Abstract
Introduction:
Patients with metastatic breast cancer (MBC) often report severe, long-standing concerns with their sexual quality of life (QOL), yet interventions for this population are scarce. We evaluated the efficacy of a couple-based sexual QOL intervention adapted for MBC couples in a randomized controlled trial.
Methods:
Fifty-five female MBC patients reporting sexual concerns and their intimate partners (N=110 participants) were randomized to Adapted Intimacy Enhancement (AIE), a four-session videoconference intervention providing education and skills training for coping with sexual/intimacy concerns, or Enhanced Care-As-Usual (ECAU; informational booklet). Outcomes (measured at baseline, post-intervention, and 6-month follow-up) included patients’ sexual outcomes (sexual function/distress/self-efficacy; primary), patients’ psychosocial outcomes (sexual communication, relationship intimacy, and psychological distress; secondary), and similar partner outcomes (secondary). Mixed linear regression models assessed intervention effects on outcomes at follow-ups; psychosocial outcomes were analyzed using dyadic analyses. Effect sizes (Cohen’s d) were calculated.
Results:
Compared to ECAU, patients in AIE reported greater improvements in overall sexual function (p=.018), desire (p=.007), and sexual distress (p=.046) at 6-months, and in sexual satisfaction at both post-intervention (p=.02) and 6-months (p<.001); and partner in AIE reported greater improvements in sexual distress (p=.006), sexual self-efficacy (p=.008), sexual communication (p=.004), and relationship intimacy (p=.01) at 6-months. Effects were largest for patient sexual satisfaction and partner sexual distress at 6-months.
Conclusion:
Compared to a detailed informational booklet on sex/intimacy, the couple-based AIE intervention yielded long-term benefits for MBC patients’ sexual outcomes and partners’ sexual distress and psychosocial outcomes. Future research should identify intervention mediators and optimal dissemination methods.
Keywords: Breast cancer, Sexual dysfunction, Dyadic Coping, Intimacy, Videoconference Intervention, Randomized Controlled Trial
Précis:
This trial evaluated the efficacy of a four-session videoconference sexual quality of life intervention, called Adapted Intimacy Enhancement (AIE), providing education and skills training for coping with sexual/intimacy concerns, in couples facing metastatic breast cancer (MBC). Compared to an Enhanced Care-as-Usual control that included a detailed informational booklet, the AIE intervention showed significant long-term effects for improvements in MBC patients’ sexual outcomes, including sexual function and distress, and partners’ sexual distress and psychosocial outcomes.
Introduction
As treatments for metastatic breast cancer (MBC) improve, women with this disease are increasingly living longer after diagnosis.1 The increased survival necessitates heightened attention to areas of quality of life (QOL) affected by treatments for MBC, which include sexual QOL, defined here as sexual adjustment across biological, psychological, and interpersonal domains.2 Up to 85% of women with MBC report sexual concerns (i.e., concerns related to sexual QOL),3 including vaginal dryness and discomfort,3,4 loss of breast and nipple sensitivity,5 decreased sexual interest,4,6 body image difficulties,7,8 and decreased sexual activity and physical intimacy.9 Compared to women with early-stage BC, women with MBC commonly report more severe, long-standing, and often intractable sexual problems,9 making it crucial that these issues be addressed.
Many women with MBC are motivated to preserve physical intimacy within their partnered relationships6,10 and would like assistance with sexual concerns.11,12 While sexual health is included in clinical guidelines for women with breast cancer (BC) of all stages (e.g., National Comprehensive Cancer Network Guidelines),13,14 patients with MBC appear particularly likely to have sexual health concerns excluded from their clinical visits compared to those with early-stage BC.4,15,16 The lack of routine discussion of sexual health concerns leaves women with MBC poorly equipped to handle sexual concerns and thus at risk for compromised QOL.
Women with MBC have specific needs that warrant attention in a sexual QOL intervention, including unique sexual concerns (e.g., bone pain interfering with sexual activity)12 and an increased physical and emotional symptom burden,17,18 all of which affect women’s sexual QOL.11,12 They also face lifespan concerns19,20 that shape the relational context of sex and intimacy for themselves and their partners.9 These issues are lacking in existing sexual QOL interventions for BC survivors, which generally have been designed for women with early-stage BC and evaluated in trials that excluded women with metastatic disease.21,22 By targeting the interpersonal context of BC-related sexual concerns23 and joint (i.e., communal) coping efforts by patients and partners,24 a couple-based intervention could be particularly effective in addressing sexual concerns in this population.
Therefore, we conducted a randomized controlled trial to evaluate the efficacy of a couple-based sexual QOL intervention designed for women with MBC reporting sexual concerns and their intimate partners. This intervention, Adapted IE (AIE), which was adapted from an earlier version that addressed sexual concerns for early-stage BC survivor couples, Intimacy Enhancement (IE), provides education and skills training relevant to MBC-related sexual QOL.25 We hypothesized that compared to an enhanced care-as-usual (ECAU) control condition, the AIE intervention would produce greater improvements from baseline to post-intervention and 6-month follow-up in (a) patient sexual outcomes (sexual function, sexual distress, and self-efficacy for coping with sexual concerns; primary), (b) patient psychosocial outcomes (sexual communication, relationship intimacy, and psychological distress; secondary), and (c) equivalent partner sexual and psychosocial outcomes (secondary).
