Cancer-related sexual dysfunction is one of the most common and distressing consequences of the illness, which, if untreated, persists or worsens over time [1-4]. Among adolescents and young adults—individuals aged between 15 and 39 years at diagnosis—a considerable body of research has unveiled unique challenges [5,6] including disruption of normative physical, psychosocial, and emotional development, which can lead to sexual dysfunction [7-13]. Studies have consistently documented that adolescents and young adults report greater psychological [14,15] and physical morbidity [5,6,16] than older survivors and healthy peers, including elevated rates of sexual dysfunction [11,13,17-21] often accompanied by lower satisfaction with sex life [22-26], delays in meeting sexual milestones [21,27,28], and reduced frequency of sexual activity [21,27]. Between 42% and 52% of adolescent and young adult survivors experience 1 or more sexual problems [12,13,29], with one-third of them reporting worse sexual function up to 2 years post diagnosis [13]. Differences exist by sex, with females reporting higher dysfunction scores [30-32]. Young female survivors experience greater problems with pain, lubrication, desire, and sexual satisfaction than healthy peers [22-26,28]. Qualitative studies document that women report pain, lack of desire, and reduced sexual enjoyment, while males experience erectile dysfunction, ejaculation, and arousal problems [12]. While aggregate data from large studies report that the majority of adolescents and young adult survivors were involved in a relationship [12,21], cancer and treatment-related side effects proved to be detrimental to masculinity and perceived closeness with partners [21-27]. Sexual dysfunction, body image concerns, and fertility status may limit the confidence in being both physically and emotionally intimate [29,31,33,34] and contribute to more negative outcomes [29,31,33-35].

In comparison with other cancer types, the incidence of colorectal cancer (CRC) has been increasing at an alarming rate [36-41] for the adolescent and young adult group. Recent reports have projected that by 2030, the largest increase in the incidence of colon (90%) and rectal (125%) cancer will occur for the 20-34–year-old group [36-39,42-45]. Treatments include a combination of chemotherapy, pelvic radiation, and abdominoperineal resection—often with a temporary or permanent ostomy—which negatively impact psychological, sexual, and reproductive health outcomes [46-49]. Patients with early-onset CRC experience elevated psychological distress and social and physical burden, often resulting from issues with bowel control or incontinence and body image [50,51]. Rates of sexual dysfunction are higher than those of other cancer types [51]. Additionally, approximately 48% of young patients with CRC reported that sexual health issues have negatively affected the relationship with their partner [52,53]. Despite the burden associated with the long-term symptoms that accompany this cancer type and elevated rates of impaired functioning, sexual health has been mostly addressed as an individual experience without exploring how young patients with and survivors of CRC cope with sexual distress in the context of their relationship with a partner [10,14,35,54,55].

It is well recognized that the multidimensional distress of cancer affects both patients and partners [3,56-59]. Yet, only a few studies have investigated sexual health outcomes from a couple perspective among adolescents and young adults despite 3 important considerations. First, partners play a critical role in providing emotional, physical, and practical support [56,57,59,60]. Intimate partners also contribute to patients’ adjustment to the illness: distress experienced by either partner has been found to directly affect distress levels in the other, with negative outcomes in quality of life, relationship functioning, and mental health for discordant couples [61-64]. Second, integrative models of sexuality place greater emphasis on psychosocial and interpersonal factors [65,66]. This finding supports the notion that greater attention should be placed on the psychosocial experience of both members of the dyad, in terms of shared loss and coordinated strategies to cope with cancer-related sexual dysfunction [3,60,67,68]. Finally, recent findings indicate that interventions addressing both partners’ experiences in the context of sexual recovery and treatment are feasible and acceptable and they improve outcomes for both [58,69-76]. Hence, there is a critical need to investigate interpersonal characteristics that influence adolescent and young adult cancer survivors and their partners’ experience with sexual dysfunction. This knowledge gap affects the provision of comprehensive sexual health care for adolescent and young adult cancer survivors [12,19,20,35] and the development of interventions tailored to the needs of individuals and couples at higher risk of sexual distress during survivorship.

This paper describes the protocol of the AYA CRC SHARE (ie, Sexual Health And REproductive concerns) project, which investigates sexual and reproductive issues of young adult CRC survivors and their partners within the first 5 years after diagnosis. This study will fill a significant gap in the current body of evidence assessing the long-term consequences of treatments for CRC on sexual health and wellbeing–related outcomes. In addition, this investigation will inform a subsequent intervention to enhance couples’ coping and communication skills critical to sexual intimacy.

