Study protocol of the TIRED study:A randomised controlled trial comparing either graded exercise therapy for severe fatigue or cognitive behaviour therapy with usual care in patients with incurable cancer

Background: Fatigue is a common and debilitating symptom for patients with incurable cancer receiving systemic treatment with palliative intent. There is evidence that non-pharmacological interventions such as graded exercise therapy (GET) or cognitive behaviour therapy (CBT) reduce cancer-related fatigue in disease-free cancer patients and in patients receiving treatment with curative intent. These interventions may also result in a reduction of fatigue in patients receiving treatment with palliative intent, by improving physical fitness (GET) or changing fatigue-related cognitions and behaviour (CBT). The primary aim of our study is to assess the efficacy of GET or CBT compared to usual care (UC) in reducing fatigue in patients with incurable cancer. Methods: The TIRED study is a multicentre three-armed randomised controlled trial (RCT) for incurable cancer patients receiving systemic treatment with palliative intent. Participants will be randomised to GET, CBT, or UC. In addition to UC, the GET group will participate in a 12-week supervised exercise programme. The CBT group will receive a 12-week CBT intervention in addition to UC. Primary and secondary outcome measures will be assessed at baseline, post-intervention (14 weeks), and at follow-up assessments (18 and 26 weeks post-randomisation). The primary outcome measure is fatigue severity (Checklist Individual Strength subscale fatigue severity). Secondary outcome measures are fatigue (EORTC-QLQ-C30 subscale fatigue), functional impairments (Sickness Impact Profile total score, EORTC-QLQ-C30 subscale emotional functioning, subscale physical functioning) and quality of life (EORTC-QLQ-C30 subscale QoL). Outcomes at 14 weeks (primary endpoint) of either treatment arm will be compared to those of UC participants. In addition, outcomes at 18 and 26 weeks (follow-up assessments) of either treatment arm will be compared to those of UC participants. Discussion: To our knowledge, the TIRED study is the first RCT investigating the efficacy of GET and CBT on reducing fatigue during treatment with palliative intent in incurable cancer patients. The results of this study will provide information about the possibility and efficacy of GET and CBT for severely fatigued incurable cancer patients

Psychological distress and illness perceptions in thyroid cancer survivors: Does age matter?

Purpose:  To examine the role of differentiated thyroid cancer (DTC) patients' age in illness perceptions and psychological distress, and the potential moderating role of age in the relationship between illness perceptions and psychological distress.  Methods:  We used the Netherlands Cancer Registry to select all patients diagnosed with thyroid cancer between 1990 and 2008 (n = 568). Patients filled out the Hospital Anxiety and Depression Scale (HADS) and Brief Illness Perception Questionnaire. Levels of psychological distress and illness perceptions were compared between the different DTC survivor age groups (adolescents and young adults [AYAs; 18-39 years], middle-aged adults [40-64 years], and older survivors [65-84 years]).   Results:  Among 293 respondents with DTC, AYAs (n = 84) had more faith in the fact that their treatment can help them, and reported a stronger belief in understanding their illness compared to middle-aged (n = 172) and older adults (n = 37). No differences regarding age were seen on the other six illness perception subscales. AYAs did report significantly less distress (HADS caseness = 13.8%) compared to middle-aged (28.7%) and older adults (22.2%). Most illness perception subscales were associated with distress and the associations with age were mixed. AYAs and older patients who believed that their illness would continue for a long time reported more distress, but this association was not found for the middle-aged group.  Conclusion: Illness perceptions play a key role in the experience of distress years after diagnosis and this is related to age. AYA and older cancer patients may be particularly vulnerable to distress related to maladaptive cancer-related beliefs/perceptions

Psychological Distress and Illness Perceptions in Thyroid Cancer Survivors:Does Age Matter?

Contains fulltext : 220532.pdf (Publisher’s version ) (Closed access)Purpose: To examine the role of differentiated thyroid cancer (DTC) patients' age in illness perceptions and psychological distress, and the potential moderating role of age in the relationship between illness perceptions and psychological distress. Methods: We used the Netherlands Cancer Registry to select all patients diagnosed with thyroid cancer between 1990 and 2008 (n = 568). Patients filled out the Hospital Anxiety and Depression Scale (HADS) and Brief Illness Perception Questionnaire. Levels of psychological distress and illness perceptions were compared between the different DTC survivor age groups (adolescents and young adults [AYAs; 18-39 years], middle-aged adults [40-64 years], and older survivors [65-84 years]). Results: Among 293 respondents with DTC, AYAs (n = 84) had more faith in the fact that their treatment can help them, and reported a stronger belief in understanding their illness compared to middle-aged (n = 172) and older adults (n = 37). No differences regarding age were seen on the other six illness perception subscales. AYAs did report significantly less distress (HADS caseness = 13.8%) compared to middle-aged (28.7%) and older adults (22.2%). Most illness perception subscales were associated with distress and the associations with age were mixed. AYAs and older patients who believed that their illness would continue for a long time reported more distress, but this association was not found for the middle-aged group. Conclusion: Illness perceptions play a key role in the experience of distress years after diagnosis and this is related to age. AYA and older cancer patients may be particularly vulnerable to distress related to maladaptive cancer-related beliefs/perceptions

