Development of a Web-based Family Intervention for BRCA Carriers and Their Biological Relatives: Acceptability, Feasibility, and Usability Study.

BACKGROUND: Carriers of breast cancer gene (BRCA) mutations are asked to communicate genetic test results to their biological relatives to increase awareness of cancer risk and promote use of genetic services. This process is highly variable from family to family. Interventions that support communication of genetic test results, coping, and offer decision support in families harboring a pathogenic variant may contribute to effective management of hereditary cancer. OBJECTIVE: The aim of this paper was to describe the development of the Family Gene Toolkit, a Web-based intervention targeting BRCA carriers and untested blood relatives, designed to enhance coping, family communication, and decision making. METHODS: We present findings from focus groups regarding intervention acceptability and participant satisfaction and from a pre-post pilot study with random allocation to a wait-listed control group regarding intervention feasibility and usability. RESULTS: The Family Gene Toolkit was developed by a multidisciplinary team as a psycho-educational and skills-building intervention. It includes two live webinar sessions and a follow-up phone call guided by a certified genetic counselor and a master's prepared oncology nurse. Each live webinar includes two modules (total four modules) presenting information about BRCA mutations, a decision aid for genetic testing, and two skill-building modules for effective coping and family communication. Participants in focus groups (n=11) were highly satisfied with the intervention, reporting it to be useful and describing clearly the important issues. From the 12 dyads recruited in the pre-post pilot study (response rate 12/52, 23%), completion rate was 71% (10/14) for intervention and 40% (4/10) for wait-listed control groups. CONCLUSIONS: Acceptability and satisfaction with the Family Gene Toolkit is high. On the basis of the findings from usability and feasibility testing, modifications on timing, delivery mode, and recruitment methods have been implemented. TRIAL REGISTRATION: ClinicalTrials.gov NCT02154633; https://clinicaltrials.gov/ct2/show/NCT02154633 (Archived by WebCite at http://www.webcitation.org/6yYNvLPjv).

Multilingual Self-Management Resources for Prostate Cancer Survivors and Their Partners: Results of a Long-Term Academic-State Health Department Partnership to Promote Survivorship Care.

OBJECTIVE: To provide innovative, evidence-based self management information and supportive care for prostate cancer survivors and their partners. We describe how an academic-public partnership facilitated the broad dissemination of evidence-based, multilingual survivorship educational materials via a state-managed prostate cancer website. METHODS: We outline the steps of an academic-public partnership leading to dissemination of online, survivorship materials as a resource for prostate cancer survivors and their partners. We examined the 5-year utilization of the materials from January 2011 to December 2015 according to 14 content areas (e.g., urinary, bowel, and sexual problems, fatigue, communication, cancer stress) and across 3 languages (English, Spanish, Arabic). RESULTS: The total number of prostate cancer survivorship materials downloaded from January 2011 to December 2015 was 89,348. The number of downloaded materials increased over time from 6,421 in 2011 to 17,496 in 2015. The most commonly downloaded content area was urine problems (27.5%), followed by bowel problems (23.4%) and sexual side effects (16.2%). The majority of downloaded materials was in English (86.3%), followed by Spanish (9.8%) and Arabic (3.9%). CONCLUSION: The academic-public partnership facilitated broad dissemination of evidence-based informational materials for prostate cancer survivors and their partners through a state-managed website from 2011 to 2015. Given the increasing role of academic-public partnerships in funding and development of robust, sustainable prostate cancer survivorship resources, this work serves as an introduction to these evidence-based materials and highlights a successful model of engagement between practitioners, research scientists, and public health administration.

Implementation of a Psychoeducational Program for Cancer Survivors and Family Caregivers at a Cancer Support Community Affiliate: A Pilot Effectiveness Study.

