Gynecological cancer refers to cancer involving the female reproductive tract.1 According to the World Health Organization,2 cervical, uterine, and ovarian cancers were the third, sixth, and eighth most common cancers, respectively, in women in the world. In China, the number of cases of gynecological cancer is increasing because of an expanding and aging population. In 2012, China’s population was 1 347 350 000.3 All current data indicate that the incidence of uterine and ovarian cancers will rapidly increase, and cervical cancer in particular is set to increase in young women.3
The diagnosis of gynecological cancer and the effects of various treatments have many physical and psychological ramifications4 that have adverse effects on sexual functioning in different ways and to different extents.5 Any adverse changes in sexual functioning may reflect problems in quality of life and psychological aspects, such as physical symptoms, emotional state, self-esteem, self-perception, sense of well-being, life satisfaction, and social relationships.6,7 Sexual morbidity has been found to be correlated with greater depression and symptoms of stress as well as a poorer psychological quality of life.8 Treatment of sexual morbidity among gynecological cancer survivors might improve their psychological adjustment and quality of life.
Although psychoeducational interventions appear to have positive effects on sexual functioning as well as mood, body image, and quality of life among gynecological cancer patients,9–11 the evidence for these effects is far from conclusive. The development and testing of complex interventions are best begun with a review of the available evidence and theory to inform intervention design.12 Therefore, the objectives of this study were to conduct a systematic review regarding whether the provision of psychoeducational interventions optimizes sexual functioning, psychological outcomes, and quality of life of gynecological cancer patients and to identify design implications of effective psychoeducational interventions in clinical practice and future psychoeducational intervention research.
To identify the best available research evidence related to the effects of psychoeducational interventions on sexual functioning, quality of life, and psychological outcomes in gynecological cancer patients, the following review questions were addressed:
- What is the effectiveness of psychoeducational interventions in improving sexual functioning, psychological outcomes, and quality of life among gynecological cancer patients?
- How effective are the various components, formats, providers, time frame, and the duration of psychoeducational interventions in improving these outcomes?
A comprehensive search was carried out to retrieve both published and unpublished studies in English and Chinese. Chinese studies were examined because the authors of the review are Chinese and able to read Chinese. A total of 30 electronic databases were included from the inception of the databases to April 2012. The electronic databases containing primary publications written in English included Academic Search Premise, British Nursing Index, CINAHL, Cochrane Library, ERIC (Educational Resources Information Center), EMBASE, Global Health, MEDLINE, PsycArticles, Psychology: A SAGE Full-Text Collection, PsycINFO, ScienceDirect, and Scopus. Electronic databases containing published studies in Chinese included CJN (China Journal Net), CBM (Chinese Biomedical Literature Database), CMCC (Chinese Medical Current Contents), HKInChiP (Hong Kong Index to Chinese Periodicals), HyRead, TEPS (Taiwan Electronic Periodical Services), and WanFang Data. A further 10 databases were searched for gray literature or unpublished studies. A combination of keywords “gynecologic* cancer,” “gynecologic* neoplasm,” “gynecologic* tumor,” “ovarian cancer,” “ovarian neoplasm,” “ovarian tumor,” “uterine cancer,” “uterine neoplasm,” “uterine tumor,” “cervical cancer,” “cervical neoplasm,” “cervical tumor,” “psychoeducation*,” “psycho education*,” “patient education,” “teaching,” “counseling,” “psychotherapy,” “self-help groups,” “social support,” “support group,” “cognitive therapy,” “behavior* therapy,” “models, theoretical,” “sexuality,” “sexual function*,” “quality of life,” “psychosocial wellbeing,” “body image,” “self concept,” “mood,” “anxiety,” and “depression” were used. Chinese search terms for the English keywords were used to identify Chinese articles. Reference lists and bibliographies of all retrieved articles were also screened to further identify relevant studies.
Inclusion and Exclusion Criteria
This systematic review considered all studies that used a randomized controlled trial (RCT) design to evaluate the effects of psychoeducational interventions that aimed at improving sexual functioning, quality of life, and psychological outcomes of gynecological cancer patients who were older than 18 years and who had a primary gynecological cancer confirmed by pathology test. Studies were excluded from the review if they were written in a language other than English and Chinese or were combining psychoeducational interventions with some other interventions such as music therapy or medical therapy.
The methodological quality of eligible studies was independently assessed by 2 reviewers with the use of the Joanna Briggs Institute (JBI) critical appraisal checklists for experimental studies.13 Any disagreements between the reviewers were resolved by discussion or consultation with a third reviewer.
