJECTIVES: This evidence-based pilot study evaluated the feasibility and preliminary efficacy of the nurse-guided, psychoeducational, family-based FOCUS program intervention at a local oncology outpatient clinic. METHODS: 30 patient-caregiver dyads were recruited from a local oncology clinic. Intervention delivery occurred using home visits and telephone calls. Self-administered questionnaires were used to assess participants' self-efficacy, quality of life (QOL), and coping pre- and postintervention, and intervention satisfaction postintervention. Three tailored psychosocial education sessions were held during a 6- to 9-week period. FINDINGS: Significant changes in outcomes were found, including increased self-efficacy in both patients and caregivers, higher QOL in caregivers, and decreased use of substances for coping in patients. There was a trend for patients' emotional well-being to improve over time; other aspects of QOL showed little change. There were no significant changes in caregivers' coping.

Symptom distress and quality of life among Black Americans with cancer and their family caregivers.

OBJECTIVE: Black Americans are disproportionately affected by cancer and chronic diseases. Black patients with cancer and their family caregivers may concurrently experience symptoms that influence their wellbeing. This study investigates the influence of mental and physical symptom distress on quality of life (QOL) among Black Americans with cancer and their family caregivers from a dyadic perspective. METHODS: One hundred and fifty-one dyads comprised of a Black American with breast, colorectal, lung or prostate cancer and a Black family caregiver were included in this secondary analysis of pooled baseline data from three studies. Self-reports of problems managing 13 symptoms were used to measure mental and physical symptom distress. Descriptive statistics and the actor-partner interdependence model were used to examine symptom prevalence and the influence of each person's symptom distress on their own and each other's QOL. RESULTS: Fatigue, sleep problems, pain and mental distress were prevalent. Patients and caregivers reported similar levels of mental distress; however, patients reported higher physical distress. Increased patient mental distress was associated with decreased patient QOL (overall, emotional, social, functional). Increased patient physical distress was associated with decreased patient QOL (overall, physical, emotional, functional) and decreased caregiver emotional wellbeing. Increased caregiver mental distress was associated with decreased caregiver QOL (overall, emotional, social, functional) and decreased patient overall QOL. Increased caregiver physical distress was associated with decreased caregiver QOL (overall, physical, functional), decreased patient emotional wellbeing, and better patient social wellbeing. CONCLUSIONS: Supporting symptom management in Black patient/caregiver dyads may improve their QOL.

Enhancing survivorship care planning for patients with localized prostate cancer using a couple-focused web-based, mHealth program: the results of a pilot feasibility study.

PURPOSE: To examine the feasibility of an enhanced survivorship care plan (ESCP) that integrated the web-based program Patient Education Resources for Couples (PERC) into a standardized survivorship care plan (SCP) and estimated the outcomes of ESCPs versus SCPs. METHODS: In this randomized pilot trial, localized prostate cancer (PC) patients and partners (i.e., couple) were randomly assigned to ESCP that contained a link to PERC or to SCP that contained a link to general PC information on the National Cancer Institute website. Couples completed assessments measuring quality of life (QOL), appraisal of symptoms, and coping resources at baseline (T1) and 4-6 months later (T2). We examined feasibility (e.g., recruitment and retention) using descriptive statistics. Linear mixed models examined changes in couples' outcomes over time and Poisson regression examined differences in patient healthcare utilization. RESULTS: Sixty-two couples completed T1 surveys (recruitment rate 41.6%) and were randomly assigned to receive ESCP (n = 31) or SCP (n = 31). Twenty-eight (ESCP) and 25 (SCP) couples completed T2 surveys (retention rates = 90.3% vs. 80.7%). ESCP participants (70%) reviewed webpages consistent with patients' symptoms. ESCP patients reported greater program satisfaction (p = 0.02) and better urinary symptom scores (p < 0.01) than SCP patients. CONCLUSIONS: Delivering ESCPs that embed a web-link to a couple-focused, tailored program is feasible and can potentially improve patient outcomes. The promising results need to be validated in a larger definitive trial using a diverse sample. IMPLICATIONS FOR CANCER SURVIVORS: SCPs, enhanced using a web-based intervention (e.g., PERC), may help PC cancer survivors better manage their urinary symptoms. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04350788.

