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 Table of Contents  
ORIGINAL ARTICLE
Year : 2022  |  Volume : 7  |  Issue : 2  |  Page : 83-94

Psychocognitive functions among breast cancer survivors: A randomized controlled trial


1 Department of Nursing Education, Post Graduate Institute of Medical and Education Research, Chandigarh, India
2 Department of Radiation Oncology, Post Graduate Institute of Medical and Education Research, Chandigarh, India
3 Department of Psychiatry, Post Graduate Institute of Medical and Education Research, Chandigarh, India
4 Department of General Surgery, Post Graduate Institute of Medical and Education Research, Chandigarh, India

Date of Submission16-Jan-2022
Date of Decision06-Jun-2022
Date of Acceptance07-Jun-2022
Date of Web Publication22-Jul-2022

Correspondence Address:
Ms. Deeksha Sharma
Nursing Officer, Department of Radiation Oncology, AIIMS Rishikesh, Uttarakhand
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jncd.jncd_6_22

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  Abstract 


Purpose: Chemotherapy-related cognitive impairments (CRCIs) are one of the adverse effects of chemotherapy, so there is a need to explore alternative measures to maintain normal cognitive functions or to prevent decline in cognitive abilities. This study was conducted to assess the effectiveness of Cognitive Training Interventions Package on cognitive functions among breast cancer survivors (BCSs).
Materials and Methods: A total of 59 BCSs were randomly assigned to control and intervention groups. Participants of the intervention group were provided with a Cognitive Training Interventions Package to be practiced from 1st cycle until the completion of 4th cycle of chemotherapy. Both the groups were reassessed on the 4th cycle of chemotherapy. FACT Cog Version-3, Post Graduate Institute Memory Scale (PGIMS), and trail making test were used to assess cognitive functions. Activities of daily livings (ADLs) and depression, stress, and anxiety were measured using Barthel Index Scale and Depression, Anxiety, and Stress Scale-21, respectively. Satisfaction level among participants was measured using a self-structured questionnaire.
Results: The mean age was 50.82 ± 10.12 years in the control group and 50 ± 11.24 years in the intervention group. BCSs in the intervention group demonstrated a significant improvement in attention and concentration (P = 0.02); retention for similar pairs (P = 0.001); recognition (P = 0.01); and visual attention, processing speed, and executive functions (P = 0.01). Intervention group also showed a significant improvement in ADLs (P = 0.04). Overall, the participants in the experimental group were more satisfied (mean = 2.00) as compared to those in the control group (mean = 1.896), which is supported by the observed statistical significant difference in the satisfaction levels of the participants (P = 0.04). Reduction in the levels of anxiety and depression was also noticed in both the groups but it was not significant.
Conclusion: Cognitive training interventions package was beneficial for BCSs with CRCI to overcome cognitive impairments.

Keywords: Breast cancer survivors, chemotherapy-related cognitive impairments, cognitive impairments


How to cite this article:
Sharma D, Yadav BS, Dutta M, Kaur S, Kumar K, Dahiya D. Psychocognitive functions among breast cancer survivors: A randomized controlled trial. Int J Non-Commun Dis 2022;7:83-94

How to cite this URL:
Sharma D, Yadav BS, Dutta M, Kaur S, Kumar K, Dahiya D. Psychocognitive functions among breast cancer survivors: A randomized controlled trial. Int J Non-Commun Dis [serial online] 2022 [cited 2022 Aug 14];7:83-94. Available from: https://www.ijncd.org/text.asp?2022/7/2/83/351747




