Development and feasibility of an exercise therapy intervention for older women with advanced epithelial ovarian cancer referred to neoadjuvant chemotherapy prior to possible interval debulking surgery.

Objective: This study describes the development and examines the feasibility of an exercise therapy program for women aged 70 years or older with advanced EOC, receiving neoadjuvant chemotherapy (NACT) before possible major surgery. Methods: In this feasibility study, patients participated in a mainly home-based exercise therapy program, including progressive resistance training, physical activity, and support from the supervising physiotherapist. The program included both supervised virtual and face-to-face sessions and self-administered daily exercise. Clinician-reported, patient-reported and physical performance measures were collected before and after NACT. Retention, adherence, and compliance to the program was monitored, and patient acceptability was explored in semi-structured interviews. Results: Fifteen patients, median age of 77 years (range 70-85) completed the exercise therapy program concurrently to receiving NACT lasting a median of 12 weeks. Patients were physically frail at baseline but improved at follow-up on measures of performance status, level of frailty, patient-reported physical fitness, lower body strength, aerobic functional capacity, basic mobility, balance, and number of steps per day. High levels of participation were found to both supervised and self-administered exercise. Patient interviews highlighted the homebased setting, the individualised tailoring of exercises and the support from the physiotherapist as reasons to complete the exercise therapy program as prescribed. Conclusions: The exercise therapy program was found to be feasible and acceptable in women aged 70 years or older with advanced EOC, receiving NACT before possible major surgery. The observed improvements and the positive experiences perceived by the patients support future application in research and clinical practice.

Impact of FRAilty screening and Geriatric assessment and INtervention in older patients with epithelial Ovarian Cancer: A multicenter randomized clinical trial protocol (FRAGINOC).

INTRODUCTION: Radical surgery combined with chemotherapy is the only potential curative treatment of patients with advanced epithelial ovarian cancer (EOC). However, 43% of older Danish patients with EOC are not referred to surgery due to frailty, age, or fear of complications. Comprehensive geriatric assessment (CGA) has demonstrated ability to reduce frailty in older patients, but there is a knowledge gap regarding its effect before or during treatment in older adults with EOC. This protocol presents a randomized controlled trial (RCT), which evaluates the effect of CGA-based interventions including individualized physical exercise therapy in older adults with EOC during neoadjuvant chemotherapy (NACT). MATERIALS AND METHODS: This RCT will include patients aged ≥70 years with primary EOC referred to NACT. Patients will be randomized 1:1 to intervention or standard of care, along with neoadjuvant antineoplastic treatment. Stratification for performance status and center of inclusion will be performed. In the intervention arm, a geriatrician will perform CGA and corresponding geriatric interventions and patients will undergo an individualized home-based exercise program managed by a physiotherapist. All patients will be evaluated with Geriatric-8, modified Geriatric-8, clinical frailty scale, and physical tests at randomization. Predictive values (positive/negative) will be evaluated for CGA detected impairments. The primary endpoint is the proportion of patients referred to interval debulking surgery (IDS). Secondary endpoints include the proportion who complete oncological treatment, improvements in physical tests, quality of life measured by European Organization for Research and Treatment of Cancer-Quality of Life questionnaires at inclusion, after three cycles of chemotherapy, and at end of chemotherapy treatment. Furthermore, the association between results of geriatric screening tests, CGA, and physical tests with complication rate and progression free survival will be examined. The primary outcome will be analyzed with logistic regression in the intention-to-treat population. Power calculations reveal the need to enroll 216 patients. DISCUSSION: The present study examines whether CGA-based interventions including individualized physical exercise can increase the referral rate for potential curative IDS in older patients with EOC. If successful, this will result in more patients undergoing surgery and completing chemotherapy, preventing complications, and ultimately improving quality of life and survival. The study setup may establish the basis for direct clinical implementation if proven effective.

External validation and diagnostic value of the Elderly Functional Index version 2.0 for assessing functional status and frailty in older Danish patients with gastrointestinal cancer receiving chemotherapy: A prospective, clinical study.

