CancerNCT03492073
Effectiveness of an Individual Mindfulness-based Intervention for Cancer Patients in a Advanced Stage of the Disease and Their Relatives
A study testing Emotional Supportive Mindfulness-based Program and Emotional Supportive Program in people with Cancer, run by Instituto de Investigación Hospital Universitario La Paz.
Trial summary
The importance of emotional regulation interventions in cancer patients and primary caregivers is clearly established, since it helps them manage their emotions. The aim of the study was to analyze the differential effect between two Emotional Support programs, one of them based on Mindfulness, and the other one… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Emotional Supportive Mindfulness-based Program and Emotional Supportive Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 14 Nov 2016to 20 Dec 2018
- 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
- Older than 18 years old.
- Being in treatment in one of the Oncology units at Hospital Universitario La Paz.
- Capable of a minimum level of performance that allows intervention.
- The doctor responsible of the patient considers that the program will help the cancer patient and that the patient is capable to participate on it.
- Capable of understanding and giving his or her written informed consent.
Who cannot join
- Intellectual disability or cognitive impairment or dementia.
- Insufficient knowledge of the language to understand and participate on the intervention program.
- Serious mental illness in acute state at the moment of the beginning of the intervention.
- Autolytic ideas at the moment of the assessment.
About this study
The importance of emotional regulation interventions in cancer patients and primary caregivers is clearly established, since it helps them manage their emotions.
The aim of the study was to analyze the differential effect between two Emotional Support programs, one of them based on Mindfulness, and the other one Emotional Support as usual, on advanced cancer patients (stage III \& IV) admitted to a Madrid Community Hospital La Paz and their relatives.
Read the detailed description
It is clearly demonstrated that Emotional Regulation interventions are very important in cancer patients in any stage of the disease.
Great emotional burden has also been described in case of main caregivers and other relatives of the patients.
Diagnosis, treatment and survival of cancer patients are related to a complex set of stressors that have their own effects on the results of the treatments: activity daily life changes, social impairment, role changes, thought about the possibility of a relapse and possibility of death…
It has been elucidated that psychological interventions, as cognitive therapy or other types of psychotherapy, may improve the psychosocial outcomes (for example, quality of life).
During the last years, many researches have assessed the effect of Mindfulness interventions on cancer patients. Mindfulness is defined as the intention of paying full attention, moment to moment, to your experiences, without judgement.
Regular Mindfulness practice cultivates an acceptance state, improves emotional regulation strategies, improves quality of life, reduces rumination thinking, anxiety and depression.
The general aim of the present investigation is studying the effect of an Emotional Supportive based-mindfulness Program versus an Emotional Supportive Program (without Mindfulness component). Both programs are offered to cancer patients in an advanced stage of disease, admitted in the oncology section of the Hospital Universitario La Paz, and their relatives.
The investigator's hypothesis are:
- Both programs will reduce emotional distress, decreasing from 4 to 5 points out of 10 on average on the Distress thermometer (DT).
- Both interventions will improve moderately the score on Quality of Life measures (EORTC QLQ-15-PAL), obtaining 10-20 more points than at the initial assessment.
- Both interventions will reduce the emotional burden of the main caregiver (ZARIT short-form), obtaining a score under 17 points, which indicates "no familiar giving-up".
- Emotional Supportive based-Mindfulness Program will improve the scores on Philadelphia Mindfulness Scale (PHLMS) and acceptance, more than the Emotional Supportive Program will do.
The investigators will conduct a Randomized Controlled Trial with two treatment arms in an advanced-cancer patients sample of patients under hospitalization at Hospital Universitario La Paz, Madrid.
After all recollection of data is done, the investigators will conduct statistic analysis in order to accept or refuse our hypothesis.
- Conditions
- Cancer
- Being tested
- Emotional Supportive Mindfulness-based Program, Emotional Supportive Program
- Keywords
- Mindfulness, Oncology, Cancer, Emotional distress, Quality of life
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Supportive Mindfulness-based ProgramBehavioural
Mindfulness training
Emotional Supportive ProgramBehavioural
Narrative-orientated therapy.
| Study group | Role | What they receive |
|---|---|---|
| Emotional Supportive Mindfulness-based Program | Experimental | The program is based on 15/20 minutes sessions of meditative practices in which can participate only the patients, only his/her caregiver, or both.
Number of sessions is an independent outcome, because it depends on the number of days of hospitalization. Receives: Behavioral: Emotional Supportive Mindfulness-based Program |
| Emotional Supportive Program | Active comparator | The program is based on 15/20 minutes sessions based on narrative therapy, in which the patient or his/her caregiver or both can talk about their emotions.
