Cancer RehabilitationOnkoREHABNCT06945757
Evaluation of an Oncological Rehabilitation Program as Part of the Promotion of Therapeutic Physical Activity in Adults Cancer Patients
An observational study of Cancer Rehabilitation, run by Andrea Fontana at 1 site in Switzerland.
Trial summary
It is estimated that there were 19.3 million newly diagnosed cancer cases and almost 10 million cancer-related deaths globally in 2020. Despite the numerous advances in cancer treatment, cancer incidence and mortality have been increasing over the years, thus making cancer one of the greatest health threats to human… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer Rehabilitation
- What is being tested?
- Physical Exercise
- How many people
- 250 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2025to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Oncological Patients
Who may be able to join
- Male or female patients, with an history of malignancy, who are going to start, are currently undergoing primary cancer treatment or just ended their oncological treatment, independent of cancer type.
- Age between 18 and 80 years.
- Available 2 days per week all along the program duration.
Who cannot join
- Major foreseeable risk of impossibility to participate in the session due to therapeutic toxicities or other reasons that may lead to a sustainable lack of compliance incompatible with the continuation of the program.
- Patients not having a full decisional capacity
- Patients not able to maintain a satisfactory professional or personal aptitude during the program.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Luzerner Kantonsspital
Lucerne, Canton of Lucerne, 6004
ANDREA ORLANDO Fontana, 0795472905, andrea.o.fontana@gmail.com
About this study
It is estimated that there were 19.3 million newly diagnosed cancer cases and almost 10 million cancer-related deaths globally in 2020. Despite the numerous advances in cancer treatment, cancer incidence and mortality have been increasing over the years, thus making cancer one of the greatest health threats to human beings.
In recent decades, the advent of novel therapies in cancer has significantly prolonged the survival of oncological patients, yet many of these individuals are left with residual deficits, particularly motor and neurological, as well as cancer-related fatigue and depression.
Read more
Exercise-based cancer rehabilitation is one of the main strategies which has been proved to be an effective way to improve the quality of life of cancer survivors. There are three main types of exercise training included as part of cancer rehabilitation: resistance exercise, aerobic exercise, and the combination of both. Furthermore, cognitive, and psychological support during this period might have a synergistic effect with physical activity.
Although rehabilitation procedures are very well established after cardiovascular and neurological events, such as myocardial infarction or stroke, their role in oncology has only marginally been investigated nor completely accepted by the medical community. Nevertheless, cumulating evidence with clinical experience suggests that physical activity has emerged as an important complementary supportive care for cancer patients and can improve the care of patients with cancer and their quality of life.
General clinical guidelines recommend that cancer rehabilitation begins ideally at the time of cancer diagnosis and continues through and beyond cancer treatment, but this is rarely done in clinical practice.There has been an effort to conduct qualitative studies to evaluate the effects of physical activity on cancer patients, with a particular focus on factors influencing an active lifestyle in cancer patients during or right after conclusion of oncological treatments. Most of these studies have been regrouping patients with a specific cancer type, with a particular focus on breast cancer. Nevertheless, it is relatively difficult to gain evidence from single qualitative studies on it owns, mostly due to the variety of qualitative methodologies employed and the lack of consistent results.
The principal aim of cancer rehabilitation is to help patients regain functioning, promote their independence and to increase their social participation, no matter how long or short the timescale. To evaluate and optimize rehabilitation, it is therefore very important to measure its outcomes in a structured and reproducible way. In recent exercise guidelines, most of the available evidence on the efficacy of oncology rehabilitation is derived from randomized controlled trials (RCTs), which have strengthened the body of proof for the efficacy of exercise in cancer rehabilitation, but on the other side they have been reported to lack generalizability to the clinical setting. In these trials, patients often must meet pre-specified criteria (e.g., diagnosis, disease stage, age) to be eligible for enrolment in RCTs and must give consent to participate. This might bias results toward a healthier, fitter, and more motivated population, which may not be comparable to a broader population of cancer survivors. While RCTs have the most powerful study design to investigate the efficacy of rehabilitation in a specific population under ideal circumstances, observational studies may be more appropriate to evaluate interventions in daily practice and in more heterogeneous populations with complex, chronic diseases such as cancer.