INTRODUCTION: Patient perspectives on functioning are often overlooked in oncology practice. This study externally validates the ELderly Functional Index (ELFI), a patient-reported measure for assessing multidimensional functioning, in older patients with gastrointestinal cancer receiving chemotherapy. The study compares ELFI scoring methods, evaluates its diagnostic value with geriatric oncology tools, and proposes a cut-off point for clinical use. MATERIALS AND METHODS: Danish patients aged ≥70 years with gastrointestinal cancer undergoing chemotherapy from a prospective, observational study were included. Two ELFI scoring methods, item-based and domain-based, were compared. Internal consistency reliability, validity, and correlations between ELFI, its component scales, and measures of functioning/frailty (including Eastern Cooperative Oncology Group Performance Status [ECOG-PS], Geriatric-8 [G8], Vulnerable Elders Survey-13 [VES-13], Timed-Up-and-Go [TUG], and 30-s chair stand test [30CST]) were investigated. Sensitivity and specificity analyses evaluated the ability of ELFI to predict frailty outcomes and identified frailty thresholds. Receiver operating characteristic analyses assessed the diagnostic ability of ELFI, alongside other measures, for oncological outcomes and frailty differentiation. Equipercentile equating methods enabled ECOG-PS, ELFI, and G8 mapping. RESULTS: One hundred fifty-four patients (median age 73.5 years, range 70-85) undergoing curative- or palliative-intent chemotherapy (49%) were included. ELFI demonstrated good internal consistency (Cronbach's alpha = 0.82) and acceptable convergent, structural, and discriminant validity. ELFI showed moderate to very strong correlations with its component scales (r = 0.40-0.93), and weaker correlations with frailty measures (r = 0.02-0.60). ELFI score < 80 indicated frailty risk, with almost fivefold risk of ECOG-PS 2 at follow-up (odds ratio[OR] = 4.8, 95% confidence interval [CI] 1.4-15.9), and predicted G8, VES-13, TUG, and 30CST frailty at follow-up, not completing planned chemotherapy (OR = 3.1; 95%CI 1.5-6.2), mono-therapy (OR = 3.5; 95%CI 1.5-8.1), initial dose reduction (OR = 4.9; 95%CI 2.0-12.1), and shorter overall survival (hazard ratio = 2.0, 95%CI 1.4-3.0). A preliminary crosswalk between ECOG-PS, ELFI, and G8 was established. DISCUSSION: ELFI was validated as a concise patient-reported measure of functional status in older patients with cancer and its relationship to frailty. ELFI demonstrated comparable predictive ability to other tools for oncological outcomes. Both scoring methods yielded similar results, with the domain-based method (ELFI v2.0) endorsed for consistency. ELFI v2.0 score of 80 was suggested as the frailty threshold in this population, supporting its clinical utility.

Symptoms of total pain experienced by older people with advanced gastrointestinal cancer receiving palliative chemotherapy.

OBJECTIVE: Little is known about concurrent physical, psychological, social and spiritual distress experienced by older patients during early stages of advanced cancer while receiving life-prolonging treatment. Drawing on the concept of total pain, this study explored the multi-faceted symptoms of pain in older patients with advanced gastrointestinal cancer while receiving palliative chemotherapy. METHODS: A total of 14 in-depth interviews with seven participants were conducted, one interview at the beginning and one after completion of chemotherapy. Participants were ≥70 years, diagnosed with advanced gastrointestinal cancer and receiving palliative chemotherapy. RESULTS: Thematic analysis revealed four themes: variability and inevitability of physical pain, ways of coping with psychological pain, mitigating social pain through contributions to social life and the anticipation of existential pain in old age. Conducting two interviews with each participant foregrounded the changing nature of the participants' experienced symptoms and life perspectives while receiving palliative chemotherapy. Further, old age was experienced as integral to how participants described their situation and indicated an acceptance of old age. CONCLUSION: Older adults with advanced cancer are affected by multiple-faceted symptoms resulting from cancer and its treatment. The concept of total pain is suggested to guide interdisciplinary palliative care in earlier stages of advanced cancer.

Frailty screening for predicting rapid functional decline, rapid progressive disease, and shorter overall survival in older patients with gastrointestinal cancer receiving palliative chemotherapy - a prospective, clinical study.