BACKGROUND: Psychoeducational interventions, tested for efficacy in randomized clinical trials, are seldom implemented in clinical practice where cancer survivors and their family caregivers can benefit from them. OBJECTIVE: This study examined the effectiveness of the FOCUS Program on cancer survivors' and their family caregivers' outcomes when implemented at a Cancer Support Community (CSC) affiliate by agency social workers. Study aims were to (1) test effects of the program on survivor and caregiver outcomes as a unit and (2) determine program feasibility in terms of enrollment, retention, intervention fidelity, and satisfaction. METHODS: A preintervention and postintervention pilot effectiveness study was conducted with 34 cancer survivor-caregiver dyads (ie, pairs). The FOCUS Program, originally delivered by nurses in dyads' homes, was modified to a small-group format and delivered by CSC social workers. The primary outcome was quality of life (QOL). Intermediary outcomes were benefits of illness/caregiving, communication, support, and self-efficacy. Analyses included repeated-measures analysis of variance. RESULTS: Dyads had significant improvements in total QOL; physical, emotional, and functional QOL; benefits of illness; and self-efficacy. Effect sizes were similar to prior randomized clinical trial findings. Although dyads were difficult to recruit (enrollment, 60%), both retention (92%) and intervention fidelity (94%) were high. CONCLUSIONS: It was possible to implement the FOCUS Program at a CSC affiliate by agency staff, obtain positive intervention effects, and maintain intervention fidelity. IMPLICATIONS FOR PRACTICE: Researchers and clinicians need to collaborate to implement more evidence-based interventions in practice settings for cancer survivors and their family caregivers.

The Interdependence of Advanced Cancer Patients' and Their Family Caregivers' Mental Health, Physical Health, and Self-Efficacy over Time.

BACKGROUND: The challenges of advanced cancer have health implications for patients and their family caregivers from diagnosis through end of life. The nature of the patient/caregiver experience suggests that their mental and physical health maybe interdependent, but limited empirical evidence exists. PURPOSE: This study used social cognitive theory as a framework to investigate individual and interpersonal influences on patients' and their family caregivers' mental health, physical health, and self-efficacy as individuals to manage the challenges of advanced disease over time. METHODS: Patients and caregivers (484 patient-caregiver dyads) completed surveys at baseline, 3 and 6 months. Longitudinal dyadic analysis techniques were used to examine (i)the influence that patients and caregivers had on their own mental health, physical health, and self-efficacy (actor effects)and (ii) the influence that they had on each other's health outcomes (partner effects). We also examined the influence of self-efficacy on mental and physical health over time. RESULTS: Consistent with our hypotheses, each person's mental health, physical health, and self-efficacy had significant effects on their own outcomes over time (actor effects). Patients and caregivers influenced one another's mental and physical health (partner effects), but not their self-efficacy. In addition, patients and caregivers with higher self-efficacy had better mental health, and their partners had better physical health. CONCLUSIONS: Patients' and caregivers' mental and physical health were interdependent. Each person's cancer-related self-efficacy influenced their own mental and physical health. However, a person's self-efficacy did not influence the other person's self-efficacy.

A tailored Web-based psychoeducational intervention for cancer patients and their family caregivers.

BACKGROUND: Most programs addressing psychosocial concerns of cancer survivors are in-person programs that are expensive to deliver, have limited availability, and seldom deal with caregivers' concerns. OBJECTIVE: This study examined the feasibility of translating an efficacious nurse-delivered program (FOCUS Program) for patients and their caregivers to a tailored, dyadic Web-based format. Specific aims were to (1) test the preliminary effects of the Web-based intervention on patient and caregiver outcomes, (2) examine participants' program satisfaction, and (3) determine the feasibility of using a Web-based delivery format. METHODS: A phase 2 feasibility study was conducted with cancer patients (lung, breast, colorectal, prostate) and their family caregivers (N = 38 dyads). The Web-based intervention provided information and support tailored to the unique characteristics of each patient, caregiver, and their dyadic relationship. Primary outcomes were emotional distress and quality of life. Secondary outcomes were benefits of illness/caregiving, communication, support, and self-efficacy. Analyses included descriptive statistics and repeated-measures analysis of variance. RESULTS: Dyads had a significant decrease in emotional distress, increase in quality of life, and perceived more benefits of illness/caregiving. Caregivers also had significant improvement in self-efficacy. There were no changes in communication. Participants were satisfied with program usability, but recommended additional content. CONCLUSIONS: It was possible to translate a clinician-delivered program to a Web-based format that was easy to use and had positive effects on dyadic outcomes. IMPLICATIONS FOR PRACTICE: The Web-based program is a promising way to provide psychosocial care to more patients and caregivers using fewer personnel. It needs further testing in a larger randomized clinical trial.