A major determinant of functional capacity is exercise behaviour. The beneficial effects of physical exercise have been shown to improve multiple aspects of health in cancer survivors, including quality of life, fatigue, as well as all cause and cancer specific mortality.
Physical impairments and psychosocial symptoms should be assessed and treated concomitantly, and lifestyle and exercise interventions provided to optimize functioning and quality of life (QoL). Quality of life can be defined as a multidimensional structure that reflects a person's subjective evaluation of their well-being and functioning across multiple life domains, and each of these should be specifically addressed by cancer support services. According to Ferrans, five dimensions of QoL have been described: physical; functional; psychological/emotional; social; and spiritual. Ideally, all these dimensions should be explored in cancer patients in relation to exercise.
Metanalysis across several studies have shown that patients noticed consistent improvements in their physical and psychological functioning and health. Furthermore, many patients have reported that exercise has helped them to better manage the physical consequences of cancer and its treatment, contributing to their overall fitness.
Read the detailed description
The aim of this study is to evaluate the feasibility, acceptability, and effectiveness of a 12-weeks rehabilitation program on cancer patients currently undergoing or having just completed any type of oncological treatment.
- Conditions
- Cancer Rehabilitation
- Being tested
- Physical Exercise
- Keywords
- Cancer, physical activity, rehabilitation
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ExerciseOther
Patients will participate in the routine rehabilitation program for 12 weeks, consisting of two 1h30 one-to-one sessions per week of physical activity administered by experienced physical therapist. Both sessions of the week are tailored to the need of the individual participant and are typically structured as follow:
- 10 minutes of warming up by light exercises
- 20 minutes of coordination exercises
- 20 minutes of strengths exercises
- 20 minutes of mobility exercises
- 10-15 minutes of cool down and stretching
Patients will further benefit during the 12-weeks program of several individual encounters with a psycho-oncologist, a nurse specialized in cognitive support and a nutritionist. Furthermore, a dietician will conduct an introductory evaluation, several intermediate evaluations and a final evaluation on nutritional status and habits of the patients.
| Study group | Role | What they receive |
|---|---|---|
| Patients starting, undergoing or having completed chemotherapy | Not described Receives: Other: Physical Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Assessment of Cancer Therapy
The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire designed to measure quality of life. The FACT-G measures five domains of quality of life: physical well-being, social/family well-being, relationship with physician, emotional well-being, and functional well-being. Scoring the FACT-G is performed through a simple sum of item scores. Each subscale is scored, and a total score for the FACT-G is obtained by adding each of the subscale scores. Higher scores for the scales and subscales indicate better quality of life in cancer patients.
Measured: 36 months
Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale (HADS), has been developed to identify caseness (possible and probable) of anxiety disorders and depression among patients in non-psychiatric hospital clinics. Concretely, it is subdivided into an Anxiety subscale (HADS-A) and a Depression subscale (HADS-D) both containing seven intermingled items. A score ≤7 corresponds to "no depression or anxiety," a score of 8-10 is a minor depression/anxiety, a score of 11-15 a moderate depression/anxiety and a score ≥16 is defined as severe depression/anxiety
Measured: 36 months
Questionnaire on Distress in Cancer Patients Short-From-QSC-R10 (FBK-R10)
The "Questionnaire on Distress in Cancer Patients Short-From-QSC-R10" (FBK-R10) is a short questionnaire designed to measure psychological distress and burden of cancer patient. It is particularly focused on emotional distress of oncological patients. It comprises ten individual questions from the five areas: psychosomatic distress, anxiety, restrictions in everyday life, social distress and information deficit. In relation to each individual question, the patient states whether the situation applies to them and, if it does, the extent to which they feel burdened by it (rating scale from 0-5). The FBK-R10 is evaluated by summing up the indicated load strengths of the individual questions, with a possible score between 0 and 50. A Score > 14 points means positive screening for psychosocial distress.