Materials & Methods
Research Design and Study Sample
A two-group RCT design with pretest and repeated posttest measures was used. Female adults diagnosed with metastatic (Stage IV) BC in a stable cohabiting relationship (for ≥6 months) reporting sexual concerns (score ≥3/10 on a screener item adapted from the Patient Care Monitor)26,27 were eligible. Patients were excluded due to: inability to speak English; Eastern Cooperative Oncology Group (ECOG) score28 >2 or being deemed medically unable to participate; major cognitive impairment/psychiatric disturbance for patient/partner; prior patient history of other cancers; no reliable telephone access; hearing impairment; current marital/couple therapy, and current pregnancy.
Procedure
Patients were recruited through Fox Chase Cancer Center (FCCC) clinics and community-based cancer support organizations. For clinic-based recruitment, potentially eligible candidates were identified from providers’ clinic schedules, institution tumor registries, or clinician referrals. Candidates received introductory letters/emails and were screened for eligibility via telephone. For community-based recruitment, methods included emails (i.e., “email blasts”) sent to members of community cancer support organizations (see Results for list), newsletters, social media posts, website advertisements, and advertising at community-based educational events (e.g., webinars),. Both members of the couple were required to consent to participate.
Enrolled couples (N=55) were randomized 1:1 to AIE or ECAU, with stratification by age at diagnosis (≤ 45 vs. > 45) and study site (FCCC vs. community). Couples received up to $170 as an incentive for completing surveys. Recruitment and data collection were completed between June 2022 and April 2025. The Institutional Review Board approved the trial (FCCC Protocol #20-1039). This study trial was registered at clinicaltrials.gov (Trial #NCT05636943; November 21, 2022).
Assessments
Data collection was completed using REDCap.29 Participants without computer access completed paper and pencil surveys. Outcomes were assessed at baseline (T1), post-intervention (T2), and 6-month follow-up (T3). All participants completed post-intervention program evaluations. Higher scores on all measures indicate higher endorsement of that construct (e.g., higher sexual function, greater sexual distress); exceptions are noted.
Measures
Patient Sexual Outcomes (Primary).
Primary outcomes were patient sexual function, sexual distress, and self-efficacy for coping with sexual concerns. Patient sexual function was assessed using the widely used 19-item Female Sexual Function Index (FSFI),30,31 which includes a total score [range=2-36] and six sexual function domain scores (Desire, Arousal, Lubrication, Orgasm, Pain, and Satisfaction). Patient sexual distress was assessed using the 13-item Female Sexual Distress Scale-Revised (FSDS-R32; range=0-52). Patient self-efficacy for coping with sexual concerns was assessed through 3 published items27 [range=0-10] measuring confidence in communicating effectively with [your] partner about issues related to physical intimacy/sex, dealing effectively with sexual difficulties, and enjoying intimacy despite physical limitations.
Patient and Partner Psychosocial Outcomes (Secondary).
These measures were completed by both patients and partners. Sexual communication was assessed through a 6-item version of the Dyadic Sexual Communication Scale33 (DSCS; range=1-36).34 Relationship intimacy was assessed using the 17-item Miller Social Intimacy Scale (MSIS; range=17-170),35 which measures emotional closeness toward one’s partner. Psychological distress was assessed using the Patient Health Questionnaire-9 Item (PHQ-9)36 and Generalized Anxiety Disorder 7-Item measures (GAD-7).37
Partner Sexual Outcomes (Secondary).
Partner sexual function was assessed using the International Index of Erectile Function (IIEF)38 for male partners and the FSFI30 for female partners; similar to prior studies,25 the total scale score reflecting overall sexual function is reported. Partner sexual distress was assessed using the Index of Sexual Satisfaction (ISS),39 a 25-item scale that assesses the degree of distress within the sexual relationship [range=0-100] for male partners and the FSDS-R (explained above) for female partners. Higher scores on the ISS indicate higher levels of distress. Partner self-efficacy for coping with sexual concerns was assessed as described above.
Clinical and Socio-demographic Factors.
Patients’ clinical patient characteristics were obtained through medical chart review (see Table 1). For community-recruited patients, after obtaining permission, attempts were made to obtain medical notes to extract clinical information. Socio-demographic data were obtained via self-report.
Table 1.
