Clinical trial · Interventional
Role of Caregiver in the Clinical Pathway of Patients With Breast and Prostate Cancer
The Role of Caregiver in the Clinical Pathway of Patients Newly Diagnosed With Breast and Prostate Cancer: a Randomized Study
NCT06468293CI-TRIAL-00078105unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Psychological support | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control group
- description
- Non psychological support intervention
- type
- OTHER
- label
- Intervention group
- description
- Psychological support intervention with scheduled appointment within the period of diagnostic assessment
- interventionNames
- Other: Psychological support
Primary outcomes (1)
- measure
- Evaluation of the compliance with therapy
- timeFrame
- 6 months
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.