Hematological CancerNCT05486273
Evaluation of the Impact of Sports-inspired Onco-coaching on Health-related Quality's Life of the Patients in Cancer Remission After Allogeneic Transplantation of Hematopoietic Stem Cells
A study testing interviews with coachs, semi-structured interviews and questionnaires and semi-structured interviews and questionnaires in people with Hematological Cancer, run by Institut Paoli-Calmettes.
Trial summary
To measure the impact of a coaching program on the patient's health-related quality of life 15 months post-transplant (M15/R12). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematological Cancer
- What is being tested?
- interviews with coachs, semi-structured interviews and questionnaires and semi-structured interviews and questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2023to 2 Jan 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 18 years of age and have a good understanding and practice of the French language,
- Have been treated by an allogeneic hematopoietic stem cell transplant
- Signed consent to participate,
- Affiliation with a social security plan, or beneficiary of such a plan.
Who cannot join
- Patients under treatment for complications (infections, GvHD,...) except patients with cGvHD requiring corticosteroid therapy less than or equal to 1 mg/kg daily
- Patient with progressive or relapsing hematological disease,
- Person in an emergency situation, adult under legal protection (guardianship, curatorship or safeguard of justice), or unable to express his/her consent,
- Person requiring psychotherapeutic care
- Impossibility to submit to the follow-up of the trial for geographical, social or psychological reasons.
Trial locations and contacts
No sites are listed yet.
Allison ARTHUR contact
About this study
Official title: Evaluation of the Impact of Sports-inspired Onco-coaching on Health-related Quality's Life of the Patients in Cancer Remission After Allogeneic Transplantation of Hematopoietic Stem Cells : a Randomized Controlled Trial REBOND2-IPC 2022-009
To measure the impact of a coaching program on the patient's health-related quality of life 15 months post-transplant (M15/R12).
Read the detailed description
After signing the consent form and validating the inclusion and non-inclusion criteria, patients will be included in the study. They will be randomized unequally (2:1) into one of the study groups:
- OC (Onco-Coaching) group: patients will undergo onco-coaching sessions at a rate of 1 session/month until 6 months post-inclusion (M9/R6). 73 patients will be randomized in this group
- Group C (Control): Patients will not receive onco-coaching follow-up, but will be able to benefit from classical management in full autonomy. 35 patients will be randomized in this group
- Conditions
- Hematological Cancer
- Being tested
- interviews with coachs, semi-structured interviews and questionnaires, semi-structured interviews and questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interviews with coachs, semi-structured interviews and questionnairesOther
You will be offered 6 coaching sessions at a rate of one session per month and the first interview will be conducted on the day of inclusion or within one month of inclusion, the others will take place at R6 and R12. Questionnaires will be administered on the day of inclusion and then at R1, R6, R9 and R12. RO is the day of inclusion and it corresponds to M3 (3 months post transplant)
semi-structured interviews and questionnairesOther
The first interview will be conducted on the day of inclusion or within one month of inclusion, the others will take place at R6 and R12.Questionnaires will be administered on the day of inclusion and then at R1, R6, R9 and R12. RO is the day of inclusion and it corresponds to M3 (3 months post transplant)
| Study group | Role | What they receive |
|---|---|---|
| Groupe OC (Onco-Coaching) | Experimental | You will be offered 6 coaching sessions at a rate of one session per month. The first session will take place in the month following your inclusion in the study.
The study also includes the evaluation, by quality of life questionnaires, of the well-being variables (Self-efficacy, Capabilities, PANAS and Life Satisfaction, Hope, Anxiety and Depression in hospital, Subjective well-being and Health benefit).
