Introduction

Despite more than 35 years of community education on skin cancer prevention and early detection, Australia retains the unwanted reputation as the melanoma center of the world. With more than 12,950 new cases estimated to have been diagnosed in 2015, melanoma is the third most common cancer in Australian men and women, accounting for 10 % of all new cancer cases [1, 2]. Mortality is stable and lower than for other common cancers; however, melanoma has a disproportionately heavy impact on productive years of life because it is the most common cancer in young adults aged 15–45 years [1].

Epidemiological data suggest that different clinical patterns of the disease are associated with different contributions of risk factors, such as the number and type of benign melanocytic nevi, the character and intensity of skin pigmentation, skin sensitivity to sunlight, sun exposure, and genetic factors [3–5]. People with a history of multiple primary melanomas, or a primary melanoma and multiple dysplastic nevi, have a lifetime risk 10 times that in the general population [6]. Risk is also elevated in those who have had a single melanoma, with estimates of risk between 5- and 9-fold higher compared to the general population [7, 8]. The 10-year absolute risk of primary melanoma after a previous diagnosis is at least 10 % in Sydney, Australia [9], and risk remains elevated more than 20 years after initial diagnosis [8].

Diagnosis and treatment of melanoma typically occurs at an early stage, yielding good prognoses. This, coupled with the often healthy outward appearance of early-stage melanoma patients, may contribute to the prevailing belief that these patients have “little or nothing to worry about” [10]. Despite a good prognosis, however, people with early-stage melanoma face the immediate stress of a life-threatening disease, as well as the threat of recurrence or systemic spread. In one recent study, many people with a history of melanoma reported sustained uncertainty and fear regarding their melanoma risk [11] and, in another, 72 % of participants reported levels of fear of cancer recurrence indicative of a need for psychological intervention [12]. Nonetheless, the emotional needs of people with melanoma are still not well recognized or supported clinically [13], and a number of patient (e.g., stigma, cost, limited awareness), health professional (e.g., limited awareness, low confidence), and health system (e.g., cost, under-prioritization) factors may serve as barriers to timely access to psychological care [14, 15].

Evidence-based guidelines for the clinical management of melanoma recommend that “psychological interventions and psycho-education be made available to all patients with melanoma to improve their quality of life” [16]; however, psycho-educational resources are infrequently implemented as part of melanoma care programs [17, 18]. Information is one of the greatest areas of unmet need for patients [19]. Bonevski et al., for example, assessed the needs of outpatients attending a melanoma clinic and found that six of the 10 highest ranked needs concerned health information [20]. Studies consistently demonstrate that patients who receive information according to their preferences report greater emotional well-being and fewer psychosomatic complaints [21, 22]. Studies also show that patient education is one of the strongest predictors of implementation of appropriate and thorough skin self-examination and healthy adaptation to disease risk [18, 23].

Objective

Intervention studies designed to address the psycho-educational needs of people with melanoma are rare [18], and to the best of our knowledge, there are no interventions specifically tailored to those at very high risk of new primary disease. The objective of this study was to pilot a newly developed, evidence-based, psycho-educational resource for people with a history of melanoma. Given our previous findings that people with melanoma have a strong preference for paper-based resources [24], the delivery format chosen was that of a printed booklet. The aims were to assess the extent to which the booklet was acceptable and relevant, as well as its emotional impact and the extent to which it met patients’ information needs. To inform future implementation strategies, we also examined the likelihood that health professionals would recommend, use, or disseminate the booklet within their clinical practice. Suggestions for improving the booklet were also elicited.

Methods

Participants

The study comprised three groups: (1) people at high risk of new primary disease due to multiple previous melanomas or a previous melanoma and dysplastic nevus syndrome (DNS; i.e., >100 mole and >5 atypical moles and at least 1 mole with a diameter > 8 mm), (2) people at moderate risk due to one previous melanoma and no DNS, and (3) health professionals involved in the clinical care of people with melanoma. Melanoma survivors were identified via the High Risk Clinic at the Sydney Melanoma Diagnostic Centre (Group 1) or the Melanoma Institute Australia (Group 2), the world’s largest clinical service dedicated to the treatment of melanoma. Eligibility criteria included age over 18 years and sufficient English language skills to complete the questionnaire independently. Individuals with a current diagnosis of metastatic cancer were not approached, as the booklet was not designed to meet the needs of this patient group. Health professionals with a special interest in melanoma from the disciplines of dermatology, oncology, general medicine, nursing, psychology, public health, and social work were identified via professional networks and organizations.