Using a state cancer registry to recruit young breast cancer survivors and high-risk relatives: protocol of a randomized trial testing the efficacy of a targeted versus a tailored intervention to increase breast cancer screening.

BACKGROUND: The Michigan Prevention Research Center, the University of Michigan Schools of Nursing, Public Health, and Medicine, and the Michigan Department of Community Health propose a multidisciplinary academic-clinical practice three-year project to increase breast cancer screening among young breast cancer survivors and their cancer-free female relatives at greatest risk for breast cancer. METHODS/DESIGN: The study has three specific aims: 1) Identify and survey 3,000 young breast cancer survivors (diagnosed at 20-45 years old) regarding their breast cancer screening utilization. 2) Identify and survey survivors' high-risk relatives regarding their breast cancer screening utilization. 3) Test two versions (Targeted vs. Enhanced Tailored) of an intervention to increase breast cancer screening among survivors and relatives. Following approval by human subjects review boards, 3,000 young breast cancer survivors will be identified through the Michigan Cancer Registry and mailed an invitation letter and a baseline survey. The baseline survey will obtain information on the survivors': a) current breast cancer screening status and use of genetic counseling; b) perceived barriers and facilitators to screening; c) family health history. Based on the family history information provided by survivors, we will identify up to two high-risk relatives per survivor. Young breast cancer survivors will be mailed consent forms and baseline surveys to distribute to their selected high-risk relatives. Relatives' baseline survey will obtain information on their: a) current breast cancer screening status and use of genetic counseling; and b) perceived barriers and facilitators to screening. Young breast cancer survivors and high-risk relatives will be randomized as a family unit to receive two versions of an intervention aiming to increase breast cancer screening and use of cancer genetic services. A follow-up survey will be mailed 9 months after the intervention to survivors and high-risk relatives to evaluate the efficacy of each intervention version on: a) use of breast cancer screening and genetic counseling; b) perceived barriers and facilitators to screening; c) self-efficacy in utilizing cancer genetic and screening services; d) family support related to screening; e) knowledge of breast cancer genetics; and f) satisfaction with the intervention. DISCUSSION: The study will enhance efforts of the state of Michigan surrounding cancer prevention, control, and public health genomics.

A randomized controlled trial of a self-management psychosocial intervention for men with prostate cancer and their partners: a study protocol.

BACKGROUND: Little is known about interventions to help men and their partners cope with the after effects of prostate cancer treatment. The lack of in-depth descriptions of the intervention content is hindering the identification of which intervention (or component of an intervention) works. AIM: To describe the development and evaluation of the content of a self-management psychosocial intervention for men with prostate cancer and their partners. DESIGN: A feasibility randomized controlled trial including structure, process, and outcome analysis. METHODS: This 9-week intervention commences on completion of treatment and consists of three group and two telephone sessions. The intervention focuses on symptom management, sexual dysfunction, uncertainty management, positive thinking and couple communication. Forty-eight couples will be assigned to either the intervention or a control group receiving usual care. Participants will be assessed at baseline, immediately postintervention and at 1 and 6 months postintervention. Outcome measures for patients and caregivers include self-efficacy, quality of life, symptom distress, uncertainty, benefits of illness, health behaviour, and measures of couple communication and support. An additional caregiver assessment will be completed by the partner. DISCUSSION: The main purpose of this feasibility study is to investigate the acceptability of the CONNECT programme to men with prostate cancer and their partners and to gain feedback from the participants and facilitators to make changes to and enhance the programme. Reasons why men do not want to participate will be collated to enhance recruitment in the future. We will also test recruitment strategies, randomization procedures, and the acceptability of the questionnaires. Ethical approval granted December 2010.