  Introduction Top


In 2018, breast cancer was the most commonly diagnosed cancer in females and the leading cause of cancer deaths.[1] Chemotherapy is frequently used to treat breast cancer.[2] Although chemotherapy is a very effective treatment modality, it comes with its own set of side effects, cognitive impairments being one of them. Cognitive impairments also known as chemo-brain or chemo-fog or chemotherapy-related cognitive impairments (CRCI) affects the ability of a person to multitask, to be attentive or concentrate and bring changes in a person's visual processing and executive functions.[3] Anthracyclines and taxanes are standard chemotherapeutic agents administered to breast cancer survivors (BCSs). These agents can damage normal, noncancerous cells and might affect biochemical processes in a manner that leads to chemotherapy induced cognitive deficits.[4] There are no specific drugs for CRCI treatment, as a result patients are administered drugs meant for the treatment of some other neurological disorders.[5] This also takes a toll on the patients' health. This warrants a need among health care professionals to search for alternative measures to treat these cognitive impairments so as to reduce the burden on patient's health. Some cognitive rehabilitation programs utilize exercises, tasks that use memory and puzzles to rehabilitate one's mind. Cognitive Training Interventions assumes that repetitive training on cognitive tasks, such as those that involve visual-motor processing speed, can spawn repair of damaged neurocircuitry to recover memory functions.[6],[7]

The purpose of this pilot study was to assess the effectiveness of Cognitive Training Interventions Package on cognitive functions and quality of life in BCSs. Primary outcome was cognitive functions specifically subjective cognitive functions (FACT-Cog Scale) and subsets of memory (Post Graduate Institute Memory Scale [PGIMS]). Secondary outcomes were activities of daily living (ADL); depression, stress and anxiety, quality of life (QoL) and satisfaction level among BCSs. We hypothesized that there will be a significant improvement in above outcome variables among the BCSs receiving Cognitive Training Interventions Package at 0.05 level of significance.


  Materials and Methods Top


Participants

BCSs scheduled for the first cycle of chemotherapy, either before or after breast surgery, receiving anthracyclines and taxanes as chemotherapeutic agents, able to read, write and to understand Hindi and English language were recruited in this randomized open label study. BCSs who had previous history of cancer, neurological and mental health disorders, receiving radiotherapy along with chemotherapy and not willing to participate were excluded. Participants were recruited from Radiation Oncology and General Surgery outpatient department (OPD), Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh India between July 2018 and July 2020. The study was approved by the Institute Ethics Committee. We planned to enroll 30 patients per group to achieve 27 per group after attrition to provide 80% power for two sided parametric tests to detect large (0.80) effect sizes for the primary outcome between each intervention and control group [Figure 1].
Figure 1: Consort diagram

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Randomization and schedule

Eligible participants, identified on OPD visit or by referring physician, were randomized to control and intervention groups using lottery method. Written informed consent was obtained after informing them about the procedure of data collection at the time of enrolment and baseline assessment was carried out. At baseline (1st cycle of chemotherapy) information regarding sociodemographic; clinical and treatment profile was obtained and cognitive functions, ADLs, depression anxiety and stress level were assessed. In the 4th week (2nd cycle) along with routine care, participants of intervention group were provided with Cognitive Training Interventions Package. Whereas participants of control group were continued with routine care and completed all assessment on the same timeline as the intervention group.

All the participants were followed up on OPD basis at 4th (2nd cycle), 8th (3rd cycle) and 12th week (4th cycles). The cognitive functions; ADLs; level of depression; anxiety and stress were assessed at each follow up visit and counseling was given as per observation and participants' requirement. Participants of both the groups were reassessed for any change in cognitive functions (memory, attention/concentration; executive functions); ADLs and reduction in level of stress, anxiety and depression after the completion of 4th cycle (12th week).

Interventions package

Cognitive training interventions package includes

  • An educational guidebook


  • Including information about causes, signs and symptoms, early detection, prevention and treatment modalities of breast cancer and CRCI.

    Mental and physical exercises to enhance cognitive abilities.

  • Counseling sessions


  • Three sessions of 25 min each at 4th week (2nd cycle), 8th week (3rd cycle) and 12th week (4th cycle).

  • Meditation audio


  • It was a 10 min meditation audio on whatsapp to practice twice in a day.