Participant Characteristics
| M (SD) or N (%) | ||||||
|---|---|---|---|---|---|---|
| Patients | Partners | |||||
| Characteristic | All (N=55) |
AIE (N=28) |
ECAU (N=27) |
All (N=55) |
AIE (N=28) |
ECAU (N=27) |
| Age (years) | 49.38 (9.85) | 50.29 (10.14) | 48.44 (9.65) | |||
| Sexual concerns [0-10] | 8.38 (1.77) | 7.93 (2.14) | 8.85 (1.13) | -- | -- | -- |
| Length of relationship (yr) | 20.67 (11.60) | 23.29 (11.37) | 17.96 (11.42) | -- | -- | -- |
| Time since dx (mo) | 85.75 (68.87) | 75.00 (65.37) | 96.89 (71.84) | -- | -- | -- |
| Gender | ||||||
| Female | 55 | 28 | 27 | 4 (7.3%) | 2 (7.1%) | 2 (7.4%) |
| Male | 0 | 0 | 0 | 51 (92.7%) | 26 (92.9%) | 25 (92.6%) |
| Education | ||||||
| Less than high school | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 3 (5.4%) | 1 (3.6%) | 2 (7.4%) |
| High school | 6 (10.9%) | 2 (7.1%) | 4 (14.8%) | 5 (9.1%) | 0 (0.0%) | 5 (18.5%) |
| Some college | 8 (14.5%) | 4 (14.3%) | 4 (14.8%) | 14 (25.5%) | 9 (32.1%) | 5 (18.5%) |
| College degree | 24 (43.6%) | 13 (46.4%) | 11 (40.7%) | 19 (34.5%) | 11 (39.3%) | 8 (29.6%) |
| Graduate school | 17 (30.9%) | 9 (32.1%) | 8 (29.6%) | 14 (25.5%) | 7 (25.0%) | 7 (25.9%) |
| Employment | ||||||
| Full/part time/self-employed | 23 (41.8%) | 9 (32.1%) | 14 (51.9%) | 46 (83.6%) | 22 (78.6%) | 24 (88.9%) |
| Retired | 7 (12.7%) | 4 (14.3%) | 3 (11.1%) | 7 (12.7%) | 4 (14.3%) | 3 (11.1%) |
| Unemployed/ disability | 25 (45.4%) | 15 (53.6%) | 10 (37.0%) | 2 (3.6%) | 2 (7.1%) | 0 (0.0%) |
| Relationship status | ||||||
| Married | 51 (92.7%) | 26 (92.9%) | 25 (92.6%) | -- | -- | -- |
| Cohabitating, not married | 4 (7.3%) | 2 (7.1%) | 2 (7.4%) | -- | -- | -- |
| Sexual orientation | ||||||
| Bisexual | 1 (1.8%) | 1 (3.6%) | 0 (0.0%) | 2 (3.6%) | 1 (3.6%) | 1 (3.7%) |
| Heterosexual/straight | 49 (89.1%) | 25 (89.3%) | 24 (88.9%) | 49 (89.1%) | 24 (85.7%) | 25 (92.6%) |
| Homosexual/lesbian/gay | 3 (5.5%) | 1 (3.6%) | 2 (7.4%) | 3 (5.5%) | 2 (7.1%) | 1 (3.7%) |
| Other/don’t know | 2 (3.6%) | 1 (3.6%) | 1 (3.7%) | 1 (1.8%) | 1 (3.6%) | 0 (0.0%) |
| Race | ||||||
| Asian | 1 (1.8%) | 1 (3.6%) | 0 (0.0%) | 3 (5.5%) | 2 (7.1%) | 1 (3.7%) |
| Black/African American | 5 (9.1%) | 4 (14.3%) | 1 (3.7%) | 7 (12.7%) | 5 (17.9%) | 2 (7.4%) |
| Other/More than one | 3 (5.5%) | 1 (3.6%) | 2 (7.4%) | 2 (3.6%) | 1 (3.6%) | 1 (3.7%) |
| White/Caucasian | 46 (83.6%) | 22 (78.6%) | 24 (88.9%) | 43 (78.2%) | 20 (71.4%) | 23 (85.2%) |
| Ethnicity | ||||||
| Hispanic | 3 (5.5%) | 1 (3.6%) | 2 (7.4%) | 1 (1.8%) | 0 (0.0%) | 1 (3.8%) |
| Non-Hispanic | 52 (94.5%) | 27 (96.4%) | 25 (92.6%) | 52 (98.1%) | 27 (100%) | 25 (96.2%) |
| Surgery | ||||||
| Lumpectomy/BCT | 6 (10.9%) | 3 (10.7%) | 3 (11.1%) | -- | -- | -- |
| Mastectomy, reconstruction | 17 (30.9%) | 7 (25.0) | 10 (37.0%) | -- | -- | -- |
| Mastectomy, without reconstruction | 6 (10.9%) | 3 (10.7%) | 3 (11.1%) | -- | -- | -- |
| Mastectomy, unknown reconstruction | 4 (7.3%) | 1 (3.6%) | 3 (11.1%) | -- | -- | -- |
| No surgery received | 6 (10.9%) | 5 (17.9%) | 1 (3.7%) | -- | -- | -- |
| Therapies received | ||||||
| Chemotherapy | 35 (63.6%) | 17 (60.7%) | 18 (66.7%) | -- | -- | -- |
| Endocrine therapy (ever) | 34 (61.8%) | 16 (57.1%) | 18 (66.7%) | |||
| Tamoxifen | 7 (20.6%) | 3 (18.8%) | 4 (22.2%) | -- | -- | -- |
| Aromatase inhibitor | 12 (35.3%) | 4 (25.0%) | 8 (44.4) | -- | -- | -- |
| Both | 13 (38.2%) | 7 (43.8%) | 6 (33.3%) | -- | -- | -- |
| Endocrine therapy/ovarian supp. (current) | 6 (10.9%) | 1 (3.6%) | 5 (18.5%) | -- | -- | -- |
| Immunotherapy | 24 (43.6%) | 13 (46.4%) | 11 (40.7%) | -- | -- | -- |
| Ovarian suppression | 19 (34.5%) | 7 (25.0%) | 12 (44.4%) | -- | -- | -- |
| Radiotherapy | 30 (54.5%) | 15 (53.6%) | 15 (55.6%) | -- | -- | -- |
| Gynecologic surgery | ||||||
| Hysterectomy | 10 (18.2%) | 5 (17.9%) | 5 (18.5%) | -- | -- | -- |
| Oophorectomy | 9 (16.4%) | 4 (14.3%) | 5 (18.5%) | -- | -- | -- |
| Menopausal status | ||||||
| Pre-menopausal | 8 (14.5%) | 5 (17.9%) | 3 (11.1%) | -- | -- | -- |
| Peri-menopausal | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | -- | -- | -- |
| Post-menopausal | 19 (34.5%) | 12 (42.9%) | 7 (25.9%) | -- | -- | -- |
Note: dx=diagnosis; tx=treatment; recon=reconstruction; Missing data on particular items/variables is as follows: Ethnicity (2 partners); Radiation (20 patients); Surgery (16 patients); Endocrine therapy (18 patients); Type of endocrine therapy (2 patients on endocrine therapy missing); Chemotherapy (18 patients); Immunotherapy (21 patients); Ovarian suppression (23 patients); Current use of endocrine therapy/ovarian suppression (45 patients); Oophorectomy history (40 patients); Hysterectomy history (39 patients); Menopausal status (28 patients)
Other Measures.
