Abstract
Background:
Recurrent gynecologic cancer patients experience symptoms that affect psychological, emotional, social and physical well-being. Chemotherapy can further exacerbate these symptoms. Poor mood, pain and fatigue are linked and are detrimental to quality of life. Interventions targeting these symptoms may improve patient-reported outcomes and performance status.
Objectives:
To determine the ability of a humorous digital media attention diversion to improve symptom domains of positive and negative mood during chemotherapy for patients with recurrent gynecologic cancers.
Study design:
This randomized, crossover clinical trial enrolled women with recurrent gynecologic cancers. Subjects participated over 3 cycles of chemotherapy. The primary outcome was the change in mood on the validated PANAS-X instrument, which measures positive and negative affect domains. All subjects completed the PANAS-X after receiving chemotherapy during cycle 1 on study. In Arm 1, subjects watched their choice of humorous movies on a digital media device while receiving chemotherapy during cycle 2 on study. They selected from non-humorous movies during cycle 3 on study. In Arm 2, the order of movies was reversed. After each cycle, mood, fatigue and other patient reported outcomes were assessed for comparison with baseline measurements.
Results:
The target enrollment of 66 subjects was achieved. Subjects watched humorous content for an average of 96.0 minutes and non-humorous content for an average of 62.5 minutes. Negative mood improved after exposure to humorous (p=0.017) and non-humorous content (p=0.001). Patient-reported fear also improved after exposure to both humorous (p=0.038) and non-humorous content (p=0.002). Subjects reported higher use of affiliating and self-effacing humor types.
Conclusion:
Offering patients a choice of digital media during chemotherapy significantly improved negative mood and fear. This was seen with both humorous and non-humorous content. This low-cost and low-risk intervention should be implemented as an attention diversion to improve negative mood and fear for patients receiving chemotherapy.
Keywords: Quality of life, cancer recurrence, attention diversion, chemotherapy
Precis
Humorous and non-humorous digital content can improve negative mood for recurrent GYN cancer patients receiving chemotherapy. This can be accomplished in a sustainable and low-cost manner in chemotherapy infusion centers.
Introduction
Chemotherapy is associated with symptoms and side effects that adversely affect patients’ quality of life (1,2). When first diagnosed, most women with gynecologic malignancies receive primary surgery and many undergo chemotherapy. When diagnosed with a recurrence, most patients receive additional chemotherapy, which has been identified as the most distressing form of cancer treatment (3). Patients expect to undergo significant side effects from chemotherapy, which include fatigue, nausea, sleep disturbance, weight loss, hair loss, and skin problems (4). In fact, patients who receive chemotherapy report worse fatigue, depression, anxiety, and sleep patterns (5–7). Quality of life can be significantly impacted not only by changes in their physical health but also by the changes that occur in their psychological, social, and spiritual well-being with diagnosis, treatment and survivorship (8).
Numerous studies have demonstrated that humor positively affects physical and psychological well-being. Humor increases pain tolerance, improves anxiety and memory, reduces stress and improves immunity (9–14). While little is known about the physical and psychological effects of humor on patients receiving chemotherapy, a recent study reported that patients receiving chemotherapy use humor to cope and overwhelmingly welcome its use during their care (15). However, there have been no prospective clinical trials investigating humor’s effect on mood among patients being treated with chemotherapy.
The objective of this study was to determine whether viewing humorous and non-humorous digital content during chemotherapy infusion improves mood, fatigue and other psychosocial patient reported outcomes (PROs) among women with gynecologic cancers. Based on prior research regarding the healthy influence of humor, we hypothesized that humorous digital content would increase positive affect and reduce negative affect. Our secondary hypothesis was that having an attention diversion - whether humorous or not - could positively impact mood.
Materials and Methods
Eligible adult patients had a pathologically proven gynecologic cancer and were diagnosed with a recurrence of that malignancy either by pathology or radiography. They had to have a plan to receive chemotherapy for the recurrence at the University of Wisconsin Carbone Cancer Center, be anticipated to receive at least three cycles of the recommended chemotherapy from the time of enrollment; be 18 years of age or older; and be fluent in written and spoken English. Patients were excluded for inability to use audio or video media due to auditory or ocular dysfunction or if they were incarcerated.
