NCT05791747

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

March 21, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

March 14, 2023

Last Update Submit

March 28, 2023

Conditions

Keywords

cancer colorectalhypnoserepresentations

Outcome Measures

Primary Outcomes (1)

  • 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 ?

    30 minutes

Secondary Outcomes (2)

  • Barriers and levers to using hypnosis

    30 minutes

  • Intention to turn to hypnosis

    30 minutes

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men and women diagnosed with colorectal cancer, still in treatment or not.

You may qualify if:

  • Age ≥ 18 years
  • Having been diagnosed with colorectal cancer
  • Able to understand and read French

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université de Nîmes

Nîmes, Gard, 30000, France

Location

Related Publications (1)

  • 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

    BACKGROUND

MeSH Terms

Conditions

Colonic NeoplasmsImmobility Response, Tonic

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesBehavior, AnimalBehaviorMotor Activity

Central Study Contacts

Louise Baussard, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
OTHER
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 14, 2023

First Posted

March 30, 2023

Study Start

March 21, 2023

Primary Completion

May 31, 2023

Study Completion

June 30, 2023

Last Updated

March 30, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

The principal investigator shares with the co-investigator the research protocol, consent, data collected

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
From january 2023 to december 2023 (one year)
Access Criteria
professionnal computer only

Locations