The course of self-perceived cognitive functioning among patients with lymphoma and the co-occurrence with fatigue and psychological distress.

PURPOSE: To investigate the proportion of patients with lymphoma with persistent clinically relevant cognitive impairment, and its relation to  treatment, fatigue, and psychological distress. METHODS: Patients with diffuse-large-B-cell-lymphoma (DLBCL), follicular-lymphoma (FL), and chronic-lymphocytic-leukemia (CLL)/small-lymphocytic-lymphoma (SLL), diagnosed between 2004-2010 or 2015-2019, were followed up to 8 years post-diagnosis. Sociodemographic and clinical data were obtained from the Netherlands Cancer Registry and the Population-based HAematological Registry for Observational Studies. The EORTC QLQ-C30 was used to assess cognitive functioning and fatigue, and the HADS to assess psychological distress. Individual growth curve models were performed. Results were compared with an age- and sex-matched normative population. RESULTS: A total of 924 patients were included (70% response rate). Persistent cognitive impairment was twice as high in patients (30%) compared to the normative population (15%). Additionally, 74% of patients reported co-occurring symptoms of persistent fatigue and/or psychological distress. Patients with FL (- 23 points, p < 0.001) and CLL/SLL (- 10 points, p < 0.05) reported clinically relevant deterioration of cognitive functioning, as did the normative population (FLnorm - 5 points, DLBCLnorm - 4 points, both p < 0.05). Younger age, higher fatigue, and/or psychological distress at inclusion were associated with worse cognitive functioning (all p's < 0.01). Treatment appeared less relevant. CONCLUSION: Almost one-third of patients with lymphoma report persistent cognitive impairment, remaining present up to 8 years post-diagnosis. Early onset and co-occurrence of symptoms highlight the need for clinicians to discuss symptoms with patients early. IMPLICATIONS FOR CANCER SURVIVORS: Early recognition of cognitive impairment could increase timely referral to suitable supportive care (i.e., lifestyle interventions) and reduce (long-term) symptom burden.

Evaluation of an individual feedback report on patient-reported outcomes in the Prospective Dutch ColoRectal Cancer cohort.

PURPOSE: Returning patient-reported outcomes to patients might aid patients in detecting symptoms and might facilitate early intervention. This descriptive study evaluates the use of an individual feedback report on patient-reported outcomes for colorectal cancer patients and aims to assess differences in patient, tumor, and treatment characteristics and cohort retention between patients who opt and do not opt for the feedback report. METHODS: Patients with colorectal cancer participating in the nationwide Prospective Dutch ColoRectal Cancer Cohort, who filled in questionnaires digitally between June 2018 and January 2019, were included. Participants were given the option to receive a feedback report at baseline, 3, 6, and 12 months. The usefulness, content, and layout of the feedback report were evaluated. Differences in patient, tumor, and treatment characteristics, patient-reported outcomes, and cohort retention at subsequent questionnaires between participants who did and did not opt for feedback were assessed. RESULTS: A total of 484 participants were included of whom 293 (61%) opted for feedback. The feedback report was considered useful by 92%. No differences in patient, tumor, and treatment characteristics, and patient-reported outcomes were found between participants who did and did not opt for feedback. The response rate was higher among patients who opted for feedback compared to patients who did not opt for feedback at T3 (84 vs 74%), but not at T6 and T12. CONCLUSION: The feedback report was used by 6 out of 10 patients. The feedback report was considered valuable and associated with a higher subsequent response rate.

Web-Based Return of Individual Patient-Reported Outcome Results Among Patients With Lymphoma: Randomized Controlled Trial.