Patients enrolled in this randomized, crossover study participated over the course of three cycles of chemotherapy (Figure 1 & Figure 2). This study was approved by the Protocol Review and Monitoring Committee of the University of Wisconsin Carbone Cancer Center (4/22/2013) and the University of Wisconsin Health Sciences Institutional Review Board (2013-0618). The study was registered at Clinicaltrials.gov (NCT01901835).
Figure 1 -.
Consort Diagram
Figure 2 –
Study Schema
Subjects received chemotherapy on cycle 1 day 1 after enrolling on study in the standard fashion. At the end of the day, study assessments were completed as detailed below. Upon enrollment, subjects were randomly assigned (in a 1:1 fashion) to either Arm 1 or Arm 2 of the study. A permuted block randomization technique with block size 4-6 was performed with the randomization outcome retrieved by study staff via OnCore Clinical Trial Management System (Madison, WI) after input from trial statistical team. Subjects assigned to Arm 1 received a digital media device (iPad 2nd generation, Apple, Cupertino, CA) with pre-loaded humorous movies to watch during cycle 2 day 1 on study. Following the receipt of chemotherapy, the digital media devices were returned and subjects completed study assessments prior to leaving the chemotherapy infusion area as detailed below. During cycle 3 day 1 of chemotherapy, subjects received a digital media device with pre-loaded non-humorous movies to watch. Following receipt of chemotherapy, the digital media device was returned and subjects completed study assessments prior to leaving the chemotherapy infusion area as detailed below. In Arm 2, the procedure was the same with the order of movies reversed. Subjects received the devices upon checking in at the cancer center and were equipped with two pair of headphones and a Y-connector. The second set of headphones and the Y-connector were provided so that an individual accompanying the subject could watch simultaneously. Subjects were blinded to the types of movies they were to be receiving. They were informed that the two sets of movies would be different. Clinicians were also blinded as to which set of movies participants would be receiving on a given day.
The options for humorous movies included: 50/50, Harold and Maude, Annie Hall, Airplane! Bridesmaids, Meet the Parents, Mrs. Doubtfire, My Big Fat Greek Wedding, and Something’s Gotta Give. The films were selected because they represent different chronological eras as well as varied genres of humor: gallows/dark humor, classic comedies, blockbuster films, and romantic comedies. The documentary options for non-humorous movies were subjected to a similar process to incorporate varied themes, subject matter, tone and era. These selections included: Air Guitar in Oulu, Menopause in an Hour, Sync or Swim, Niagara Falls: Raging Rapids, Titans of Yoga, Convention, 24 Hours on Craigslist, The African Lion, The Bridge, and Scenes from a Parish. A member of the research staff delivered the devices to the subjects and ensured that the subject was familiar with the functionality of the device when they presented to the cancer center on the morning of chemotherapy. Additionally, each device contained a step-by-step instruction card for the subject to reference. The subjects were able to select, play, and pause their selection(s) throughout the day while receiving chemotherapy. Other functionalities of the digital media device were disabled (i.e. internet connectivity) to ensure additional diversions with the tablet were unavailable. The subjects returned the devices upon leaving the cancer center each day.
Baseline demographic data, cancer characteristics, treatment history and medical history were taken from the electronic medical record. Subjects reported history of anxiety or depression and any current or prior treatment for those conditions.
After cycle 1, subjects completed the Positive and Negative Affect Scale-Extended (PANAS-X) instrument, the Brief Fatigue Inventory (BFI), and the Humor Styles Questionnaire (HSQ). After cycle 2, the PANAS-X and BFI were completed. After cycle 3, subjects completed the PANAS-X and BFI for the final time, along with questions regarding perceived quality of study materials and ease of use of study materials.