Details of the included studies were extracted and summarized by 2 reviewers independently with the use of the modified version of the JBI data extraction form, which was tailored for this systematic review. Discrepancies between the reviewers were resolved by discussion. The data extracted included the settings; the population and participant demographics; participant inclusion and exclusion criteria; study methods; the contents, formats, providers, and duration of the interventions; and outcome measures and results. If data were missing from the included studies, study authors were contacted for the needed information.
Quantitative results of comparable studies were pooled in statistical meta-analysis using RevMan 5.1. As all studies used different scales to measure outcomes and continuous data were reported, the standardized mean differences (SMDs) and their 95% confidence intervals (CIs) were calculated. The clinical heterogeneity of the studies was assessed by considering the similarities in participants’ characteristics, study design and setting, and their intervention and outcome measure. The statistical heterogeneity of the studies was assessed using the I2. Sufficiently similar studies in terms of clinical heterogeneity were pooled using fixed- or random-effects models if I2 ≦ 40% or I2 > 40%, respectively.14 For those clinical heterogeneous studies, where statistical pooling of results of the included studies was not appropriate or possible, the findings were summarized in narrative form.
Description of Studies
The search strategy identified 18 102 citations, of which 17 049 were English, and 1053 were Chinese. After removal of duplicates and examination of the titles and abstracts, 69 potential citations were identified. Ten English and 4 Chinese citations were additionally identified from reference lists and bibliographies of these studies. Full-text screening excluded 36 English and 3 Chinese studies. The remaining 44 studies, 13 English and 31 Chinese, were subject to assessment of eligibility and appraisal of methodological quality. Two English studies and all 31 Chinese citations were finally excluded. The reason for excluding the English studies was that they used mixed types of cancer participants, but retrieval of data for subgroup analysis was not possible. The reason for excluding the Chinese studies was the generally poor quality of the reports. The flowchart in Figure 1 illustrates the study retrieval and selection.
In total, 11 English studies met the inclusion criteria and were included in the review. The characteristics and results of the 11 included studies are summarized in Table 1. A meta-analysis was conducted for 4 comparable studies.15–18
Methodological Quality of the Included Studies
Of the 11 RCTs, 7 reported using an adequate randomization method to allocate participants to treatment and control groups.16–22 The remaining 4 trials claimed to use randomization, but no details of the procedure were provided.15,23–25
Most studies used self-reported questionnaires to measure outcomes, and so blinding of assessors was not possible. Only 1 study was able to blind the assessor.19 Owing to the active participation in the psychoeducational interventions, blinding to participants was also impossible. Blinding to allocator was performed in 6 trials.17,18,20–22,25 Most trials did not perform a power estimation to calculate the sample size. Only 1 study reported using power estimation to calculate the samples.20
Regarding the results, 4 studies did not report mean and standard deviation (SD).20–22,24 Authors were contacted to retrieve the data but did not reply. Three studies did not conduct intention-to-treat analysis to analyze the data.22,23,25 Two studies had no missing data as no one withdrew,15,21 and the remaining studies performed intention-to-treat analysis.16–20,24 The methodological quality of the included studies is summarized in Table 2.
A total of 11 English studies involving 11 RCTs and 975 gynecological cancer patients met the inclusion criteria for the systematic review. Seven trials were undertaken in the United States.15–17,19,23–25 The others were conducted in Australia, Canada, Hong Kong, and the United Kingdom.18,20–22
All participants were gynecological cancer patients. Sample sizes varied from 23 to 353. However, most studies had small samples. Only 3 studies included more than 100 participants.16,17,20
Most studies adopted multiple instruments to measure multiple outcomes. In total, 38 different instruments were used across the trials. Three of the studies measured sexual functioning,20–22 6 studies measured quality of life,15,17,20,21,23,24 and 7 measured psychological outcomes including anxiety, depressive symptoms, distress, adjustment to illness, mood, uncertainty, self-esteem, and coping.16–20,24,25
Effects of Psychoeducational Interventions on Measuring Outcomes
Among the 3 studies measuring the effects on sexual functioning, there was evidence from 1 RCT that psychoeducational interventions improved this outcome. The interventions provided in individual or group format were equally effective in improving sexual relationships 6 months later.19 On the other hand, another 2 studies indicated that the psychoeducational interventions appeared to be helpful in improving sexual health including more frequent sexual intercourse, improved knowledge of sexuality, and reduced anxiety and fears about sex, but there was no impact on sexual functioning scores.21,22
QUALITY OF LIFE
Among the 6 studies assessing quality of life, 2 reported negative results.17,20 A further 4 RCTs reported evidence that psychoeducational interventions enhanced the quality of life of gynecological cancer patients.15,21,23,24
Two comparable studies compared psychoeducational interventions with information provision (146 participants).15,17 The pooled result, combined as an SMD, of the physical aspect of quality of life was −0.12 (95% CI, −0.45 to 0.20; P = .46), showing no significant benefit for the psychoeducational interventions, with a mild significant heterogeneity (I2 = 24%) (Figure 2). The SMD of the mental aspect of quality of life was −0.41 (95% CI, −0.74 to −0.08; P = .01), indicating that information provision demonstrated significant effects on the mental quality of life without heterogeneity (I2 = 0%) (Figure 3).