They should be completed at the time of inclusion in the protocol at 1, 3, 6, 9 and 12 months after inclusion. The purpose of these interviews is to ask more specific questions about the impact of the program. Receives: Other: interviews with coachs, semi-structured interviews and questionnaires |
| Groupe C (Contrôle) | Active comparator | the patient will have standard management including also questionnaires and semi-structured interviews within the same time frame as the experimental arm. Receives: Other: semi-structured interviews and questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the impact of a coaching program on the patient's health-related quality of life 15 months post-transplant (M15/R12).
evolution over time of the FACT-BMT( Functional Assessment of Cancer Therapy - Bone Marrow Transplantation) score during the first 15 months after transplantation the highest score corresponds to a worse condition of the patient.the value are between 0 and 200
Measured: from inclusion(RO=M3) to R12( Month 15 =12 month post inclusion)
Secondary outcomes (6)
To measure the impact of a coaching program on patient quality of life sub-dimensions 15 months post-transplant (M15/R12).
evolution of the FACT-BMT(Functional Assessment of Cancer Therapy - Bone Marrow Transplantation) score up to R12 evolution over time of sub-scores related to physical well-being, social well-being, functional well-being and relationship with the physician.the quality of life is a questionnaire with scores ranging from 5 to 20
Measured: from inclusion(RO=M3) to R12(Month15 =12 month post inclusion)
Measure the impact of a coaching program on the patient's empowerment (capabilities, subjective well-being, hope and self-efficacy).
evolution over time of self-efficacy (the higher the score, the better the efficiency), capability, subjective well-being and hope scores
Measured: from inclusion(RO=M3) to R12(Month15 =12 month post inclusion)
Measure the impact of a coaching program on reducing emotional distress.
changes over time in HADS scores (Hospital Anxiety and Depression Scale)the highest score corresponds to high anxiety and depression the value are between 0 and 21 but if the patient has a score higher than 11, he is suffering from anxiety or depression
Measured: from inclusion(RO=M3) to R12(Month 15 =12 month post inclusion)
Evaluate the cost-utility of the coaching program.
incremental cost-effectiveness ratio (QALYs)
Measured: from inclusion(RO=M3) to R12(Month15 =12 month post inclusion)
Assess correlations between quality of life and patient empowerment
evolution over time of the patient's speech (semi-directive interviews)
Measured: from inclusion(RO=M3) to R12(Month15 =12 month post inclusion)
Assess the overall survival of participants
measure the overall survival rate at M15/R12
Measured: from inclusion(RO=M3) to R12(Month15 =12 month post inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start2 Jan 2023 (estimated)
- Primary completion2 Jan 2026 (estimated)
- Study completion2 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological CancerStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- They will be randomized unequally (2:1) into one of the study groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Didier BLAISE, Pr, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486273
- Sponsor's protocol ID
- REBOND2-IPC 2022-009
- Status last verified
- Aug 2022
- First submitted
- 28 Jul 2022
- Last updated
- 26 Oct 2022
- 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 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Sports-inspired Onco-coaching on Health-related Quality's Life of the Patients in Cancer Remission After Allogeneic Transplantation of Hematopoietic Stem Cells : a Randomized Controlled Trial REBOND2-IPC 2022-009
- ClinicalTrials.gov ID
- NCT05486273
- Acronym / sponsor ID
- REBOND2-IPC 2022-009
- Conditions
- Hematological Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 2 Jan 2023 (estimated)
- Primary completion
- 2 Jan 2026 (estimated)
- Study completion
- 2 Jan 2026 (estimated)
- First posted
- 3 Aug 2022 (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.
To measure the impact of a coaching program on the patient's health-related quality of life 15 months post-transplant (M15/R12).
Detailed description
After signing the consent form and validating the inclusion and non-inclusion criteria, patients will be included in the study. They will be randomized unequally (2:1) into one of the study groups:
- OC (Onco-Coaching) group: patients will undergo onco-coaching sessions at a rate of 1 session/month until 6 months post-inclusion (M9/R6). 73 patients will be randomized in this group
- Group C (Control): Patients will not receive onco-coaching follow-up, but will be able to benefit from classical management in full autonomy. 35 patients will be randomized in this group
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- They will be randomized unequally (2:1) into one of the study groups
| Arm | Type | Receives |
|---|---|---|
| Groupe OC (Onco-Coaching) | Experimental | Other: interviews with coachs, semi-structured interviews and questionnairesYou will be offered 6 coaching sessions at a rate of one session per month. The first session will take place in the month following your inclusion in the study. The study also includes the evaluation, by quality of life questionnaires, of the well-being variables (Self-efficacy, Capabilities, PANAS and Life Satisfaction, Hope, Anxiety and Depression in hospital, Subjective well-being and Health benefit). They should be completed at the time of inclusion in the protocol at 1, 3, 6, 9 and 12 months after inclusion. The purpose of these interviews is to ask more specific questions about the impact of the program. |
| Groupe C (Contrôle) | Active comparator | Other: semi-structured interviews and questionnairesthe patient will have standard management including also questionnaires and semi-structured interviews within the same time frame as the experimental arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be at least 18 years of age and have a good understanding and practice of the French language,
- Have been treated by an allogeneic hematopoietic stem cell transplant
- Signed consent to participate,
- Affiliation with a social security plan, or beneficiary of such a plan.