BACKGROUND: There has been a cultural shift toward patient engagement in health, with a growing demand from patients to access their results. OBJECTIVE: The Lymphoma Intervention (LIVE) trial is conducted to examine the impact of return of individual patient-reported outcome (PRO) results and a web-based self-management intervention on psychological distress, self-management, satisfaction with information, and health care use in a population-based setting. METHODS: Return of PRO results included comparison with age- and sex-matched peers and was built into the Patient-Reported Outcomes Following Initial Treatment and Long-Term Evaluation of Survivorship registry. The self-management intervention is an adaptation of a fully automated evidence-based intervention for breast cancer survivors. Patients with lymphoma who completed the web-based questionnaire were equally randomized to care as usual, return of PRO results, and return of PRO results plus self-management intervention. Patients completed questionnaires 9 to 18 months after diagnosis (T0; n=227), 4 months (T1; n=190), 12 months (T2; n=170), and 24 months (T3; n=98). RESULTS: Of all invited patients, 51.1% (456/892) responded and web-based participants (n=227) were randomly assigned to care as usual (n=76), return of PRO results (n=74), or return of PRO results and access to Living with lymphoma (n=77). Return of PRO results was viewed by 76.7% (115/150) of those with access. No statistically significant differences were observed for psychological distress, self-management, satisfaction with information provision, and health care use between patients who received PRO results and those who did not (P>.05). Use of the self-management intervention was low (2/76, 3%), and an effect could therefore not be determined. CONCLUSIONS: Return of individual PRO results seems to meet patients' wishes but had no beneficial effects on patient outcome. No negative effects were found when individual PRO results were disclosed, and the return of individual PRO results can therefore be safely implemented in daily clinical practice. TRIAL REGISTRATION: Netherlands Trial Register NTR5953; https://www.trialregister.nl/trial/5790. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-017-1943-2.

Web-Based Self-Management for Patients With Lymphoma: Assessment of the Reach of Intervention of a Randomized Controlled Trial.

BACKGROUND: Randomized controlled trials (RCTs) often provide accurate estimates of the internal validity of an intervention but lack information on external validity (generalizability). We conducted an RCT on the effectiveness of a self-management intervention among patients with lymphoma in a population-based setting. OBJECTIVE: The objectives of the current study were to describe the proportion of RCT participants compared to all patients invited to participate, and compare sociodemographic and clinical characteristics of RCT participants with all respondents, all patients invited to participate, and all patients selected from the Netherlands Cancer Registry (NCR) to determine the reach of the intervention. An additional objective was to assess differences on RCT outcome variables between RCT and paper respondents. METHODS: Patients with lymphoma or chronic lymphocytic leukemia ≥18 years old at diagnosis from 13 hospitals in the Netherlands were selected from the population-based NCR, which routinely collects data on sociodemographic and clinical characteristics. Eligible patients were invited to participate in an RCT and complete a questionnaire. Web-based completion determined RCT enrollment, whereas paper respondents were followed observationally. RESULTS: A total of 1193 patients were selected from the NCR, 892 (74.77%) of whom were invited to participate in the trial by their hematologist after verifying eligibility. Among those invited, 25.4% (227/892) completed the web-based questionnaire and were enrolled in the RCT. The RCT participants were younger and there was a higher proportion of men than nonparticipants (P<.001). In addition, 25.7% (229/892) of those invited opted to participate in the paper-based observational follow-up study. Compared with paper respondents, RCT participants were younger (P<.001), with a higher proportion of men (P=.002), and had higher education levels (P=.02). RCT participants more often wanted to receive all available information on their disease (P<.001), whereas paper respondents reported higher levels of emotional distress (P=.009). CONCLUSIONS: From a population-based sample of eligible patients, the participation rate in the RCT was approximately 25%. RCT participants may not be representative of the target population because of different sociodemographic and clinical characteristics. Since RCT participants represent a minority of the target population, RCT results should be interpreted with caution as patients in the RCT may be those least in need of a self-management intervention. TRIAL REGISTRATION: Netherlands Trial Register NTR5953; https://www.trialregister.nl/trial/5790.

Health-Related Quality of Life, Satisfaction with Care, and Cosmetic Results in Relation to Treatment among Patients with Keratinocyte Cancer in the Head and Neck Area: Results from the PROFILES Registry.