A total of 7 studies measured the effects of psychoeducational interventions on psychological outcomes including anxiety, depression, distress, adjustment to illness, mood, self-esteem, coping, and uncertainty.16–20,24,25 Among the 5 RCTs assessing the effects on depressive symptoms, 3 assessed anxiety as well.16–20 There were contradictory findings about whether the psychoeducational interventions reduced levels of anxiety and depressive symptoms. Two studies comparing psychoeducational interventions with usual care (406 participants) were comparable.16,18 The SMD of depressive symptoms was −0.80 (95% CI, −1.05 to −0.54; P < 0.00001), showing that the interventions had a significant effect, without heterogeneity (I2 = 0%) (Figure 4).
Evidence regarding the effect of psychoeducational interventions on levels of distress was mixed. One RCT reported no change in distress levels among gynecological cancer patients20; however, another 3 studies showed beneficial effects resulting from psychoeducational interventions.16,17,24 The individual format of interventions achieved a significant decrease in cancer-specific distress over time.16,17 If the interventions were provided to an individual patient with couple participation, overall distress scores for the combined population were also significantly lower from the baseline up to 3 months (P = 0.03).24
Evidence regarding the effect of psychoeducational interventions on adjustment to illness was also inconsistent. One study reported no improvement,25 but another study reported a better response.19 On the other hand, psychoeducational group intervention was found to have no significant effects on mood change in the intervention group.25 Chan et al20 indicated that, when using individually tailored psychoeducational interventions, there were also no significant effects on self-esteem among participants. Similarly, no significant improvement in perceived coping ability was observed when using individually tailored psychoeducational interventions in gynecologic cancer patients.20 There were contradictory findings regarding the impact of psychoeducational interventions on uncertainty. When the individual format of interventions was provided by the oncology advanced practice nurse, there was an effect of improved uncertainty in patients.17 However, individual interventions with couple participation demonstrated no statistically significant changes in the uncertainty scale over time.24
Design of Psychoeducational Interventions for Gynecological Cancer Patients
In order to provide effective psychoeducational interventions for gynecological cancer patients, the best designs including components, format, provider, provision time frame, and duration were identified from the reviewed studies.
Of the included studies, psychoeducational interventions incorporated a range of different components in the trials. The 3 main components of the interventions were as follows: information provision, behavior therapy, and psychological support. These 3 main components were used by 9 reviewed studies for their trials of psychoeducational interventions.15,16,18–23,25 The remaining 2 studies combined information provision and psychological support in the interventions.17,24 A combination of 3 main components was found to be superior to a combination of 2 of the components.
Among 11 RCTs, only 5 developed psychoeducational interventions based on established models or frameworks.15,19,22,24,25 The following models were used in designing the interventions: the thematic counseling model,19 the cognitive-behavioral, problem-focused framework,15,25 the information-motivation-behavioral skills model,22 and the Conceptual Quality-of-Life Model.24 These models achieved a significant improvement in sexual relationships, quality of life, distress, and better compliance with the use of vaginal dilators among women with gynecological cancer.
With regard to the format of the interventions, 6 trials were run using the individual format,15–18,20,23 2 using the individual format with couple participation interventions,21,24 and 2 using the group format.22,25 The remaining 1 trial compared individual and group interventions.19 Among the individual psychoeducational interventions, 2 were conducted by telephone,15,23 2 were done face-to-face,18,20 and the remaining 2 combined face-to-face and telephone calls.16,17 There was no consistent finding for what might be the most effective format for psychoeducational interventions. It was found that the individual format with couple participation and group format were both effective in improving sexual functioning outcomes. Regarding quality of life, the individual format and the individual format with couple participation were effective. As for psychological outcomes, inconsistent effects were achieved whether individual or group formats were used. Cain et al19 likewise indicated that either an individual or a group format was effective with regard to sexual functioning, anxiety and depressive symptoms, and adjustment to illness using the same content and components for the interventions.