Number of sessions is an independent outcome, because it depends on the number of days of hospitalization. Receives: Behavioral: Emotional Supportive Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mindfulness
Philadelphia Mindfulness Scale (PHLMS). Attention to the present moment and Acceptance.
Measured: At day one of the intervention
Mindfulness
Philadelphia Mindfulness Scale (PHLMS). Attention to the present moment and Acceptance.
Measured: At the end of the six sessions(each session is every three days)
Secondary outcomes (8)
Quality of life.
Quality of life in advanced-cancer patients. (EORTC QLQ - C15-PAL).
Measured: At day one of the intervention
Caregiver emotional burden.
Zarit. Emotional burden of the main caregiver. Impact of caring, interpersonal relationship and self-efficacy expectations.
Measured: At day one of the intervention
Emotional distress
Distress thermometer (DT), scores from 1 to 10. Emotional distress.
Measured: At day one of the intervention
Daily life Performance
Karnofsky Performance Status. It gives a measure of the dependency level of the patients, and the level of support that the cancer patient needs.
Measured: At day one of the intervention
Number of sessions
number of sessions of emotional support intervention or mindfulness emotional support intervention
Measured: At the end of the six sessions(each session is every three days)
Quality of life.
Quality of life in advanced-cancer patients. (EORTC QLQ - C15-PAL).
Measured: At the end of the six sessions(each session is every three days)
Caregiver emotional burden.
Zarit. Emotional burden of the main caregiver. Impact of caring, interpersonal relationship and self-efficacy expectations.
Measured: At the end of the six sessions(each session is every three days)
Emotional distress
Distress thermometer (DT), scores from 1 to 10. Emotional distress.
Measured: At the end of the six sessions(each session is every three days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start14 Nov 2016
- Primary completion15 Dec 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beatriz Rodriguez Vega, Study chair, Hospital Universitario La Paz. Universidad Autónoma de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492073
- Sponsor's protocol ID
- 2
- Status last verified
- Dec 2017
- First submitted
- 4 Dec 2017
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fallowfield L, Jenkins V. Psychosocial/survivorship issues in breast cancer: are we doing better? J Natl Cancer Inst. 2014 Nov 27;107(1):335. doi: 10.1093/jnci/dju335. Print 2015 Jan.
PubMed 25432407Hewitt M, Breen N, Devesa S. Cancer prevalence and survivorship issues: analyses of the 1992 National Health Interview Survey. J Natl Cancer Inst. 1999 Sep 1;91(17):1480-6. doi: 10.1093/jnci/91.17.1480.
PubMed 10469749Alfano CM, Rowland JH. Recovery issues in cancer survivorship: a new challenge for supportive care. Cancer J. 2006 Sep-Oct;12(5):432-43. doi: 10.1097/00130404-200609000-00012.
PubMed 17034679Fors EA, Bertheussen GF, Thune I, Juvet LK, Elvsaas IK, Oldervoll L, Anker G, Falkmer U, Lundgren S, Leivseth G. Psychosocial interventions as part of breast cancer rehabilitation programs? Results from a systematic review. Psychooncology. 2011 Sep;20(9):909-18. doi: 10.1002/pon.1844. Epub 2010 Sep 6.
PubMed 20821803Lotfi-Jam K, Carey M, Jefford M, Schofield P, Charleson C, Aranda S. Nonpharmacologic strategies for managing common chemotherapy adverse effects: a systematic review. J Clin Oncol. 2008 Dec 1;26(34):5618-29. doi: 10.1200/JCO.2007.15.9053. Epub 2008 Nov 3.
PubMed 18981466Carlson LE. Mindfulness-based interventions for physical conditions: a narrative review evaluating levels of evidence. ISRN Psychiatry. 2012 Nov 14;2012:651583. doi: 10.5402/2012/651583. Print 2012.
PubMed 23762768Gil F, Grassi L, Travado L, Tomamichel M, Gonzalez JR; Southern European Psycho-Oncology Study Group. Use of distress and depression thermometers to measure psychosocial morbidity among southern European cancer patients. Support Care Cancer. 2005 Aug;13(8):600-6. doi: 10.1007/s00520-005-0780-0. Epub 2005 Mar 11.
PubMed 15761700Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.
PubMed 8433390Gort AM, March J, Gomez X, de Miguel M, Mazarico S, Balleste J. [Short Zarit scale in palliative care]. Med Clin (Barc). 2005 May 7;124(17):651-3. doi: 10.1157/13074742. Spanish.