Genetic Testing and Surveillance of Young Breast Cancer Survivors and Blood Relatives: A Cluster Randomized Trial.

We compared a tailored and a targeted intervention designed to increase genetic testing, clinical breast exam (CBE), and mammography in young breast cancer survivors (YBCS) (diagnosed <45 years old) and their blood relatives. A two-arm cluster randomized trial recruited a random sample of YBCS from the Michigan cancer registry and up to two of their blood relatives. Participants were stratified according to race and randomly assigned as family units to the tailored (n = 637) or the targeted (n = 595) intervention. Approximately 40% of participants were Black. Based on intention-to-treat analyses, YBCS in the tailored arm reported higher self-efficacy for genetic services (p = 0.0205) at 8-months follow-up. Genetic testing increased approximately 5% for YBCS in the tailored and the targeted arm (p ≤ 0.001; p < 0.001) and for Black and White/Other YBCS (p < 0.001; p < 0.001). CBEs and mammograms increased significantly in both arms, 5% for YBCS and 10% for relatives and were similar for Blacks and White/Others. YBCS and relatives needing less support from providers reported significantly higher self-efficacy and intention for genetic testing and surveillance. Black participants reported significantly higher satisfaction and acceptability. Effects of these two low-resource interventions were comparable to previous studies. Materials are suitable for Black women at risk for hereditary breast/ovarian cancer (HBOC).

Acceptability of a Dyadic Psychoeducational Intervention for Patients and Caregivers.

PURPOSE: To assess participants' acceptability of the FOCUS program, a psychoeducational intervention, delivered to multiple patient-caregiver dyads in a small-group format. PARTICIPANTS & SETTING: A total of 72 adults diagnosed with cancer and their caregivers (36 dyads) who participated in 1 of 11 FOCUS programs delivered at two Cancer Support Community affiliates. METHODOLOGIC APPROACH: A pre-/postintervention design was used to implement the FOCUS program. The FOCUS Satisfaction Instrument measured participants' satisfaction with the program, usefulness of the materials, helpfulness in coping with cancer, duplication of services, willingness to recommend the program to others, and the most and least beneficial aspects. Descriptive statistics, t tests, and content analysis were used. FINDINGS: Most participants reported that the program did not duplicate services, that it helped them cope with cancer, and that they would recommend the program to others. The most beneficial aspects of the program were the group format and the dyadic approach. IMPLICATIONS FOR NURSING: A group format and dyadic approach to address the psychosocial impact of cancer is highly valued by individuals with cancer and their caregivers. Nurses are well positioned to lead implementation of programs like the FOCUS program that complement other cancer support services.

Psychometric properties of the FACT-G quality of life scale for family caregivers of cancer patients.

PURPOSE: This study aimed to examine psychometric properties of a caregiver version of the well-established Functional Assessment of Cancer Therapy-General Scale (FACT-G) after conducting focus groups and obtaining expert input. METHODS: We made minor wording modifications to the Patient FACT-G to enable caregivers to report how the illness affected their overall quality of life (QOL) and well-being on four subscales (physical, social, emotional, functional). We tested the acceptability, precision, factor structure, reliability and validity of the Caregiver FACT-G among partners of prostate cancer patients (N = 263) and caregivers (spouses, siblings, adult children) of patients with advanced cancer (breast, lung, colorectal, prostate) (N = 484) using data from two Randomized Clinical Trials (RCTs). RESULTS: With a factor structure similar to the Patient FACT-G, Caregiver FACT-G was acceptable and precise in measuring caregiver QOL, with high inter-factor correlations and internal consistency reliability (Cronbach's alphas 0.81-0.91). The Caregiver FACT-G had strong convergent validity demonstrated by significant positive correlations with caregiver self-efficacy (0.25-0.63), dyadic communication (0.18-0.51), and social support (0.18-0.54) in both samples. It also had strong discriminant validity evidenced by significant inverse correlations with negative appraisal of caregiving (- 0.37 to - 0.69), uncertainty (- 0.28 to - 0.53), hopelessness (- 0.25 to - 0.60), and avoidant coping (- 0.26 to - 0.58) in both samples. Caregivers' baseline FACT-G scores were significantly associated with their physical (0.23) and mental well-being (0.54; 4-month follow-up) and their depression (- 0.69; 3-month follow-up), indicating strong predictive validity. CONCLUSION: This is the first study evaluating the psychometric properties of the Caregiver FACT-G. More psychometric testing is warranted, especially among caregivers of diverse sociocultural backgrounds.

