Cancer ColorectalNCT05791747
Representations, Beliefs and Attitudes Towards Hypnosis in Patients Followed for Colorectal Cancer
An observational study of Cancer Colorectal and Hypnosis, Animal, run by University of Nimes at 1 site in France.
Trial summary
Over the past decade, changes in knowledge and attitudes toward complementary and alternative medicine have been occurring. One study shows that 21% of patients are turning to them. In contrast, hypnosis is among the least used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Colorectal, Hypnosis, Animal
- What is being tested?
- semi-structured interviews
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 21 Mar 2023to 30 Jun 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men and women diagnosed with colorectal cancer, still in treatment or not.
Who may be able to join
- Age ≥ 18 years
- Having been diagnosed with colorectal cancer
- Able to understand and read French
Who cannot join
- Patients who do not have a telephone or devices that allow remote interviewing
- Medical (neurological, psychiatric, etc.) or psychological conditions that do not allow participation in the study (completion of the consent form and coherent speech for the interview)
- Hearing impaired patient without hearing aids
- Patient under guardianship or court protection
Trial locations and contacts
1 site in 1 country.
About this study
Over the past decade, changes in knowledge and attitudes toward complementary and alternative medicine have been occurring. One study shows that 21% of patients are turning to them. In contrast, hypnosis is among the least used. While perceptions of alternative medicine are improving, there is still widespread skepticism about the beliefs of hypnosis and this may explain why patients are not turning to it. Although its use in oncology is no longer in question, and its efficacy in the management of side effects has been demonstrated, no recent qualitative study has been conducted to examine the representations of hypnosis among cancer patients. It therefore seems relevant to us today to know the evolution of the representations and attitudes of cancer patients towards hypnosis.
Read the detailed description
Cancer patients experience psychological difficulties during the disease, associated with treatment, and even in the post-treatment period. Among the most common, they mention emotional distress, significant fatigue, sleep disturbance, or pain. Several authors agree that there is a cluster of four core symptoms associated with the disease and its treatments, including fatigue, nausea/vomiting, depression and pain. These symptoms have a significant impact on daily activities, resulting in a decrease in quality of life.
Reducing the symptoms of cancer to the sole etiology of the disease or its treatments does not allow us to consider a management action. Indeed, patients with cancer face the diagnosis and follow a course of care that includes many medical therapies (surgery, chemotherapy, radiotherapy, etc.). Integrative medicine takes into account the need for these medical therapies by adding the importance of supportive care for patients. Specifically, the expected effects are to reduce the after-effects for people thanks to an offer of support care adapted to their needs and regularly evaluated, ensuring a better quality of life immediately and in the longer term, as well as by providing information that allows patients to make the most informed choices possible.
Physical activity, dietary monitoring, and psychosocial interventions remain the most common complementary therapies offered to patients to reduce treatment side effects. Among this wide choice, patients can find themselves lost. Over the past decade, changes in knowledge and attitudes toward complementary and alternative medicine have been occurring. For example, one study found that 21% of patients are turning to them, indicating a growing interest in this type of care.
While perceptions of alternative medicine are improving, there is still widespread skepticism about hypnosis. As a result, even though scientific research shows positive effects of this type of therapy, a 2006 study in Canada found that out of 15 breast cancer patients using psychosocial therapies, only 6% used hypnosis. Another study conducted in 2018 confirms these results: on a population of 212 patients with different cancers, it appears that hypnosis is the therapy least used and whose interest is lowest.
Few studies have been conducted to determine the reasons for this lack of interest or the beliefs that are associated with hypnosis. Existing research suggests that patients lack information about hypnosis and its effectiveness, may have ambivalent perceptions about it or be skeptical of its effectiveness, and that their beliefs may be influenced by the media. Specifically, one study point out that positive attitudes toward hypnosis are even associated with better hypnotic response. While its use in oncology is no longer in question, no recent qualitative study has been conducted questioning the representations of hypnosis with cancer patients. It therefore seems relevant to us today to know the evolution of the representations and attitudes of cancer patients towards hypnosis. To do this, and according to Leventhal's model of self-regulation, the information obtained by a patient, whether or not it is medically based, is integrated by the patient in order to provide a "lay" understanding of the subject in question. Activated representations may then be guided by the individual's current and prior awareness or by social messages from perceived significant others or authoritative sources and this impacts attitudes.
The aim of the study was to investigate psychosocial representations related to hypnosis in colorectal cancer patients and to assess the impact of these representations on the intention to use hypnosis.
