|Ahead of print publication
A Pilot Intervention Study to Improve Sexuality Outcomes in Breast Cancer Survivors
Natalia Gondim de Almeida1, Tish M Knobf2, Marcos Renato de Oliveira1, Marina de Góes Salvetti3, Mônica Oliveira Batista Oriá4, Ana Virginia de Melo Fialho1
1 Department of Nursing, State University of Ceara, Fortaleza, Ceará, Brazil
2 School of Nursing, Yale University, New Haven, CT, USA
3 School of Nursing, University of São Paulo, São Paulo, Brazil
4 Department of Nursing, Federal University of Ceará, Fortaleza, Ceará
|Date of Submission||21-Aug-2019|
|Date of Acceptance||12-Nov-2019|
|Date of Web Publication||14-Jan-2020|
Natalia Gondim de Almeida,
Department of Nursing, State University of Ceara, Fortaleza, Ceará, Brazil
Source of Support: None, Conflict of Interest: None
Objective: The main objective of the study is to assess the efficacy of the Permission, Limited information, Specific Suggestion, and sexual therapy (PLISSIT) model directly with breast cancer survivor (BCS) on sexual function and quality of life (QOL) domains. Methods: A pilot control trial was conducted comparing the PLISSIT model intervention to usual care. The intervention was delivered by two health professionals (nurse and professional sexual therapist) consisted of five sessions on counseling, genitalia anatomy, human sexual response, and sexual function. Data were collected before and 3 months after the intervention using the Female Sexual Function Index and the World Health Organization QOL-BREF questionnaire. Results: The sample consisted of 19 BCS (11 intervention, 8 controls) with a mean age of 54.5 8 years (standard deviation = 7.14) and the majority were married, Black or mixed Brazilian, received chemotherapy, radiation and/or hormonal therapy, and education varied from high school to college. There was significant improvement in physical health (P = 0.031), social relationships (P = 0.046), orgasm (P = 0.055), and pain (P = 0.049) over time and the intervention resulted in improved arousal (P = 0.038). Conclusions: The results suggest that the PLISSIT model may be an effective intervention for BCS in coping with and managing changes in sexuality and sexual function after treatment. It is important that nurses are aware of sexual intimacy concerns for BCS and integrate assessment into their nursing care.
Keywords: Breast cancer, sexual counseling, sexuality, woman health
|How to cite this URL:|
de Almeida NG, Knobf TM, de Oliveira MR, Salvetti Md, Oriá MO, Fialho AV. A Pilot Intervention Study to Improve Sexuality Outcomes in Breast Cancer Survivors. Asia Pac J Oncol Nurs [Epub ahead of print] [cited 2020 Feb 27]. Available from: http://www.apjon.org/preprintarticle.asp?id=276060
| Introduction|| |
Breast cancer is the most common type of cancer in women worldwide., The incidence of breast cancer in South America is modest (46/100,000 age-standardized population) compared to that in the United States and Western Europe. The 5-year survival rate for women with breast cancer has risen dramatically in Brazil to 87.4%.
Today, as the survival rate for women with breast cancer increases, the treatment regimens are accompanied by a range of physical, psychological, existential, and social concerns. Body image, including the feelings of femininity and attractiveness, improves between 10 months and 3 years after surgery. Sexual attractiveness and feelings of comfort during sexual intimacy are most problematic over the first 1–2 years.
Sexuality is normally an essential part of life. As there has been a substantial increase in the number of breast cancer survivors (BCSs), it is critical to address their quality of life (QOL) after treatment.
There is a gradual improvement in QOL for many BCSs following primary and adjuvant therapies. However, persistent physical symptoms can result in psychological distress and poor QOL. Specifically, alterations in sexuality and sexual function associated with breast cancer treatment adversely affect the physical, psychological, and social well-being domains of a woman's QOL.,,, This can result in sexual dysfunction, such as lower sexual interest, desire, pain, orgasm disorders, and decreased self-confidence., Significant predictors of poor sexual function are vaginal dryness, poor marital/relationship satisfaction, and body stigma feelings.