  • Video on diet


  • It was a 10 min video regarding diet. It included information on what to take and what to avoid during chemotherapy.

  • Telephonic reminder


  • A telephonic reminder twice a week until the completion of 4th cycle of chemotherapy to reinforce participants to adhere to the Cognitive Training Interventions Package, and to assess for any complications.

  • Follow up


  • In 4th (2nd cycle), 8th (3rd cycle), 12th (4th cycle) week on OPD basis.

  • Satisfaction questionnaire of participants.


Measures

Participants were assessed with the same tools at baseline and each follow up. All used research tools were standardized and demonstrated validity and reliability except interview schedule which was validated by experts from concerned departments of PGIMER, Chandigarh. Interview schedule included sociodemographic and clinical profile of participants. Others standardized tools were

Functional Assessment of Cancer Therapy-Cog (version-3)

Used to measure subjective cognitive functions of the participants. The scale contains 37 items in four subscales namely: Perceived cognitive impairments (Cog PCI), perceived cognitive ability (Cog PCA), deficit observed or commented on by Others (CogOth), and cognitive changes affecting QOL (CogQOL). For each item of the Cog PCI and CogOth subscales a five-point Likert-type scale was used, with responses ranging from 0 (never) to 4 (several times per day). The CogPCA and CogQOL subscales used a five-point severity scale, with responses ranging from 0 (not at all) to 4 (very much).[8]

Post Graduate Institute Memory Scale

A comprehensive and simple scale to measure verbal and nonverbal memories based on neurological theory. It is used to measure-remote memory, recent memory, mental balance, attention/concentration, delayed recall, immediate recall, verbal retention for similar pairs, retention of dissimilar pairs, visual retention and recognition. Interpretation was based on percentiles range from (0-100). Range was classified as (80-100) excellent memory, (60-80) above average memory, (40-60) average memory, (20-40) below average memory, (00-20) low level memory.[9]

Trail making test

A short and convenient estimate of cognitive functions, principally attention, working memory and executive functions. It is a brief paper and pencil neurological test and consists of two parts. Part A-consists of one sample test and one task. The worksheet consists of numbers 1 to 25. Time taken to join consecutive numbers is taken as the subjects score. Part B-consists of a sample test as well as the main task. Subjects are asked to connect numbers-alphabets as fast as they can. Performance is considered to be impaired if scores exceed 40 seconds for part A and 91 s for part B.[10]

Barthel Index Scale for activities of daily livings

Used to measure performance in activities ADLs. Each performance item is rated on this scale with a given number of points assigned to each level or ranking. It uses ten variables including feeding; bathing; grooming; dressing; bowel; bladder; toilet use; transfers; mobility and stairs use. Each item contains three items scored as 0, 5 or 10. Total score is 100. Score 0-20 indicates total dependence; 21-60 as severe dependence; 61-90 as moderate dependence and as 91-99 slight dependence.[11]

Depression, Anxiety, and Stress Scale-21

A set of three self-report scales designed to measure the emotional status of depression, anxiety, and stress. Each of the three Depression, Anxiety, and Stress Scale-21 (DASS-21) scales contains 7 items, divided into subscale with similar content. The depression scale assesses dysphoria, hopelessness, devaluation of life, self deprecation, lack of interest/involvement, anhedonia and inertia. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale is sensitive to levels of chronic nonspecific arousal. It assesses difficulty in relaxing, nervous arousal, and being easily upset/agitated, irritable/over-reactive and impatient. Scores for depression, anxiety, and stress are calculated by summing the scores for the relevant items. Score of test are categorized into normal, mild, moderate, severe and extremely severe.

