- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03975621
Nurse AMIE: Addressing Metastatic Individuals Everyday (NurseAMIE)
Nurse AMIE: A Tablet Based Supportive Care Platform in Metastatic Breast Cancer (AMIE = Addressing Metastatic Individuals Everyday)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Pennsylvania
-
Hershey, Pennsylvania, Förenta staterna, 17033
- Penn State Cancer Institute
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Women with metastatic breast cancer
- ECOG performance score ≤3.
- English Speaking
- With sufficient vision/hearing or family support
- Willingness to be randomized
Exclusion Criteria:
- Medical or psychiatric conditions (beyond breast cancer, its treatment, and its symptoms) that would impair our ability to test study hypotheses (e. g. psychotic disorders, dementia, inability to give informed consent or follow the instruction).
- Patients who are receiving any other behavioral intervention
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Immediate Intervention
The immediate intervention group will receive the intervention at the time of consent (baseline) and will be enrolled in the intervention for a total of 6 months.
Patients will receive the tablet, a pedometer and an exercise band.
Patients will use Nurse AMIE while receiving weekly phone calls from a patient navigator.
After 90 days of the intervention observation will take place for 90 days, the patient will be asked to continue using Nurse AMIE without a patient navigator's presence.
|
Patient will receive the tablet, a pedometer (to track their steps) and an exercise band (to complete the exercise videos). Use of Nurse AMIE while receiving intervention phone calls from a patient navigator. After 90 days, observation begins and the patient will be asked to continue using Nurse AMIE without a patient navigator's presence. |
Experimentell: Delayed Intervention
The delayed intervention group will receive the intervention 3 months after consent (6 months of intervention with 3 months delay total of 9 months); the patient will then follow the same pattern as listed above.
The only difference is we will ask the delayed intervention group to wear a FitBit device for 1 week following consent in order to gain baseline data as to their activity/movement.
|
Patient will receive the tablet, a pedometer (to track their steps) and an exercise band (to complete the exercise videos). Use of Nurse AMIE while receiving intervention phone calls from a patient navigator. After 90 days, observation begins and the patient will be asked to continue using Nurse AMIE without a patient navigator's presence. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Feasibility of the Application: The proportion of women who consent, take a tablet home, who actually interact with the tablet and participate at least one month of the program.
Tidsram: 3 Months
|
Feasibility is defined as the proportion of women who consent, take a tablet home, who actually interact with the tablet and participate at least one month of the program.
|
3 Months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Acceptability of the Application: The proportion of patients who agree to participate among those deemed eligible and cleared by oncologist.
Tidsram: 3 Months
|
The proportion of patients who agree to participate among those deemed eligible and cleared by oncologist.
|
3 Months
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Quality of Life: Short Form 36
Tidsram: Through study completion, an average of 9 months
|
The Short Form 36 Health Survey (SF-36) is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and an abbreviated variant of it. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. |
Through study completion, an average of 9 months
|
Quality of Life: Functional Assessment of Cancer Therapy- Breast
Tidsram: Through study completion, an average of 9 months
|
The Functional Assessment of Cancer Therapy-Breast (FACT-B), is a 44-item self-report instrument designed to measure multidimensional quality of life (QOL) in patients with breast cancer. The FACT-B questionnaire includes 44 items, consisting of 5 subscales, all subscale items are summed to a total. The higher the score the better QOL |
Through study completion, an average of 9 months
|
Physical Function: Short Physical Performance Battery
Tidsram: Through study completion, an average of 9 months
|
Objectively-measured physical function will be assessed using the Short Physical Performance Battery (SPPB).
The SPPB is an accumulation of balance tests, 4-meter gait speed, and 5-chair stands.
Based on the time needed to complete the chair stands, a score is given.
A summation of scores from all tests is taken, ranging from 0 -12.
A higher score = Higher physical function.
|
Through study completion, an average of 9 months
|
Sleep: Sleep Quality Assessment (PSQI)
Tidsram: Through study completion, an average of 9 months
|
Sleep quality and sleep problems will be assessed with the validated and frequently used Pittsburgh Sleep Quality Index (PSQI). In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. |
Through study completion, an average of 9 months
|
Pain: Brief Pain Inventory (Short Form)
Tidsram: Through study completion, an average of 9 months
|
Bodily pain will be assessed using the Brief Pain Inventory- Short form (BPI-SF). The BPI gives two main scores: a pain severity score and a pain interference score. The pain severity score is calculated from the four items about pain intensity. Each item is rated from 0, no pain, to 10, pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40. The pain interference score corresponds to the item on pain interference. The seven sub-items are rated from 0, does not interfere, to 10, completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70. |
Through study completion, an average of 9 months
|
Fatigue: Brief Fatigue Inventory
Tidsram: Through study completion, an average of 9 months
|
The Brief Fatigue Inventory (BFI) is used to rapidly assess the severity and impact of cancer-related fatigue.
An increasing focus on cancer-related fatigue emphasized the need for sensitive tools to assess this most frequently reported symptom.
The six interference items correlate with standard quality-of-life measures.
|
Through study completion, an average of 9 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Kathryn H Schmitz, PhD, Penn State University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- STUDY00011444
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