BACKGROUND: Little is known about the impact of keratinocyte cancer (KC) and its treatment on health-related quality of life (HRQoL). OBJECTIVES: The objectives of the present study were (1) to evaluate HRQoL among patients with KC in a population-based setting and compare this with an age- end sex-matched normative population and (2) to compare HRQoL, satisfaction with care, and cosmetic results among patients who underwent conventional excision, Mohs' micrographic surgery, or radiotherapy. METHOD: A random sample of 347 patients diagnosed with cutaneous basal cell or squamous cell carcinoma in the head and neck area between January 1, 2010, and December 31, 2014, were selected from the Netherlands Cancer Registry (NCR) and were invited to complete a questionnaire on HRQoL, satisfaction with care, and cosmetic results. Data were collected within Patient-Reported Outcomes Following Initial Treatment and Long-term Evaluation of Survivorship (PROFILES). Outcomes were compared to an age- and sex-matched normative population. RESULTS: Two hundred fifteen patients with KC returned a completed questionnaire (62% response). Patients with KC reported better global quality of life (79.6 vs. 73.3, p < 0.01) and less pain (p < 0.01) compared to the normative population. No statistically significant differences in HRQoL, satisfaction with care, and cosmetic results were found between patients with KC who underwent conventional excision, Mohs' micrographic surgery, or radiotherapy. CONCLUSIONS: The impact of KC and its treatment seems relatively low and more positive than negative as patients reported better HRQoL compared to an age- and sex-matched normative population, probably due to adaptation. No statistically significant differences between treatment types were found concerning HRQoL, patient satisfaction, and cosmetic results. This information could be used by healthcare professionals involved in KC care to improve patients' knowledge about different aspects of the disease as patient's preference is an important factor for treatment choice.

More frequent use of health care services among distressed compared with nondistressed survivors of lymphoma and chronic lymphocytic leukemia: Results from the population-based PROFILES registry.

BACKGROUND: Follow-up care for a growing population of survivors of lymphoma and chronic lymphocytic leukemia (CLL) together with the adverse effects these survivors may experience as a result of their cancer and treatment have led to more pressure being placed on health care services. The objectives of the current study were to: 1) compare the use of medical care services by survivors with that of a normative population; 2) evaluate the use of medical and psychosocial care services among distressed and nondistressed survivors; and 3) identify associated sociodemographic and clinical factors. METHODS: Survivors of lymphoma and CLL diagnosed between 1999 and 2012 were selected via the population-based Netherlands Cancer Registry and completed the Hospital Anxiety and Depression Scale questionnaire and questions regarding health care. Outcomes were compared with an age-matched and sex-matched normative population. RESULTS: A total of 1444 survivors responded (69%). Survivors of lymphoma and CLL contacted their general practitioner (3.8 vs 2.3; P<.001) and medical specialist (5.7 vs 1.6; P<.001) more often within the last year compared with a normative population. In addition, psychologically distressed survivors had even more medical contacts and received psychosocial care more often compared with nondistressed survivors. In addition to psychological distress, comorbidity, female sex, and older age were found to be associated with a greater use of medical services, whereas younger age was associated with receiving psychosocial care. CONCLUSIONS: Survivors of lymphoma and CLL, especially those who are psychologically distressed, report an increased use of health care services compared with a normative population. Further studies are needed to explore whether the use of widely applicable psychosocial interventions could reduce the frequency of medical contacts. Cancer 2018;124:3016-24. © 2018 Netherlands Comprehensive Cancer Organisation. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.

"Am I normal?" The Wishes of Patients With Lymphoma to Compare Their Patient-Reported Outcomes With Those of Their Peers.

BACKGROUND: Providing feedback to patients on their patient-reported outcomes (PROs) can help patients in monitoring their functioning and symptoms and may help empower them. OBJECTIVE: The objective of this study was to investigate whether patients with lymphoma wished to receive PRO feedback, including the option to compare their scores with those of their peers, and how this feedback was evaluated. METHODS: We invited 64 patients participating in a lymphoma cohort who were eligible for a follow-up questionnaire and gave them the option to receive PRO feedback. Patients completed questions about health-related quality of life (HRQoL) and symptoms. PRO feedback was provided via bar charts. RESULTS: Of the 64 invited patients, 45 participated (response rate 70%) and 36 of those (80%) wished to receive PRO feedback. The vast majority (34/36, 94%) compared their scores with those of a lymphoma reference cohort, and 64% (23/36) compared their score with those of a normative population without cancer. All patients wished to receive feedback on their HRQoL, and 29 (81%) to 33 (92%) wanted feedback on their functioning, fatigue, neuropathy, anxiety, and depressive symptoms. Of the 36 participants wishing to receive PRO feedback, 35 (97%) viewed it as being useful, with reassurance and knowledge about their own functioning in relation to what is "normal" being the most frequently mentioned reasons. CONCLUSIONS: A high number of patients with lymphoma wished to receive PRO feedback. Patients reported the comparison of their scores versus a lymphoma reference cohort as most valuable. Further research should investigate whether PRO feedback could increase empowerment and possibly improve HRQoL.