OBJECTIVES: A growing number of older patients with cancer require well-founded clinical decision-making. Frailty screening is suggested as a service to improve outcomes in vulnerable older patients with cancer. This prospective study examined the value of frailty screening to predict rapid functional decline, rapid progressive disease (PD) and shorter overall survival (OS) in older patients with gastrointestinal cancer receiving palliative chemotherapy. MATERIALS AND METHODS: Patients aged ≥70 years were screened for frailty in an oncologic department after clinical decision but before starting palliative chemotherapy. Screening was repeated at first response evaluation after approximately two months of chemotherapy. Frailty screening tools included performance status (PS), Charlson Comorbidity Index, G-8 using two different cut-offs (G814,G811), VES-13, Timed-Up-and-Go, Handgrip strength and falls. RESULTS: A total of 170 patients were included, median age was 75.5 (70-88) years and 65.9% were male. The frequency of frailty varied from 14% to 74% according to the chosen frailty tool. In multivariate analysis G814 predicted OS (HR 1.5; 95%CI 1.0-2.4), whereas G811 predicted PD (OR 2.4; 1.1-5.6) and OS (HR 2.1; 1.4-2.9). VES-13 predicted functional decline (OR 3.5; 1.0-11.6), PD (OR 3.5; 1.5-8.4) and OS (HR 1.7; 1.2-2.4). Timed-Up-and-Go predicted OS (HR 1.8; 1.1-2.7). Handgrip strength and falls predicted functional decline (OR 4.5; 1.1-19 and OR 6.1; 1.4-25.8, respectively). PS predicted PD (OR 6.2; 2.6-14.7) and OS (HR 2.2; 1.5-3.2). CONCLUSION: VES-13 was useful for predicting all three endpoints of interest. Frailty tools covering domains of functioning and nutrition are suggested for older patients with advanced gastrointestinal cancer.

Health-related quality of life in patients with multiple myeloma participating in a multidisciplinary rehabilitation program.

Patients with multiple myeloma (MM) report high symptom burden and functional disabilities resulting in impaired health-related quality of life (HRQoL). Effective evidence-based rehabilitation guidelines are needed for patients with MM to improve HRQoL. The primary aim of this study was to investigate HRQoL in patients with rehabilitation needs living their everyday life. Patients with MM in remission attended a 12-week multidisciplinary rehabilitation program including a 5-day residential course, home-based exercise and a 2-day follow-up course. The patients were referred by the treating haematologist and completed a booklet of validated HRQoL questionnaires at baseline and before arriving for the 2-day follow-up course. The proportion of participants with moderate to severe symptoms and functional problems were assessed at the two time points and multivariate logistic regression was used to investigate explaining factors of impaired HRQoL at baseline. Ninety-two patients participated with a follow-up compliance rate of 90%. Median age was 67 years and median time since diagnosis was 26 months (ranged 5 months to 15.6 years). The most frequently reported symptoms were global quality of life, role functioning, fatigue, pain, peripheral neuropathy and physical functioning. Pain and fatigue were both highly coherent with impairment in physical functioning and those two symptoms explained most HRQoL impairments. Overall, the participants reported no change in HRQoL after the 12-week rehabilitation program. The study supports the need for an evidence-based guideline for rehabilitation and palliative care to patients with MM in remission living their everyday life.

Everyday living with pain - reported by patients with multiple myeloma.