The PANAS-X assesses both positive and negative mood (16). Additionally, the PANAS-X instrument has been validated for use when evaluating a subject’s mood referent to the day of instrument administration. This is referred to as the Today score. The Cronbach’s coefficient α for reliability for the positive affect scale ranges from 0.83 to 0.90 and from 0.85 to 0.90 for the negative affect scale. The intercorrelation for the two subscales is −0.05. Additionally, embedded within the PANAS-X negative affect scale are subscales that include assessments for fear (α=0.88) and sadness (α=0.89). Subscales for joviality (α=0.93), self-assurance (α=0.83, attentiveness (α=0.72, and serenity (α=0.74) are embedded in the positive affect scale.
The BFI is a validated instrument to assess fatigue experienced by cancer patients over the 24-hour period prior to administration. The Cronbach’s alpha for this scale is 0.82 to 0.97 (17). The HSQ is an instrument validated for use in adolescents to the elderly with Cronbach’s alpha 0.77 to 0.81 (18). It is useful for understanding how people use humor and whether their humor style is detrimental or beneficial for their psychosocial well-being. It measures the degree to which one prefers the following: affiliating humor, self-effacing humor, aggressive humor, and self-defeating humor.
The primary outcomes were positive mood and negative mood as measured by the PANAS-X instrument. It was anticipated that exposure to the films would result in a mean improvement of at least 4 points in the PANAS-X positive affect score (13). Assuming a baseline score of 28 in advanced cancer patients as reported by Voogt et al. (19), this corresponded to an effect size of 0.4. Correlation between assessment time points was estimated at 0.4 based on previous studies. (16,19). To detect an effect size of 0.4 for the changes from baseline between intervention groups with 80% power at the two-sided 0.05 significance level (0.025 after using a Bonferroni adjustment for co-primary outcomes), a total sample size of 66 patients was estimated assuming no carryover effect between interventions and a loss rate of 5%.
Patient and treatment characteristics were summarized and compared between study arms and between subjects who did not complete the study using the Wilcoxan rank sum test for continuous variables and Fisher’s exact test for categorical variables. PANAS-X positive and negative affect scores, HSQ scores, and BFI total scores with absolute and percentage changes from baseline within each arm were calculated and compared using Wilcoxan signed rank test. A linear mixed model was used to analyze the order effect of which intervention was received first as well as the carryover effect. All statistical tests were two-sided with 5% set as the level of statistical significance (p<0.05). Statistical analysis was done with R statistical package version 3.3.1, including the “nlme” and “ggplot2” packages.
Results
During the study period from March 2014 to March 2016, 66 patients scheduled to receive chemotherapy for a recurrent gynecologic malignancy at the University of Wisconsin Carbone Cancer Center were assigned as follows: Arm 1, n = 33; Arm 2, n=33. Successful enrollment of eligible subjects was 67% (Figure 1). Six subjects in Arm 1 did not complete the study due to death (n=1), discontinuation of therapy (n=3), voluntary withdrawal (n=1) and change to oral chemotherapy (n=1). Six subjects in Arm 2 did not complete the study due to death (n=1), discontinuation of therapy (n=2), and voluntary withdrawal (n=3). Enrollment ended due to target accrual. There was no differential loss to follow-up.
Baseline characteristics in Table 1 are presented by those who completed and did not complete the study. Given the cross-over nature of the study, all subjects who completed the study received the same interventions. Those who did not complete the study had a higher BMI (median BMI 32.9 kg/m2 vs. 27.2 kg/m2), proportionally more recurrent uterine cancers (42% vs 19%) and more high-grade histology (89% vs 67%). Those who did not complete the study had more prior recurrences (median 2.5 vs 1) but no meaningful differences in mental health history. Overall, most subjects were Caucasian (98%), had an ECOG performance status of 0-1 (98%), had ovarian cancer (74%), and had serous histology (80%). Half of the subjects were receiving a platinum-containing doublet chemotherapy regimen (50%).
