Cancer
Conditions
Brief summary
The following randomized longitudinal study will evaluate the long term impact of caregivers' involvement in cancer care pathway, including a psychological support intervention on the dyads to be delivered after the detection of a suspected cancer and before the visit with the oncologist for discussing therapeutic options.
Detailed description
The following randomized longitudinal study will evaluate the long term impact of caregivers' involvement in cancer care pathway, including a psychological support intervention on the dyads to be delivered after the detection of a suspected cancer and before the visit with the oncologist for discussing therapeutic options. Moreover, a battery of self-report questionnaires will be administered, and sociodemographic and clinical data will be collected. The time window in which to deliver the support intervention is after the detection of a suspected cancer and before the visit with the oncologist, at the time when the patient undergoes diagnostic exams (to understand the type of tumor he/she is affected by), and the most suitable therapeutic protocol have to be discussed with the oncologist.
Interventions
OTHERPsychological support
Psychological support intervention
Sponsors
European Institute of Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patient: * Patient aged ≥18 years at the time of recruitment. * Patients who have just received a cancer diagnosis and have yet to discuss with their oncologist the treatment to undergo after diagnosis of breast or prostate cancer. * Early-stage cancer (I or II). Caregiver: * Age ≥ 18 at the time of recruitment. * Taking care of the patient.
Exclusion criteria
Patients: * Presence of early mental disorders (before age 40) or severe neurological disorder. * Patients with advanced stage cancer for which the path is already defined (palliative care patients). Caregivers: ● Presence of early mental disorders (before age 40) or severe neurological disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the compliance with therapy | 6 months | The primary endpoint of this study is to observe a difference of 3 points in the average values of the Interpersonal aspect of care and Subjective norm subscales of the Adherence Determination Questionnaire (ADQ), in favor of the intervention group. Response options for each item formed a 5-point Likert scale (1 = strongly disagree; 2 = disagree; 3 = neither agree nor disagree; 4 = agree; 5 = strongly agree). The ADQ questionnaire contains 38 questions, with items 15 and 17 through 24 specifically phrased for patients who have cancer |
Countries
Italy
Contacts
Primary ContactGabriella Pravettoni
Outcome results
None listed