Primary outcomes, cognitive functions and memory were assessed with FACT scale, Trail making test and PGIMS scale, respectively. Secondary outcomes, ADL; depression, stress and anxiety, QoL and satisfaction level were assessed using Barthel Index Scale, DASS-21, FACT Cog (version-3) and satisfaction questionnaire, respectively.[12]

Statistical analyses

Data was analyzed manually and using Statistically Package for Social Science (SPSS) program version 23. Analysis was carried out in two sections: firstly, for baseline assessment and secondly for the effectiveness of Cognitive Training Interventions Package on outcome variables. Baseline variables were compared between both the groups using chi square test and fisher's exact test. To assess improvement due to Cognitive Training Interventions Package, P value of both the groups was reported and significance was assessed at less than 0.05 level.


  Results Top


Total 62 eligible BCSs were enrolled and consented to participate. Three participants dropped out before they were randomly assigned. Although both the groups were somewhat similar in baseline sociodemographic, clinical, tumor, and treatment profile, the intervention group also had more chemotherapy, more mixture of anthracyclines/taxanes (100% were anthracycline only in the control arm). Furthermore, type of surgery was more likely to be mastectomy in the intervention group [Table 1], [Table 2], [Table 3].
Table 1: Sociodemographic characteristics of the participants

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Table 2: Clinical profile of the participants

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Table 3: Tumor and treatment profile of the participants

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Cognitive functions

Fact-Cog (Version-3)

There was no significant difference noticed in any component of FACT Cog version-3 scale like PCIs; comments from others; PCA; and QOL of the participants [Table 4]. Improvement was noticed in “comments from others”, before interventions 93.1% participants in control and 70% in intervention group never received 'comments from others' but after interventions this number increased up to 100% in participants of control and 86.7% in intervention group.
Table 4: Effectiveness of interventions on the level of perceived cognitive impairments, comments from others, perceived cognitive abilities, and quality of life in participants as per Functional Assessment of Cancer Therapy - Cognitive Function (version-3) Scale

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Activities of daily livings

There was a significant difference in ADLs (P = 0.04) [Table 5] and improvement in some of the activities was seen in both the groups.
Table 5: Comparison of activities of daily living before and after interventions using Barthel Index Scale

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Depression, anxiety, and stress

Reduction in the level of anxiety and depression after interventions among participants of both the groups was noticed but it was not significant [Table 6].
Table 6: Level of depression, stress and anxiety before and after interventions among participants

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Satisfaction level

With the care provided there was a significant difference (P = 0.04) observed between the satisfaction levels of participants in control (routine care) and intervention group (Cognitive Training Interventions Package along with routine care). 13.3% of the participants in the intervention group were highly satisfied as compared to none in the control group [Figure 2].
Figure 2: Comparison of satisfaction level among participants of control and intervention groups *Significant at P < 0.05

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Supplementary table and figures

Post Graduate Institute Memory Scale

After implementing Cognitive Training Interventions Package significant improvement was seen in some aspects of cognition like attention and concentration (P = 0.02), retention for similar pairs (P = 0.001), and recognition (P = 0.001) [Table 7].
Table 7: Effectiveness of interventions on memory of subjects receiving chemotherapy using Post Graduate Institute Memory Scale

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Activities of daily living

Some of the ADLs like transfers from bed to chair and back, mobility on level surface were improved among participants of both the groups after interventions while participants became dependent to perform ADLs such as grooming, dressing, bathing, and climbing stairs [Table 8].
Table 8: Activities of daily living before and after intervention in control and intervention groups

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  Discussion Top


In this study, implementation of Cognitive Training Interventions Package resulted in significant improvement in cognitive functions and satisfaction level. These findings are consistent with the study hypothesis. Reduction in the level of anxiety and depression among BCSs in the intervention group was also noticed but it was not significant. No reduction in the stress level was observed among participants of both the groups.