Procedure

The research protocol was endorsed by the Scientific Advisory Committee of the Psycho-oncology Co-operative Research Group (PoCoG), the appropriate Human Research Ethics Committees gave approval, and informed consent was obtained from all participants. Eligible individuals were sent a letter of invitation from their treating clinician (Groups 1 and 2) or the principal investigator (Group 3), accompanied by a participant information sheet, consent form, and reply paid envelope. Individuals who did not decline participation were telephoned 14 days after invitation letters were mailed to determine interest. For those who provided consent, the psycho-educational resource and study questionnaire were mailed. A free-call telephone line was established to facilitate participant engagement with the research team throughout the study.

Development of the psycho-educational resource

A psycho-educational resource for people with melanoma, in the form of a 68-page, A5-sized, color-printed booklet entitled, Melanoma: Questions and Answers, was developed by a multidisciplinary team (psychology, dermatology, general medicine, genetic epidemiology, public health, genetic counseling, genetic education, health economics, translational science, melanoma patient representatives) in accordance with: relevant published evidence e.g., [11, 18, 24]; the Medical Research Council’s framework for developing and evaluating complex interventions [25]; the Transactional Model of Stress and Coping [26, 27]; clinical practice guidelines on the (a) management of melanoma [16], (b) psychosocial care of adults with cancer [28], and (c) presentation of evidence to consumers [29]. Early prototypes were developed and revised using an iterative process, in partnership with representatives from key professional bodies such as the Australasian College of Dermatologists, the Australian Psychological Society, NSW Health, and National Clinical Trials Groups (PoCoG and the Australian and New Zealand Melanoma Trials Group, ANZMTG), as well as four people (two men and two women) with a history of melanoma (two at high risk and two at moderate risk of developing new primary disease). Detailed summaries of the feedback gathered throughout this iterative process were prepared, discussed with the research team, and used to directly inform the revision process. The Flesch-Kincaid reading level was set to Grade 8 (age 12–14 years), and pictorial representations of disease risk estimates were developed.

The booklet comprised seven modules, each designed to stand alone and address unique aspects of supportive care (see Table 1). Features integrated throughout the booklet included:

  • Photographs to illustrate different types of melanoma and skin lesions, as well as complex health behaviors (e.g., skin self-examination);

  • One hundred-Person Risk Diagrams to convey disease risk (see Fig. 1a);

  • A Question Prompt Sheet designed to support melanoma-related communication during clinical encounters (see Fig. 1b) [30];

  • Verbatim quotes on a range of issues from Australians who have had melanoma e.g., [31];

  • Aides to assist clinical care record keeping (e.g., diagnosis, treatments, monitoring, scheduled consultations);

  • Contact details for a range of reputable services and resources.

Table 1 Content of the booklet, Melanoma: Questions and Answers
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Fig. 1
figure 1

Examples of the content, format, and features of the psycho-educational booklet. a Use of photographic images to supplement information on dysplastic nevus syndrome and 100-person diagrams to communicate disease risk. b Question Prompt Sheet tailored for use during melanoma-related clinical interactions

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Measures

For patients, a self-administered survey instrument, comprised of validated and purposively developed measures, assessed:

  1. (1)

    Demographic and clinical characteristics (nine items): age, sex, marital status, educational attainment, gross weekly household income [32], residential location, country of birth, language(s) spoken at home, and diagnosis of melanoma in the past 2 years. In addition, data on number of previous melanomas and presence of DNS were collected via medical records.

  2. (2)

    Resource acceptability (20 items): The validated User Manual Acceptability measure [33] was adapted to assess reading time and thoroughness, booklet length, information flow, and comprehensibility, perceived appropriateness and appeal of booklet design and features, perceived quality (0 = “poor” to 3 = “excellent”), and helpfulness of each tool (0 = “not at all helpful” to 3 = “very helpful”), with space for additional feedback and general impressions.