- Conditions
- Cancer Colorectal, Hypnosis, Animal
- Being tested
- semi-structured interviews
- Keywords
- cancer colorectal, hypnose, representations
- Medical subject headings
- Colonic Neoplasms, Immobility Response, Tonic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semi-structured interviewsOther
This is an observational study Patients included in the study will conduct semi-structured interviews to discuss their knowledge and/or experience with supportive care, particularly hypnosis
What is being measured
The primary outcome is the main question the study is designed to answer.
social representations
The representations will be questioned in terms of identity, beliefs, consequences, temporality and controlability. Semi-structured interviews with qualitative analyses will be conducted to explore represenations in cancer patients. The five major questions as are follows : What is hypnosis/hypnotherapy for you ? What do you think about hypnosis ? If you were to turn to this technique, what would be your expectations ? At what point in your illness/treatment would hypnosis be most appropriate ? Do you think hypnosis can help you manage the symptoms of your illness or the side effects of treatment ?
Measured: 30 minutes
Secondary outcomes (2)
Barriers and levers to using hypnosis
Identify what constitutes obstacles and levers to the use of hypnosis in analysing answers made at questions above
Measured: 30 minutes
Intention to turn to hypnosis
What impacts intentions and attitudes towards hypnosis, semi-structured interviews will conclude with the following questions: - Do you intend to turn to this technique or refer a loved one ? What would make it easier for you to access hypnosis ?
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start21 Mar 2023 (estimated)
- Primary completion31 May 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer ColorectalStudies 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
- Ecologic or community
- Time perspective
- Other
- Enrolment
- 15 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Nimes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baussard Louise, University of Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791747
- Sponsor's protocol ID
- UNimes3
- Status last verified
- Mar 2023
- First submitted
- 14 Mar 2023
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The principal investigator shares with the co-investigator the research protocol, consent, data collected
Publications
Corbett, T., Groarke, A., Walsh, J. C., & McGuire, B. E. (2016). Cancer-related fatigue in post-treatment cancer survivors: Application of the common sense model of illness representations. BMC Cancer, 16(1), 919. https://doi.org/10.1186/s12885-016-2907-8 Curt, G. A., Breitbart, W., Cella, D., Groopman, J. E., Horning, S. J., Itri, L. M., Johnson, D. H., Miaskowski, C., Scherr, S. L., Portenoy, R. K., & Vogelzang, N. J. (2000). Impact of Cancer-Related Fatigue on the Lives of Patients: New Findings From the Fatigue Coalition. The Oncologist, 5(5), 353-360. https://doi.org/10.1634/theoncologist.5-5-353 Forlenza, M. J., Hall, P., Lichtenstein, P., Evengard, B., & Sullivan, P. F. (2005). Epidemiology of cancer-related fatigue in the Swedish twin registry. Cancer, 104(9), 2022-2031. Helyer, L. K., Chin, S., Chui, B. K., Fitzgerald, B., Verma, S., Rakovitch, E., Dranitsaris, G., & Clemons, M. (2006). The use of complementary and alternative medicines among patients with locally advanced breast cancer - a descriptive study. BMC Cancer, 6(1), 39. https://doi.org/10.1186/1471-2407-6-39 Henry, D. H., Viswanathan, H. N., Elkin, E. P., Traina, S., Wade, S., & Cella, D. (2008). Symptoms and treatment burden associated with cancer treatment: Results from a cross-sectional national survey in the U.S. Supportive Care in Cancer, 16(7), 791-801. https://doi.org/10.1007/s00520-007-0380-2 Hofman, M., Ryan, J. L., Figueroa-Moseley, C. D., Jean-Pierre, P., & Morrow, G. R. (2007). Cancer-Related Fatigue: The Scale of the Problem. The Oncologist, 12(S1), 4-10. https://doi.org/10.1634/theoncologist.12-S1-4 Lawrence, D. P. (2004). Evidence Report on the Occurrence, Assessment, and Treatment of Fatigue in Cancer Patients. Journal of the National Cancer Institute Monographs, 2004(32), 40-50. https://doi.org/10.1093/jncimonographs/lgh027 Leventhal, H., & Diefenbach, M. (1991). The Active Side of Illness Cognition. In J. A. Skelton & R. T. Croyle (Éds.), Mental Representation in Health and Illness (p. 247-272). Springer US. https://doi.org/10.1007/978-1-4613-9074-9_11 Lind, S. B., Jacobsen, H. B., Solbakken, O. A., & Reme, S. E. (2021). Clinical Hypnosis in Medical Care: A Mixed-Method Feasibility Study. Integrative Cancer Therapies, 20, 153473542110586. https://doi.org/10.1177/15347354211058678 Mendoza, M. E., Capafons, A., & Jensen, M. P. (2017). Hypnosis attitudes: Treatment effects and associations with symptoms in individuals with cancer. American Journal of Clinical Hypnosis, 60(1), 50-67. Miller, S. J., Schnur, J. B., Montgomery, G. H., & Jandorf, L. (2015). African-Americans and Latinos' Perceptions of Using Hypnosis to Alleviate Distress Before a Colonoscopy. NCCN. (2022). NCCN Clinical Practice Guidelines in Oncology-Cancer-Related Fatigue. NCCN.org. Qureshi, M., Zelinski, E., & Carlson, L. E. (2018). Cancer and Complementary Therapies: Current Trends in Survivors' Interest and Use. Integrative Cancer Therapies, 17(3), 844-853. https://doi.org/10.1177/1534735418762496
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Representations, Beliefs and Attitudes Towards Hypnosis in Patients Followed for Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05791747
- Acronym / sponsor ID
- UNimes3
- Conditions
- Cancer Colorectal, Hypnosis, Animal
- Keywords
- cancer colorectal, hypnose, representations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of NimesUniversity, hospital or other
- Study start
- 21 Mar 2023 (estimated)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 30 Mar 2023 (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.