Psychosocial interventions aimed at sexual rehabilitation that could focus on helping survivors address body shame and the associated avoidant behaviors, thereby facilitating adjustment, integration, and acceptance of their body, have been recommended.
Complicating the physical and psychological distress associated with changes in sexuality and sexual function is the lack of communication about these issues with health-care providers.,, There are resources available for nurses and physicians to initiate a conversation about sexuality. One resource is the Permission, Limited Information, Specific Suggestion, sexual therapy (PLISSIT) model, which provides a guide for patient-provider communication related to sexual and partner issues.,,,,, The PLISSIT model may be used directly to promote coping for those BCSs experiencing alterations in sexuality and sexual function. In addition, since mastectomy is the most common primary treatment for breast cancer in Brazil and because of the possible negative effects of mastectomy on women's lives, this study explored the use of the PLISSIT model with BCSs following a mastectomy and compared its impact on QOL and sexuality outcomes to that of usual care.
| Methods|| |
A nonrandomized pre-/postpilot study was conducted. The study was approved by the Ethics Committee Assis Chateaubriand Maternity School in Fortaleza, Brazil, and was registered with the Brazilian Clinical Trials Registry (Registration No. RBR-33tdwy).
Study population and sample
Eligible participants were BCSs who were >6 months since surgery, >18 years of age, and sexually active. BCS participants who were taking antidepressants or who had difficulty participating in two or more sessions and/or had scheduling difficulties were excluded. Sexually active was defined as a history of consensual penetrative vaginal intercourse, and it included masturbation.
The power calculation for the sample was based on a published study that reported mean scores for the Female Sexual Function Index (FSFI); a sample of 10–22 was estimated with a power of 99.9% at the significance level of 5%.
The participants were recruited from December 08, 2016, to April 06, 2017. Recruitment flyers were posted in the breast cancer departments of Assis Chateaubriand Maternity School and the support group for BCSs, the Touch of Life Association (a nongovernmental organization). The participants from the breast cancer department contacted the researcher by phone from the information given on the flyers, while the participants from the Touch of Life Association were invited to attend and participate in the intervention group sessions during the association's monthly meeting.
A total of forty participants were eligible and recruited for the study. Seventeen participants declined to be included, and the remaining 23 participants were assigned to one of two groups. Of the remaining 23 participants, 15 participants were assigned to the intervention group, and 8 of the participants were assigned to the control group. Four participants were excluded from the intervention group because they attended <2 intervention sessions and one participant dropped out after 3 months as a result of scheduling difficulties [Figure 1]. All participants signed written informed consent forms. Questionnaires were administered to both groups of participants prior to the interventions and 3 months after baseline data collection.
The intervention consisted of the utilization of the Sexual Counselling Intervention for BCSs (SCIBCSs) that was based on the PLISSIT model.
There were 5 weekly sessions, lasting approximately 1.5 h each [Table 1]. The SCIBCS followed a specific protocol and included counseling, information about genitalia anatomy, human sexual response, sexuality, and sexual function. There was adequate time to encourage and engage participants in the discussion of the information that was presented, and the presentations were followed with question and answer sessions. The counseling was performed by a licensed sexual therapist and by a registered nurse with a master's degree in nursing who was trained by the sexual therapist to conduct the session with her. The intervention was conducted in a BCS group setting. The PLISSIT model addressed both the biological and psychological aspects of sexuality and sexual function.
|Table 1: Sexual counseling intervention for breast cancer survivors protocol|
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The control condition was conducted during the monthly Touch of Life Association, and this meeting was conducted during March 2017. The control group received the same information as the intervention group, which was based on health education, using media resources as a tool to deliver the information. A health education lecture with sexuality as the main topic was presented and lasted approximately 2 h.
All measurements were administered in Portuguese using translated and validated versions of the original instruments., The FSFI was used to evaluate sexual function. It is composed of six subscales, and the sum of the scores measures the degree of desire, arousal, lubrication, orgasm, satisfaction, and pain (dyspareunia). The internal consistency of the scale has been established, with a Cronbach's alpha coefficient of 0.95. The total scores ranged from 2 to 36, with a higher score indicative of better sexual function. The Portuguese version of the FSFI was validated with Brazilian women and is indicated for use in clinical research.