  3. (3)

    Relevance (six items): Participants rated relevance of the booklet to their situation (0 = “strongly disagree” to 3 = “strongly agree”), anticipated use and benefits, and likelihood of recommending it to others with melanoma.

  4. (4)

    Improvement in unmet information needs (11 items): A modified version of the Cancer Survivors’ Unmet Needs (CaSUN) questionnaire [34] assessed 11 unmet information needs commonly reported by melanoma survivors [11, 24]. For each item, participants rated the level of need (0 = “no need” to 3 = “high need”) prior to receiving the booklet, and whether the need was satisfied (yes/no) after reading the booklet.

  5. (5)

    Emotional responses: The 42-item Fear of Cancer Recurrence Inventory (FCRI) [35] to assessed dimensions of fear of cancer recurrence (FCR) in the past month (range 0–168), with higher scores indicative of greater FCR. A score of ≥13 on the severity subscale (range 0–36) is considered indicative of a fear response warranting clinical assessment [36]. The Hospital Anxiety and Depression Scale (HADS) has two seven-item subscales measuring anxiety and depression (subscale range 0–21) [37]. Subscale scores ≥11 indicate clinically significant distress [37]. One item assessed whether reading the booklet aroused worry or anger.

  6. (6)

    Dissemination preferences (three items): Optimal time of booklet dissemination (diagnosis, 1 week post-diagnosis, 1 month post-diagnosis, follow-up consultation, other), format (paper-based, web-based), and delivery mechanism (doctor, clinic nurse, receptionist, waiting room, other).

Health professionals were asked to complete ratings (from their own perspective) for almost all items described above, except the FCRI and HADS. Unmet needs were assessed from the perspective of patients. Additional items assessed anticipated timing and mode of booklet distribution, and likelihood of using the booklet during clinical consultations. Health professionals also indicated their profession, and years and type of practice (public or private sector).

Results

Response rates and sample characteristics

Forty adults with a history of melanoma (20 high-risk, 20 moderate-risk) were sent an invitation package, of whom two individuals were not contactable, two declined participation, and 17 did not return the questionnaire, resulting in 19 completed questionnaires (10 high-risk, 9 moderate-risk) and yielding a response rate of 50 % among eligible, contactable melanoma survivors (19/38). Mean age of participants with a melanoma history was 58.1 years (SD = 10.6, range 42–79 years; see Table 2 for demographics). Participants and non-participants did not differ according to age (p = 0.44), sex (p = 0.34), or melanoma risk category (p = 0.34). Of the 12 health professionals approached, 10 completed questionnaires (response rate 83 %). Mean age of health professionals was 42.8 years (SD = 9.4, range 30–59 years), all but one was female, and mean number of years in professional practice was 14.7 (SD = 9.0).

Table 2 Demographic, clinical, psychosocial, and professional characteristics of the sample (N = 29)
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Acceptability

The booklet was well read; almost all participants read it from “cover to cover” (12/19 patients, 6/10 health professionals) or “quite thoroughly” (4/19 patients, 3/10 health professionals), and only a small proportion read it “briefly” (2/19 patients, 1/10 health professionals) or read only personally-relevant sections (1/19 patients). A sizeable proportion of participants (6/19 patients, 6/10 health professionals) reported taking about one hour to read the booklet, while the remainder took about two hours (6/19 patients, 1/10 health professionals), or 15–30 min (5/19 patients, 2/10 health professionals). Almost all participants (18/19 patients, 9/10 health professionals) perceived the booklet as “just right” in length, as “easy to understand” (18/19 patients, 9/10 health professionals), and well-ordered (14/19 patients, 7/10 health professionals). Almost all participants (18/19 patients, 7/10 health professionals) perceived the title as appropriate, and most perceived the cover as appealing (16/19 patients, 9/10 health professionals) and as “standing out” from other available melanoma-related resources (13/19 patients, 7/10 health professionals).

All melanoma survivors and most health professionals (7/10) liked the booklet design and layout, and found the presentation “professional” (17/19 patients, 8/10 health professionals) and “warm” (13/19 patients, 6/10 health professionals). Only one health professional perceived the booklet as “too plain,” and no participants found the booklet “confusing”, “difficult to follow”, or “too busy or cluttered”. Almost all found the headings and subheadings useful (18/19 patients, 9/10 health professionals), and most liked the colors (12/19 patients, 7/10 health professionals), images (11/19 patients, 9/10 health professionals), and quotes from people with a melanoma history (12/19 patients, 8/10 health professionals). To improve the design, two patients suggested adding module numbers or colored page edges to clearly demarcate each section.