The Client Satisfaction Questionnaire (CSQ-8),40 a validated survey of satisfaction with therapeutic services, assessed intervention acceptability at post-intervention.
Study Arms
Enhanced Care-as-Usual (ECAU; Information and Resources on Sex and Intimacy).
Couples in the ECAU arm received their usual care in addition to a ~20-page paper booklet with detailed information on a range of topics including coping as a couple with MBC, effects of MBC diagnosis and treatments on intimacy and sexuality; estrogen and women’s sexual function; vaginal health issues and management strategies; pelvic rehabilitation; coping with reduced sexual desire; and body image concerns. This material was reviewed extensively by the investigator team, which has expertise in cancer-related sexual function, BC clinical practice, cancer survivorship, and couples’ interventions. Institutional and external resources for addressing sexual concerns were also provided.
Adapted Intimacy Enhancement (AIE).
AIE participants received the same booklet and four weekly sessions (60-75 minutes) with a licensed mental health professional delivered via Zoom consisting of education and skills training to address patients’ sexual concerns and enhance couples’ physical and relational intimacy. The AIE protocol was modified from a couple-based sexual QOL intervention previously delivered via telephone with demonstrated positive effects in populations with both metastatic and non-metastatic cancer,27,41,42 most recently in a trial in early-stage BC survivor couples.25 Most of the intervention content was maintained from the previous version as it remained relevant, while minor changes were made to particular exercises to enhance relevance as informed by a previous qualitative study in MBC couples.9
Session 1 includes information on key sexual and intimacy topics (e.g., etiology of sexual concerns in MBC, sexual response cycles), goal setting to address sexual concerns, and an introduction to training in physical intimacy skills (i.e., sensate focus, or non-demand sensual touching exercises) through a stepped series of home practice exercises.43 Session 2 teaches skills for communicating effectively with one’s partner about sex/intimacy. Session 3 includes training in skills based in cognitive and couple therapy for restructuring negative/inflexible thoughts pertaining to sex and intimacy44,45 and engaging in intimacy-building activities.46 Finally, Session 4 focuses on planning ahead for intimacy through anticipating sexual/intimacy challenges and devising coping strategies. Home practice exercises are assigned between sessions to enhance skill acquisition.
Sessions were audio-recorded for supervision and to allow for adherence checks. The interventionist completed session adherence forms after each session and participated in regular supervision administered by the PI (JBR).
Data Analysis
The primary analyses examined whether, relative to ECAU, AIE led to greater improvements at the two post-intervention assessments (post-intervention; 6-month follow-up) in patient sexual outcomes (sexual function, sexual distress, self-efficacy for coping with sexual concerns). In addition to overall patient sexual function, separate models were fit for each sexual function domain. For all regressions, absolute Cohen’s d effect sizes were derived from the regression model estimates to quantify the magnitude of the effects.47
For outcomes assessed using different scales in patients and partners, we used linear mixed effects regression models with subject-specific random intercepts (separate models for each outcome), with intervention as the independent variable, the outcome as the dependent variable, and intervention x time interaction effects considered if the intervention effect differed by follow-up time. Baseline scores on the outcome measure were included in regression analyses as control variables. Socio-demographic and clinical variables were examined for potential imbalance across study arms; since none were found to be different, they were not included as control variables. Differences in estimated marginal means between the AIE and control conditions were calculated at each time point to formally test for differences between study arms.
For outcomes assessed using the same scales in patients and partners (i.e., self-efficacy for coping with sexual concerns and psychosocial outcomes), we simultaneously modeled patient/partner outcomes via multi-level (hierarchical) mixed effects models to account for interdependence within couples and longitudinal correlation within individuals over time. To assess intervention effects, we included a three-way interaction (intervention × time × role [patient vs. partner]) to evaluate whether the effect of the intervention differed at different time points for patients and partners. All analyses followed the intention-to-treat principle and included all available outcome data.
Sample Size Calculations.