The World Health Organization QOL-BREF questionnaire (WHOQOL-BREF) consists of 26 questions; it has been translated and validated and its internal consistency, concurrent reliability, and content reliability have been established. The scale ranges from 0 to 100 and higher scores indicate a better QOL. The Cronbach's alpha for WHOQOL-BREF was 0.91.
The primary analytic approach was to describe and compare the means of WHOQOL-BREF and FSFI domains between the two study groups (intervention and control) over time and by group. The variables included were from the WHOQOL-BREF (physical health, psychological, social relationships, and environment) and from the FSFI (desire, arousal, lubrication, orgasm, satisfaction, and pain). A t-test was used to compare mean values for the intervention and control groups. IBM SPSS Statistics for Windows version 22.0 (IBM Corp., Armonk, NY) was used, and significant results were reported at P < 0.05. To compare the variables over time, a general linear model was used. The significance level was set at α = 0.05 for all analyses. The homogeneity testing of the groups was analyzed using an independent sample t-test.
| Results|| |
Characteristics of the sample
The sample consisted of 19 BCSs (11 interventions and 8 controls), and there were no significant differences in demographic or cancer characteristics between the groups at baseline [Table 2]. The women were, on average, 54.58 years (standard deviation [SD] = 7.14), mixed-tone Brazilian (52.2%), and while not significant, more women in the intervention group were married compared to the control group. The average time since surgery was 7.07 years (SD = 4.97) years; the majority underwent radical mastectomy. Approximately, half of the women had breast reconstruction, and nearly, two-thirds received multimodality treatment (chemotherapy, radiation, and hormone therapy).
The mean QOL at baseline was rated as moderately good and was improved at 3 months in both groups (P = 0.02). Physical health improved over time in both groups (P = 0.03) as well as social relationships (P = 0.046). Sexual function was rated as low in both groups at baseline, indicating a level of sexual dysfunction with no significant changes over time or by group assignment. Self-rated orgasm and pain improved over time in both groups (P = 0.05), and there was a significant improvement in arousal in the intervention group compared to a decrease in the control group (P = 0.038). Compared to the usual care group, the intervention group improved on arousal over time (P = 0.038), and there was a trend toward less pain (P = 0.068).
In summary, there were slight to moderate QOL improvements in both groups over time, and the findings suggest that the PLISSIT intervention improved arousal with a slight trend in pain improvement (P = 0.068) [Table 3].
|Table 3: Comparison of mean scores over time for the intervention and control groups (n=19)|
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| Discussion|| |
In our pilot clinical trial, the majority of women underwent radical mastectomy 95% and 47% had breast reconstruction. Gass et al. compared QOL and sexuality outcomes in women who had a lumpectomy, mastectomy, or mastectomy plus reconstruction. Their findings showed no significant difference in sexual functioning across the three surgical modalities. Although some subscales of the FSFI demonstrated higher scores for women who had lumpectomy versus mastectomy, our patients primarily had mastectomy.
It is also unclear if surgery alone contributed to the sexuality outcomes, as 57.8% received multimodality therapy following surgery (chemotherapy, radiation, and hormonal treatment). It is important to highlight that chemotherapy is known to negatively affect sexuality and sexual function.,,,, In a prospective study collecting data on QOL and sexual function during and after chemotherapy for breast cancer, decreased libido, increased discomfort, and adverse effects on pleasure, orgasm, and frequency of sexual activity were reported after therapy.
Our pilot study determined that the PLISSIT model is a clinically feasible and acceptable intervention., Several studies have shown positive results of nurse-delivered psychoeducational interventions focused on the sexuality of cancer patients.
More intense and longer interventions to improve sexuality outcomes in BCSs have been tested. In a sample of 169 BCSs who were >3 years since diagnosis, cognitive behavioral therapy delivered by professionals over 24 weeks improved sexual functioning, desire and arousal, and decreased discomfort for the intervention group compared to the control group.