PubMed 15882512Cardaciotto L, Herbert JD, Forman EM, Moitra E, Farrow V. The assessment of present-moment awareness and acceptance: the Philadelphia Mindfulness Scale. Assessment. 2008 Jun;15(2):204-23. doi: 10.1177/1073191107311467. Epub 2008 Jan 9.
PubMed 18187399
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Individual Mindfulness-based Intervention for Cancer Patients in a Advanced Stage of the Disease and Their Relatives
- ClinicalTrials.gov ID
- NCT03492073
- Acronym / sponsor ID
- 2
- Conditions
- Cancer
- Keywords
- Mindfulness, Oncology, Cancer, Emotional distress, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- 14 Nov 2016 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 10 Apr 2018 (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.
The importance of emotional regulation interventions in cancer patients and primary caregivers is clearly established, since it helps them manage their emotions.
The aim of the study was to analyze the differential effect between two Emotional Support programs, one of them based on Mindfulness, and the other one Emotional Support as usual, on advanced cancer patients (stage III \& IV) admitted to a Madrid Community Hospital La Paz and their relatives.
Detailed description
It is clearly demonstrated that Emotional Regulation interventions are very important in cancer patients in any stage of the disease.
Great emotional burden has also been described in case of main caregivers and other relatives of the patients.
Diagnosis, treatment and survival of cancer patients are related to a complex set of stressors that have their own effects on the results of the treatments: activity daily life changes, social impairment, role changes, thought about the possibility of a relapse and possibility of death…
It has been elucidated that psychological interventions, as cognitive therapy or other types of psychotherapy, may improve the psychosocial outcomes (for example, quality of life).
During the last years, many researches have assessed the effect of Mindfulness interventions on cancer patients. Mindfulness is defined as the intention of paying full attention, moment to moment, to your experiences, without judgement.
Regular Mindfulness practice cultivates an acceptance state, improves emotional regulation strategies, improves quality of life, reduces rumination thinking, anxiety and depression.
The general aim of the present investigation is studying the effect of an Emotional Supportive based-mindfulness Program versus an Emotional Supportive Program (without Mindfulness component). Both programs are offered to cancer patients in an advanced stage of disease, admitted in the oncology section of the Hospital Universitario La Paz, and their relatives.
The investigator's hypothesis are:
- Both programs will reduce emotional distress, decreasing from 4 to 5 points out of 10 on average on the Distress thermometer (DT).
- Both interventions will improve moderately the score on Quality of Life measures (EORTC QLQ-15-PAL), obtaining 10-20 more points than at the initial assessment.
- Both interventions will reduce the emotional burden of the main caregiver (ZARIT short-form), obtaining a score under 17 points, which indicates "no familiar giving-up".
- Emotional Supportive based-Mindfulness Program will improve the scores on Philadelphia Mindfulness Scale (PHLMS) and acceptance, more than the Emotional Supportive Program will do.
The investigators will conduct a Randomized Controlled Trial with two treatment arms in an advanced-cancer patients sample of patients under hospitalization at Hospital Universitario La Paz, Madrid.
After all recollection of data is done, the investigators will conduct statistic analysis in order to accept or refuse our hypothesis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emotional Supportive Mindfulness-based Program | Experimental | Behavioral: Emotional Supportive Mindfulness-based ProgramThe program is based on 15/20 minutes sessions of meditative practices in which can participate only the patients, only his/her caregiver, or both. Number of sessions is an independent outcome, because it depends on the number of days of hospitalization. |
| Emotional Supportive Program | Active comparator | Behavioral: Emotional Supportive ProgramThe program is based on 15/20 minutes sessions based on narrative therapy, in which the patient or his/her caregiver or both can talk about their emotions. Number of sessions is an independent outcome, because it depends on the number of days of hospitalization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Older than 18 years old.
- Being in treatment in one of the Oncology units at Hospital Universitario La Paz.
- Capable of a minimum level of performance that allows intervention.
- The doctor responsible of the patient considers that the program will help the cancer patient and that the patient is capable to participate on it.
- Capable of understanding and giving his or her written informed consent.
Key exclusion criteria (4 listed)
- Intellectual disability or cognitive impairment or dementia.
- Insufficient knowledge of the language to understand and participate on the intervention program.
- Serious mental illness in acute state at the moment of the beginning of the intervention.
- Autolytic ideas at the moment of the assessment.