Nurses and clinical psychologists were the most common providers of psychoeducational interventions.16,17,19–24 Other providers included social workers, graduate students, and doctors.15,16,18,19,24,25 Nurses were found to be in the most ideal position to provide psychoeducational interventions. The interventions provided by nurses improved sexual functioning, quality of life, anxiety and depressive symptoms, distress levels, adjustment to illness, and uncertainty.
Regarding the provision time frame of the interventions, 4 psychoeducational intervention trials were run after treatment and during the disease-free period.15,23–25 Three trials were conducted all through active treatment,16,18,22 2 were done before treatment started and continued after the patient was discharged,19,21 and the remaining 2 were run throughout active treatment and continued after the patient was discharged.17,20 The psychoeducational interventions that were provided before treatment started and that continued after patients were discharged seemed to give the most effective overall outcomes. Giving information to patients about their illness and the treatment to be provided to them before the start of treatment helped prepare the patients for any adverse changes to their sexual health. If the interventions continued until they were discharged, the patients had opportunities to discuss sexual difficulties with providers and thus were able to improve their sexual functioning and quality of life. These interventions reduced their anxiety and depressive symptoms, lessened their levels of distress, and helped them adjust to their illness.
Concerning the duration of interventions, most offered more than 5 sessions for participants.15–17,19,20,23,25 2 provided 4 sessions,21,24 1 provided 2 sessions,22 and 1 provided 1 session only.18 Five trials provided sessions of less than 1 hour’s duration,15,16,18,23,24 and 2 lasted 1.5 hours.22,25 Other studies did not mention the duration of each session.17,19–21 Overall, psychoeducational interventions with 4 sessions and lasting from 30 minutes to 1 hour for each session were of the most suitable duration for gynecological cancer patients. It was found that intervention periods that were of long duration and that took place too frequently tended to overwhelm and exhaust the patients. On the other hand, periods that were too short might not achieve the desired effects. Therefore, in order to achieve the best results, a schedule of 1 session before cancer treatment starts, along with 3 sessions while treatment is being actively received and continuing after the patient has been discharged, should be provided.
According to the National Cancer Institute,26 50% of gynecological cancer survivors have long-term sexual dysfunction. Although psychoeducational interventions were recommended to improve patient outcomes,27,28 the evidence of their effectiveness was far from conclusive. Besides, the design of the interventions varied in different countries and different studies. Thus, a review was undertaken to identify the best available evidence on the effects of psychoeducational interventions for gynecological cancer patients in improving their sexual functioning, quality of life, and psychological outcomes, as well as effective design for the interventions.
Limited systematic reviews have been conducted on psychoeducational interventions for gynecological cancer patients. Only 1 systematic review has been performed previously to provide evidence for the effects of psychosocial interventions on quality of life among women with gynecological cancer.29 However, there was no synthesized evidence of their effects on sexual functioning and psychological outcomes. Similar to the result of that review,29 this current systematic review suggested that psychoeducational interventions seemed to improve the quality of life among gynecological cancer patients. However, the meta-analysis result on the quality of life indicated that information provision (control group) was superior to the psychoeducational interventions (intervention group) in improving patients’ quality of life, but limited to the mental aspects. This finding might be due to the heterogeneous samples between the intervention and control groups in the 2 comparable studies for the meta-analysis.15,17 The study demonstrating the beneficial effects of psychoeducational interventions had a small sample size, 23 participants,15 whereas the study demonstrating an insignificant effect had a larger sample size, 123 participants.17 The latter study reported poorer baseline scores in quality of life among the intervention group. Although it stated that there was no significant difference in terms of the demographic and clinical characteristics among the intervention and control groups, the intervention group had better mental and physical quality of life over time than did the control group, after adjustment for covariate variables including age, race, marital status, education, disease status, comorbidities, and income. Consequently, the result of this meta-analysis should be interpreted cautiously. One study demonstrated that routine use of formal psychological therapies did not have a significant effect on quality of life among gynecological cancer patients.20 The psychological interventions might only be provided to those patients in need.