Quality was rated highly; overall mean quality ratings (out of 3) were 2.7 (SD = 0.3) and 2.6 (SD = 0.6) for high- and moderate-risk groups respectively, and 2.4 (SD = 0.4) for health professionals (see Table 3). Patients rated the Question Prompt Sheet as the most helpful tool, followed by the 100-Person Risk Diagrams, and the tool developed to assist patients in keeping track of their melanoma care (see Table 3). Health professionals perceived the 100-Person Risk Diagrams and Skin Self-Examination Guide as most helpful to patients.

Table 3 Mean perceived quality and helpfulness ratings for each booklet component, with each module rated from 0 (“poor”) to 3 (“excellent”) in terms of perceived quality, and each tool rated from 0 (“not at all helpful”) to 3 (“very helpful”) in terms of perceived helpfulness
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Relevance

Almost all patients perceived the booklet as personally relevant now (17/19), as well as at the time of initial diagnosis (15/19). All but one patient believed that the booklet addressed the concerns of people with melanoma and would recommend the booklet to others affected by the disease. Seven participants anticipated taking the booklet to medical consultations. All health professionals perceived the booklet as helpful for recently diagnosed and high-risk melanoma patients. Almost all (8/10) would recommend the booklet to people with melanoma and believed patients would actively use it. All health professionals and 17/19 patients perceived the booklet as helping patients to better cope with their experiences of melanoma. One participant wrote, “I like the book. It lets you know that others have the same feelings and gives suggestions to cope or reach out if needed” (High-risk, aged 58).

Improvement in unmet information needs

Almost all unmet information needs reported by patients were met by the booklet (see Table 4). The mean number of unmet needs reported by patients decreased from 9.1 (SD = 2.6) to 0.8 (SD = 1.2) after reading the booklet. The need for up-to-date information on advances in melanoma treatment remained unsatisfied for 5/19 patients and 7/10 health professionals.

Table 4 Perceived improvement in unmet information needs, with frequencies reported separately for high-risk (n = 10) and moderate-risk (n = 9) patients, as well as health professionals (n = 10)
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Emotional responses

One high-risk and two moderate-risk participants (all women) reported feeling “upset, worried, or angry” after reading the booklet. For one participant, reading about risk factors had been upsetting “as I hadn’t thought about it for some time” (High-risk, aged 44). Another participant expressed anger about reading information “that I should have been told but never was” (Moderate-risk, aged 51). The third participant disclosed existing fears about melanoma recurrence. Mean HADS-Anxiety and HADS-Depression scores were within the healthy range (see Table 2). One third of high- and moderate-risk participants reported fear of cancer recurrence warranting clinical assessment (see Table 2).

Dissemination preferences

All but two patients indicated a preference for receiving the booklet at diagnosis; the remaining two high-risk participants preferred receipt 1 week post-diagnosis. All patients preferred a paper-based over a web-based format, and all but one wanted to receive the booklet from their doctor (one participant preferred clinic nurse or receptionist). All health professionals believed that the booklet should be provided to patients. Most wanted to deliver the booklet themselves (7/10), as a paper-based resource (9/10), and all believed that they could incorporate the booklet within their clinical consultations, preferably at the time of diagnosis (8/10). The clinic nurse was identified as the most appropriate professional to support patients’ ongoing booklet use (9/10).

Discussion

People with melanoma often report pervasive fears about cancer recurrence [11, 12], lingering questions about risk and prognosis [11], and difficulties accessing appropriate and timely emotional support [11, 24]. The evaluated booklet, Melanoma: Questions and Answers, was designed to provide information and resources to acknowledge and address these needs in a way that was both scientifically rigorous and psychologically informed. Responses were overwhelmingly positive; the booklet was rated highly in terms of acceptability, relevance, quality and quantity of information, utility of health education tools, and capacity to address unmet information needs. The booklet was evaluated in a sample of patients where most (74 %) did not have a university degree and was rated easy to understand. Only a small proportion of participants reported reading the booklet “briefly” or in part (n = 4), indicating that overall, the booklet was well read. Moreover, participants reported a striking reduction in unmet information needs as a result of reading the booklet. These results highlight the potential value of simple, evidence-based psycho-educational interventions tailored to the unique informational needs of specific disease groups [18].

