Oncologic ComplicationsBACKMORE2024NCT06858241
Patient Intake At the 'MOvement and REhabilitation (MO.RE.)
An observational study of Oncologic Complications, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
Trial summary
In recent years, there has been an exponential increase in studies regarding the benefits of physical activity in oncology, with significant results on improving both physical and psychological outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncologic Complications
- How many people
- 95 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2022to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a history of malignant tumor diagnosis, managed by the Oncology and Hematology Units of the USL-IRCCS of Reggio Emilia, who requested a consultation at the MO.RE. clinic between August 2022 and June 2024
Who may be able to join
- Diagnosis of malignant tumor
- Access to the MO.RE. clinic for recommendations on exercise/physical activity
- Age over 18 years
Who cannot join
- Language barrier
- Conditions that prevent the individual from performing physical activity independently
Trial locations and contacts
1 site in 1 country.
Italy1 site
AUSL-IRCCS of Reggio EmiliaOperational Unit of Physical Medicine and Rehabilitation AUSL - IRCCS Reggio Emilia, Reggio Emilia, Emilia Romagna 42123
Reggio Emilia, 42123
About this study
Official title: Patient Intake At the 'MOvement and REhabilitation (MO.RE.)' Clinic: a Retrospective Observational Study on the Appropriateness of Access and the Needs Expressed by Patients. (BACKMORE2024)
In recent years, there has been an exponential increase in studies regarding the benefits of physical activity in oncology, with significant results on improving both physical and psychological outcomes. When appropriately dosed, physical activity can help individuals with a history of cancer to cope with pain and Cancer-Related Fatigue, and improve their quality of life, both during and after cancer treatments.
Given the incidence and prevalence of cancer, along with the increase in survival due to advancements in cancer care, it is becoming increasingly important to promote an active lifestyle.
Read more
For this reason, in August 2022, the MOvement and REhabilitation (MO.RE.) clinic was opened by the S.C. of MFR, dedicated to individuals with a history of cancer at any stage of treatment, with the aim of offering consultations with an experienced physiotherapist to personalize a physical activity program that can help regain a good quality of life, return to daily activities, and prevent the onset of other diseases and recurrences.
The clinic also provides therapeutic education activities, following WHO guidelines, on proper lifestyle for wellness and secondary prevention.
The aim of our study is to retrospectively analyze the patients who requested a consultation at the MO.RE. clinic between August 2022 and June 2024, in order to describe and evaluate the appropriateness of access to the clinic, the expressed needs, and some clinical and rehabilitative data."
- Conditions
- Oncologic Complications
- Keywords
- Onc-hematological patients, Physical Activity, Physical Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients who requested a consultation at the MO.RE. clinic between August 2022 and June 2024 | Patients with a history of malignant tumor diagnosis, managed by the Oncology and Hematology Units that need a MO.RE. clinic consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cancer patients who accessed the MO.RE. service, matching appropriateness criteria
The referral of the patient is considered appropriate, if the patient corresponds to these criteria:
- cancer patient needing information about a personalized physical activity program
- patient with a good performance status evaluated according to ECOG performance status scale (score 0 or 1)
- absence of bone metastases.
Measured: 2 years
Secondary outcomes (5)
Sample description by socio-demographic data
To describe the sample, data will be collected at the first access at MO.RE. service, concerning:
- age (measured in years)
- gender (M/F)
- education level (number of years attending school)
- occupation (descriptive)
- Municipality of residence (distance from hospital).
Measured: 2 years
Sample description by clinical data
To describe the sample, data will be collected at the first access at MO.RE. service, concerning:
- Performance status at the first access to MO.RE. service
- Location of primary tumor
- Ongoing anticancer therapy
- surgery (type of intervention and time elapsed between surgery and access to the MO.RE. service)
- Complications, if any
- Presence of bone metastases
- Description of any ongoing or completed rehabilitation program
- Amount of physical activity pre- and post-cancer diagnosis
- Signs and symptoms related to cancer or anticancer therapies
- patients specific needs
- patient referral (how did patients access MO.RE. service? by oncologist referral, by other patients suggestion, information by social media, other)
Measured: 2 years
Number of cancer patients who needed counselling on physical activity and self-managed exercise after MO.RE. access
At the end of the evaluation at MO.RE. service, a number of empowered cancer patients are able to self-manage physical activity in their life, after receiveing specific information about type, intensity, timing and frequency of appropriate exercise.
