Goal-Focused Emotion-Regulation Therapy (GET) for young adult survivors of testicular cancer: a pilot randomized controlled trial of a biobehavioral intervention protocol

The identification of core components and the development of the GET intervention come from preliminary empirical work with young adult testicular cancer survivors. First, an in-depth interview study of a diverse sample (N = 21; 48% ethnic minority) of young adult survivors of testicular cancer [41] revealed that young men perceive that life goals are an important aspect of adapting to testicular cancer, and identified goal and values clarification, engagement and disengagement from life goals, and the ability to express and process emotional responses to disrupted goals among critical self-regulation skills regarding behavioral and emotional responses to cancer-related stressors. Second, they identified a preference for action orientation, positivity, achievement, and practical realism. This included an inclination toward the use of an active, approach-oriented stance to pursuing prior goals and/or reengaging with new goals after cancer. Third, findings suggested that when goal navigation capacity was low or impaired, young men were less likely to benefit from their efforts at approach-oriented coping.

In a follow-up observational study of the same population (N = 171), Hoyt et al. [28] identified measurable goal-related processes including “goal navigation”, or the capacity to identify and pursue valued life goals. Goal navigation demonstrated cross-sectional associations with aspects of cancer-related adjustment. In regression analyses controlling for age and time since diagnosis, goal navigation was positively associated with emotional (B = 0.35, p < 0.001), social (B = 0.24, p < 0.01), and functional (B = 0.28, p < 0.001) well-being [41]. Further, a theoretical model of goal navigation using a self-regulation framework was identified and tested [42]. Goal navigation skills were negatively correlated with depressive symptoms (r = − 0.41, p < 0.01) and positively correlated with physical functioning (r = 0.28, p < 0.01), and these were mediated by possessing a sense of meaning in goal pursuit (indirect effects: depressive symptoms (r = − 0.50, p < 0.05), physical health (r = 0.34, p < 0.05)) and emotion regulation skill (indirect effects: depressive symptoms (r = − 0.08, p < 0.05), physical health (r = 0.11, p < 0.05)).

In a follow-up, at-home monitoring study (unpublished data) to examine associations of goal navigation skill, emotion regulation, and salivary markers of diurnal cortisol and α-amylase, the use of emotion regulation skills and salivary measures were collected daily for 2 days. Low levels of goal navigation capacity were significantly associated with greater use of less constructive emotion regulation strategies and higher daily salivary cortisol output (area under the curve). Poor self-regulation skills underscore dysregulation of biological processes with strong potential to lead to declines in physical health and mood.

Taken together, these findings underscored development of GET and an initial intervention manual which was tested to establish the feasibility and acceptability for the patient population. This included initial patient focus group interviews, as well as a series of individual patient interviews to gain feedback into session content, intervention length and format, and structured at-home components. A revised manual emerged that, based on findings, included more “normalization of experience”, opportunities to address cancer-specific topics (e.g., cancer-related disclosure, self-care after cancer), and bolstering of emotion regulation skill-building.

Next, the revised intervention was pilot tested with six young adult testicular cancer patients to assess tolerability, acceptability, adherence, and retention. This was done through examination of treatment completion and engagement with at-home exercises as well as in-depth post-participation interviews. Supporting tolerability and acceptability, all six participants completed all study sessions with no adverse events. Also, participants’ engagement with assigned at-home exercises were coded as “attempted/not attempted” to inform adherence. Moderate adherence was observed with 78% of assigned activities attempted. Interview transcripts were analyzed with a targeted inductive procedure of thematic analysis. This involved thorough reading and review of transcripts, synthesis of key conceptual findings, and the generation of descriptive conclusions. Conclusions identified eagerness for a survivorship intervention, affirmation of the importance of the identified intervention targets, satisfaction with the intervention length and depth, and desire for study interventionists to challenge participants to “go deeper” in the process of identifying and processing emotions. Participants also identified the desire to hear more perspectives from other testicular cancer survivors. Finally, the manual was further refined based on interview findings. This included the inclusion of patient quotes in study participant hand-outs.

GET is a six-session intervention delivered over 8 weeks to enhance self-regulation through improved goal navigation skills, improved sense of meaning and purpose, and better ability to regulate specific emotional responses. GET draws heavily from the principles of Hope Therapy [43], with an emphasis on goal navigation skill-building. Components of Hope Therapy have been used successfully in cancer survivorship interventions [44]. This includes work on goal-setting with a focus on assessing progress toward achieving specific, realistic, and measurable goals. Patients identify value-derived goals (i.e., goals for the most important domains of one’s life) and ones sufficiently important to sustain movement toward them in the short-term future. They discuss their goal possibilities, providing a forum to ensure that goals are manageable and consistent with identified values. Patients learn strategies to refine their goals (e.g., approaching goals rather than avoiding obstacles, defining markers of progress), generate pathways to goals, and address potential obstacles and blockages. Additionally, goals provided the context for demonstrations of agentic thinking (e.g., I will be able to do this) and interventions to increase agentic thinking. Specific attention is given to career/education-related goals. Emotion regulation components include basic cognitive restructuring skills, cognitive distancing, and coping efficacy skills (matching the correct coping skill to specific circumstances) (see Table 1).