Table 1:
Patient and Treatment Characteristics
| Factor | Completed study (N=54) | Did not complete study (N=12) |
|---|---|---|
| Median age (range) | 62 (48-89) | 62 (35-72) |
| Median BMI (range) | 27.2 (19.1-63.7) | 32.9 (20.5-53) |
| Marital status | ||
| Married | 35 (65%) | 8 (67%) |
| Divorced | 3 (6%) | 2 (17%) |
| Single | 10 (19%) | 1 (8%) |
| Widowed | 6 (11%) | 1 (8%) |
| Race | ||
| Caucasian | 53 (98%) | 12 (100%) |
| Black | 1 (2%) | 0 (0%) |
| ECOG performance status | ||
| 0 | 35 (65%) | 7 (58%) |
| 1 | 19 (35%) | 4 (33%) |
| 2 | 0 (0%) | 1 (8%) |
| Site | ||
| Ovary/Fallopian tube/PPC | 43 (80%) | 6 (50%) |
| Cervix | 1 (2%) | 1 (8%) |
| Uterus | 10 (19%) | 5 (42%) |
| Histology | ||
| Serous | 47 (87%) | 6 (50%) |
| Endometrioid | 5 (9%) | 3 (25%) |
| Other | 2 (4%) | 3 (25%) |
| Tumor grade | ||
| 1 | 5 (9%) | 2 (17%) |
| 2 | 1 (2%) | 2 (17%) |
| 3 | 48 (89%) | 8 (67%) |
| Current chemotherapy | ||
| Carboplatin-containing doublet | 30 (56%) | 3 (25%) |
| Single-agent Doxil | 8 (15%) | 3 (25%) |
| Other single-agent therapy | 10 (18%) | 6 (50%) |
| Bevacizumab-based therapy | 6 (11%) | 0 |
| Median previous cycles of current chemo (range) | 1 (0-18) | 0.5 (0-6) |
| Median # of recurrences (range) | 1 (1-7) | 2.5 (1-8) |
| History of depression | ||
| No | 37 (69%) | 9 (75%) |
| Yes | 17 (31%) | 3 (25%) |
| History of anxiety | ||
| No | 40 (74%) | 8 (67%) |
| Yes | 14 (26%) | 4 (33%) |
| Current psychiatric meds | ||
| No | 37 (69%) | 7 (58%) |
| Yes | 17 (31%) | 5 (42%) |
| Previous psychiatric meds | ||
| No | 32 (59%) | 6 (50%) |
| Yes | 22 (41%) | 6 (50%) |
| Used psychiatrist/psychologist/counselor services | ||
| No | 38 (70%) | 8 (67%) |
| Yes | 16 (30%) | 4 (33%) |
The mean baseline PANAS-X positive affect score was higher than we had anticipated at 30 in Arm 1 and 30.1 in Arm 2 (Table 2), and the negative affect scores of 14.5 in Arm 1 and 15.4 in Arm 2 were lower than anticipated. Previous work in advanced cancer patients demonstrated mean positive affect scores of 27.7 and negative affect scores of 17.6 (19). Mean baseline BFI scores were comparable in both arms (3.53 and 3.66 respectively). From the HSQ, subjects in both arms reported using Affiliating humor (means 38.8 for Arm 1 and 44.6 for Arm 2) and Self-effacing humor (means 39.8 for Arm 1 and 42.1 for Arm 2) more often than Aggressive humor (means 23.3 for Arm 1 and 20.2 for Arm 2) or Self-defeating humor (means 23.3 for Arm 1 and 23.1 for Arm 2). Affiliating humor and Self-effacing humor are considered more positive humor styles.