Measured: 36 months
Multidimensional Fatigue Inventory
The Multidimensional Fatigue Inventory (MFI) is a 20-item scale designed to assess the severity of fatigue experienced by cancer patients, as well as its impact on their ability to function33. It is designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. It can be administered in a clinical setting as part of patient screening processes and may also be useful for clinical trials. As a short scale that can be rapidly administered and easily understood, the MFI is designed to be well tolerated by patients suffering even the most severe degrees of fatigue.
Measured: 36 months
Scored Patient-Generated Subjective Global Assessment
The Patient-Generated Subjective Global Assessment (PG-SGA) is a patient reported instrument for assessment of nutrition status in patients with cancer, as many patients have nutritional issues during or after competing their treatment regime34. It has been well characterized in patients undergoing chemo- and radiation therapy.
Measured: 36 months
Secondary outcomes (4)
Physiological Effects of Training
Physical outcomes evaluating performance will be assessed at the beginning of the 12-weeks program and immediately after completion of the program.
Test 1: Sit-and-stand test
The 60 Seconds Sit-to-Stand Test investigates the ability to stand up from a sitting position. The test typically assesses the maximum number of times a subject can stand up and sit down on a regular chair in each period, usually 60 Seconds.
Test 2: Body Composition
Body composition will be assessed by bioimpedance analysis (BIA), an electrical method of assessing human body composition with the potential of quantifying total body water, fluid volumes, body cell mass, and fat-free body mass.
Test 3: Hand Grip Strength The Hand Grip strength will be assessed using a handgrip dynamometer. It measures the maximum isometric strength of the hand and forearm muscles, and research has shown that it may have use as a prognostic indicator for health outcomes, including cognition, mobility, functional status.
Measured: 36 months
Patient Satisfaction Questionnaire
Patients will be asked to complete an in-depth questionnaire including closed and open-ended questions about their experience of the program to assess patient satisfaction at the end of the 12-weeks program.
Measured: 36 months
6 Months Follow-Up Questionnaire
6 months after completion of the 12-weeks program, patients will be asked to complete an in-depth questionnaire including closed and open-ended questions about their current situation, including well-being and current participation in physical activities.
Measured: 36 months
Collection of Socio-Economical Data over 12 Months after completion of the program
Patients socio-economical, demographic and health data are routinely collected. We will prospectively analyse patients' health data up to 12 months after completion of the program to defer health economics parameters that might help improve guidelines for physical activity in cancer patients.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start1 Mar 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer RehabilitationStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrea Fontana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrea Fontana, Luzerner Kantonsspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945757
- Sponsor's protocol ID
- OnkoREHAB
- Acronym
- OnkoREHAB
- Status last verified
- Apr 2025
- First submitted
- 8 Jan 2025
- Last updated
- 25 Apr 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 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Oncological Rehabilitation Program as Part of the Promotion of Therapeutic Physical Activity in Adults Cancer Patients
- ClinicalTrials.gov ID
- NCT06945757
- Acronym / sponsor ID
- OnkoREHAB / OnkoREHAB
- Conditions
- Cancer Rehabilitation
- Keywords
- Cancer, physical activity, rehabilitation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Andrea FontanaUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 25 Apr 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.
It is estimated that there were 19.3 million newly diagnosed cancer cases and almost 10 million cancer-related deaths globally in 2020. Despite the numerous advances in cancer treatment, cancer incidence and mortality have been increasing over the years, thus making cancer one of the greatest health threats to human beings.
In recent decades, the advent of novel therapies in cancer has significantly prolonged the survival of oncological patients, yet many of these individuals are left with residual deficits, particularly motor and neurological, as well as cancer-related fatigue and depression.
Exercise-based cancer rehabilitation is one of the main strategies which has been proved to be an effective way to improve the quality of life of cancer survivors. There are three main types of exercise training included as part of cancer rehabilitation: resistance exercise, aerobic exercise, and the combination of both. Furthermore, cognitive, and psychological support during this period might have a synergistic effect with physical activity.