Key exclusion criteria (5 listed)
- Patients under treatment for complications (infections, GvHD,...) except patients with cGvHD requiring corticosteroid therapy less than or equal to 1 mg/kg daily
- Patient with progressive or relapsing hematological disease,
- Person in an emergency situation, adult under legal protection (guardianship, curatorship or safeguard of justice), or unable to express his/her consent,
- Person requiring psychotherapeutic care
- Impossibility to submit to the follow-up of the trial for geographical, social or psychological reasons.
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 |
|---|---|---|
| interviews with coachs, semi-structured interviews and questionnairesYou will be offered 6 coaching sessions at a rate of one session per month and the first interview will be conducted on the day of inclusion or within one month of inclusion, the others will take place at R6 and R12. Questionnaires will be administered on the day of inclusion and then at R1, R6, R9 and R12. RO is the day of inclusion and it corresponds to M3 (3 months post transplant) | Other | Groupe OC (Onco-Coaching) |
| semi-structured interviews and questionnairesThe first interview will be conducted on the day of inclusion or within one month of inclusion, the others will take place at R6 and R12.Questionnaires will be administered on the day of inclusion and then at R1, R6, R9 and R12. RO is the day of inclusion and it corresponds to M3 (3 months post transplant) | Other | Groupe C (Contrôle) |
Primary outcome
To measure the impact of a coaching program on the patient's health-related quality of life 15 months post-transplant (M15/R12).
Time frame: from inclusion(RO=M3) to R12( Month 15 =12 month post inclusion)
evolution over time of the FACT-BMT( Functional Assessment of Cancer Therapy - Bone Marrow Transplantation) score during the first 15 months after transplantation the highest score corresponds to a worse condition of the patient.the value are between 0 and 200
6 secondary outcomes
To measure the impact of a coaching program on patient quality of life sub-dimensions 15 months post-transplant (M15/R12).
Time frame: from inclusion(RO=M3) to R12(Month15 =12 month post inclusion)
Measure the impact of a coaching program on the patient's empowerment (capabilities, subjective well-being, hope and self-efficacy).
Time frame: from inclusion(RO=M3) to R12(Month15 =12 month post inclusion)
Measure the impact of a coaching program on reducing emotional distress.
Time frame: from inclusion(RO=M3) to R12(Month 15 =12 month post inclusion)
Evaluate the cost-utility of the coaching program.
Time frame: from inclusion(RO=M3) to R12(Month15 =12 month post inclusion)
Assess correlations between quality of life and patient empowerment
Time frame: from inclusion(RO=M3) to R12(Month15 =12 month post inclusion)
Assess the overall survival of participants
Time frame: from inclusion(RO=M3) to R12(Month15 =12 month post inclusion)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- 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.
Allison ARTHUR contact
Didier BLAISE, Pr principal investigator
Institut Paoli-Calmettes
Questions about this trial
What is this clinical trial studying?
A study testing interviews with coachs, semi-structured interviews and questionnaires and semi-structured interviews and questionnaires in people with Hematological Cancer, run by Institut Paoli-Calmettes.
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 4 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: status not confirmed, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominique GENRE, Dr (0491223778, drci.up@ipc.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the impact of a coaching program on the patient's health-related quality of life 15 months post-transplant (M15/R12). (time frame: from inclusion(RO=M3) to R12( Month 15 =12 month post inclusion)). 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 26 Oct 2022.