Moderators of the effect of psychosocial interventions on fatigue in women with breast cancer and men with prostate cancer: Individual patient data meta-analyses.

OBJECTIVE: Psychosocial interventions can reduce cancer-related fatigue effectively. However, it is still unclear if intervention effects differ across subgroups of patients. These meta-analyses aimed at evaluating moderator effects of (a) sociodemographic characteristics, (b) clinical characteristics, (c) baseline levels of fatigue and other symptoms, and (d) intervention-related characteristics on the effect of psychosocial interventions on cancer-related fatigue in patients with non-metastatic breast and prostate cancer. METHODS: Data were retrieved from the Predicting OptimaL cAncer RehabIlitation and Supportive care (POLARIS) consortium. Potential moderators were studied with meta-analyses of pooled individual patient data from 14 randomized controlled trials through linear mixed-effects models with interaction tests. The analyses were conducted separately in patients with breast (n = 1091) and prostate cancer (n = 1008). RESULTS: Statistically significant, small overall effects of psychosocial interventions on fatigue were found (breast cancer: ß = -0.19 [95% confidence interval (95%CI) = -0.30; -0.08]; prostate cancer: ß = -0.11 [95%CI = -0.21; -0.00]). In both patient groups, intervention effects did not differ significantly by sociodemographic or clinical characteristics, nor by baseline levels of fatigue or pain. For intervention-related moderators (only tested among women with breast cancer), statistically significant larger effects were found for cognitive behavioral therapy as intervention strategy (ß = -0.27 [95%CI = -0.40; -0.15]), fatigue-specific interventions (ß = -0.48 [95%CI = -0.79; -0.18]), and interventions that only targeted patients with clinically relevant fatigue (ß = -0.85 [95%CI = -1.40; -0.30]). CONCLUSIONS: Our findings did not provide evidence that any selected demographic or clinical characteristic, or baseline levels of fatigue or pain, moderated effects of psychosocial interventions on fatigue. A specific focus on decreasing fatigue seems beneficial for patients with breast cancer with clinically relevant fatigue.

Disparities in genetic services utilization in a random sample of young breast cancer survivors.

PURPOSE: Increasing use of genetic services (counseling/testing) among young breast cancer survivors (YBCS) can help decrease breast cancer incidence and mortality. The study examined use of genetic services between Black and White/Other YBCS, attitudes and knowledge of breast cancer risk factors, and reasons for disparities in using genetic services. METHODS: We used baseline data from a randomized control trial including a population-based, stratified random sample of 3000 potentially eligible YBCS, with oversampling of Black YBCS. RESULTS: Among 883 YBCS (353 Black, 530 White/Other) were significant disparities between the two racial groups. More White/Other YBCS had received genetic counseling and had genetic testing than Blacks. Although White/Other YBCS resided farther away from board-certified genetic counseling centers, they had fewer barriers to access these services. Black race, high out-of-pocket costs, older age, and more years since diagnosis were negatively associated with use of genetic services. Black YBCS had lower knowledge of breast cancer risk factors. Higher education and genetic counseling were associated with higher genetic knowledge. CONCLUSION: Racial inequalities of cost-related access to care and education create disparities in genetic services utilization. System-based interventions that reduce socioeconomic disparities and empower YBCS with genetic knowledge, as well as physician referrals, can increase access to genetic services.