These findings suggest that interventions are needed in clinical practice, as they have demonstrated the ability to improve outcomes for survivors, even several years after therapy. It is important for health-care professionals to be aware of problems related to sexual intimacy and to be prepared to not only provide information about these issues but also to reflect on expectations versus reality together with the women.
| Limitations|| |
There are three limitations: the small sample size, challenges with randomization, and the timing and scheduling of the hospital-based intervention sessions. Thus, some participants chose their group based on their preference and schedule. This was also not a prospective study, and it is unknown if an earlier intervention, such as immediately following therapy, might have provided more robust data to assess the type of interventions, and their effects on outcomes. Data were only collected on QOL and sexuality, and it is known that a breast cancer diagnosis and the psychosexual distress related to sequelae from treatment affect the partner and couple relationship. No data were collected from the other participants in the partner relationship.
Implication for practice and future research
Nurses need to be informed about the scope of the sexuality issues for BCSs and the critical need for screening assessment so that appropriate referrals or interventions can be initiated. It is especially important for nurses who practice globally in countries where they may have less autonomy or training in psychosocial-sexual responses of survivors. The preliminary findings of this study suggest that the PLISSIT model may be an effective intervention for BCSs. It is feasible in both the inpatient and outpatient settings for nurses, although system factors, educational gaps, and administrative support would need to be enhanced to effectively develop a plan to implement routine assessment.
The importance of sexual and vaginal health to QOL was reported by 87% of the participants in this study. These women also reported a lack of knowledge about vaginal and sexual health promotion strategies. Thus, the use of the PLISSIT model was effective in addressing this gap in knowledge.
Future research should consider prospective longitudinal study designs and inclusion of other factors that might influence sexuality and sexual function outcomes, such as quality of the partner relationship, and data collected from partners, such as emotional well-being. Qualitative inquiry to explore experiences of BCSs and/or their partners and/or couples could provide a grounded perspective and could generate data on the best type, duration, and content of interventions, especially in culturally diverse populations. Qualitative inquiry could also be conducted within an intervention trial to better understand the acceptability of the intervention and its valued components.
| Conclusion|| |
The PLISSIT model had favorable effects on QOL and sexuality over the time. The results suggest the intervention might have an effective benefit for BCSs in coping with and managing changes in sexuality and sexual function after treatment. This study do provide nurses insight for the importance to integrate assessment of sexual intimacy into their nursing care for BCSs.
Financial support and sponsorship
This work was supported by the Improvement of Higher Education Personnel (CAPES) (Grant No. 88881.131668/2016).
Conflicts of interest
There are no conflicts of interest.
| References|| |
Steward BW, Wild CP. World Cancer Report 2014. Lyon, Geneva: International Agency for Research on Cancer, World Health Organization; 2014.
Parkin DM, Fernández LM. Use of statistics to assess the global burden of breast cancer. Breast J 2006;12 Suppl 1:S70-80.
Allemani C, Weir HK, Carreira H, Harewood R, Spika D, Wang XS, et al
. Global surveillance of cancer survival 1995-2009: Analysis of individual data for 25,676,887 patients from 279 population-based registries in 67 countries (CONCORD-2). Lancet 2015;385:977-1010.
Fallbjörk U, Rasmussen BH, Karlsson S, Salander P. Aspects of body image after mastectomy due to breast cancer – A two-year follow-up study. Eur J Oncol Nurs 2013;17:340-5.
Boquiren VM, Esplen MJ, Wong J, Toner B, Warner E, Malik N. Sexual functioning in breast cancer survivors experiencing body image disturbance. Psychooncology 2016;25:66-76.
Knobf MT. Clinical update: Psychosocial responses in breast cancer survivors. Semin Oncol Nurs 2011;27:e1-4.
Fobair P, Spiegel D. Concerns about sexuality after breast cancer. Cancer J 2009;15:19-26.
Hughes MK. Alterations of sexual function in women with cancer. Semin Oncol Nurs 2008;24:91-101.
Tierney DK. Sexuality: A quality-of-life issue for cancer survivors. Semin Oncol Nurs 2008;24:71-9.
Jun EY, Kim S, Chang SB, Oh K, Kang HS, Kang SS. The effect of a sexual life reframing program on marital intimacy, body image, and sexual function among breast cancer survivors. Cancer Nurs 2011;34:142-9.