Evidence regarding the effects of psychoeducational interventions on psychological outcomes including anxiety and depressive symptoms, distress and adjustment to illness, mood, self-esteem, uncertainty, and coping was mixed. This might be due to the wide varieties of intervention components, formats, providers, provision time frames, and durations in the 7 studies measuring this outcome. The pooled effects of psychoeducational interventions showed significant impact on depressive symptoms when compared with usual care.16,18 However, it is important to note that many psychometric tools such as the Beck Depression Inventory and the Hospital Anxiety and Depression Scale are designed to assess the depressive symptoms rather than to diagnose depression.30,31
Three studies examined the effect of psychoeducational interventions on sexual functioning among gynecological cancer patients, and the evidence was inconclusive.19,21,22 The statistically insignificant improvement was shown in 2 studies; the reason might be due to the measurement tool used, the Lasry Sexual Functioning Scale for breast cancer patients, which was not tested for its reliability and validity in gynecological cancer patients.21 In addition, the very low compliance rate for the intervention group (<50%) in the other study might reflect the participants’ perceptions of the interventions.22
Our review findings suggest that psychoeducational interventions have positive effects on gynecological cancer patients. However, the review findings on the effects of psychoeducational interventions on patient outcomes could not be generalized to all gynecological cancer patients from different cultural backgrounds as most included studies were conducted in Western countries, with only 1 study conducted in Hong Kong. Although articles written in the Chinese language were one of the inclusion criteria, all of these identified articles were finally excluded because of their poor quality. On the other hand, the review findings on the effective design of psychoeducational interventions might be applicable to all ethnic backgrounds. The information needs of gynecological cancer patients from Western countries, as well as from Eastern countries, for example, Hong Kong, on sexual aspects were found to be similar. All of them indicated that information about the sexual consequences of gynecological cancer and treatment was important to them. Acquisition of such information was helpful in removing worries about sexual life as well as in managing sexual problems afterward.11,32–35 Although the need for sexuality information was not investigated in gynecological cancer patients in other Eastern countries, Japanese and South Asian breast cancer survivors indicated that a complete understanding of the possible adverse effects of cancer diagnosis and treatment on sexuality, as well as information on managing sexual changes, was helpful to them when coping with sexual problems.36–38 As a result, sexual functioning seems to be a universal concern in female cancer survivors in both Western and Eastern countries, and the effective design of psychoeducational interventions identified from the systematic review can meet their needs.
In addition, it is premature to generalize the review findings to practice as most of the included RCT studies were not adequately powered or lacked design rigor to meet the guidelines set by the CONSORT statement.39 Of the 11 studies included, the methodological quality was fair. Inadequate reporting was a common concern. Although attempts were made to contact the authors for additional information, only 1 author replied. As a result, most of the studies could not be included for meta-analysis. In addition, different components of psychoeducational interventions were used in the studies, so the interventional effects could be diffused, and most outcomes reported in the included studies were summarized in narrative form.
Implications for Practice and Research
To provide the best patient care, psychoeducational interventions should be incorporated into usual care for gynecological cancer patients with resources allocated. It is best if the psychoeducational interventions incorporate all 3 components, that is, information provision, behavior therapy, and psychological support, and it should be ensured that they are based on a model or framework. The format could be individual with couple or group, depending on the objectives of the interventions. The nurse would act as the intervener. The provision time frame should begin before treatment starts and continue after discharge, and the number of sessions should be 4. As for the schedule of the interventions, it is suggested that there be 1 session before cancer treatment starts and 3 sessions during and after treatment and discharge. Each session should last no longer than 1 hour.
In addition, cultural differences should be taken into account when designing the psychoeducational interventions for gynecological cancer patients, even though the needs for sexuality information appeared to be consistent across different cultural backgrounds. For example, Chinese values with respect to modesty and family obligation contributed to the lack of open discussion on sexuality. Communication regarding sexual behavior is considered embarrassing, and sexual concerns usually focused on fertility and practical issues such as pain management during intercourse.40,41
Provision of psychoeducational interventions for gynecological cancer patients might reduce the high cost of medical consultation for sexuality-related issues, which could offset the manpower cost for providing the interventions. Analysis of cost-effectiveness of psychoeducational interventions is recommended in future studies.
This systematic review assesses the effects of psychoeducational interventions for gynecological cancer patients on sexual functioning, quality of life, and psychological outcomes and seeks to identify the most suitable components, format, provider, provision time frame, and duration of the interventions. Psychoeducational interventions reduced the levels of depressive symptoms among gynecological cancer patients. It is thought that information provision might be the active component in the interventions that improved the mental aspect of quality of life. However, methodological flaws in the clinical trials were revealed, and this affected the generalizability of the findings. Better designed RCTs with an adequate sample size are needed to further examine the effects of psychoeducational interventions in improving psychological well-being among gynecological cancer patients. Sufficient information about the randomization procedure and results with mean and SD should be provided. The use of similar comparison groups should be considered to allow pooling of the results owing to the diversity of interventions.
The authors acknowledge The JBI Library of Systematic Reviews, the Joanne Briggs Institute.
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