Two measures are used in participant screening, as described earlier: the Distress Thermometer (DT) and the Cancer Assessment for Young Adults (CAYA-T; Goal Navigation Skill subscale). The DT [39] is a single-item visual analog scale used to screen cancer patients and ICs for psychological distress with a 0–10 range accompanied by a 34-item problem checklist [49]. Extensive research has identified a score of 4 or greater for identifying clinically significant distress [50, 51].

Goal navigation skill is measured by the goal navigation scale of the CAYA-T [28]. The CAYA-T has been validated on a sample of young adult men with testicular cancer and has demonstrated good psychometric properties in this population.

Depression and anxiety will be assessed using the Hospital Anxiety and Depression Scale (HADS) [52], a 14-item self-rated questionnaire of overall psychological distress, well tested in cancer populations [53].

Emotion regulation skills will be measured by the Emotion Regulation Questionnaire (ERQ) [54]. The ERQ is a widely used 10-item scale designed to measure respondents’ tendency to regulate their emotions in two ways: cognitive reappraisal and expressive suppression. Respondents answer each item on a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree).

Goal navigation skill is measured by the goal navigation scale of the CAYA-T, as already described. In addition, goal regulation capacity will be measured by agency and pathways. The Hope Scale [55] is a 12-item measure of a respondent’s level of hope. In particular, the scale is divided into two subscales that comprise Snyder’s cognitive model of hope: agency (i.e., goal-directed energy) and pathways (i.e., planning to accomplish goals).

Career confusion will be measured with the Career Thoughts Inventory (CTI) [56]. The CTI is a 48-item measure that is designed to assess career navigation difficulty and is normed on adult populations. The CTI yields a total score as well as scores on three construct scales: decision-making confusion, commitment anxiety, and external conflict.

Demographic information, past/current psychosocial service use, support needs, intervention preferences, and perceived barriers are assessed through Likert-scale ratings and open-ended items. Clinical information will also be assessed via medical record review and via self-report. In addition, we will thoroughly assess for medical comorbidities and physical health symptoms.

We will focus on five inflammatory biomarkers that have proinflammatory function, are associated with distress symptoms, and/or have angiogenic properties: IL-6, IL-1RA, CRP, sTNFrR2, and VEGF. Blood samples for circulating inflammatory markers will be collected between the hours of 8 a.m. and 4 p.m. by a trained phlebotomist by venipuncture into EDTA heparinized tubes, placed on ice, centrifuged for acquisition of plasma within 30 min, and stored at − 80 °C for subsequent batch testing. Plasma levels of identified markers will be determined by enzyme-linked immunosorbent assay according to the assay manufacturer’s protocols. CRP will be determined by a high-sensitivity enzyme-linked immunosorbent assay according to the assay manufacturer’s protocol. All samples will be run in duplicate, and assays will be repeated on two separate days for sTNFr and IL-6; intraassay and interassay mean levels will be used in all analyses.

We will focus on two salivary stress biomarkers. These include salivary cortisol, as a downstream marker of HPA activity, and salivary α-amylase (sAA), as a proxy measure of SAM activation; they can be measured concomitantly [57] and together offer a comprehensive view of physiological stress, as differing diagnostic and treatment effects have been observed between these markers [58]. Both salivary cortisol and sAA follow a distinct diurnal rhythm: cortisol levels peak approximately 30 min after awakening and decrease throughout the day, whereas sAA has a pronounced decline after awakening followed by an increase across the day [57].

Diurnal rhythm in salivary markers will be measured over 2 days at baseline and post intervention. Participants will collect saliva samples in their natural environment upon awakening, 30 min later, 8 h later, and at bedtime as recommended by Nicolson [38]. Participants will be instructed to go about their normal daily activities on the days of data collection and will complete a diary to assess relevant health behaviors (e.g., caffeine use). To avoid sample contamination, they will be instructed to avoid brushing their teeth, eating, or drinking within 20 min before sampling. Participants will be instructed to keep samples refrigerated prior to returning them to the research laboratory and returned salivettes will be stored in a freezer at – 80 °C until analyzed. After data collection is complete, salivary markers will be analyzed with a time-resolved fluorescence immunoassay. Several indices will be computed including diurnal slope, area under the daily curve, cortisol awakening response, and total daily cortisol output.

Six participants who complete the GET sessions will be invited to complete a semi-structured qualitative interview, using a semi-structured interview guide. Consecutive participants completing GET will be offered participation in the interviews until six interviews are completed. The interview will focus on understanding feasibility, tolerability, and acceptability of GET and overall trial participation from the patient’s perspective. Through the interviews, participants will provide information about their experience of participating in GET, including challenges to their participation and elements that they found most and least appealing. Qualitative methods will be employed to elicit and evaluate participant responses to the semi-structured interview. The interview transcripts will be analyzed with a targeted inductive procedure of qualitative thematic text analysis [59]. This process will involve thorough reading and review of transcripts by an analysis team; synthesizing key conceptual findings of each transcript; identifying key conceptual findings across all transcripts; and generating descriptive and interpretive themes for the entire data set.

A 16-item questionnaire administered after the last session was adapted from a measure used in currently/past federally funded intervention studies. Items query subjects’ responses to the various components of the intervention (e.g., content, timing, and length of sessions), and will be used for intervention modification.