This study is underpinned by a theoretical model that integrates the Biopsychosocial Model of Sexuality after Cancer developed by Bober and Varela [65], with Wittmann’s Sexual Recovery Model [67,77,78]. Bober and Varela [65] have outlined an integrative biopsychosocial model, where cancer-related sexual problems exist at the intersection of biological (ie, body image change, fatigue, pain, and loss of sensation), psychological (ie, depression and anxiety), sociocultural (ie, social and cultural norms), and interpersonal factors such as relationship quality, intimacy, and communication [65]. Wittman [74,78] has extended this work, illustrating how changes in sexual functioning after cancer represent a loss for both patients and partners. Their model conceptualizes sexual recovery as a process that shares similarities with the grief experience [67,74,77-79]. Finally, if we consider cancer and the resulting sexual loss as a dyadic stressor, it is possible to postulate that dyadic coping strategies are needed to adjust to this transition. According to the Systemic-Transactional Model [80], dyadic coping includes both partners’ strategies to manage their own and their partners’ distress as well as coordinated coping behaviors implemented by the dyad in response to stressful situations that may affect the quality of the relationship. Therefore, our work investigates whether dyadic coping behaviors that characterize the exchange within young partners may alleviate the burden associated with sexual distress experienced after cancer.

This study will use an explanatory sequential mixed methods approach [81] to (1) characterize sexual function, sexual distress, body image, fertility concerns, and dyadic coping among adolescent and young adult CRC survivors and their partners using validated measures (n=60 couples); (2) examine the reciprocal influence of each partner’s sexual function (model 1) and dyadic coping style (model 2) on self-reported sexual distress; (3) identify interpersonal or couple characteristics associated with their ability to cope with sexual dysfunction; and (4) integrate quantitative and qualitative findings to expand the current understanding of dyadic adjustment to sexual distress (Figure 1).

The target sample includes 60 dyads composed of young adult CRC survivors and their romantic partners (n=120). A subset of 20 couples (n=40) will complete an in-depth dyadic interview with 2 members of the research team to further explore couple-based strategies implemented to cope with cancer-related sexual dysfunction. Couples will be selected for the qualitative component of the study based on their score on the sexual distress measure (see Quantitative Web-Based Survey Study Component). Couples scoring in the highest and lowest 10th percentile will be invited to complete qualitative interviews. Inclusion criteria for cancer survivors consist of (1) having received a diagnosis of CRC (stages I-IV) within 5 years prior to study enrollment; (2) being in a romantic relationship with a partner; (3) being older than 18 and younger than 39 years at the time of diagnosis; and (4) speaking English. Intimate partners are included in the study if they are (1) older than 18 years and (2) able to speak in English. Exclusion criteria are (1) cognitive impairment or severe mental illness that would impede the completion of self-report instruments; (2) attending couples therapy at the time of survey completion; (3) currently receiving end-of-life care; and (4) the partner is not present or unwilling to participate. No exclusions will be made on the basis of gender identity, sexual orientation, ethnicity, or cultural background.

Multiple recruitment strategies will be implemented to reach the expected sample size of adolescent and young adult couples inclusive of CRC survivors and their partners. Informational flyers and social media scripts will be distributed among advocacy and community-based organizations for individuals with CRC, adolescents and young adults with cancer, and sexual or reproductive health with the help of a CRC survivor and advocate who is a member of the research team (AR). Investigators will also recruit participants at CRC events and conferences. We will work closely with the University of Texas MD Anderson Cancer Center Adolescent and Young Adult Program to promote study recruitment through existing listerves and private social media groups. In addition to active recruitment, study investigators (CA, DW, and MR) will share the study with psychosocial oncology providers and pediatric or medical oncologists to encourage them to refer participants to the study.

Potential participants can self-refer to the study in two ways: (1) by clicking on the URL and QR code, which will link them to a web-based study information form and screening questions or (2) by contacting the research team directly via email or telephone. The study information form includes a list of exclusionary criteria, and potential participants can opt out of the study if they present any of the characteristics that would interfere with their ability to qualify for the study activities. To preserve the integrity of the data, a brief telephone screening ascertaining age, cancer diagnosis, and relationship status will be implemented. Upon successful recruitment, participants will receive an individualized link to complete the web-based survey. They will be asked for their permission for the study team to contact their romantic partners, and couple completion of the survey will be monitored through individual and dyadic identifiers. Inclusion in the study is based on both partners’ provision of informed consent and completion of study questionnaires. If only one partner completes the study questionnaire or if less than 50% of the survey questions are answered, they will be excluded from the final sample. Two reminders will be sent to the participants and their partners. Additionally, among couples who express interest in participating in the qualitative component of the study while completing the survey, dyadic interviews will be conducted, with 10 couples reporting elevated sexual distress and 10 couples reporting low sexual distress (based on our sample distribution of scores) to appraise strategies implemented to cope with cancer-related sexual dysfunction.

This study will be performed in accordance with the tenets of the Declaration of Helsinki. The University of Houston’s institutional review board has reviewed and approved the study protocol (reference number STUDY00003538). Informed consent will be obtained from each participant before commencement of study research activities.

Recruitment and consenting of study participants will occur mostly through web- and internet-based approaches. A cover letter precedes the web-based survey explaining the study aims and procedures. Written information describing the research will be provided to survey participants, and this information will reference the optional interview procedures for a portion of the sample. Upon survey completion, a US $30 Amazon gift card (US $60 per couple) will be distributed via email. Additionally, a US $60 electronic gift card will be provided to each partner after participating in the dyadic interview (US $120 per couple).

