CancerETAPNCT04665973
Effect of an Oral Therapeutic Patient Education Session on Physical Activity in Patients With Cancer
A study testing Therapeutic patient education : oral semi-structured interview and Therapeutic patient education : booklet (passive) in people with Cancer, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Despite significant evolution of cancer therapies from the early 20th century, these therapies are still associated with toxic effects that negatively impact the patient's performance status, quality of life and survival. The role of physical activity to counteract these side effects is acknowledged. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Cancer
- What is being tested?
- Therapeutic patient education : oral semi-structured interview and Therapeutic patient education : booklet (passive)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteBelgium
- Study dates
- 7 Dec 2020to 29 Jul 2022
- Phase
- Interventional
- 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 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged between 18 and 84 years
- Suffering from a first cancer, with the exception of the following cancers in the patient's history (provided that they have been successfully treated):
- non-melanoma skin cancer,
- carcinoma in situ of the uterine cervix
- ductal carcinoma in situ.
- Preserved performance status (ECOG scale ≤ 1),
Show all 12Show fewer
- Starting one of the following systemic cancer therapies:
- chemotherapy,
- immunotherapy,
- targeted therapies,
- Able to understand and read French
- Life expectancy of at least 1 year
Who cannot join
- Poor cognitive function (Mini-Mental State Examination ≤ 24/30)
- Having a recurrence of cancer, with the exception of the following cancers in the patient's history (provided that they have been successfully treated):
- non-melanoma skin cancer,
- carcinoma in situ of the uterine cervix,
- ductal carcinoma in situ.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Brief Therapeutic Patient Education Session on Physical Activity in Patients at the Onset of Cancer Therapy: A Randomized Controlled Trial
Despite significant evolution of cancer therapies from the early 20th century, these therapies are still associated with toxic effects that negatively impact the patient's performance status, quality of life and survival. The role of physical activity to counteract these side effects is acknowledged. However, cancer patients are often misinformed about the potential benefits of physical therapy during cancer therapy. In this context, the role of therapeutic patient education seems essential.
Because of lack of time, therapeutic patient education (TPE) is often provided via an information booklet. However, the investigators assume that a face-to-face interview results in a greater impact on patient's behavior change (the level of physical activity during cancer therapy, in our case). This research project is designed to challenge this hypothesis. The investigators hypothesize that a brief oral educational session of 30 minutes provided at the very beginning of cancer therapy will enhance the physical activity level of our patients for at least 6 months, i.e. during their cancer therapy.
Read the detailed description
The investigators aim to compare the effects of two forms of TPE on the patient's PA level. In one of the two forms, TPE is delivered using an information booklet accompanied with a semi-structured oral interview (intervention group), whereas in the other form TPE is only delivered via the booklet (control group). The investigators hypothesize that the brief oral educational session of 30 minutes provided at the very beginning of cancer therapy will enhance the PA level of our patients for at least 6 months, i.e. during their cancer therapy.
The study is designed as a double-blind randomized controlled trial. The primary outcome is the evolution in each group of the PA level (via the international physical activity questionnaire (IPAQ) - long form) between the start of cancer therapy and 6-month follow-up.
Eligible patients will be randomly assigned either to the intervention group (TPE includes the information booklet + the semi-structured oral intervention provided by a physiotherapist) or to the control group (TPE will consist only in the information booklet). Patients and assessors will be blinded.
The relative efficacy of these 2 treatment arms will be evaluated at baseline, after 3 months at a visit for a follow-up medical consultation set by the oncologist, and after 6 months at a second follow-up consultation.
- Conditions
- Cancer
- Being tested
- Therapeutic patient education : oral semi-structured interview, Therapeutic patient education : booklet (passive)
- Keywords
- Therapeutic Patient Education, Physical Activity
- 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.
Therapeutic patient education : oral semi-structured interviewBehavioural
The physiotherapist discusses and goes through each page of the booklet and involves the patient as much as possible. He demonstrates the exercises proposed in the booklet and then ask the patient to perform them in front of him. The physiotherapist tries to identify the patient's needs and suggests different ways to ensure that the patient has different opportunities to maintain the best possible level of PA
Therapeutic patient education : booklet (passive)Behavioural
The booklet (11 pages): explains why it is important to maintain a good level of PA as part of cancer treatment and reviews the most common side effects of cancer therapy and the relative importance of PA in combating these effects (pages 2-3) ; defines PA, its modalities and possible security precautions (pages 4-5), suggests exercises to be performed oneself and a target intensity to be reached (pages 6-8), provides a roadmap to be completed oneself (pages 9-10), and outlines procedures for joining an exercise medicine group (page 11).