Over the past decade, changes in knowledge and attitudes toward complementary and alternative medicine have been occurring. One study shows that 21% of patients are turning to them. In contrast, hypnosis is among the least used. While perceptions of alternative medicine are improving, there is still widespread skepticism about the beliefs of hypnosis and this may explain why patients are not turning to it. Although its use in oncology is no longer in question, and its efficacy in the management of side effects has been demonstrated, no recent qualitative study has been conducted to examine the representations of hypnosis among cancer patients. It therefore seems relevant to us today to know the evolution of the representations and attitudes of cancer patients towards hypnosis.
Detailed description
Cancer patients experience psychological difficulties during the disease, associated with treatment, and even in the post-treatment period. Among the most common, they mention emotional distress, significant fatigue, sleep disturbance, or pain. Several authors agree that there is a cluster of four core symptoms associated with the disease and its treatments, including fatigue, nausea/vomiting, depression and pain. These symptoms have a significant impact on daily activities, resulting in a decrease in quality of life.
Reducing the symptoms of cancer to the sole etiology of the disease or its treatments does not allow us to consider a management action. Indeed, patients with cancer face the diagnosis and follow a course of care that includes many medical therapies (surgery, chemotherapy, radiotherapy, etc.). Integrative medicine takes into account the need for these medical therapies by adding the importance of supportive care for patients. Specifically, the expected effects are to reduce the after-effects for people thanks to an offer of support care adapted to their needs and regularly evaluated, ensuring a better quality of life immediately and in the longer term, as well as by providing information that allows patients to make the most informed choices possible.
Physical activity, dietary monitoring, and psychosocial interventions remain the most common complementary therapies offered to patients to reduce treatment side effects. Among this wide choice, patients can find themselves lost. Over the past decade, changes in knowledge and attitudes toward complementary and alternative medicine have been occurring. For example, one study found that 21% of patients are turning to them, indicating a growing interest in this type of care.
While perceptions of alternative medicine are improving, there is still widespread skepticism about hypnosis. As a result, even though scientific research shows positive effects of this type of therapy, a 2006 study in Canada found that out of 15 breast cancer patients using psychosocial therapies, only 6% used hypnosis. Another study conducted in 2018 confirms these results: on a population of 212 patients with different cancers, it appears that hypnosis is the therapy least used and whose interest is lowest.
Few studies have been conducted to determine the reasons for this lack of interest or the beliefs that are associated with hypnosis. Existing research suggests that patients lack information about hypnosis and its effectiveness, may have ambivalent perceptions about it or be skeptical of its effectiveness, and that their beliefs may be influenced by the media. Specifically, one study point out that positive attitudes toward hypnosis are even associated with better hypnotic response. While its use in oncology is no longer in question, no recent qualitative study has been conducted questioning the representations of hypnosis with cancer patients. It therefore seems relevant to us today to know the evolution of the representations and attitudes of cancer patients towards hypnosis. To do this, and according to Leventhal's model of self-regulation, the information obtained by a patient, whether or not it is medically based, is integrated by the patient in order to provide a "lay" understanding of the subject in question. Activated representations may then be guided by the individual's current and prior awareness or by social messages from perceived significant others or authoritative sources and this impacts attitudes.
The aim of the study was to investigate psychosocial representations related to hypnosis in colorectal cancer patients and to assess the impact of these representations on the intention to use hypnosis.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Other
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women diagnosed with colorectal cancer, still in treatment or not.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Having been diagnosed with colorectal cancer
- Able to understand and read French
Key exclusion criteria (4 listed)
- Patients who do not have a telephone or devices that allow remote interviewing
- Medical (neurological, psychiatric, etc.) or psychological conditions that do not allow participation in the study (completion of the consent form and coherent speech for the interview)
- Hearing impaired patient without hearing aids
- Patient under guardianship or court protection
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 |
|---|---|---|
| semi-structured interviewsThis is an observational study Patients included in the study will conduct semi-structured interviews to discuss their knowledge and/or experience with supportive care, particularly hypnosis | Other | – |
Primary outcome
social representations
Time frame: 30 minutes
The representations will be questioned in terms of identity, beliefs, consequences, temporality and controlability. Semi-structured interviews with qualitative analyses will be conducted to explore represenations in cancer patients. The five major questions as are follows : What is hypnosis/hypnotherapy for you ? What do you think about hypnosis ? If you were to turn to this technique, what would be your expectations ? At what point in your illness/treatment would hypnosis be most appropriate ? Do you think hypnosis can help you manage the symptoms of your illness or the side effects of treatment ?