We designed the study to detect effects of the AIE intervention on changes in the primary study outcomes (patient sexual function, sexual distress, self-efficacy for coping with sexual concerns) compared to the control arm, after maximum potential attrition. The study was powered to detect effects for patient sexual distress, as it had the smallest observed difference-in changes of the 3 patient sexual outcomes in pilot data (difference= ~7.8, SD 9.2).27 We anticipated up to 18% loss to follow-up at 6 months for a final sample size of 92 participants (23 couples per arm). With 23 patients per group at 6-month follow-up, we estimated having 80% power to find a difference of this magnitude with 5% two-sided type-I error. We anticipated >90% power to detect an intervention effect for the other two outcomes, given the larger differences seen in the pilot data [sexual function: 9.8 (SD 8.2), self-efficacy: 24.7 (SD 22.8)].
Results
Enrollment and Survey Completion
The study CONSORT48 diagram is shown in Figure 1. Of the 107 patients screened for eligibility, 85 (79%) were eligible. 58 patients (68%) and their partners consented, 55 of whom were randomized (AIE: N=28 couples, ECAU: N=27 couples; 110 participants), 11 (20%) through clinic recruitment and 44 (80%) through community sites (CancerCare: 12 couples; Dr. Susan Love Research Foundation: 8 couples; Metavivor: 7 couples; Young Survival Coalition: 5 couples; Cancer Support Community: 4 couples; and other various community sites: 8 couples). Three couples were recruited through personal referral. Most participants (n=92; 84%) were retained to study completion. Four couples were withdrawn (3 in AIE; 1 in ECAU) around the time of the 6-month follow-up due to the patient’s health declining (n=2 patients) or death (n=2 patients). Enrolled patients reported worse sexual concerns at screening (M=8.38, SD=1.77) than eligible candidates who declined participation (M=5.98, SD=3.13, p<.001) but did not differ on age at diagnosis (p>.05).
Figure 1.
Study Flow Diagram (CONSORT)
Note: A half-completed follow-up survey represents instances where half of a couple completed an assessment (e.g., 0.5 post-intervention survey completed indicates only the patient completed the survey and the partner did not).
Study Sample
Table 1 shows baseline demographic and clinical characteristics for the study sample. Most couples were in long-term opposite-sex relationships (93%). Participants were mostly White (81%) or Black (11%) and highly educated (90% >high school education); 42% of patients and 84% of partners were working at least part-time.
Interventionist Adherence
Interventionist adherence to the AIE manual was checked using a standardized checklist on 10 AIE sessions from 10 unique couples chosen randomly by a reviewer (LSP) who was familiar with the intervention but not involved in intervention delivery or supervision. Overall adherence was 95%.
Intervention Completion and Acceptability
As shown in Figure 1, of the 28 couples assigned to AIE, 27 (96%) completed one session, 26 (93%) completed two sessions, and 22 (79%) completed three and four sessions. Program satisfaction (CSQ-8) scores were very good (Overall Mean=28.63; SD=3.83).27
Patient Sexual Outcomes (Primary)
Patient Sexual Function
Relative to those in ECAU, patients in AIE showed significantly greater increases in overall sexual function from baseline to 6-month follow-up (p=.018; d=.52) but not to immediately post-intervention (see Table 2). Regarding the sexual function domains, relative to patients in ECAU, those in AIE showed significantly greater increases in sexual satisfaction from baseline to post-intervention (p=.02; d=.56) and 6-month follow-up (p<.001; d=.93) and sexual desire at 6-month follow-up only (p=.007; d=59). No other group differences in sexual function domains were found.
Table 2.
Patients’ Mean Outcomes at Baseline, Post-intervention, and 6-month Follow-Up and Between Group Differences from Mixed-Effects Models
| Mean Values at Each Assessment | Between-Group Differences | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| T1 | T2 | T3 | T1-T2 | T1-T3 | |||||
| Mean (SD) | Mean (SD) | Mean (SD) | Coef (SE) | p | Effect Size | Coef (SE) | p | Effect Size | |
| Sexual Function (FSFI Total Score) | 0.97 (1.46) | .51 | .14 | 3.71 (1.54) | .018 | .52 | |||
| AIE | 11.77 (8.07) | 15.19 (8.56) | 16.93 (9.72) | ||||||
| ECAU | 9.65 (6.77) | 11.97 (7.12) | 10.62 (7.05) | ||||||
| Sexual Function (Satisfaction) | 0.85 (0.36) | .020 | .56 | 1.48 (0.37) | <.001 | .93 | |||
| AIE | 2.74 (1.40) | 3.78 (1.29) | 3.93 (1.57) | ||||||
