IMpact of PRehabilitation in Oncology Via Exercise - Breast Cancer
Sleutelwoorden
Abstract
Datums
| Laatst geverifieerd: | 12/31/2019 |
| Eerste ingediend: | 02/20/2018 |
| Geschatte inschrijving ingediend: | 04/05/2018 |
| Eerst geplaatst: | 04/12/2018 |
| Laatste update ingediend: | 01/06/2020 |
| Laatste update geplaatst: | 01/08/2020 |
| Werkelijke startdatum van het onderzoek: | 10/14/2017 |
| Geschatte primaire voltooiingsdatum: | 06/30/2019 |
| Geschatte voltooiingsdatum van het onderzoek: | 06/30/2019 |
Conditie of ziekte
Interventie / behandeling
Behavioral: Exercise
Behavioral: Prehabilitation Education
Fase
Armgroepen
| Arm | Interventie / behandeling |
|---|---|
| Experimental: Partly Supervised Prehabilitation Will be offered an initial one week (5 days for 3 hours each) supervised exercise prehabilitation program including a two hour group-based prehabilitation class at Penn State Rehabilitation Hospital, Hummelstown. The following weeks till surgery the learned exercise program should be done home-based for 5 times a week. A weekly phone call during this period will help to support and adapt the exercise program. | |
| Active Comparator: Home-based Prehabilitation Will be offered an individual one-on-one appointment for an exercise introduction session with an exercise and cancer specialist and weekly phone calls to support and adapt the exercise program. The exercises should be done home-based for 5 times a week until the time of surgery. Furthermore, a two hour group-based prehabilitation class at the Penn State Hershey Cancer Institute will be offered. | |
| Active Comparator: Control Group Will be offered a two hour group-based prehabilitation class at the Penn State Hershey Cancer Institute. | |
| No Intervention: Comparison group- women too active Added comparison group: Women who are ineligible on the basis of 'engaging in systematic intense exercise training (at least 1h twice a week) will be recruited to complete measures only, with no randomization |
Geschiktheidscriteria
| Leeftijden die in aanmerking komen voor studie | 18 Years Naar 18 Years |
| Geslachten die in aanmerking komen voor studie | All |
| Accepteert gezonde vrijwilligers | Ja |
| Criteria | Inclusion Criteria: - Unilateral or bilateral primary carcinoma of the breast, confirmed histologically by core biopsy - Not metastatic (stage <4) - Females and males ≥18 years of age - Fluent in written and spoken English - Must be able to provide and understand informed consent - Must have an ECOG PS of ≤ 2 - Scheduled for lump- or mastectomy at Penn State Cancer Institute - ≥ 2 weeks till primary treatment - Primary attending surgeon approval Exclusion Criteria: - Receiving neoadjuvant chemotherapy, radiotherapy or hormone therapy - Not fluent in written and spoken English - Evidence in the medical record of an absolute contraindication (e.g. Heart insufficiency > NYHA III or uncertain arrhythmia; uncontrolled hypertension; severe renal dysfunction (GFR < 30%, Creatinine> 3mg/dl; insufficient hematological capacity like either hemoglobin value below 8 g/dl or thrombocytes below 30.000/µL; reduced standing or walking ability) for exercise - Pregnant women - Engaging in systematic intense exercise training (at least 1h twice per week) |
Resultaat
Primaire uitkomstmaten
1. Safety of the exercise intervention (assessed by standardized questionnaire) [Through study intervention, an average of 3 weeks]
2. Feasibility of the exercise intervention (assessed via exercise logs) [Through study intervention, an average of 3 weeks]
3. Acceptability of the exercise intervention (assessed via patient flow diagram) [During Recruitment till first intervention is delivered (with one week after enrolment)]
Secundaire uitkomstmaten
1. Health-Related Quality of Life: EORTC QLQ-C30, version 3.0 [Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery]
2. Breast cancer-related symptoms and quality of Life [Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery]
3. Fatigue [Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery]
4. Sleep [Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery]
5. Depression [Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery]
6. Shoulder Problems [Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery]
7. Physical activity behavior [Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery]
8. Symptoms [Weekly from baseline to 6 weeks after Surgery]