Due to alterations in the neuronal structure with the increasing age, considerable changes in the cognitive abilities are common to occur.[13] Similar results were seen in the current study where in more than 50% of the participants were above the age of 50 years. Contrary to this study, breast cancer is more likely to be diagnosed early in women with higher education possibly due to higher awareness and exposure to information which an uneducated or a less educated person might lack. Higher educated women are more likely to suffer less cognitive impairments due to early diagnosis and treatment.[14] Increase in unemployment can be a reason for increase in mortality due to cancer. This might happen due to a lower economic status and an inability of a person to pay for their treatment. Since the unemployed person is less likely to undergo treatment or might undergo treatment at a later stage in the disease they are more likely to suffer more cognitive impairments.[15] Similar to this study, where 73% of the participants who suffered cognitive impairments were unemployed. Social support is likely to enhance the survival rate in women as a result of enhanced coping skills, more opportunities of sharing information and an increase in emotional support.[16] This might be an important factor in dealing with cognitive impairments and needs to be further explored in future studies. Higher cognitive performance, before undergoing adjuvant treatment, is seen in patients in earlier stages of cancer and it declines as one progresses to a higher stage.[17] Similar to this study, where majority of the participants in early stages undergoing neo adjuvant treatment suffered less cognitive impairments. Good dietary habits are a boosting factor to improve cognitive impairments.[18] In this study, the participants were made aware about the benefits of good dietary habits as part of the Cognitive Training Interventions Package and its actual effects on the cognitive abilities of BCSs can be further explored in future studies. Increased cognitive impairments postsurgical procedures in BCSs in known to occur.[19] This study had similar findings where in majority of the participants who had suffered cognitive impairments had undergone surgery.

A significant improvement was noticed in attention and concentration, retention for similar pairs and recognition subsets of memory in the intervention group. An improvement in average recent memory, visual attention, immediate and delayed recall, retention of similar and dissimilar pairs and recognition except remote memory and mental balance subsets of memory was seen among participants of both the groups.

Other studies have also reported improvement in cognitive functions with different interventions. In a study conducted by Bernstein et al.[20] they reported improvement in memory domain of BCSs with CRCD after psychoeducational interventions. Another study by Flak et al.[21] also noticed a positive impact of computer based working memory training in reducing cognitive impairments and reported an ingress positive changes in memory functions among elderly patients.

Deficits in visual attention, working memory, processing speed and executive functions were noticed among the participants of both the groups. Other similar studies have also reported deficits in visual processing,[22],[23] visual motor functioning,[23],[24],[25] attention and executive functioning due to chemotherapy.[26],[27] In our study after interventions significant improvement (P = 0.01) was noticed in visual attention, processing speed and executive functions of participants in both the groups. These findings are consistent with a study conducted by Damholdt et al.[28] where web based cognitive training resulted in an improvement in verbal and working memory. Similarly Ferguson et al.[29] also reported an improvement in perceived cognitive impairments and neuropsychological processing speed after implementation of videoconference delivered cognitive behavioral therapy.

In the current study, ADLs were significantly improved post intervention among the participants. It was observed that some of the ADLs like grooming, dressing, transfers from bed to chair and back, mobility on level surface were improved among participants of both the groups after interventions. Participants became dependent to perform ADLs like bathing (24.1% and 40%) and to climb stairs (82.8% and 76.7%) for control and intervention groups, respectively. A cross sectional descriptive study also reported similar findings where more than 40% of the patients reported changes after diagnosis in at least 8 out of 22 daily activities like exercise, reading, speaking on phone, visiting with friends etc.[30] Another randomized controlled trial also reported an improvement in physical activity, fitness and specific aspects of psychological wellbeing as a result of physical activity counseling in breast cancer patients.[31] Morbid obesity can have certain effects on patient's activity of daily living. But none of the participants in the current study were in that category. On the other hand, studies in the literature show protective effect of higher body mass index (BMI) on activity of daily living.[32] Based on that it can be concluded that higher BMI will not be an interfering factor for ADL in the current study.