Although rehabilitation procedures are very well established after cardiovascular and neurological events, such as myocardial infarction or stroke, their role in oncology has only marginally been investigated nor completely accepted by the medical community. Nevertheless, cumulating evidence with clinical experience suggests that physical activity has emerged as an important complementary supportive care for cancer patients and can improve the care of patients with cancer and their quality of life.
General clinical guidelines recommend that cancer rehabilitation begins ideally at the time of cancer diagnosis and continues through and beyond cancer treatment, but this is rarely done in clinical practice.There has been an effort to conduct qualitative studies to evaluate the effects of physical activity on cancer patients, with a particular focus on factors influencing an active lifestyle in cancer patients during or right after conclusion of oncological treatments. Most of these studies have been regrouping patients with a specific cancer type, with a particular focus on breast cancer. Nevertheless, it is relatively difficult to gain evidence from single qualitative studies on it owns, mostly due to the variety of qualitative methodologies employed and the lack of consistent results.
The principal aim of cancer rehabilitation is to help patients regain functioning, promote their independence and to increase their social participation, no matter how long or short the timescale. To evaluate and optimize rehabilitation, it is therefore very important to measure its outcomes in a structured and reproducible way. In recent exercise guidelines, most of the available evidence on the efficacy of oncology rehabilitation is derived from randomized controlled trials (RCTs), which have strengthened the body of proof for the efficacy of exercise in cancer rehabilitation, but on the other side they have been reported to lack generalizability to the clinical setting. In these trials, patients often must meet pre-specified criteria (e.g., diagnosis, disease stage, age) to be eligible for enrolment in RCTs and must give consent to participate. This might bias results toward a healthier, fitter, and more motivated population, which may not be comparable to a broader population of cancer survivors. While RCTs have the most powerful study design to investigate the efficacy of rehabilitation in a specific population under ideal circumstances, observational studies may be more appropriate to evaluate interventions in daily practice and in more heterogeneous populations with complex, chronic diseases such as cancer.
A major determinant of functional capacity is exercise behaviour. The beneficial effects of physical exercise have been shown to improve multiple aspects of health in cancer survivors, including quality of life, fatigue, as well as all cause and cancer specific mortality.
Physical impairments and psychosocial symptoms should be assessed and treated concomitantly, and lifestyle and exercise interventions provided to optimize functioning and quality of life (QoL). Quality of life can be defined as a multidimensional structure that reflects a person's subjective evaluation of their well-being and functioning across multiple life domains, and each of these should be specifically addressed by cancer support services. According to Ferrans, five dimensions of QoL have been described: physical; functional; psychological/emotional; social; and spiritual. Ideally, all these dimensions should be explored in cancer patients in relation to exercise.
Metanalysis across several studies have shown that patients noticed consistent improvements in their physical and psychological functioning and health. Furthermore, many patients have reported that exercise has helped them to better manage the physical consequences of cancer and its treatment, contributing to their overall fitness.
Detailed description
The aim of this study is to evaluate the feasibility, acceptability, and effectiveness of a 12-weeks rehabilitation program on cancer patients currently undergoing or having just completed any type of oncological treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients starting, undergoing or having completed chemotherapy | – | Other: Physical Exercise |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Oncological Patients
Key inclusion criteria (3 listed)
- Male or female patients, with an history of malignancy, who are going to start, are currently undergoing primary cancer treatment or just ended their oncological treatment, independent of cancer type.
- Age between 18 and 80 years.
- Available 2 days per week all along the program duration.
Key exclusion criteria (3 listed)
- Major foreseeable risk of impossibility to participate in the session due to therapeutic toxicities or other reasons that may lead to a sustainable lack of compliance incompatible with the continuation of the program.
