Ethic Statement
This study was approved by the Institutional Review Board of the University of L’Aquila, Italy (Prot. N° 16372/2019). Informed consent was obtained from each participant, and all procedures were in accordance with the Declaration of Helsinki.
Participants
Participants were n.84 female patients aged 35-50 years old (mean age 42.2, ±8.3), living in central Italy distributed in n.2 groups: a) M group (Mg) composed of n. 42 patients with melanoma diagnosis (Stage 0-II) and b) B group (Bg) composed of n. 42 patients with breast cancer diagnosis (Stage 0-II). All patients had early stage diagnosis by early screening.
Eligible participants have been approached to be enrolled in the study at the Oncological Dermatology Division (Resp. Prof. Fargnoli) and Oncological Medicine Division (Dir. Prof. Ficorella) of S. Salvatore Hospital in L’Aquila (IT). We contacted 114 eligible patients, of whom 84 provided informed consent; 28 patients did not consent to participate in the experimental protocol; whereas two patients signed the informed consent form, but at the first session, they declined further involvement (dropped out).
Demographic characteristics of the participants are reported in Table 1.
Table 1. Sociodemographic data of participants.
Age, years
|
Breast group
(mean age 45.3, sd±1.5)
|
Melanoma group
(mean age 45.5, sd±2.5)
|
Relationship status
Married/living with partner
Single
|
80,9%
19,0%
|
78,5%
21,4%
|
Education
Not graduate
High school
Graduation
|
19,0%
52,3%
28,5%
|
4,7%
64,2%
30,9%
|
Occupation
Housewife
Employed
Self-employed
|
27,9%
53,5%
17,4%
|
23,8%
57,1%
19,0%
|
TNM Cancer stage
0
I
II
|
47,6%
28,5%
23,8%
|
40,4%
57,1%
2,3%
|
Diagnosis Timing
T0
T1
T2
|
30,9%
57,1%
11,9%
|
21,4%
45,2%
33,3%
|
Inclusion criteria have been: a) 20-50 years old; b) no cancer recurrence (2nd primary diagnosis); and c) diagnosis of melanoma/breast cancer had been in the time period from 0 to 36 months. Participants were eligible to enrol in the study if they had a breast cancer diagnosis or melanoma and followed a clinical path within 24 months following diagnosis, and after surgical intervention and/or treatment with adjuvant chemotherapy, radiation therapy, or both, for stages 0-II cancer.
Medical staff applied the TMN classification of malignant tumours, a cancer staging system developed by the American Joint Committee on Cancer and the Union for International Cancer Control (UICC), to classify the cancer stage of patients.
Measurement
Sociodemographic variables
Sociodemographic data were collected. First, demographic data were provided via the self-report of patients; we selected independent variables for inclusion in the analyses if they were characteristic of the age/life stage (e.g. having children, marital status, education, occupation) related to the cancer. Second, clinical data were obtained from the patients’ medical records regarding melanoma and breast cancer stage, treatments, and therapies.
Psychological tests
The psychological battery was composed of self-reports: the Psychological Distress Inventory (PDI) to measure distress, the Depression Anxiety Stress Scale 21 (DASS-21) to assess signs of anxiety, depression, stress, and Metacognition Questionnaire 30 (MCQ-30) to detect metacognitive thinking.
Psychological Distress Inventory (PDI) [8]. This is a 5-point self-administered 13 item-questionnaire developed to measure level of psychological distress caused by cancer. The standard score indicates the presence/absence of psychological distress. The internal reliability was good (a=0.86).
Depression Anxiety Stress Scales-21 (DASS-21) [10]. DASS-21 is a 21-item self-report questionnaire assessing three dimensions (7 items per subscale): depression, anxiety and stress. Patients are asked to score every item on a scale from 0 (did not apply to me at all) to 3 (applied to me very much). Sum scores are computed by adding up the scores on the items per (sub)scale and multiplying them by a factor 2. Sum scores for each of the subscales may range between 0 and 42.
Metacognition Questionnaire-30 (MCQ-30) [9]. It is a self-report assessing a range of metacognitive beliefs and processes relevant to the vulnerability and maintenance of psychological disorders. The items are rated on a 4-point Likert scale from 1 (do not agree) to 4 (completely agree). The items are grouped into five subscales: a) Cognitive Confidence (CC), b) Positive Beliefs about Worry (POS), c) Cognitive Self-Consciousness (CSC), d) Negative Beliefs about Uncontrollability and Danger (NEG), e) Need to Control Thoughts (NC). The MCQ-30 has good internal consistency, as do its five subscales.
Body Self-perception questionnaire (BSPq). It is an ad hoc questionnaire consisting of 16 items aimed to measure three domains of body image: a) Treatment Consequences on Body Image (TCBI); Social Wellness (SW), and Physical Feeling, (PF). Responses are based on a 4-point Likert scale. The pilot study previously conducted showed a good reliability.
Procedure
Medical staff in the Oncological Dermatology Division (Director Prof. M.C. Fargnoli) identified eligible melanoma patients and medical staff in the Oncological Medicine Division (Director Prof. C. Ferri) identified eligible patients with breast cancer. All participants gave informed consent at the time of enrolment. Trained clinical psychologists (blinded to the aim of the study) conducted the psychological evaluations lasted 40 minutes in a dedicated room. The participants filled out digital versions of the questionnaires. Participants were recruited on outpatient basis during their scheduled medical follow-ups. Data were collected anonymously.
Study design
We conducted an observational study to evaluate the emotional traits, body self-perception, and metacognitions in melanoma and breast cancer patients. Descriptive statistics were calculated for baseline characteristics and outcome measures. One-way analysis of variance (ANOVA) and analysis of covariance were conducted to detect the statistical significance of the overall differences across the examined psychological variables, while a MANOVA was performed to calculate the significant differences according to cancer type. Statistical analyses were performed using the jamovi 1.6.10.0 with a fixed α-value ≤0.05.