OBJECTIVES: The prevalence and impact of pain among patients with multiple myeloma (MM) in their everyday life require renewed attention. MM patients' survival has increased considerably over the last decades and active disease episodes are interrupted by longer periods with disease inactivity. The aim with this study is to explore pain intensity and pain interference with daily activities during periods of stable or inactive MM disease. METHODS: In a cross-sectional study from September 2017 to May 2019, self-reliant MM patients in stable disease filled a comprehensive selection of validated questionnaires regarding pain, other symptoms and quality of life, which they experienced in their daily living. Patient reported pain intensity and interference with daily activities were analyzed for associations with several clinical and demographic factors and discussed from a total pain perspective. The two outcomes, pain intensity and pain interfering with daily activities, were analyzed in two age groups (<65 years or ≥65 years). RESULTS: Among 92 participants, 80% experienced pain to interfere with their daily activities (equal in both age groups), and 63% reported moderate to severe pain intensity; (75% ≥65 years, and 49% <65 years). Pain intensity was significantly associated with signs of depression (OR 4.0 [95% CI: 1.2-13.9]) and age ≥65 years (OR 3.3 [95% CI: 1.2-9.2]). Pain interfering with daily activities was nearly significantly associated with bone involvement (OR 3.4 [95% CI: 1.0-11.6]) and signs of depression (OR 5.9 [95% CI: 1.0-36.3]). The patients were bothered with many problems in addition to pain; fatigue (91%), bone involvement (74%), signs of depression (41%), signs of anxiety (32%), comorbidity (29%) and uncertainty in relation to employment or pension (25%). Neuropathic pain was more prevalent in the feet (33% [95% CI: 23%, 43%]) compared with pain in the hands (13% [95% CI: 7%, 22%]). CONCLUSIONS: In periods of stable disease, many MM patients continue to live with intense pain interfering with their daily activities. Additional or associated problems are the presence of bone involvement, neuropathic pain, older age, uncertainty in relation to employment or pension, comorbidity, signs of depression, anxiety and fatigue. This highlights the importance of health professionals being receptive to the patients' experience of pain throughout their trajectories, to assess pain systematically and to interpret this experience from a total pain perspective. While pain problems in relation to diagnosing and treating MM is well known, this study brings the message that even during periods of stable or inactive MM disease, the patients experience pain with a moderate to severe intensity, that interferes with their everyday living. The improved survival and the consequential long trajectories make coherence in the pain treatment even more important for the patients, who may see different professionals in different health care settings for different reasons. The patient group requires a coordinated, holistic patient-centered pain treatment throughout the disease trajectory.

Associations between perceived information needs and anxiety/depressive symptoms among cancer caregivers: A cross-sectional study.

Purpose: Caregivers to cancer patients often experience information needs. This study investigates the associations between perceived information needs and anxiety/depressive symptoms among caregivers to cancer patients.Design: Cross-sectional study using self-completed questionnaires.Sample: A total of 128 caregivers to cancer patients who participated in a rehabilitation stay at REHPA, The Danish Knowledge Center for Rehabilitation and Palliative Care, from April 2016 to March 2017.Methods: The caregivers completed a questionnaire assessing both information needs and anxiety/depressive symptoms. We used ordinal logistic regressions to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for the associations between seven information needs and anxiety/depressive symptoms. The reference group was caregivers with no perceived information needs.Findings: The combined score of perceived information needs was associated with higher odds of anxiety (OR = 3.86 per unit increase, 95% CI 1.85-8.03) and depressive symptoms (OR = 3.83 per unit increase, 95% CI 1.15-12.75). For the individual items, our results showed higher odds of anxiety symptoms for caregivers with perceived information needs regarding (1) the disease and its course, for both little need for information (OR = 3.62, 95% CI 1.39-9.43) and substantial need for information (OR = 4.57, 95% CI 1.40-14.93); however, for substantial information needs, an interaction with gender was found showing higher odds for men (OR = 28.90, 95% CI 4.46-187.41), but no significant association for women. Also, substantial need for information regarding the disease and its course were associated with higher odds of depressive symptoms (OR = 11.43, 95% CI 1.18-111.21). Furthermore, we found higher odds of anxiety symptoms for caregivers who perceived information needs regarding (2) which symptoms and adverse effects to be aware of; (3) how to help and support a cancer patient; (4) expected mental responses in a person with cancer; (5) how to find information on the internet, and (6) where to direct caregiver questions and/or concerns after patient discharge.Conclusions: Among caregivers to cancer patients, perceived needs regarding the disease and its course were associated with higher odds of anxiety and depressive symptoms. Furthermore, several other information needs were associated with anxiety symptoms.Implications for Psychosocial Providers or Policy: To prevent unnecessary anxiety and depressive symptoms among cancer caregivers, health care professionals should be aware of the importance of informing caregivers regarding the disease and its course. Other issues to address concerning anxiety symptoms are information regarding which symptoms and adverse effects to be aware of; how to help and support a cancer patient; expected mental responses in a person with cancer; how to find information on the internet; and where to direct caregiver questions and/or concerns after patient discharge.