Male DA, Fergus KD, Cullen K. Sexual identity after breast cancer: Sexuality, body image, and relationship repercussions. Curr Opin Support Palliat Care 2016;10:66-74.
Perz J, Ussher JM, Australian Cancer and Sexuality Study Team. A randomized trial of a minimal intervention for sexual concerns after cancer: A comparison of self-help and professionally delivered modalities. BMC Cancer 2015;15:629.
Ayaz S, Kubilay G. Effectiveness of the PLISSIT model for solving the sexual problems of patients with stoma. J Clin Nurs 2009;18:89-98.
Rostamkhani F, Jafari F, Ozgoli G, Shakeri M. Addressing the sexual problems of Iranian women in a primary health care setting: A quasi-experimental study. Iran J Nurs Midwifery Res 2015;20:139-46.
Faghani S, Ghaffari F. Effects of sexual rehabilitation using the plissit model on quality of sexual life and sexual functioning in post-mastectomy breast cancer survivors. Asian Pac J Cancer Prev 2016;17:4845-51.
Farnam F, Janghorbani M, Raisi F, Merghati-Khoei E. Compare the effectiveness of PLISSIT and sexual health models on women's sexual problems in Tehran, Iran: A randomized controlled trial. J Sex Med 2014;11:2679-89.
Khakbazan Z, Daneshfar F, Behboodi-Moghadam Z, Nabavi SM, Ghasemzadeh S, Mehran A. The effectiveness of the Permission, Limited Information, Specific Suggestions, Intensive Therapy (PLISSIT) model based sexual counseling on the sexual function of women with Multiple Sclerosis who are sexually active. Mult Scler Relat Disord 2016;8:113-9.
Moreira JR, Sabino Neto M, Pereira JB, Biasi T, Garcia EB, Ferreira LM. Sexuality of women that suffered mastectomy and those who had been submitted to the mammary reconstruction. Rev Bras Mast 2011;20:177-82.
Annon J. Behavioral treatment of sexual problems. New York, NY: Harper & Row; 1976.
Thiel Rdo R, Dambros M, Palma PC, Thiel M, Riccetto CL, Ramos Mde F. Translation into portuguese, cross-national adaptation and validation of the female sexual function Index. Rev Bras Ginecol Obstet 2008;30:504-10.
Fleck MP, Louzada S, Xavier M, Chachamovich E, Vieira G, Santos L, et al
. Application of the Portuguese version of the abbreviated instrument of quality life WHOQOL-bref. Rev Saude Publica 2000;34:178-83.
Gass JS, Onstad M, Pesek S, Rojas K, Fogarty S, Stuckey A, et al
. Breast-specific sensuality and sexual function in cancer survivorship: Does surgical modality matter? Ann Surg Oncol 2017;24:3133-40.
Farthmann J, Hanjalic-Beck A, Veit J, Rautenberg B, Stickeler E, Erbes T, et al
. The impact of chemotherapy for breast cancer on sexual function and health-related quality of life. Support Care Cancer 2016;24:2603-9.
Kim JH, Yang Y, Hwang ES. The effectiveness of psychoeducational interventions focused on sexuality in cancer. Cancer Nurs 2015;38:E32-42.
Hummel SB, van Lankveld JJDM, Oldenburg HSA, Hahn DEE, Kieffer JM, Gerritsma MA, et al
. Efficacy of internet-based cognitive behavioral therapy in improving sexual functioning of breast cancer survivors: Results of a randomized controlled trial. J Clin Oncol 2017;35:1328-40.
Rottmann N, Gilså Hansen D, dePont Christensen R, Hagedoorn M, Frisch M, Nicolaisen A, et al
. Satisfaction with sex life in sexually active heterosexual couples dealing with breast cancer: A nationwide longitudinal study. Acta Oncol 2017;56:212-9.
Stabile C, Goldfarb S, Baser RE, Goldfrank DJ, Abu-Rustum NR, Barakat RR, et al
. Sexual health needs and educational intervention preferences for women with cancer. Breast Cancer Res Treat 2017;165:77-84.
| Authors|| |
Natalia Gondim de Almeida
[Table 1], [Table 2], [Table 3]