Lymphoma InterVEntion (LIVE) - patient-reported outcome feedback and a web-based self-management intervention for patients with lymphoma: study protocol for a randomised controlled trial.

BACKGROUND: Patients with lymphoma are at risk of experiencing adverse physical and psychosocial problems from their cancer and its treatment. Regular screening of these symptoms by the use of patient-reported outcomes (PROs) could increase timely recognition and adequate symptom management. Moreover, self-management interventions intend to enhance knowledge and skills and empower patients to better manage their disease and related problems. The objective of the Lymphoma InterVEntion (LIVE) trial is to examine whether feedback to patients on their PROs and access to a web-based, self-management intervention named Living with lymphoma will increase self-management skills and satisfaction with information, and reduce psychological distress. METHODS/DESIGN: The LIVE randomised controlled trial consists of three arms: (1) standard care, (2) PRO feedback, and (3) PRO feedback and the Living with lymphoma intervention. Patients who have been diagnosed with Hodgkin lymphoma, non-Hodgkin lymphoma, including chronic lymphocytic leukaemia, as registered in the Netherlands Cancer Registry in various hospitals will be selected for participation. Patients are invited via their haemato-oncologist 6 to 15 months after diagnosis. The PRO feedback includes a graphical overview of patients' own symptom and functioning scores and an option to compare their scores with those of other patients with lymphoma and a normative population of the same age and sex. The Living with lymphoma intervention is based on cognitive behavioural therapy components and includes information, assignments, assessments, and videos. Changes in outcomes from baseline to 16 weeks, 12, and 24 months post intervention will be measured. Primary outcomes are self-management skills, satisfaction with information, and psychological distress. Secondary outcomes are health-related quality of life, illness perceptions, fatigue, and health care use. DISCUSSION/DESIGN: The results of the LIVE trial will provide novel insights into whether access to PRO feedback and the Living with lymphoma intervention will be effective in increasing self-management skills and satisfaction with information, and reducing distress. The LIVE trial is embedded in a population-based registry, which provides a unique setting to ascertain information on response, uptake, and characteristics of patients with lymphoma in web-based intervention(s). When effective, PRO feedback and Living with lymphoma could serve as easily and widely accessible interventions for coping with lymphoma. TRIAL REGISTRATION: Netherlands Trial Register, identifier NTR5953 . Registered on 14 July 2016.

Impaired Health Status, Psychological Distress, and Personality in Women and Men With Nonobstructive Coronary Artery Disease: Sex and Gender Differences: The TWIST (Tweesteden Mild Stenosis) Study.

BACKGROUND: Patients with nonobstructive coronary artery disease (NOCAD; wall irregularities, stenosis <60%), and women with NOCAD in particular, remain underinvestigated. We examined sex and gender (S&G) differences in health status, psychological distress, and personality between patients with NOCAD and the general population, as well as S&G differences within the NOCAD population. METHODS AND RESULTS: In total, 523 patients with NOCAD (61±9 years, 52% women) were included via coronary angiography and computed tomography as part of the TWIST (Tweesteden Mild Stenosis) study. Generic health status (12-item Short Form physical and mental scales and fatigue), psychological distress (Hospital Anxiety and Depression Scale anxiety and depressive symptoms and Global Mood Scale negative and positive affect), and personality (Type D personality) were compared between patients with NOCAD and an age- and sex-matched group of 1347 people from the general population. Frequency matching was performed to obtain a similar sex distribution in each age-decile group. Both men and women with NOCAD reported impaired health status, more psychological distress, and Type D personality compared with men and women in the reference group. Women reported more psychosocial distress compared with men, but no significant sex-by-group interaction effects were observed. Women with NOCAD reported impaired health status, more anxiety, and less positive affect, but no differences in depressive symptoms, angina, or Type D personality when compared with men with NOCAD. Age, education, employment, partner, and alcohol use explained these S&G differences within the NOCAD group. CONCLUSIONS: In both men and women, NOCAD was associated with impaired health status, more psychological distress, and Type D personality when compared with a reference population. Factors reflecting S&G differences explained these S&G findings in patient-reported outcomes. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01788241.