Post intervention, a slight reduction was noticed in depression and anxiety level among BCSs as a result of participants shifting from mild and severe to normal level on DASS-21. These results are consistent with the study done by Komatsu et al.[33] where guided self-help interventions resulted in a slight improvement in measures taken by BCSs to enhance QoL and to manage depression and anxiety. Post intervention both the groups had somewhat similar levels of anxiety and depression wherein improvement was seen in both the groups. Psychosocial stressors may be greater in the economically less privileged patients. The intervention group also had more chemotherapy, more mixture of anthracyclines/taxanes (100% were anthracycline only in the control arm). Also type of surgery was more likely to be mastectomy in the intervention group. Surgery is also known to add to foggy brain/chemo brain symptoms. Since these factors were not stratified and predefined in this study these may influence the observations reported so these should be interpreted with caution.

Post intervention we noticed a higher satisfaction level with respect to the care provided (Cognitive Training Interventions Package versus routine care) among the BCSs of intervention group as compared to those in control group. Since patients in the intervention group were provided information on breast cancer symptoms, treatments, its duration and side effects and were also given dietary advise, so they were better prepared for the treatment. This might have helped in reducing their stress and improved their QoL. Similar findings were also reported by Griggs et al.[34] where after interventions significant improvement in satisfaction level related to treatment information was observed among BCSs. These findings suggest that implementation of Cognitive Training Interventions Package may result in significant improvement in cognitive functions, subsets of memory like attention and concentration, retention for similar pairs, recognition, visual attention, processing speed, executive functions, ADLs and satisfaction level among patients. Therefore, these interventions should be used routinely to achieve better psychosocial outcomes and QoL of these patients.

We did not do subjective assessment of neurocognitive impairment in this study. Although, subjective neurocognitive impairment has been reported to be higher than the objective neurocognitive impairment measured by neuropsychological tests. However, the most common cognitive impairment seen in both methods is decline in memory. Both subjective and objective tests cannot be used together because they can cause fatigue. Other factors which affect cognitive function are age, fatigue and depression. Negative emotions because of the cancer diagnosis or treatments may also affect cognitive function, satisfaction and daily life of the patients. Sleep quality is also one of the predictors of cognitive impairment.

There are certain limitations of the current study. Due to limited data collection period as BCSs were only observed up to 4th cycle of chemotherapy late cognitive changes could not be assessed. Patients were not blinded to the staff. Since there was not randomization stratified based on predefined risk factors, the two cohorts were different in few parameters like socioeconomic class, surgery and chemotherapy. These factors may also affect QoL of these patients. Since some of the chemotherapeutic agents used in treatment may take much more time to affect cognitive functions therefore it might not be possible to conclude their impact on cognitive functions. All BCSs of the control group enrolled in the study were provided with the Cognitive Training Interventions Package after completion of study. In future, follow-up studies can be carried out to evaluate long term effects of chemotherapy on cognitive functions and effectiveness of cognitive training interventions package on reducing the likelihood of long-term cognitive deficits as well as complications.


  Conclusion Top


To summarize the study, since the cognitive training interventions package was education cum demonstration it was found significantly effective in terms of improvement in the primary outcome specifically, subsets of memory like attention and concentration, retention for similar pair and recognition. Although some improvement was seen in the subjective cognitive functions, it was not significant. When considering the primary outcome, improvement was seen in 20% of the total participants enrolled in the interventions group. Effectiveness of this package was also observed in the secondary outcomes as the level of anxiety and depression among survivors in the intervention group decreased and the QOL and satisfaction level of the participants increased. Therefore, in the scope of this study, effectiveness of Cognitive Training Interventions Package in terms of reduction in cognitive impairments related to chemotherapy can be established. Further studies are needed to determine specific chemotherapeutic agents that cause cognitive decline and their onset of action when they start to cause damage and whether these impairments disappear on their own.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Acknowledgment

The authors would like to express deep and sincere gratitude to Ms. Maninderdeep Kaur (Nursing Tutor, PGIMER Chandigarh), for her valid inputs in the study. We conclude our acknowledgment and appreciate all those who have contributed to this study directly or indirectly.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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    Figures

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