Cancer Cancer
Conditions
Interventions
After signing the informed consent, participants will complete an assessment protocol that will include an initial interview and questionnaires/tests about their health condition (in digital files). A
Sponsors
IPO Porto
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 05/03/2025: 1. Adult subjects =18 years old 2. Able to provide informed consent to participate in the study 3. Able to self-report pain 4. Recent diagnosis (less than 6 months) of cancer affecting the lung, breast, pancreas or colon (with metastases or not) 5. Not having started systemic cancer treatment 6. Have a life expectancy of at least 12 months 7. Ability to use the internet and WhatsApp or have a person (family member, caregiver) to help them Previous inclusion criteria: 1. Adult subjects =18 years old 2. Able to provide informed consent to participate in the study 3. Able to self-report pain 4. Recent diagnosis (less than 6 months) of cancer affecting the lung, breast, pancreas or colon (with metastases or not) 5. Not having started cancer treatment (all treatments are included) 6. Have a life expectancy of at least 12 months 7. Ability to use the internet and WhatsApp or have a person (family member, caregiver) to help them
Exclusion criteria
Exclusion criteria: 1. Pregnant women or women of fertile age not having efficacious contraception during the whole period of the study 2. Neurological and psychiatric disease (except anxiety and depression) 3. Unstable medical conditions (e.g., uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease) 4. History of neurosurgery, traumatic brain injury with loss of consciousness, and/or cortical lesions 5. History of non-malignant chronic pain
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured before the antineoplastic treatment, 6 months after Visit 1 (basal assessment) and 12 months after Visit 1 (basal assessment): 1. Pain intensity and distress measured using an 11-point (0-10) numerical rating scale (NRS) measure of pain intensity (in the last week) and an NRS for distress (unpleasantness) caused by pain 2. Functional impact of pain and quality of life (QoL) measured using the Brief Pain Inventory (BPI), the Short Form 36 Health Survey (SF-36) and EQ- 5D-3L (EuroQol) 3. Functionality or performance status measured using the Eastern Cooperative Oncology Group (ECOG) scale 4. Sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI) 5. Fatigue measured using the Modified Fatigue Impact Scale (MFIS) 6. Emotional functioning measured using the Brief Measure for Assessing General Anxiety Disorder (GAD7) and the Patient Health Questionnaire (PHQ-9) 7. Catastrophizing measured using the Pain Catastrophism Scale (PCS) | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
Denmark, Portugal, Romania, Spain
Outcome results
None listed