| Study group | Role | What they receive |
|---|---|---|
| Oral semi-structured interview | Experimental | The oral semi-structured interview uses the principles of motivational interviewing (partnership with the patient, no judgment, altruism, evocation) and follow the content of the booklet used in the control group. Receives: Behavioral: Therapeutic patient education : oral semi-structured interview |
| Booklet | Active comparator | The information booklet was designed by the physiotherapists at Cliniques universitaires Saint-Luc and is specifically dedicated to raise patient's awareness about the benefits of physical activity (PA) in the context of cancer. Receives: Behavioral: Therapeutic patient education : booklet (passive) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in PA level
The PA level will be estimated in MET/h/week via the International Physical Activity Questionnaire (long form) validated in French in subjects aged 18-84 years.
The questionnaire classifies the subject according to 3 activity levels: inactive, moderate, high
Measured: At baseline and 6 months (at the occasion of a second follow-up visit set with the oncologist) after the start of the cancer therapy
Secondary outcomes (8)
Changes in PA level
The PA level will be estimated in MET/h/week via the International Physical Activity Questionnaire (long form) validated in French in subjects aged 18-84 years.
The questionnaire classifies the subject according to 3 activity levels: inactive, moderate, high
Measured: At baseline and 3 months (at the occasion of a first follow-up visit set with the oncologist) after the start of the cancer therapy
Changes in BMI
Body mass index (BMI) is measured as weight (kg) divided by height is meters squared (m²)
Measured: At baseline, 3 months and 6 months after the start of the cancer therapy
Changes in fatigue
Fatigue is measured via the Functional Assessment of Chronic Illness Therapy - Fatigue scale (FACIT-F).
The scale is a 40-item measure that assesses self-reported fatigue and its impact upon daily activities and function.
The total score range from 0 to 160. The lower the score, the higher the fatigue.
Measured: At baseline, 3 months and 6 months after the start of the cancer therapy
Changes in quality of life
Quality of life is measured via the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30).
The QLQ-C30 is composed of both multi-item scales and single-item measures. There are 30 items. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. All single-item measures range in score from 0 to 100.
A high score for a functional scale represents a high / healthy level of functioning, A high score for the global health status / QoL represents a high QoL, A high score for a symptom scale / item represents a high level of symptomatology / problems.
Measured: At baseline, 3 months and 6 months after the start of the cancer therapy
Changes in exercise capacity
Exercise capacity is measured via the 1-minute sit-to-stand test
Measured: At baseline, 3 months and 6 months after the start of the cancer therapy
Changes in handgrip strength test
Handgrip strength test is measured via the JAMAR dynamometer
Measured: At baseline, 3 months and 6 months after the start of the cancer therapy
Number of steps
The number of steps taken weekly via an application (ITO) downloaded on the patient's phone
Measured: At 3 months and 6 months after the start of the cancer therapy
Number of patients entering a group of exercise medicine
The proportion of patient who started a program of exercise medicine will be calculated in each group
Measured: At 6 months after the start of the cancer therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start7 Dec 2020
- Primary completion29 Jul 2022
- Study completion29 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Poncin, PT, PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665973
- Sponsor's protocol ID
- ETAP
- Acronym
- ETAP
- Status last verified
- Apr 2024
- First submitted
- 7 Dec 2020
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Brief Therapeutic Patient Education Session on Physical Activity in Patients at the Onset of Cancer Therapy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04665973
- Acronym / sponsor ID
- ETAP / ETAP
- Conditions
- Cancer
- Keywords
- Therapeutic Patient Education, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- 29 Jul 2022 (actual)
- Study completion
- 29 Jul 2022 (actual)
- First posted
- 14 Dec 2020 (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.
Despite significant evolution of cancer therapies from the early 20th century, these therapies are still associated with toxic effects that negatively impact the patient's performance status, quality of life and survival. The role of physical activity to counteract these side effects is acknowledged. However, cancer patients are often misinformed about the potential benefits of physical therapy during cancer therapy. In this context, the role of therapeutic patient education seems essential.
Because of lack of time, therapeutic patient education (TPE) is often provided via an information booklet. However, the investigators assume that a face-to-face interview results in a greater impact on patient's behavior change (the level of physical activity during cancer therapy, in our case). This research project is designed to challenge this hypothesis. The investigators hypothesize that a brief oral educational session of 30 minutes provided at the very beginning of cancer therapy will enhance the physical activity level of our patients for at least 6 months, i.e. during their cancer therapy.