Randomized clinical trial of a brief and extensive dyadic intervention for advanced cancer patients and their family caregivers.

BACKGROUND: Few intervention programs assist patients and their family caregivers to manage advanced cancer and maintain their quality of life (QOL). This study examined (i) whether patient-caregiver dyads (i.e., pairs) randomly assigned to a brief or extensive dyadic intervention (the FOCUS Program) had better outcomes than dyads randomly assigned to usual care and (ii) whether patients' risk for distress and other factors moderated the effect of the brief or extensive program on outcomes. METHODS: Advanced cancer patients and their caregivers (N = 484 dyads) were stratified by patients' baseline risk for distress (high versus low), cancer type (lung, colorectal, breast, or prostate), and research site and then randomly assigned to a brief (three-session) or extensive (six-session) intervention or control. The interventions offered dyads information and support. Intermediary outcomes were appraisals (i.e., appraisal of illness/caregiving, uncertainty, and hopelessness) and resources (i.e., coping, interpersonal relationships, and self-efficacy). The primary outcome was QOL. Data were collected prior to intervention and post-intervention (3 and 6 months from baseline). The final sample was 302 dyads. Repeated measures MANCOVA was used to evaluate outcomes. RESULTS: Significant group by time interactions showed that there was an improvement in dyads' coping (p < 0.05), self-efficacy (p < 0.05), and social QOL (p < 0.01) and in caregivers' emotional QOL (p < 0.05). Effects varied by intervention dose. Most effects were found at 3 months only. Risk for distress accounted for very few moderation effects. CONCLUSIONS: Both brief and extensive programs had positive outcomes for patient-caregiver dyads, but few sustained effects. Patient-caregiver dyads benefit when viewed as the 'unit of care'.

The impact of caregiving on the psychological well-being of family caregivers and cancer patients.

OBJECTIVES: To provide an overview of patient and caregiver emotional distress; examine the sources of their distress, review evidence-based interventions that can reduce distress, and provide guidelines for assessment and intervention. DATA SOURCES: Peer-reviewed publications. CONCLUSION: There is a significant, reciprocal relationship between patient and caregiver emotional distress. Sources of distress vary by phase of illness. Evidence-based interventions can reduce distress and anxiety, but often are not implemented in practice. IMPLICATIONS FOR NURSING PRACTICE: Nurses need to assess patients and family caregivers for distress and intervene to reduce distress by fostering patient-caregiver teamwork, communication, and self-care; providing information; and referring to resources as needed.

Adapting an in-person patient-caregiver communication intervention to a tailored web-based format.

BACKGROUND: Interventions that target cancer patients and their caregivers have been shown to improve patient-caregiver communication, support, and emotional well-being. OBJECTIVE: To adapt an in-person communication intervention for cancer patients and caregivers to a web-based format, and to examine the usability and acceptability of the web-based program among representative users. METHODS: A tailored, interactive web-based communication program for cancer patients and their family caregivers was developed based on an existing in-person, nurse-delivered intervention. The development process involved: (1) building a multidisciplinary team of content and web design experts, (2) combining key components of the in-person intervention with the unique tailoring and interactive features of a web-based platform, and (3) conducting focus groups and usability testing to obtain feedback from representative program users at multiple time points. RESULTS: Four focus groups with 2-3 patient-caregiver pairs per group (n = 22 total participants) and two iterations of usability testing with four patient-caregiver pairs per session (n = 16 total participants) were conducted. Response to the program's structure, design, and content was favorable, even among users who were older or had limited computer and Internet experience. The program received high ratings for ease of use and overall usability (mean System Usability Score of 89.5 out of 100). CONCLUSIONS: Many elements of a nurse-delivered patient-caregiver intervention can be successfully adapted to a web-based format. A multidisciplinary design team and an iterative evaluation process with representative users were instrumental in the development of a usable and well-received web-based program.

Factors associated with prostate cancer patients' and their spouses' satisfaction with a family-based intervention.