Feasibility and Acceptability of a Mobile Phone App Intervention for Coping With Cancer as a Young Adult: Pilot Trial and Thematic Analysis

BackgroundMany young adult patients do not receive adequate psychosocial services to help them cope with cancer. ObjectiveThis study aims to assess the feasibility and acceptability of a smartphone app (iaya) intervention that was designed to create an engaged community of young adult patients and help them learn emotional coping skills. MethodsFor this single-group pilot trial, 25 young adult patients aged 18-39 years who were receiving active cancer treatment were asked to use the iaya app for 12 weeks. To collect app use data, we used Mixpanel, an analytics platform for apps. Feasibility was assessed through rates of app sessions and the number of coping exercises engaged, and intervention acceptability was evaluated by using an app usability questionnaire and through qualitative interviews at study completion. We collected patient-reported outcome data at baseline and at week 12 to explore self-efficacy for coping with cancer, self-efficacy for managing emotions, perceived emotional support, and quality of life. ResultsBaseline patient-reported outcome data indicated that participants scored relatively low on perceived emotional support but reasonably high on self-efficacy for coping with cancer and managing emotions as well as quality of life. Participants had a mean of 13 app sessions (SD 14) and 2 coping exercises (SD 3.83) in 12 weeks. Only 9% (2/23) of participants met our combined feasibility definition of ≥10 app sessions and ≥3 coping skills from different categories. The participants’ mean usability score was 73.7% (SD 10.84), which exceeded our predefined threshold of ≥70%, and qualitative feedback was generally positive. ConclusionsAlthough perceived acceptable by patients, the iaya smartphone app did not meet the a priori feasibility criteria as a stand-alone app intervention. Future studies should screen participants for unmet coping needs and consider integrating the app as part of psychosocial care for young adult patients

Cognitive Behavioral Therapy for Treatment-Related Fatigue in Chronic Myeloid Leukemia Patients on Tyrosine Kinase Inhibitors: A Mixed-Method Study

Treatment-related fatigue significantly limits quality of life among chronic myeloid leukemia (CML) patients receiving tyrosine kinase inhibitors (TKIs), yet no interventions to reduce this symptom have been studied. We examined preliminary feasibility and efficacy of cognitive behavioral therapy for TKI treatment-related fatigue in patients with CML. We used a mixed methods convergent design and collected quantitative data through randomized single-case experiments. We included CML patients receiving TKIs and reporting severe fatigue. Within each participant, we compared CBT to a no-treatment baseline period. Fatigue severity was measured weekly with the Checklist Individual Strength. Fatigue scores were subjected to visual analyses and randomization tests for single-case experimental designs. We conducted qualitative interviews after study participation and focused on feasibility and efficacy of CBT. Visual inspection of line graphs indicated downward trends in the expected direction for fatigue in two of the four participants. The test statistics showed a decrease in fatigue severity for all participants but randomization tests did not reach statistical significance (overall p = 0.18). Participants reported qualitative improvements in level of functioning and coping with fatigue. CBT was considered feasible and acceptable for severely fatigued CML patients. Our study provided preliminary evidence for the feasibility and acceptability of CBT for severely fatigued CML patients receiving targeted therapy. We recommend further efficacy testing of this promising intervention in a pilot randomized controlled trial

Condition or cognition? Mechanism of change in fatigue in a randomized controlled trial of graded exercise therapy or cognitive behavior therapy for severe fatigue in patients with advanced cancer