| ECAU | 2.20 (1.12) | 2.55 (1.35) | 2.23 (1.27) | ||||||
| Sexual Function (Desire) | 0.38 (0.22) | 0.088 | .38 | 0.65 (0.24) | .007 | .59 | |||
| AIE | 2.29 (1.12) | 3.02 (1.34) | 2.90 (1.17) | ||||||
| ECAU | 1.66 (0.71) | 2.08 (1.09) | 1.70 (0.84) | ||||||
| Sexual Function (Arousal) | 0.18 (0.35) | 0.61 | .12 | 0.67 (0.37) | .072 | .40 | |||
| AIE | 1.80 (1.76) | 2.38 (1.88) | 2.56 (1.90) | ||||||
| ECAU | 1.56 (1.56) | 1.90 (1.54) | 1.65 (1.59) | ||||||
| Sexual Function (Lubrication) | −0.42 (0.39) | .28 | .23 | 0.60 (0.41) | .14 | .31 | |||
| AIE | 1.65 (1.61) | 1.84 (1.86) | 2.43 (1.98) | ||||||
| ECAU | 1.47 (1.60) | 2.02 (1.75) | 1.65 (1.58) | ||||||
| Sexual Function (Orgasm) | 0.11 (0.39) | .77 | .06 | 0.51 (0.41) | .22 | .26 | |||
| AIE | 1.59 (1.65) | 2.02 (2.01) | 2.23 (2.04) | ||||||
| ECAU | 1.57 (1.88) | 1.83 (2.04) | 1.63 (1.68) | ||||||
| Sexual Function (Pain) | 0.14 (0.38) | .72 | .07 | 0.23 (0.40) | .57 | .12 | |||
| AIE | 1.63 (2.23) | 2.15 (2.42) | 2.75 (2.48) | ||||||
| ECAU | 1.20 (1.84) | 1.39 (1.82) | 1.75 (2.11) | ||||||
| Sexual Distress (FSDS-R) | −4.24 (2.77) | .13 | .35 | −5.84 (2.88) | .046 | .45 | |||
| AIE | 23.46 (11.43) | 17.38 (10.01) | 18.54 (11.28) | ||||||
| ECAU | 31.23 (10.67) | 27.31 (14.16) | 28.79 (13.22) | ||||||
Note: Effect sizes were calculated based on the t-statistic. Significant effects are shown in bold. AIE=Adapted Intimacy Enhancement; ECAU=Enhanced Care-as-Usual; FSFI=Female Sexual Function Index; FSDS-R=Female Sexual Distress Scale-Revised; For FSFI total score and domains, higher scores=better function; For FSDS-R, higher scores=greater distress.
Patient Sexual Distress.
Relative to those in ECAU, patients in AIE showed significantly greater decreases in sexual distress from baseline to 6-month follow-up (p=.046; d=.45) but not to immediately post-intervention (see Table 2).
Sexual Self-Efficacy.
Dyadic analyses were conducted for this outcome, as described below (see Table 3). Results showed that patients across the two study arms did not differ significantly in self-efficacy at either the post-intervention or 6-month follow-up.
Table 3.
Mean Values at Baseline, Post-intervention, and 6-month Follow-Up for Dyadic Outcomes for Patients and Partners
| Mean Values at Each Assessment | ||||||
|---|---|---|---|---|---|---|
| Patients | Partners | |||||
| T1 | T2 | T3 | T1 | T2 | T3 | |
| Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | |
| Self-efficacy for Coping with Sexual Concerns | ||||||
| AIE | 55.71 (25.43) | 66.79 (24.03) | 67.68 (25.91) | 66.91 (28.93) | 70.14 (25.68) | 71.43 (26.07) |
| ECAU | 44.69 (24.34) | 56.15 (27.69) | 53.19 (23.62) | 63.21 (22.45) | 69.42 (24.47) | 53.33 (27.96) |
| Sexual Communication (DSCS) | ||||||
| AIE | 25.17 (6.93) | 26.33 (6.15) | 26.91 (6.15) | 25.75 (6.80) | 25.54 (6.43) | 26.78 (6.09) |
| ECAU | 23.96 (7.26) | 24.28 (7.38) | 24.65 (7.93) | 23.76 (8.13) | 25.04 (6.64) | 21.39 (6.55) |
| Relationship Intimacy (MSIS) | ||||||
| AIE | 135.86 (20.88) | 135.93 (26.45) | 136.37 (24.83) | 138.91 (19.90) | 135.07 (27.99) | 142.99 (20.63) |
| ECAU | 133.59 (26.69) | 134.99 (24.77) | 130.17 (28.32) | 132.11 (26.48) | 138.83 (20.26) | 127.39 (30.15) |
| Anxiety Symptoms (GAD-7) | ||||||
| AIE | 3.73 (3.57) | 3.74 (3.13) | 4.57 (4.58) | 2.48 (2.53) | 3.24 (3.73) | 3.46 (4.11) |
| ECAU | 4.37 (3.72) | 5.27 (4.38) | 4.71 (4.31) | 3.04 (2.94) | 4.52 (5.63) | 4.83 (5.30) |
| Depressive Symptoms (PHQ-9) | ||||||
| AIE | 5.84 (4.80) | 5.93 (3.22) | 4.89 (3.06) | 2.86 (3.17) | 3.99 (4.13) | 2.74 (2.98) |
| ECAU | 5.82 (3.16) | 7.28 (5.93) | 6.19 (3.83) | 3.52 (4.28) | 4.13 (4.74) | 5.30 (5.83) |
Note: Significant effects are shown in bold. AIE=Adapted Intimacy Enhancement; ECAU=Enhanced Care-as-Usual; DSCS=Dyadic Sexual Communication Scale; MSIS=Miller Social Intimacy Scale; GAD-7=Generalized Anxiety Disorder 7-item measure; PHQ-9=Patient Health Questionnaire 9-item measure. For self-efficacy, dyadic sexual communication, and relationship intimacy, higher scores=better function; for anxiety and depressive symptoms, higher scores=worse symptoms.
Patient and Partner Psychosocial Outcomes (Secondary)
Dyadic analyses were conducted on measures administered to both patients and partners and accounted for interdependence within couples. For partners, at 6-month follow-up, results showed positive effects of AIE on self-efficacy for coping with sexual concerns (p=.008; d=.43), sexual communication (p=.004; d=.52), and relationship intimacy (p=.01; d=.43) but not on anxiety or depressive symptoms at either time point. For patients, no significant intervention effects were found (see Table 3 and Figure 2).