Although this is considered a low-risk study, it is possible that answering questions about cancer diagnosis, sexual and reproductive health, as well as cancer-related impact on the couple’s relationship may cause participants to experience distress, sadness, or anxiety. The study team will provide participants with resources for cancer-related support in the follow-up thank you message used to disseminate the incentive. Participants can also contact the investigators or let the study team members know about their interest in being referred to community-based organizations. For partners who will participate in the qualitative interview, potential aspects of distress include cancer-related distress, sexual, fertility, and negative relational outcomes. In addition, mental health and suicide risk may emerge in the exchange with the investigators. Both participants (survivor and healthy partner) will receive a copy of the resource list created ad hoc from the research team, which includes the National Suicide Prevention Lifeline link and a 24/7 phone number. Being in an electronic format, the resource list will be attached to the thank you email for the participants, and it can also be shown directly to them upon conclusion of the interview. Other risks include breach of confidentiality or privacy. Efforts will be made to limit the potential for privacy to be threatened by a data breach: first, we made the decision of not pairing data from the web-based survey and the interview with identifying information. When data are downloaded, they will be stored in a password-protected encrypted computer. Each subject’s name will be paired with a code number, which will appear on written study material. The list pairing the subject’s name to the assigned code number will be kept separate from these materials, and only the study principal investigator will have access to this information.

Participant safety will be addressed through the implementation of the following strategies. First, survey instruments and study procedures will be reviewed and tested by expert e-patients and young CRC advocates [82] until consensus is achieved. Second, investigators will closely monitor responses to instruments assessing emotional functioning. An ad hoc list of resources in the areas of sexual health, mental health, caregiving, financial toxicity, and oncofertility has been compiled in collaboration with content experts or patient advocates, and it will be distributed to all participants at the end of the study activities. Third, 2 facilitators with expertise in research on sensitive health topics will conduct the interviews to reduce potential harm to participants because of the distress that may be elicited by the topics discussed [83], while affirming the cathartic and empowering aspect of using one’s experience to improve quality of care for adolescent and young adult couples. Additionally, to protect the individuals’ well-being and couples’ functioning, participants may opt to conduct the interview separately.

Univariate descriptive statistics and graphs will be analyzed to assess variables’ distributions. A missing data analysis will be conducted to determine whether list-wise deletion or multiple imputation will be appropriate; this will consider the amount of missingness and viability of the missing at random assumption necessary for multiple imputation [113]. Pearson r correlation coefficients will be used to assess the linear relationship among sociodemographic, clinical, and sexual or psychosocial measures, with specific attention to the variables of interest for the study. Comparisons of demographic characteristics between adolescent and young adult CRC survivors and their partners will be conducted using paired samples t tests for continuous variables and chi-square tests of association for nominal variables. Correction for multiple tests will be applied to control type I errors.

Then, the Actor-Partner Interdependence Model will be used to examine actor and partner effects of sexual function (model 1) and dyadic coping styles (model 2) on sexual distress of each member of the dyad [114-117]. A patient’s score on the predictor variable is expected to affect their own criterion variable scores (actor effect) and those of their partner (partner effect), and vice versa. Thus, it will be possible to determine whether sexual distress results from the score of the patients, partners, or both on the dyadic coping and sexual functioning measure [114,117,118]. Given the small sample size (60 dyads), the pooled regression approach will be used [114,117]. Stata (version 17; StataCorp) [119] will be used for the analysis, as the pooled regression approach is straightforwardly implemented using the mvreg command. The reasonableness of regression assumptions will be assessed using diagnostic statistics and plots [120]. Departures from assumptions will be handled using contemporary approaches such as the use of heteroscedasticity-consistent SEs. Power estimates were favorable: with a sample size of 60 dyads, assuming an α level of .05, the power of the regression F test to detect a significant model of each partner’s sexual function (model 1) and dyadic coping style (model 2) for sexual distress is approximately 0.86 in the presence of a medium effect size [115].

The qualitative phase of the study is designed to further explain quantitative results via purposive sampling of a subset of dyads. Interview recordings (n=20 dyadic interviews) will be transcribed verbatim and analyzed using thematic content analysis [121]. Transcripts will be reviewed for concordance, and discrepancies will be resolved through discussion among investigators. Qualitative data will be reviewed iteratively to reach saturation; that is, when no new information emerges during coding [122,123]. Atlas.ti software (ATLAS.ti Scientific Software Development GmbH) will be used to manage and organize qualitative data [124].

This study adopts an explanatory sequential mixed methods design, which incorporates quantitative and qualitative approaches as part of 2 consecutive phases [81]. Explanatory designs use qualitative data to explain and achieve greater understanding of the results emerging from the quantitative data [81,125]. In this design, the qualitative component builds on the survey and couples participating in the dyadic interview are selected from the sample that had previously completed the quantitative component. Integration of the 2 strands of data will be presented in a joint display table [126], thus yielding a more comprehensive view of participants’ experiences and illustrating interpersonal processes that inform couples’ coping with impaired sexual functioning.