Table 2:
Outcomes
| Factor | Arm 1 (N=33) | Arm 2 (N=33) |
|---|---|---|
| Positive Affect Scale | ||
| Cycle 1 | 30 (7.5) | 30.1 (9.5) |
| Missing | 3 | 0 |
| Post-humor | 30.1 (7.2) | 28.5 (8.8) |
| Missing | 3 | 6 |
| Post-non-humor | 27.1 (9) | 28.6 (8.2) |
| Missing | 7 | 6 |
| Negative Affect | ||
| Scale Cycle 1 | 14.5 (5.5) | 15.4 (7.1) |
| Missing | 2 | 0 |
| Post-humor | 12.5 (4.6) | 14.1 (5.8) |
| Missing | 3 | 6 |
| Post-non-humor | 12.2 (3.2) | 13.5 (6.8) |
| Missing | 8 | 5 |
| BFI | ||
| Cycle 1 | 3.53 (1.6) | 3.66 (2.4) |
| Missing | 2 | 2 |
| Post-humor | 3.43 (1.9) | 4.13 (2.3) |
| Missing | 2 | 7 |
| Post-non-humor | 3.46 (2) | 3.98 (2.2) |
| Missing | 8 | 5 |
| Affiliating humor | 38.8 (8) | 44.6 (7.4) |
| Self-effacing humor | 39.8 (6.6) | 42.1 (8.4) |
| Aggressive humor | 23.3 (8) | 20.2 (8) |
| Self-defeating humor | 23.3 (8.6) | 23.1 (9.4) |
| Ease of use | ||
| Very easy | 19 (76%) | 18 (69%) |
| Easy with some effort | 3 (12%) | 5 (19%) |
| Neutral | 1 (4%) | 1 (4%) |
| Slightly difficult but doable | 1 (4%) | 2 (8%) |
| Very difficult | 1 (4%) | 0 (0%) |
| Missing | 8 | 7 |
| Quality of materials | 2.3 (0.8) | 1.79 (0.8) |
| Missing | 8 | 7 |
As shown in Table 3 and Figure 3, the primary outcome of negative mood as measured by the PANAS-X instrument was significantly improved after watching humorous films when compared to baseline (mean change −1.68; p=0.017) and significantly improved after watching non-humorous films when compared to baseline (mean change −1.98; p=0.001). Positive mood as measured by the PANAS-X was not significantly different after watching either humorous (p=0.44) or non-humorous films when compared to baseline (p=0.061). Although, humorous movies did show less of a decline in positive mood when compared to non-humorous movies (mean decrease −0.93 vs −2.14 respectively) which narrowly fell short of significance at the p=0.05 level. Likewise, fatigue was not improved by watching either humorous (p=0.85) or non-humorous films when compared to baseline (p=0.40).
Table 3:
Changes in Outcomes from Baseline
| Positive Affect | ||
| Post-humor – Cycle 1 | −0.93 (6.7) | 0.44 |
| % change | 0.07 (24.3) | |
| Post-non-humor – Cycle 1 | −2.14 (8.1) | 0.061 |
| % change | −3.59 (29.2) | |
| Negative Affect | ||
| Post-humor–Cycle 1 | −1.68 (5.8) | 0.017 |
| % change | −6.47 (28.8) | |
| Post-non-humor–Cycle 1 | −1.98 (5.5) | 0.001 |
| % change | −9 (25.9) | |
| BFI | ||
| Post-humor – Cycle 1 | 0.15 (2) | 0.85 |
| % change | 38.75 (125.7) | |
| Post-non-humor – Cycle 1 | 0.25 (1.7) | 0.4 |
| % change | 31.53 (103.2) | |
| Fear | ||
| Post-humor–Cycle 1 | −1.26 (4.2) | 0.038 |
| % change | −6.36 (35.3) | |
| Post-non-humor–Cycle 1 | −1.66 (3.7) | 0.002 |
| % change Sadness | −11.47 (28.2) | |
| Sadness | ||
| Post-humor – Cycle 1 | −0.62 (3.3) | 0.17 |
| % change | −0.2 (37.9) | |
| Post-non-humor – Cycle 1 | −0.67 (3.4) | 0.23 |
| % change | −2.45 (35.1) | |
| Joviality | ||
| Post-humor – Cycle 1 | 1.38 (6.9) | 0.14 |
| % change | 14.15 (39.5) | |
| Post-non-humor – Cycle 1 | −1.22 (7.4) | 0.32 |
| % change | 1.11 (43.5) | |
| Self-assure | ||
| Post-humor – Cycle 1 | −0.69 (4.2) | 0.32 |
| % change | −1.06 (28) | |
| Post-non-humor – Cycle 1 | −1.58 (4.3) | 0.014 |
| % change | −7.28 (29.2) | |
| Attentive | ||
| Post-humor–Cycle 1 | −1.21 (2.3) | < 0.001 |
| % change | −6.08 (18.5) | |
| Post-non-humor–Cycle 1 | −1.41 (3) | 0.002 |
| % change | −7.96 (23.7) | |
| Serenity | ||
| Post-humor – Cycle 1 | 0.33 (3) | 0.69 |
| % change | 11.62 (47.4) | |
| Post-non-humor – Cycle 1 | −0.14 (2.9) | 0.57 |