Figure 2.
Trajectories of Change in Scores on by Role (patient vs. partner) and Study Arm (AIE vs. ECAU) for (a) Self-Efficacy for Coping with Sexual Concerns, (b) Sexual Communication, and (c) Relationship Intimacy
Note: Three-way interactions for depressive symptoms (PHQ-9) and anxiety symptoms (GAD-7) were not statistically significant and thus the graphs for these outcomes are not shown.
Partner Sexual Outcomes (Secondary)
Sexual Function and Sexual Distress.
As shown in Table 4, relative to partners in ECAU, partners in AIE showed significantly greater reductions in sexual distress (p=.006; d=.67) at 6-month follow-up. There were no intervention effects on total sexual function scores for male partners. Mean values for sexual function and sexual distress for female partners are shown in Table 4; due to the small number of female partners (n=3), these values are shown descriptively only.
Table 4.
Partners’ Mean Values at Baseline, Post-intervention, and 6-month Follow-Up and Between Group Differences for Mixed-Effects Models
| Mean Values at Each Assessment | Between-Group Differences | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| T1 | T2 | T3 | T1-T2 | T1-T3 | |||||
| Mean (SD) | Mean (SD) | Mean (SD) | Coef (SE) | P | Effect Size | Coef (SE) | P | Effect Size | |
| Sexual Function (IIEF Total Score) | −4.44 (4.56) | .33 | .26 | 1.55 (4.67) | .74 | .09 | |||
| AIE | 44.48 (21.44) | 46.95 (20.85) | 45.53 (23.37) | ||||||
| ECAU | 43.44 (20.79) | 51.14 (17.97) | 42.14 (21.78) | ||||||
| Sexual Function (FSFI Total Score) | -- | -- | -- | -- | -- | -- | |||
| AIE | 30.05 (2.33) | 33.90 (0.99) | 31.95 (2.90) | ||||||
| ECAU | 16.40 (18.67) | 33.40 (--) | 14.45 (8.84) | ||||||
| Sexual Distress (ISS) | −0.15 (3.28) | .96 | .01 | −9.57 (3.39) | .006 | .67 | |||
| AIE | 39.489 (20.628) | 36.193 (20.978) | 35.902 (20.282) | ||||||
| ECAU | 39.207 (15.880) | 34.121 (15.465) | 43.107 (17.081) | ||||||
| Sexual Distress (FSDS) | -- | -- | -- | -- | -- | -- | |||
| AIE | 7.50 (6.36) | 7.50 (7.78) | 5.50 (5.66) | ||||||
| ECAU | 26.00 (7.07) | 0.00 (--) | 29.00 (9.90) | ||||||
Note: Effect sizes were calculated based on the t-statistic. Significant effects are shown in bold. IIEF=International Index of Erectile Function; FSFI=Female Sexual Function Index; ISS=Index of Sexual Satisfaction; FSDS-R=Female Sexual Distress Scale-Revised. For IIEF and FSFI total scores, higher scores=better function; For ISS and FSDS, higher scores=greater distress; IIEF and ISS administered to male partners; FSFI and FSDS administered to female partners (n=2 each for AIE and ECAU); one ECAU female partner did not complete T2 assessment
Discussion
Results of this trial support the efficacy of the Adapted Intimacy Enhancement (AIE) intervention for MBC patients facing experiencing sexual concerns and their intimate partners. Taken together with prior research suggesting that women with MBC show interest in involving their partners in coping with sexual concerns,9 the data support the use of a couple-based approach that includes education and training in skills for coping with sexual concerns in this population. Importantly, despite the severity of patients’ sexual problems at baseline, the mean increase in total sexual function scores for patients in AIE over the course of the study was ~5 points, a clinically significant improvement.49,50 Moreover, the sizes of the effects for improvements in patients’ and partners’ sexual outcomes is in line with effect sizes from meta-analyses examining individual and couple-based interventions addressing sexual health outcomess21,51 and further supports AIE’s benefits.
The positive long-term effects of AIE seen for patients’ sexual function and distress and partners’ sexual distress are particularly noteworthy considering the nature of the booklet provided in ECAU, which included comprehensive information about MBC-related sexual health and intimacy. The relevance of this information for sexual concerns contrasts with wait-list controls or attention control conditions that provide information unrelated to sex and intimacy.25,52 Interestingly, the long-term effects seen in the present trial contrast with the finding of short-term (but not long-term) benefits seen in a previous trial of the IE intervention in early-stage BC survivor couples25. Within the context of metastatic disease, it may be that couples took a longer time to implement changes that would yield benefits for their sexual relationships compared to the early-stage BC couples, although this is conjecture. Following MBC couples for longer than 6 months would be useful in identifying patterns in improvements over time, although this may be challenging due to the often-compromised health status of this population. Indeed, compared to the early-stage BC IE trial,25 a smaller percentage of couples completed all four intervention sessions, often due to worsening health or feeling overwhelmed by responsibilities. Whether briefer interventions (e.g., single session)53 may improve completion and/or enhance outcomes in populations with advanced disease should be investigated further.