While brief information on the main treatments for melanoma was included in the booklet, the need for up-to-date information on advances in melanoma treatment remained unsatisfied for five of 12 patients. Melanoma treatment is currently a fast-moving field, with targeted therapies and immunotherapies now playing an important role in treatment of more advanced disease. More flexible, rapidly evolving and easily updated resources, such as websites and other eHealth platforms, may be better suited to addressing this need; however, in the present study, participants reported a strong preference for paper- over web-based resources. One potential solution may be to periodically supplement the booklet with an “information prescription” provided by the treating physician and tailored to guide the patient to credible web-based information about relevant new treatments or research breakthroughs [38]. Another option is to include links to websites of reputable cancer trials groups (e.g., www.australiancancertrials.gov.au); in response to participant feedback, such links have been incorporated into the booklet.

Mean perceived helpfulness scores for all tools within the booklet were high, with one exception: the mindfulness skills exercise. The mean score for this tool indicated that overall, participants found the exercise “somewhat” to “quite helpful.” Several recent trials, however, have demonstrated the efficacy of mindfulness-based interventions in cancer care, particularly in terms of assisting people to cope with the loss of control, sense of uncertainty, and fear of recurrence that often accompanies cancer diagnosis, treatment, and survivorship [39]. Several possibilities may account for this result. First, the information on mindfulness within the booklet was brief and designed to serve as an introduction to the concept and practice of mindfulness, rather than a stand-alone therapeutic intervention. This makes drawing comparisons between the booklet and published trials of mindfulness-based interventions tenuous, at best. Second, while the booklet provided psycho-education and examples of the application of mindfulness to the melanoma context, the exercise itself was not tailored to melanoma. A more tailored approach may have assisted participants in linking the practice of mindfulness to their experience of melanoma. Third, mindfulness may be best learned with an experienced practitioner guiding the learner through the process, rather than through written descriptions. Future psycho-educational resources could test this by incorporating audio-recordings of mindfulness practices.

Another salient finding was the lower mean perceived helpfulness rating assigned to the skin self-examination (SSE) guide by the moderate-risk group, compared to ratings by the high-risk and health professional groups. A key clinical distinction between the two patient groups in the present study was that participants in the moderate-risk group did not have DNS. The presence of DNS poses unique challenges to SSE, and thus, a tool designed to assist with this health behavior may be perceived more positively by those with DNS compared to those without. It is also possible that participants at different levels of melanoma risk may have different attitudes toward SSE and that different tools or technologies relating to SSE may be needed to better engage and support people at moderate risk of developing another melanomae.g., [40]. Future studies could examine the role of attitudes and beliefs in more detail [41].

In terms of dissemination preferences, all health professionals believed that the booklet should be provided to people with melanoma and intended to incorporate it in their clinical consultations, preferably at the time of initial diagnosis. Patients wanted to receive the booklet from their doctor at, or within 1 week of, diagnosis and perceived the booklet as assisting patients to cope with melanoma, even if they did not actively use the booklet during clinical consultations. These data can be used to directly inform future implementation strategies, as well as the wider dissemination and translation of the intervention into clinical practice.

Conclusions and implications for cancer survivors

This study reported on the development and evaluation of a psycho-educational booklet for men and women at moderate or high risk of developing another melanoma. While the over-representation of female health practitioners and patients born in Australia may potentially limit study generalizability, the results demonstrate the feasibility of using an intensive iterative process to develop high-quality, evidence-based resources to address the informational needs of people with melanoma. Acceptance and readability of the booklet were rated highly by patients in both melanoma risk groups, as well as by health professionals involved in melanoma care. Regarding implementation, we have undertaken a randomized controlled trial examining the efficacy and cost-effectiveness of the booklet in combination with three telephone-based sessions with a psychologist as a psycho-educational intervention (manuscript submitted) [42]. Other implementation models, such as two clinic-based sessions with a psychologist, cancer nurse, or dermatologist who can orient and support patients in their use of the booklet, would also be appropriate.