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 |
|---|---|---|
| Emotional Supportive Mindfulness-based ProgramMindfulness training | Behavioural | Emotional Supportive Mindfulness-based Program |
| Emotional Supportive ProgramNarrative-orientated therapy. | Behavioural | Emotional Supportive Program |
Primary outcome
Mindfulness
Time frame: At day one of the intervention
Philadelphia Mindfulness Scale (PHLMS). Attention to the present moment and Acceptance.
Mindfulness
Time frame: At the end of the six sessions(each session is every three days)
Philadelphia Mindfulness Scale (PHLMS). Attention to the present moment and Acceptance.
8 secondary outcomes
Quality of life.
Time frame: At day one of the intervention
Caregiver emotional burden.
Time frame: At day one of the intervention
Emotional distress
Time frame: At day one of the intervention
Daily life Performance
Time frame: At day one of the intervention
Number of sessions
Time frame: At the end of the six sessions(each session is every three days)
Quality of life.
Time frame: At the end of the six sessions(each session is every three days)
Caregiver emotional burden.
Time frame: At the end of the six sessions(each session is every three days)
Emotional distress
Time frame: At the end of the six sessions(each session is every three days)
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 2019.
- Background: PubMed 25432407Fallowfield L, Jenkins V. Psychosocial/survivorship issues in breast cancer: are we doing better? J Natl Cancer Inst. 2014 Nov 27;107(1):335. doi: 10.1093/jnci/dju335. Print 2015 Jan.
- Background: PubMed 10469749Hewitt M, Breen N, Devesa S. Cancer prevalence and survivorship issues: analyses of the 1992 National Health Interview Survey. J Natl Cancer Inst. 1999 Sep 1;91(17):1480-6. doi: 10.1093/jnci/91.17.1480.
- Background: PubMed 17034679Alfano CM, Rowland JH. Recovery issues in cancer survivorship: a new challenge for supportive care. Cancer J. 2006 Sep-Oct;12(5):432-43. doi: 10.1097/00130404-200609000-00012.
- Background: PubMed 20821803Fors EA, Bertheussen GF, Thune I, Juvet LK, Elvsaas IK, Oldervoll L, Anker G, Falkmer U, Lundgren S, Leivseth G. Psychosocial interventions as part of breast cancer rehabilitation programs? Results from a systematic review. Psychooncology. 2011 Sep;20(9):909-18. doi: 10.1002/pon.1844. Epub 2010 Sep 6.
- Background: PubMed 18981466Lotfi-Jam K, Carey M, Jefford M, Schofield P, Charleson C, Aranda S. Nonpharmacologic strategies for managing common chemotherapy adverse effects: a systematic review. J Clin Oncol. 2008 Dec 1;26(34):5618-29. doi: 10.1200/JCO.2007.15.9053. Epub 2008 Nov 3.
- Background: PubMed 23762768Carlson LE. Mindfulness-based interventions for physical conditions: a narrative review evaluating levels of evidence. ISRN Psychiatry. 2012 Nov 14;2012:651583. doi: 10.5402/2012/651583. Print 2012.
- Background: PubMed 15761700Gil F, Grassi L, Travado L, Tomamichel M, Gonzalez JR; Southern European Psycho-Oncology Study Group. Use of distress and depression thermometers to measure psychosocial morbidity among southern European cancer patients. Support Care Cancer. 2005 Aug;13(8):600-6. doi: 10.1007/s00520-005-0780-0. Epub 2005 Mar 11.
- Background: PubMed 8433390Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.
- Background: PubMed 15882512Gort AM, March J, Gomez X, de Miguel M, Mazarico S, Balleste J. [Short Zarit scale in palliative care]. Med Clin (Barc). 2005 May 7;124(17):651-3. doi: 10.1157/13074742. Spanish.
- Background: PubMed 18187399Cardaciotto L, Herbert JD, Forman EM, Moitra E, Farrow V. The assessment of present-moment awareness and acceptance: the Philadelphia Mindfulness Scale. Assessment. 2008 Jun;15(2):204-23. doi: 10.1177/1073191107311467. Epub 2008 Jan 9.
- Individual participant dataSharing planned: Undecided
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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.
Beatriz Rodriguez Vega study chair
Hospital Universitario La Paz. Universidad Autónoma de Madrid
Questions about this trial
What is this clinical trial studying?
A study testing Emotional Supportive Mindfulness-based Program and Emotional Supportive Program in people with Cancer, run by Instituto de Investigación Hospital Universitario La Paz.
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 5 inclusion and 4 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 2019. 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?
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?
Mindfulness (time frame: At day one of the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03492073, which also lists 10 linked publications.
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 2019.