In combination with findings from the earlier trial, the data also suggest sexual satisfaction is among the most sensitive sexual health outcomes to this intervention. Other domains of patients’ sexual function (e.g., arousal, pain) did not improve significantly, which may indicate that greater attention to physiologic sexual difficulties in this population is needed. In addition to patients’ sexual health outcomes, partners in AIE also experienced positive long-term benefits in reduced sexual distress, as well as long-term increases in self-efficacy for coping with sexual concerns, sexual communication, and relationship intimacy. It is unclear why these were positive effects were not also seen in patients. Partner effects could have been influenced by drop-offs on these outcomes in the ECAU group from post-intervention to 6-month follow-up, possibly due to transient effects of ECAU, although this is conjecture. Male partners of BC patients often report sexual difficulties themselves54 and difficulties coping with the impact of breast cancer-related sexual problems in their intimate relationship,9 making these positive effects on outcomes and coping especially encouraging. That partners in AIE did not see improvements in sexual function, however, suggests that more focused interventions may be required to substantially improve this outcome for partners. Finally, neither patients nor partners saw improvements in anxiety or depressive symptoms, possibly due to low levels of symptomatology on these measures.
Clinical Implications
These findings have important implications for clinical practice. For instance, although the AIE intervention showed significant benefit for patients’ overall sexual function, mean total scores at follow-ups for patients in both study arms remained in the dysfunctional range according to established cutoffs.55 This finding underscores the often severe nature of sexual problems for women with MBC reflecting cumulative effects of multiple rounds of treatments and the life-limiting nature of the diagnosis.9,18 Supplemental clinical support, including efforts to directly ameliorate biological sexual complaints, may prove useful in moving these scores into the functional range. Findings also suggest that educational materials alone are unlikely to facilitate substantial improvement in sexual health outcomes for this population.
Strengths and Limitations
This RCT had several important strengths including a couple-based approach that integrated the partner into all intervention activities, an educational control condition providing relevant information to couples, dyadic analyses to examine intervention effects when appropriate, validated outcome measures, and recruitment from community organizations including patients from multiple states, thereby bolstering the geographic variability of the sample. There are also limitations, including a small number of same-sex couples and limited race/ethnic diversity. In addition, although recruitment through community organizations is a strength, we were unable to obtain medical data for some community-enrolled patients. However, the benefits of the broadened sampling likely outweigh the limitations of the missing clinic data that resulted from this sampling strategy. Finally, we did not collect information on use of medical topical or systemic interventions (e.g., vaginal estrogens), which future studies should assess.
Conclusion
As the first trial of a psychosocial couple-based sexual QOL intervention targeted to patients and partners facing MBC, findings of this study contribute to the literature by extending the evidence base to this new and chronically underserved population. Important directions for future research include identifying optimal methods for dissemination and potential mediators of improvement. One interesting possible mediator is the use of communal coping (i.e., coping together as a couple), which is associated with better adjustment for cancer survivor couples,56,57 but has not been examined in relation to coping with sexual concerns. We are currently examining whether couples’ in-session use of first-person plural pronouns (“we-talk”),24,58 an implicit measure of communal coping, mediates effects of AIE on sexual outcomes. Information from these analyses could help us hone the intervention content to enhance its positive effects.
Acknowledgements:
We wish to acknowledge the significant contributions of Sandra Feite and Sarah McIlhenny to the study.
Funding Statement:
This study was supported by the American Cancer Society RSG-20-029-01-CPPB awarded to Dr. Jennifer Reese, with additional funding from P30CA006927 from the National Cancer Institute. The funding body had no role in the design of the study, in the collection, analysis, or interpretation of data, or in the writing of the manuscript.
Footnotes
Conflict of Interest Disclosure: The authors declare that they have no relevant conflicts of interest to report.
Ethics Approval Statement: This study was approved by the Institutional Review Board at Fox Chase Cancer Center (Protocol #20-1039).
Patient Consent Statement: All participants provided informed consent to participate in the study.
Permission to Reproduce Material from Other Sources: Not applicable
Clinical Trial Registration: This study trial was registered at clinicaltrials.gov (Trial #NCT05636943).
Contributor Information
Jennifer B. Reese, 1. Cancer Prevention and Control Program, Fox Chase Cancer Center, Philadelphia, PA; 2. Department of Social and Behavioral Sciences, College of Public Health, Temple University, Philadelphia, PA.
Lauren A. Zimmaro, 1. Division of Medical Oncology, Department of Medicine, University of Colorado School of Medicine, Aurora, CO; 2. University of Colorado Cancer Center, Aurora, CO.
Kristen A. Sorice, Cancer Prevention and Control Program, Fox Chase Cancer Center, Philadelphia, PA.
Li Zhang, Department of Biostatistics and Bioinformatics, Fox Chase Cancer Center, Philadelphia, PA.
Jessica R. Gorman, College of Health, Oregon State University, Corvallis, OR.
Mary B. Daly, Department of Clinical Genetics, Fox Chase Cancer Center, Philadelphia, PA.
Alexandra K. Zaleta, Department of Research, CancerCare, New York, NY.
Laura S. Porter, Department of Psychiatry & Behavioral Sciences, Duke University Medical Center, Durham, NC.
Data Availability Statement:
The data that support the findings of this study are available from the corresponding author upon reasonable request.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The data that support the findings of this study are available from the corresponding author upon reasonable request.