| % change | 6.15 (42.9) |
Figure 3 –
Pre- and Post-intervention Affect Scores
Analysis of the other components of the PANAS-X instrument showed that fear was improved after both humorous movies (mean change −1.26; p=0.038) and non-humorous movies (mean change −1.66; 0.002) when compared to baseline. There were no significant changes in sadness, joviality or serenity from baseline measurements.
Median watch time for humorous films was 96 minutes (range 0-236) and 62.5 minutes for non-humorous films (range 0-146 minutes; p=0.002) with confirmation of intervention delivery in 74% of visits. There was no carryover or order effect of the interventions on PANAS-X positive affect (p=0.75), PANAS-X negative affect (p=0.53) or fatigue measured by the BFI (p=0.31). Overall, 82% of users rated the materials as either “very easy” or “easy to use with some effort.” Average quality of materials (i.e. devices & content) was rated as 2.30 in Arm 1 and 1.79 in Arm 2 on a Likert scale where 1=high quality and 5=would never use again.
Additional exploratory analyses were performed to assess whether humor style correlated with changes in positive and negative affect scores after either humorous or non-humorous movies. No such relationships were identified (not shown), but this study is likely underpowered to do so. In each case, analysis was performed according to the group assigned at randomization.
Discussion
Offering a digital media attention diversion to patients undergoing chemotherapy for recurrent cancer can significantly improve feelings of negative mood and fear. This appears to be the case for both humorous and non-humorous content as demonstrated within this study. Previous investigations have shown that humor can lessen anxiety and depression and promote wellness for patients with cancer (20). It has been established as an important component of the psychosocial care of cancer patients and is nearly universally regarded as positive by patients with minor stipulations (15,21). While humorous content improved these factors, non-humorous content did as well. It may be that some people respond positively to humor, and others derive benefit from having an attention diversion - whether humorous or not. The details of how an attention diversion - humorous or otherwise - can improve mood cannot be answered by the data collected in this study.
We undertook this investigation since women with gynecologic malignancies experience significant quality of life detriments (22,23) and a well-described symptom clusters of cancer patients include mood as a major component. While we discovered that people who watched humorous films showed improvements in negative mood and fear, we also observed this for non-humorous movies. Interestingly, the non-humorous movies were able to accomplish this with significantly less time watched. The reason for this variation in watch time is unknown. We did not specifically ask the subjects about this aspect of their experience. It does not appear related to study arm or chemotherapy regimen as those were evenly balanced. The median run time for humorous selections was 98 minutes vs 84.5 minutes for the non-humorous selections and subjects were instructed to watch any combination of films throughout the day for both types of movies. The result that humorous movies seem able to prevent decreases in positive mood more than non-humorous movies merits further exploration as this finding narrowly missed statistical significance and may have been influenced by the higher than anticipated drop-out rate.