Only a few programs are designed to help couples cope with the effects of prostate cancer, and typically, only their intervention outcomes are reported. The purpose of this study was to assess prostate cancer patients' and their spouses' satisfaction with an efficacious supportive-educative, family-based intervention, and factors associated with their satisfaction. We assessed the relationship of overall satisfaction with the intervention to (1) the patients' and spouses' appraisal and the resource and quality-of-life baseline scores and (2) changes in those scores after completing the intervention. Results showed that participants were very satisfied with the program. Patients who had higher scores on baseline measures, indicating more positive appraisal of their illness, better use of resources (eg, coping, self-efficacy), and higher overall quality of life, reported more satisfaction with the intervention. For spouses, few baseline measures were related to their satisfaction; however, spouses who reported positive changes after intervention (less negative appraisal and uncertainty, better communication) reported higher satisfaction with the program. Although satisfied with the program, factors associated with patients' and spouses' satisfaction differed. To translate effective interventions to clinical practice settings, it is important to assess participants' satisfaction with program content and delivery, as well as program outcomes.

Randomized clinical trial of a family intervention for prostate cancer patients and their spouses.

BACKGROUND: Few intervention studies have been conducted to help couples manage the effects of prostate cancer and maintain their quality of life. The objective of this study was to determine whether a family-based intervention could improve appraisal variables (appraisal of illness or caregiving, uncertainty, hopelessness), coping resources (coping strategies, self-efficacy, communication), symptom distress, and quality of life in men with prostate cancer and their spouses. METHODS: For this clinical trial, 263 patient-spouse dyads were stratified by research site, phase of illness, and treatment; then, they were randomized to the control group (standard care) or the experimental group (standard care plus a 5-session family intervention). The intervention targeted couples' communication, hope, coping, uncertainty, and symptom management. The final sample consisted of 235 couples: 123 couples in the control group and 112 couples in the experimental group. Data collection occurred at baseline before randomization and at 4 months, 8 months, and 12 months. RESULTS: At 4-month follow-up, intervention patients reported less uncertainty and better communication with spouses than control patients, but they reported no other effects. Intervention spouses reported higher quality of life, more self-efficacy, better communication, and less negative appraisal of caregiving, uncertainty, hopelessness, and symptom distress at 4 months compared with controls, and some effects were sustained to 8 months and 12 months. CONCLUSIONS: Men with prostate cancer and their spouses reported positive outcomes from a family intervention that offered them information and support. Programs of care need to be extended to spouses who likely will experience multiple benefits from intervention.

Research with families facing cancer: the challenges of accrual and retention.

The purposes of this article are: (a) to describe and analyze the accrual and retention patterns in a longitudinal randomized clinical trial with prostate cancer patients and their partners, and (b) to discuss strategies that were used to overcome challenges in conducting this family-based study. Initially, 429 dyads were referred to the study. Of these, 166 were not enrolled due to refusal (n = 120) or ineligibility (n = 46), 21 of whom did not meet one or more of the inclusion criteria, and 25 of whom could not be reached within the 2-month window of eligibility. Of the 383 eligible dyads, 263 dyads were enrolled (enrollment rate of 68.7%). Accrual and retention patterns differed by research site, referral procedures, and phase of prostate cancer. The retention rate was very good with the majority of dyads (n = 218) completing all three follow-up assessments at 4, 8, and 12 months (82.9%).

Effects of a family intervention on the quality of life of women with recurrent breast cancer and their family caregivers.

BACKGROUND: The purpose of this study was to determine if patients with advanced breast cancer and their family caregivers, who participated in a family based intervention, report better quality of life and other psychosocial outcomes than dyads who received standard care alone. METHODS: Using a randomized clinical trial, 134 patients and their family caregivers were assigned to usual care (control) or to usual care plus the family intervention (experimental condition). Dyads were assessed at baseline, three- and six-months later. The intervention consisted of five sessions and addressed family involvement, optimistic attitude, coping effectiveness, uncertainty reduction, and symptom management. RESULTS: Patients in the family intervention reported significantly less hopelessness and less negative appraisal of illness than controls; their family caregivers reported significantly less negative appraisal of caregiving. Intervention effects were evident at three-months, but were not sustained at six-months. No difference was found in the quality of life of dyads in experimental or control conditions. CONCLUSIONS: Although the family intervention had positive effects initially, these effects were not sustained over time. Future studies need to consider program dose and duration of effect, outcome measures that are more sensitive to change, and realistic end-points for patients with advanced cancer.

