Desk ResearchQualitative Search

A search of PubMed identified 378 abstracts for screening. Ultimately, eight full-text articles were reviewed, and three were included in the analysis with associated concepts extracted. The major patient-reported concepts identified included lesion symptoms, overall appearance, appearance distress, cancer worry, sun behavior, negative treatment effects [appearance, negative treatment effects other (including symptomatic)], and experience of care.

Six blogs and advocacy group pages were also reviewed for concepts [selected on the basis of relevance and presence of direct patient quotes: cancer.net, Patients Like Me, Reddit support pages, Skin Cancer Foundation blog, Squamous Cell Carcinoma Foundation of SETX Facebook page, and Twitter posts (searched for groups or hashtags related to CSCC)]. These sources contained patient reports on lesion symptoms, overall appearance of the lesion, appearance-related adverse effects of treatment, other adverse effects of treatment not related to appearance, distress caused by appearance, worry about cancer overall, changes in behavior around sun exposure, and the experience of care. Detailed findings are available in the Supplementary Materials.

PRO Instruments Search

A total of 12 unique instruments were identified from PubMed and clinicaltrials.gov. Closer examination of the items and domains of the existing PRO instruments mapped to the conceptual model revealed that the most conceptually patient-relevant instruments were the European Organisation for Research and Treatment of Cancer (EORTC) Head and Neck questionnaire (consisting of 35 items), relevant items from the EORTC Item Library, and the FACE-Q® Skin Cancer questionnaire.

Sample Characteristics of Patients with CSCC Who Participated in the Interviews

A total of 22 patients with an average age of 48 years participated in interviews. The sample was predominately female (55%) and white (91%), with most participants receiving their diagnosis of CSCC more than 2 years prior to the time the study was conducted. Education levels ranged from high school graduate to post-graduate, and most were working full time (52%). Most of the participants reported receiving surgery (82%) as treatment for their CSCC. See Tables 1 and 2 for participant demographic and health information, respectively.

Table 1 Demographic characteristics of patientsTable 2 Health information of patientsQualitative Results

Patients with CSCC reported lesion symptoms such as thickness, firmness, and discoloration, but did not report being particularly affected by these symptoms in terms of their ability to function. Some lesion symptoms, such as itchiness (severe at times), were bothersome to patients. Most patient concerns, however, were related to aesthetics: discoloration, thickness/bumpiness, crustiness, firmness, roughness, scaliness, flakiness, and peeling in the lesion area.

Most patients were generally satisfied with the most common form of surgical intervention, Mohs surgery. A subgroup of patients, however—including those with residual scarring, and those who experienced long wait times during the procedure—reported dissatisfaction and negative treatment effects. Patients reported:

What I dislike is that you’re left with scarring that will always remind you, hey, you had cancer. [I]t’ll be there like a tattoo all your days. (male, 50 years).

Mohs [surgery]... takes forever to heal... And it’s right where your bra strap goes over your shoulder… [A] lot of it is just nuisance and inconvenience. (female, 83 years).

Other patients reported additional adverse effects of treatment, such as anxiety:

[M]ore had to be removed tha[n] originally thought, but they don’t make promises during the Mohs surgeries. That’s the whole point of Mohs. This is just like we’re going to just take it until it’s done… It’s pretty nerve-wracking. (female, 49 years)

I was nervous. That’s what you could say about having it, because I wasn’t sure what it was going to be like. (female, 34 years)

Adverse effects also included bleeding, numbness, and pain/discomfort after the procedure; time for the treatment site to heal; and the need to follow up appropriately with wound care after surgery. Some patients reported scarring after surgery, which was a concern for those with a lesion in a visible location such as the face. Topical chemotherapy and photodynamic therapy did not provide the same resolution as lesion excision, and patients receiving chemotherapy reported itchiness and irritation.

Conceptual Model of the Patient Experience of Living with CSCC

The conceptual model was constructed by combining the results of the desk research and the findings of the qualitative interviews (Fig. 1). During interviews, patients reported that all or nearly all concepts under the “lesion symptoms,” “overall appearance,” “appearance distress,” “cancer worry,” “psychological impact,” “sun behavior,” and “negative treatment effects other” were important categories of the CSCC patient experience.

Fig. 1

Conceptual model of patient experiences living with CSCC. Superscript 1 indicates the concept emerged from published qualitative literature and blogs; 2 from clinical websites (Mayo Clinic); 3 from clinical expert feedback; and 4 from participant interviews. CSCC cutaneous squamous cell carcinoma

Saturation Analysis

All concepts emerged in the first three transcript groups, with most emerging in the first. Additional details of already existing adverse event concepts did emerge in the last group, but no new unique concepts were found. On the basis of these results, it was determined that conceptual saturation was reached with the first 22 interviews.

Assessment of Coverage for PRO Instruments and Development of a New PRO Instrument: The Patient Experience Questionnaire for CSCC

Conceptual coverage of the PRO instruments selected from desk research (EORTC and the FACE-Q® Skin Cancer modules) was assessed against the final conceptual model using targeted subdomains considered to be relevant to assess clinical benefit. The FACE-Q® modules were found to be more conceptually aligned with the targeted health concepts. Results from mapping of concepts to items for four of the most relevant six FACE-Q® Skin Cancer modules can be seen in Table 3. The relevant FACE-Q® Skin Cancer modules are FACE-Q® Satisfaction with Facial Appearance, FACE-Q® Appraisal of Scars, FACE-Q® Cancer Worry, and FACE-Q® Appearance-related Psychosocial Distress.

Table 3 Conceptual mapping of targeted health concepts to four selected modules of the FACE-Q® Skin Cancer or PEQ-CSCC

For health concepts that did not have associated existing FACE-Q® Skin Cancer items, de novo items were developed that collectively formed the Patient Experience Questionnaire for CSCC (PEQ-CSCC). These items were developed using the same item stem and response options as items on the FACE-Q® Skin Cancer modules; items are in a draft stage and have not been debriefed with patients. Some potential concepts were eliminated or combined into a higher-level activity item owing to being too broad (e.g., inflammation), too specific, and thus not applicable to all (i.e., functional impacts, limitations doing specific activities, and limitations at work), or being signs but not symptoms (e.g., bruising, swelling, and peeling). The skin symptoms following treatment (e.g., numbness and soreness) were combined into one more general item, given that there were limited patient data to support separation of each into a single item.

Dermatologist Interviews

The three clinical expert dermatologists who were interviewed confirmed the concepts that emerged from patient interviews and desk research. In addition, these clinicians referred to concepts such as the psychological impact of CSCC, the impact of living with CSCC on sleep, and lesion-specific limitations such as the impact on socializing or using extremities affected by lesions.