Measured: 2 years
Number of cancer patients who needed counselling on physical activity and self-managed exercise after MO.RE. access
At the end of the evaluation at MO.RE. service, a number of cancer patients need a supervision by a physiotherapist, to become able to self-manage physical activity in their life. These patients receive a supervised rehabilitation program, to learn specific type, intensity, timing and frequency of appropriate exercise matching their condition.
Measured: 2 years
Number of cancer patients who needed a physiatrist evaluation before exercise
At the end of the evaluation at MO.RE. service, a number of cancer patients need a physiatrist consultation, to avoid adverse events correlated with bone metastases or because they need a specific medical evaluation before exercise.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start1 Aug 2022
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncologic ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Stefania Fugazzaro, MD, Principal investigator, AUSL-IRCCS of Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858241
- Sponsor's protocol ID
- 299/2024/OSS/AUSLRE
- Acronym
- BACKMORE2024
- Status last verified
- Feb 2025
- First submitted
- 4 Feb 2025
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Intake At the 'MOvement and REhabilitation (MO.RE.)' Clinic: a Retrospective Observational Study on the Appropriateness of Access and the Needs Expressed by Patients. (BACKMORE2024)
- ClinicalTrials.gov ID
- NCT06858241
- Acronym / sponsor ID
- BACKMORE2024 / 299/2024/OSS/AUSLRE
- Conditions
- Oncologic Complications
- Keywords
- Onc-hematological patients, Physical Activity, Physical Exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In recent years, there has been an exponential increase in studies regarding the benefits of physical activity in oncology, with significant results on improving both physical and psychological outcomes. When appropriately dosed, physical activity can help individuals with a history of cancer to cope with pain and Cancer-Related Fatigue, and improve their quality of life, both during and after cancer treatments.
Given the incidence and prevalence of cancer, along with the increase in survival due to advancements in cancer care, it is becoming increasingly important to promote an active lifestyle.
For this reason, in August 2022, the MOvement and REhabilitation (MO.RE.) clinic was opened by the S.C. of MFR, dedicated to individuals with a history of cancer at any stage of treatment, with the aim of offering consultations with an experienced physiotherapist to personalize a physical activity program that can help regain a good quality of life, return to daily activities, and prevent the onset of other diseases and recurrences.
The clinic also provides therapeutic education activities, following WHO guidelines, on proper lifestyle for wellness and secondary prevention.
The aim of our study is to retrospectively analyze the patients who requested a consultation at the MO.RE. clinic between August 2022 and June 2024, in order to describe and evaluate the appropriateness of access to the clinic, the expressed needs, and some clinical and rehabilitative data."
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who requested a consultation at the MO.RE. clinic between August 2022 and June 2024 | – | –Patients with a history of malignant tumor diagnosis, managed by the Oncology and Hematology Units that need a MO.RE. clinic consultation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a history of malignant tumor diagnosis, managed by the Oncology and Hematology Units of the USL-IRCCS of Reggio Emilia, who requested a consultation at the MO.RE. clinic between August 2022 and June 2024
Key inclusion criteria (3 listed)
- Diagnosis of malignant tumor
- Access to the MO.RE. clinic for recommendations on exercise/physical activity
- Age over 18 years
Key exclusion criteria (2 listed)
- Language barrier
- Conditions that prevent the individual from performing physical activity independently
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of cancer patients who accessed the MO.RE. service, matching appropriateness criteria
Time frame: 2 years
The referral of the patient is considered appropriate, if the patient corresponds to these criteria: * cancer patient needing information about a personalized physical activity program * patient with a good performance status evaluated according to ECOG performance status scale (score 0 or 1) * absence of bone metastases.
5 secondary outcomes
Sample description by socio-demographic data
Time frame: 2 years
Sample description by clinical data
Time frame: 2 years
Number of cancer patients who needed counselling on physical activity and self-managed exercise after MO.RE. access
Time frame: 2 years
Number of cancer patients who needed counselling on physical activity and self-managed exercise after MO.RE. access
Time frame: 2 years
Number of cancer patients who needed a physiatrist evaluation before exercise
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefania Fugazzaro, MD principal investigator
AUSL-IRCCS of Reggio Emilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncologic Complications, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cancer patients who accessed the MO.RE. service, matching appropriateness criteria (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.