- Patients not having a full decisional capacity
- Patients not able to maintain a satisfactory professional or personal aptitude during the program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical ExercisePatients will participate in the routine rehabilitation program for 12 weeks, consisting of two 1h30 one-to-one sessions per week of physical activity administered by experienced physical therapist. Both sessions of the week are tailored to the need of the individual participant and are typically structured as follow: * 10 minutes of warming up by light exercises * 20 minutes of coordination exercises * 20 minutes of strengths exercises * 20 minutes of mobility exercises * 10-15 minutes of cool down and stretching Patients will further benefit during the 12-weeks program of several individual encounters with a psycho-oncologist, a nurse specialized in cognitive support and a nutritionist. Furthermore, a dietician will conduct an introductory evaluation, several intermediate evaluations and a final evaluation on nutritional status and habits of the patients. | Other | Patients starting, undergoing or having completed chemotherapy |
Primary outcome
Functional Assessment of Cancer Therapy
Time frame: 36 months
The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire designed to measure quality of life. The FACT-G measures five domains of quality of life: physical well-being, social/family well-being, relationship with physician, emotional well-being, and functional well-being. Scoring the FACT-G is performed through a simple sum of item scores. Each subscale is scored, and a total score for the FACT-G is obtained by adding each of the subscale scores. Higher scores for the scales and subscales indicate better quality of life in cancer patients.
Hospital Anxiety and Depression Scale
Time frame: 36 months
The Hospital Anxiety and Depression Scale (HADS), has been developed to identify caseness (possible and probable) of anxiety disorders and depression among patients in non-psychiatric hospital clinics. Concretely, it is subdivided into an Anxiety subscale (HADS-A) and a Depression subscale (HADS-D) both containing seven intermingled items. A score ≤7 corresponds to "no depression or anxiety," a score of 8-10 is a minor depression/anxiety, a score of 11-15 a moderate depression/anxiety and a score ≥16 is defined as severe depression/anxiety
Questionnaire on Distress in Cancer Patients Short-From-QSC-R10 (FBK-R10)
Time frame: 36 months
The "Questionnaire on Distress in Cancer Patients Short-From-QSC-R10" (FBK-R10) is a short questionnaire designed to measure psychological distress and burden of cancer patient. It is particularly focused on emotional distress of oncological patients. It comprises ten individual questions from the five areas: psychosomatic distress, anxiety, restrictions in everyday life, social distress and information deficit. In relation to each individual question, the patient states whether the situation applies to them and, if it does, the extent to which they feel burdened by it (rating scale from 0-5). The FBK-R10 is evaluated by summing up the indicated load strengths of the individual questions, with a possible score between 0 and 50. A Score > 14 points means positive screening for psychosocial distress.
Multidimensional Fatigue Inventory
Time frame: 36 months
The Multidimensional Fatigue Inventory (MFI) is a 20-item scale designed to assess the severity of fatigue experienced by cancer patients, as well as its impact on their ability to function33. It is designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. It can be administered in a clinical setting as part of patient screening processes and may also be useful for clinical trials. As a short scale that can be rapidly administered and easily understood, the MFI is designed to be well tolerated by patients suffering even the most severe degrees of fatigue.
Scored Patient-Generated Subjective Global Assessment
Time frame: 36 months
The Patient-Generated Subjective Global Assessment (PG-SGA) is a patient reported instrument for assessment of nutrition status in patients with cancer, as many patients have nutritional issues during or after competing their treatment regime34. It has been well characterized in patients undergoing chemo- and radiation therapy.
4 secondary outcomes
Physiological Effects of Training
Time frame: 36 months
Patient Satisfaction Questionnaire
Time frame: 36 months
6 Months Follow-Up Questionnaire
Time frame: 36 months
Collection of Socio-Economical Data over 12 Months after completion of the program
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 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.
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 Cancer Rehabilitation, run by Andrea Fontana at 1 site in Switzerland.
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 3 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: looking for participants now, as of the sponsor's last update on 25 Apr 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea O Fontana, MD PhD (+41795472905, andrea.fontana@luks.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Assessment of Cancer Therapy (time frame: 36 months). The study lists 5 primary outcomes in all. 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 25 Apr 2025.