A family-based program of care for women with recurrent breast cancer and their family members.

PURPOSE/OBJECTIVES: To evaluate the FOCUS Program (family involvement, optimistic attitude, coping effectiveness, uncertainty reduction, and symptom management), a family-based program of care for women with recurrent breast cancer and their family caregivers. DATA SOURCES: Randomized clinical trial. SETTING: Midwest region of the United States. DATA SYNTHESIS: The family-based program of care consisted of five components: family involvement, optimistic attitude, coping effectiveness, uncertainty reduction, and symptom management. The program was delivered in three home visits and two follow-up phone calls over a five-month period of time. CONCLUSIONS: Patients with recurrent breast cancer and their family members reported high satisfaction with the FOCUS Program. Although the FOCUS Program had a number of strengths, limitations of the program also were identified that need to be addressed in future family-based interventions. IMPLICATIONS FOR NURSING: A need exists for family-based programs of care that enable both patients and their family members to manage the multiple demands associated with recurrent breast cancer.

Quality of life of women with recurrent breast cancer and their family members.

PURPOSE: Little information is available about the effects of recurrent breast cancer on the quality of life of women and their family members. The present study assessed patients' and family members' quality of life within 1 month after recurrence, and effects of multiple factors on quality-of-life scores. PATIENTS AND METHODS: Patient/family member dyads (N = 189) participated in this study. A stress-appraisal model guided selection of person factors, social/family factors, illness-related factors, appraisal factors, and quality of life, measured with psychometrically sound instruments. Quality of life was measured with both generic (Medical Outcomes Study SF-36) and cancer-specific (Functional Assessment of Cancer Therapy) scales. RESULTS: Patients reported significant impairments in physical, functional, and emotional well-being. Family members reported significant impairments in their own emotional well-being. Structural equation modeling revealed that self-efficacy, social support, and family hardiness had positive effects on quality of life, whereas symptom distress, concerns, hopelessness, and negative appraisal of illness or caregiving had detrimental effects. Study variables accounted for a sizable amount of variance in patients' and family members' physical and mental dimensions of quality of life (72% to 81%). Contrary to findings observed in studies of newly diagnosed breast cancer patients and spouses, little relationship was found between recurrent patients' and family members' quality of life. CONCLUSION: Women with recurrent breast cancer are in need of programs to assist them with the severe effects of the disease on their quality of life. Programs need to include family members to help counteract the negative effects of the recurrent disease on their mental health, and to enable them to continue as effective caregivers.

Couples' experiences with prostate cancer: focus group research.

PURPOSE/OBJECTIVES: To explore the experiences of couples living with prostate cancer, the impact of the illness on their quality of life, their ability to manage symptoms, and their suggestions for interventions that would help them to improve their daily experiences. DESIGN: Descriptive, qualitative. SETTING: Six focus groups were used to obtain the data; two were patient-only groups, two were spouse-caregiver groups, and two were dyad groups. The focus groups were conducted at two comprehensive cancer centers in the midwestern region of the United States. SAMPLE: 42 participants: 22 men with prostate cancer and 20 spouse-caregivers. METHODS: Focus group discussions were tape-recorded, and the content was analyzed. MAIN RESEARCH VARIABLES: Quality of life, symptom experience, and areas for intervention. FINDINGS: Four major themes emerged from the data: enduring uncertainty, living with treatment effects, coping with changes, and needing help. CONCLUSIONS: Participants had a need for information and support. Both men and spouse-caregivers felt unprepared to manage treatment effects. Symptoms had a broad effect on couples, not just men. Positive effects of the illness, as well as negative effects, emerged from the themes. IMPLICATIONS FOR NURSING: Attention needs to be given to methods of providing information and support to couples coping with prostate cancer. Both patients and partners need to be included in discussions about the effect of the illness and treatments so that both can feel more prepared to manage them.