2 secondary outcomes
Barriers and levers to using hypnosis
Time frame: 30 minutes
Intention to turn to hypnosis
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- BackgroundCorbett, T., Groarke, A., Walsh, J. C., & McGuire, B. E. (2016). Cancer-related fatigue in post-treatment cancer survivors: Application of the common sense model of illness representations. BMC Cancer, 16(1), 919. https://doi.org/10.1186/s12885-016-2907-8 Curt, G. A., Breitbart, W., Cella, D., Groopman, J. E., Horning, S. J., Itri, L. M., Johnson, D. H., Miaskowski, C., Scherr, S. L., Portenoy, R. K., & Vogelzang, N. J. (2000). Impact of Cancer-Related Fatigue on the Lives of Patients: New Findings From the Fatigue Coalition. The Oncologist, 5(5), 353-360. https://doi.org/10.1634/theoncologist.5-5-353 Forlenza, M. J., Hall, P., Lichtenstein, P., Evengard, B., & Sullivan, P. F. (2005). Epidemiology of cancer-related fatigue in the Swedish twin registry. Cancer, 104(9), 2022-2031. Helyer, L. K., Chin, S., Chui, B. K., Fitzgerald, B., Verma, S., Rakovitch, E., Dranitsaris, G., & Clemons, M. (2006). The use of complementary and alternative medicines among patients with locally advanced breast cancer - a descriptive study. BMC Cancer, 6(1), 39. https://doi.org/10.1186/1471-2407-6-39 Henry, D. H., Viswanathan, H. N., Elkin, E. P., Traina, S., Wade, S., & Cella, D. (2008). Symptoms and treatment burden associated with cancer treatment: Results from a cross-sectional national survey in the U.S. Supportive Care in Cancer, 16(7), 791-801. https://doi.org/10.1007/s00520-007-0380-2 Hofman, M., Ryan, J. L., Figueroa-Moseley, C. D., Jean-Pierre, P., & Morrow, G. R. (2007). Cancer-Related Fatigue: The Scale of the Problem. The Oncologist, 12(S1), 4-10. https://doi.org/10.1634/theoncologist.12-S1-4 Lawrence, D. P. (2004). Evidence Report on the Occurrence, Assessment, and Treatment of Fatigue in Cancer Patients. Journal of the National Cancer Institute Monographs, 2004(32), 40-50. https://doi.org/10.1093/jncimonographs/lgh027 Leventhal, H., & Diefenbach, M. (1991). The Active Side of Illness Cognition. In J. A. Skelton & R. T. Croyle (Éds.), Mental Representation in Health and Illness (p. 247-272). Springer US. https://doi.org/10.1007/978-1-4613-9074-9_11 Lind, S. B., Jacobsen, H. B., Solbakken, O. A., & Reme, S. E. (2021). Clinical Hypnosis in Medical Care: A Mixed-Method Feasibility Study. Integrative Cancer Therapies, 20, 153473542110586. https://doi.org/10.1177/15347354211058678 Mendoza, M. E., Capafons, A., & Jensen, M. P. (2017). Hypnosis attitudes: Treatment effects and associations with symptoms in individuals with cancer. American Journal of Clinical Hypnosis, 60(1), 50-67. Miller, S. J., Schnur, J. B., Montgomery, G. H., & Jandorf, L. (2015). African-Americans and Latinos' Perceptions of Using Hypnosis to Alleviate Distress Before a Colonoscopy. NCCN. (2022). NCCN Clinical Practice Guidelines in Oncology-Cancer-Related Fatigue. NCCN.org. Qureshi, M., Zelinski, E., & Carlson, L. E. (2018). Cancer and Complementary Therapies: Current Trends in Survivors' Interest and Use. Integrative Cancer Therapies, 17(3), 844-853. https://doi.org/10.1177/1534735418762496
- Individual participant dataSharing planned: Yes. The principal investigator shares with the co-investigator the research protocol, consent, data collected
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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.
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 Colorectal and Hypnosis, Animal, run by University of Nimes at 1 site in France.
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 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: status not confirmed, as of the sponsor's last update on 30 Mar 2023. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Louise Baussard, PhD (0678675243, louise.baussard@unimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
social representations (time frame: 30 minutes). 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 NCT05791747, which also lists 1 linked publication.
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 30 Mar 2023.