Detailed description
The investigators aim to compare the effects of two forms of TPE on the patient's PA level. In one of the two forms, TPE is delivered using an information booklet accompanied with a semi-structured oral interview (intervention group), whereas in the other form TPE is only delivered via the booklet (control group). The investigators hypothesize that the brief oral educational session of 30 minutes provided at the very beginning of cancer therapy will enhance the PA level of our patients for at least 6 months, i.e. during their cancer therapy.
The study is designed as a double-blind randomized controlled trial. The primary outcome is the evolution in each group of the PA level (via the international physical activity questionnaire (IPAQ) - long form) between the start of cancer therapy and 6-month follow-up.
Eligible patients will be randomly assigned either to the intervention group (TPE includes the information booklet + the semi-structured oral intervention provided by a physiotherapist) or to the control group (TPE will consist only in the information booklet). Patients and assessors will be blinded.
The relative efficacy of these 2 treatment arms will be evaluated at baseline, after 3 months at a visit for a follow-up medical consultation set by the oncologist, and after 6 months at a second follow-up consultation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral semi-structured interview | Experimental | Behavioral: Therapeutic patient education : oral semi-structured interviewThe oral semi-structured interview uses the principles of motivational interviewing (partnership with the patient, no judgment, altruism, evocation) and follow the content of the booklet used in the control group. |
| Booklet | Active comparator | Behavioral: Therapeutic patient education : booklet (passive)The information booklet was designed by the physiotherapists at Cliniques universitaires Saint-Luc and is specifically dedicated to raise patient's awareness about the benefits of physical activity (PA) in the context of cancer. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adults aged between 18 and 84 years
- Suffering from a first cancer, with the exception of the following cancers in the patient's history (provided that they have been successfully treated):
- Preserved performance status (ECOG scale ≤ 1),
- Starting one of the following systemic cancer therapies:
- Able to understand and read French
Key exclusion criteria (5 listed)
- Poor cognitive function (Mini-Mental State Examination ≤ 24/30)
- Having a recurrence of cancer, with the exception of the following cancers in the patient's history (provided that they have been successfully treated):
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 |
|---|---|---|
| Therapeutic patient education : oral semi-structured interviewThe physiotherapist discusses and goes through each page of the booklet and involves the patient as much as possible. He demonstrates the exercises proposed in the booklet and then ask the patient to perform them in front of him. The physiotherapist tries to identify the patient's needs and suggests different ways to ensure that the patient has different opportunities to maintain the best possible level of PA | Behavioural | Oral semi-structured interview |
| Therapeutic patient education : booklet (passive)The booklet (11 pages): explains why it is important to maintain a good level of PA as part of cancer treatment and reviews the most common side effects of cancer therapy and the relative importance of PA in combating these effects (pages 2-3) ; defines PA, its modalities and possible security precautions (pages 4-5), suggests exercises to be performed oneself and a target intensity to be reached (pages 6-8), provides a roadmap to be completed oneself (pages 9-10), and outlines procedures for joining an exercise medicine group (page 11). | Behavioural | Booklet |
Primary outcome
Changes in PA level
Time frame: At baseline and 6 months (at the occasion of a second follow-up visit set with the oncologist) after the start of the cancer therapy
The PA level will be estimated in MET/h/week via the International Physical Activity Questionnaire (long form) validated in French in subjects aged 18-84 years. The questionnaire classifies the subject according to 3 activity levels: inactive, moderate, high
8 secondary outcomes
Changes in PA level
Time frame: At baseline and 3 months (at the occasion of a first follow-up visit set with the oncologist) after the start of the cancer therapy
Changes in BMI
Time frame: At baseline, 3 months and 6 months after the start of the cancer therapy
Changes in fatigue
Time frame: At baseline, 3 months and 6 months after the start of the cancer therapy
Changes in quality of life
Time frame: At baseline, 3 months and 6 months after the start of the cancer therapy
Changes in exercise capacity
Time frame: At baseline, 3 months and 6 months after the start of the cancer therapy
Changes in handgrip strength test
Time frame: At baseline, 3 months and 6 months after the start of the cancer therapy
Number of steps
Time frame: At 3 months and 6 months after the start of the cancer therapy
Number of patients entering a group of exercise medicine
Time frame: At 6 months after the start of the cancer therapy
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 17 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic patient education : oral semi-structured interview and Therapeutic patient education : booklet (passive) in people with Cancer, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 12 inclusion and 5 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 17 Apr 2024. 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 Belgium. 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?
Changes in PA level (time frame: At baseline and 6 months (at the occasion of a second follow-up visit set with the oncologist) after the start of the cancer therapy). 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 17 Apr 2024.