Objective: Fatigue remains one of the most common and distressing symptoms during treatment for advanced cancer. The TIRED trial demonstrated cognitive behavior therapy’s (CBT) significant and clinically relevant effects to reduce fatigue among patients with advanced cancer, while graded exercise therapy (GET) did not prove beneficial. The present study aims to determine the mechanisms by which CBT and GET affect fatigue. Method: The TIRED trial randomized 134 patients with advanced cancer to CBT(n = 46), GET (n = 42), or usual care (n = 46). At 14 weeks, 126 evaluable patients provided fatigue data and of those 117 received ≥1 CBT or GET session or usual care. We tested a prespecified multiple mediation model with four potential mediators (physical activity, exercise capacity, self-efficacy, and fatigue catastrophizing) assessed at baseline and at 14 weeks. Post-hoc analyses also included perceived physical activity and emotional functioning as potential mediators. Results: A total of 82 of 117 patients completed all required measures. CBT reduced fatigue indirectly through its effect on self-efficacy, ab = −3.292;97.5% bootstrap CI [−6.518 to −0.598]. CBT participants experienced an increase in fatigue self-efficacy,with greater self-efficacy associated with decreased fatigue severity. There was no evidence that changes in physical activity, exercise capacity, perceived physical activity, fatigue catastrophizing, or emotional functioning mediated CBT’s or GET’s effects on fatigue. Conclusions: The effect of CBT was attributable to changes in cognition, that is, increased self-efficacy led to reduced fatigue severity. No significant mediators for GET were found. The findings inform further refinement of interventions for fatigue in this seriously ill population

Patterns and predictors of cancer-related fatigue in ovarian and endometrial cancers: 1-year longitudinal study

Background:  Fatigue is a common and distressing symptom for patients with gynecologic cancers. Few studies have empirically examined whether it spontaneously resolves. This study was aimed at identifying longitudinal patterns of fatigue and predictors of clinically significant fatigue 1 year after treatment completion. Methods:  This was a prospective cohort study of women with newly diagnosed ovarian (n = 81) or endometrial cancer (n = 181) that did not progress or recur within 1 year of treatment completion. Symptoms of fatigue, depression, and anxiety were assessed after surgery and 6 and 12 months after treatment completion with the Fatigue Assessment Scale and the Hospital Anxiety and Depression Scale. Patients' fatigue scores over time were classified (scores of 22-50, clinically significant; scores of 10-21, not clinically significant). Logistic regression models were fit to examine associations between fatigue and patient characteristics. Results:  Among 262 participants, 48% reported clinically significant fatigue after surgery. One year later, 39% reported fatigue. There were 6 patterns over time: always low (37%), always high (25%), high then resolves (18%), new onset (10%), fluctuating (6%), and incidental (5%). Patients with fatigue after surgery were more likely to report fatigue at 12 months in comparison with others (odds ratio [OR], 6.08; 95% confidence interval [CI], 2.82-13.11; P < .001). Patients with depressive symptoms also had higher odds of fatigue (OR, 3.36; 95% CI, 1.08-10.65; P = .039), although only one-third of fatigued patients reported depressive symptoms. Conclusion:  Nearly half of women with gynecologic cancers had clinically significant fatigue after surgery, whereas 44% and 39% had fatigue 6 months and 1 year later; this suggests that spontaneous regression of symptoms is relatively rare. Women who reported fatigue, depressive symptoms, or 2 or more medical comorbidities had higher odds of reporting fatigue 1 year later. Future studies should test scalable interventions to improve fatigue in women with gynecologic cancers

Patterns and predictors of cancer‐related fatigue in ovarian and endometrial cancers: 1‐year longitudinal study

Background:  Fatigue is a common and distressing symptom for patients with gynecologic cancers. Few studies have empirically examined whether it spontaneously resolves. This study was aimed at identifying longitudinal patterns of fatigue and predictors of clinically significant fatigue 1 year after treatment completion. Methods:  This was a prospective cohort study of women with newly diagnosed ovarian (n = 81) or endometrial cancer (n = 181) that did not progress or recur within 1 year of treatment completion. Symptoms of fatigue, depression, and anxiety were assessed after surgery and 6 and 12 months after treatment completion with the Fatigue Assessment Scale and the Hospital Anxiety and Depression Scale. Patients' fatigue scores over time were classified (scores of 22-50, clinically significant; scores of 10-21, not clinically significant). Logistic regression models were fit to examine associations between fatigue and patient characteristics. Results:  Among 262 participants, 48% reported clinically significant fatigue after surgery. One year later, 39% reported fatigue. There were 6 patterns over time: always low (37%), always high (25%), high then resolves (18%), new onset (10%), fluctuating (6%), and incidental (5%). Patients with fatigue after surgery were more likely to report fatigue at 12 months in comparison with others (odds ratio [OR], 6.08; 95% confidence interval [CI], 2.82-13.11; P < .001). Patients with depressive symptoms also had higher odds of fatigue (OR, 3.36; 95% CI, 1.08-10.65; P = .039), although only one-third of fatigued patients reported depressive symptoms. Conclusion:  Nearly half of women with gynecologic cancers had clinically significant fatigue after surgery, whereas 44% and 39% had fatigue 6 months and 1 year later; this suggests that spontaneous regression of symptoms is relatively rare. Women who reported fatigue, depressive symptoms, or 2 or more medical comorbidities had higher odds of reporting fatigue 1 year later. Future studies should test scalable interventions to improve fatigue in women with gynecologic cancers