Trials / Active Not Recruiting
Active Not RecruitingNCT03169075
QUALIOR Feasibility and Efficacy of a Supervised Home-based Standard Physical Exercise Program
Study Evaluating the Feasibility and Efficacy of a Supervised Home-based Standard Physical Exercise Program, for Metastatic Cancer Patients Receiving Oral Targeted Therapy: The UNICANCER SdS 01 QUALIOR Study
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 190 (actual)
- Sponsor
- UNICANCER · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase II-III study will be randomized (2:1) patients starting first-line oral targeted therapies (OTT) for metastatic cancer between an individualized supervised physical exercise programs (SPEP) by a personal coach, and recommended physical exercises via a booklet. Eligible patients will have received ≤2 lines of metastatic chemotherapy, Eastern Cooperative Oncology Group Performance status (ECOG PS) ≤2, controlled pain (visual analogue scale (VAS) \<3/10), and life expectancy ≥3 months.
Conditions
- Home Based Standardised Adapted Physical Activity Programme
- Patients Taking Oral Targeted Therapy for Metastatic Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Supervised physical exercise programs | A weekly supervised physical activity session of 60 min at the patient's home is planned for 3 months. These sessions will be supervised by an educator or physiotherapist trained, with respect to the pathology and the clinical study, specifically for this activity (Fédération Française Sport et Cancer) . The proposed exercises will be normalized and adapted to each patient's profile. Self reported questionnaires: FACT-F, FACT-G, EQ-5D, FAACT module AC/S, FACT-Gog, HADS, IPAQ, Evaluation by a coach VAE |
| BEHAVIORAL | Adapted physical activity | Program based on the recommendations for performing a physical activity. A booklet containing physical activity recommendations will be given to the patients after randomization. The weekly sessions at the patients home for the experimental group (Program A) must begin as soon as possible within the 15 days after starting oral targeted therapy. Self reported questionnaires: FACT-F, FACT-G, EQ-5D, FAACT module AC/S, FACT-Gog, HADS, IPAQ |
Timeline
- Start date
- 2017-07-11
- Primary completion
- 2024-09-30
- Completion
- 2028-07-11
- First posted
- 2017-05-30
- Last updated
- 2024-11-12
Locations
15 sites across 1 country: France
Source: ClinicalTrials.gov record NCT03169075. Inclusion in this directory is not an endorsement.