A definitive answer as to how much this digital media attention diversion may help patients is elusive. It is difficult to adjudicate the specific percentage improvement that should be required to employ an intervention that improves quality of life. The PANAS-X has no established minimal clinically important difference (MCID) and the utility of that measure is a topic of debate (24). We advocate considering multiple factors in judging the utility of these findings for patients. The intervention has no foreseeable risks, is relatively inexpensive, is a reusable resource, and does not require monitoring or oversight by clinical staff. Since previous work found that these feelings were particularly concerning to this patient population (15), and this intervention improves negative mood and fear for patients receiving chemotherapy, these factors point to this intervention meriting dissemination into clinical practice.
Reasons we were unable to show an improvement in positive affect may be due to the higher than anticipated loss rate and because the baseline scores for positive affect were higher than previously reported in the literature for advanced cancer patients (19). This made for a lower likelihood of improvement. This is informative for future studies as sample size calculations in this line of inquiry should focus on limiting decreases in positive affect rather than improving it from baseline. Our data suggest attention division interventions may be more effective for alleviating negative emotions.
The strengths of the study include its randomized design, high rate of recruitment, use of validated endpoints, external generalizability given the heterogeneity of cancers and therapies administered, and utilizing an inexpensive intervention that may easily be implemented. We also focused on a population with a high symptom burden and risk for poor quality of life who may be most likely to benefit from an intervention targeting these factors. A limitation of the study was the lack of a usual care comparison. We selected a crossover design as it is known that distraction during medical procedures can help with mood and well-being, and we wanted to determine whether humor conferred an additional benefit. In the design of the study, it was felt that subjects would be unlikely to experience a spontaneous improvement in their mood and fatigue as they receive more chemotherapy. This phenomenon seemed counter-intuitive and not supported by the literature (6). For this reason, the study was created with a randomized-crossover design rather than with a concurrent control group receiving no intervention. We cannot rule out that time or experience with chemotherapy, rather than the attention diversion, played a role in the decline in negative affect seen in the study. An additional weakness of the study includes a larger than expected loss to follow-up (18%) which may have compromised power to detect some outcomes. Additionally, this study was not designed to determine the underlying physiologic mechanisms that could have contributed to the changes observed. The authors are unable to report long-term effects of this intervention. The assessment timing was designed to evaluate whether the intervention could improve positive and negative mood and fatigue on the days of its use.
It will be important for further work to determine whether there are subsets of patients who may derive greater benefit from a humor intervention. It may be most effective for those who prefer humor as a coping strategy, those with a higher symptom burden, or those with high negative affect. A more detailed inventory of subjects’ affinity for, and use of, humor would also be helpful in targeting future interventions. Although the current study demonstrated no differential improvement in positive or negative affect related to humor style, this study is likely underpowered to adequately assess that question. Additionally, an evaluation of possible underlying physiological mechanisms, such as changes in neuroendocrine pathways of inflammatory responses already known to underlie mood and distress in cancer patients will be important for further elucidating possible downstream benefits with respect to disease outcomes.
Offering patients the opportunity to utilize a digital media attention diversion while receiving chemotherapy is a low-cost and low-risk intervention that can be implemented easily and quickly in infusion centers. This study offers evidence that these patients’ negative mood and fear can be iproved during the day they receive chemotherapy. Even small improvements can be meaningful for those confronting potentially repeated and prolonged treatment courses.
Highlights.
A digital media diversion improves negative mood and fear in recurrent GYN cancer patients receiving chemotherapy.
Both humorous and non-humorous content was able to improve negative mood.
This is a low-cost and low-risk intervention that could be implemented in infusion suites.
Acknowledgements
The research was supported by the Department of Obstetrics and Gynecology at the University of Wisconsin School of Medicine and Public Health and by the Clinical and Translational Science Award (CTSA) program, through the NIH National Center for Advancing Translational Sciences (NCATS), grant UL1TR002373. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
Footnotes
Authors’ disclosures: The authors indicated no potential conflicts of interest or financial disclosures. All authors have read and approved the manuscript.
IRB approval and informed consent: The study was approved by the human subjects committee prior to the research being conducted and all participants provided written informed consent.
Conflict of Interest Statement
The authors declare that there are no conflicts of interest.
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